Tag: Data

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Science

Asana BioSciences to present clinical data on oral ASN007, a novel ERK1/2 inhibitor, at the 32nd EORTC-NCI-AACR Symposium

LAWRENCEVILLE, N.J.–(BUSINESS WIRE)–Asana BioSciences, a clinical stage biopharmaceutical company, announced that ASN007 clinical data on safety, efficacy and pharmacokinetics in solid tumor patients will be presented at the 32nd EORTC-NCI-AACR Virtual Symposium on Molecular Targets and Cancer Therapeutics (ENA 2020) to be held on October 24-25, 2020. Details of this invited presentation are as follows:

Title: Targeting ERK with novel inhibitor ASN007

Presenter: Filip Janku, MD, PhD. Associate Professor, Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center

Session Title: New Drugs on the Horizon

Date and Time: Sunday, October 25, 2020 at 21:00 CET/4:00 PM US ET

About ASN007

ASN007 is an orally bioavailable, potent and selective inhibitor of ERK1/2 designed to potently inhibit the RAS/RAF/MEK/ERK (MAPK) signaling pathway. ASN007 shows potent preclinical activity in KRAS-driven models, irrespective of subtype mutation, and in BRAF mutant models, including RAF/MEK inhibitor-resistant melanoma. ASN007 has a long target residence time and shows activity in preclinical models using an intermittent dosing schedule. ASN007 has been evaluated in patients with advanced solid tumors, including BRAF- and KRAS-mutant cancers (NCT03415126). The maximum tolerated dose levels (MTD) and recommended Phase 2 dose (RP2D) has been determined. Clinical development of ASN007 is ongoing and aims to address the medical need across a range of cancer types defined by RAS/RAF/MEK driven mutations as monotherapy and in combinations.

About Asana BioSciences, LLC

Asana BioSciences is a clinical stage biopharmaceutical company based in Lawrenceville, NJ. Asana is focused on discovery and development of novel targeted investigational medicines in immunology/inflammation and oncology.

Additional oncology pipeline candidates in Asana’s portfolio include:

ASN003 is a dual-selective inhibitor of BRAF and PI3 kinases. Dual targeting of RAF and PI3K pathways has the potential to overcome and/or delay acquired resistance to selective RAF inhibitors. ASN003 is in Phase 1 development in patients with BRAFV600 mutated metastatic melanoma, metastatic colorectal and advanced non-small cell lung cancer (NCT02961283).

ASN004 is an antibody drug conjugate that targets the 5T4 oncofetal antigen, which is expressed in a wide range of malignant tumors but has very limited expression in normal tissues. ASN004 demonstrates robust and durable antitumor activity after single administration in multiple human tumor xenograft models. A First-in-Human Phase 1 trial is being planned.

Asana’s lead asset in the immunology/dermatology area is gusacitinib (ASN002), an oral potent inhibitor of the Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK). This potential best-in-class JAK/SYK inhibitor has been studied in over 400 patients with moderate-to-severe atopic dermatitis (AD) (NCT03531957) and chronic hand eczema (NCT03728504) in two separate Phase 2b studies, with good safety/tolerability and efficacy.

Asana’s second immunology/dermatology asset ASN008 is a novel, topical Na+-channel blocker with high functional selectivity for itch and pain sensing neurons without affecting motor neurons. In a Phase 1b study in atopic dermatitis patients, topical application of ASN008 showed rapid onset of pruritus relief after a single application, which lasted between 8-12 hours, and no tachyphylaxis to this response was observed after 2 weeks of daily application (NCT03798561). ASN008 also has potential for the treatment of pain, urologic and other chronic conditions.

Asana is also developing ASN009, a selective antagonist of the purinergic P2X3 ion channel that is activated by extracellular ATP and involved in various pain, urological and respiratory disease conditions. Preclinical proof-of-concept has been demonstrated with ASN009 in a cough model. ASN009 is currently in preclinical development.

www.asanabiosciences.com

Contacts

David Zammit

Asana BioSciences

997 Lenox Drive, Suite 220

Princeton Pike Corporate Center

Lawrenceville, NJ 08648

Ph: 908-698-0486

David.Zammit@asanabio.com

Categories
Healthcare

Merck to present new data from the company’s diverse HIV portfolio and pipeline at HIV Glasgow 2020

Researchers Will Present Week 96 Data from Phase 2b Study Evaluating Islatravir in Combination with Doravirine, and Phase 1/1b Data for MK-8507, an Investigational NNRTI for the Treatment of HIV-1 Infection

Company Plans to Advance MK-8507 into Phase 2 Evaluating its Efficacy and Safety in Combination with Islatravir as a Once-Weekly Oral Regimen

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that nine abstracts from the company’s diverse HIV portfolio and pipeline will be presented at the 2020 International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2020, October 5-8, 2020). During the congress, researchers will present new data from Merck’s HIV development program, including 96-week results from efficacy and safety analyses from the Phase 2b study of islatravir (Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI)) in combination with doravirine (PIFELTRO™) in adults with HIV-1 infection who had not previously received antiretroviral treatment. Additionally, Merck will share results from Phase 1/1b studies of MK-8507, an investigational oral non-nucleoside reverse transcriptase inhibitor (NNRTI) under development for once-weekly oral administration in combination with islatravir. These and other data, including 144-week results from the Phase 3 DRIVE-SHIFT study evaluating the effect of switching from a stable antiretroviral therapy (ART) regimen to DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate), will be shared via oral and poster presentations during the virtual congress.

“Merck remains at the forefront of research to develop new medicines for people living with HIV. The new data we will present at HIV Glasgow 2020 from our HIV research programs – for doravirine, islatravir, and now MK-8507 – demonstrate our sustained innovation and unwavering commitment to help address the global burden of HIV,” said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. “Our plans to evaluate MK-8507 as a potential partner with islatravir, as well as the ongoing clinical trials of islatravir and doravirine, illustrate the diversity of candidates in our HIV pipeline and our quest to transform the way HIV is treated.”

Select abstracts in the HIV Glasgow 2020 program include:

  • Islatravir in combination with doravirine maintains HIV-1 viral suppression through 96 weeks. Oral Presentation O415. Abstract 4913173. J.M. Molina et al.
  • Renal safety through 96 weeks from a phase 2 trial (P011) of islatravir and doravirine in treatment-naïve adults with HIV-1. Poster Presentation P048. Abstract 4919993. F. Post et al.
  • Analysis of protocol defined virologic failure through 96 weeks from a phase 2 trial (P011) of islatravir and doravirine in treatment-naïve adults with HIV-1. Poster Presentation P047. Abstract 4913025. C. Orkin et al.
  • Long-term treatment safety and efficacy following switch to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF): Week 144 results of the DRIVE-SHIFT trial. Poster Presentation P037. Abstract 4922614. P. Kumar et al.
  • Single doses of MK-8507, a novel HIV-1 NNRTI, reduced HIV viral load for at least a week. Oral Presentation O416. W. Ankrom et al.
  • Safety, tolerability and pharmacokinetics following single- and multiple-dose administration of the novel NNRTI MK-8507 with a midazolam interaction arm. Poster Presentation P099. Abstract 4913210. W. Ankrom et al.
  • Islatravir Selects for HIV-1 Variants in MT4-GFP cells that Profoundly Reduce Replicative Capacity in PBMCs and Reduce Susceptibility to Islatravir but not NRTIs. Poster Presentation P120. Abstract 4920686. T. Diamond et al.

For more information, including details around the virtual programming, please visit the HIV Glasgow 2020 website.

Indications and Usage for PIFELTRO and DELSTRIGO

PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.

Selected Safety Information about PIFELTRO and DELSTRIGO

Warning: Posttreatment Acute Exacerbation of Hepatitis B (HBV)

All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted.

PIFELTRO and DELSTRIGO are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO.

DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min.

In clinical trials in HIV-1 infected adults, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF.

Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

Because DELSTRIGO is a complete regimen, co-administration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

Co-administration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended.

If DELSTRIGO is co-administered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO.

If PIFELTRO is co-administered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart).

Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions.

Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min.

The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%).

By Week 96 in DRIVE-FORWARD, 2% of adult subjects in the PIFELTRO group and 3% in the DRV+r group had adverse events leading to discontinuation of study medication.

By Week 96 in DRIVE-AHEAD, 3% of adult subjects in the DELSTRIGO group and 7% in the EFV/FTC/TDF group had adverse events leading to discontinuation of study medication.

In DRIVE-FORWARD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-SHIFT, mean changes from baseline at Week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated.

In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult subjects in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium.

The safety of DELSTRIGO in virologically-suppressed adults was based on Week 48 data from subjects in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult subjects was similar to that in subjects with no ARV treatment history.

Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of subjects in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of subjects had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of subjects in the delayed switch group experienced ALT and AST elevations of greater than 1.25 X ULN through 24 weeks on their baseline regimen.

There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO or DELSTRIGO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Mothers infected with HIV-1 should be instructed not to breastfeed if they are receiving PIFELTRO or DELSTRIGO due to the potential for HIV-1 transmission.

About Islatravir (MK-8591)

Islatravir (formerly MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, as well as for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single investigational agent, across a variety of formulations.

Our Commitment to HIV

For more than 30 years, Merck has been committed to scientific research and discovery in HIV, and we continue to be driven by the conviction that more medical advances are still to come. Our focus is on pursuing research that addresses unmet medical needs and helps people living with HIV and their communities. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that hinder continued progress.

Our Commitment to Infectious Diseases

For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf; and Patient Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf

Please see Prescribing Information for DELSTRIGO (doravirine/3TC/TDF) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf and Patient Information for DELSTRIGO (doravirine/3TC/TDF) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.pdf

Contacts

Media:

Pamela Eisele

(267) 305-3558

Sarra S. Herzog

(201) 669-657

Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

October 1, 2020

Categories
Business

Stealthbits continues to modernize and simplify traditional PAM functions in SbPAM version 3.0

Next Generation PAM Solution Significantly Lowers Cost of Ownership, Improves Ease of Use

HAWTHORNE, N.J.–(BUSINESS WIRE)–Stealthbits Technologies, a cybersecurity software company focused on protecting an organization’s sensitive data and the credentials attackers use to steal that data, today announced the release of Stealthbits Privileged Activity Manager® (SbPAM) 3.0, their third-generation solution designed with a modernized and simplified approach to Privileged Access Management (PAM).

PAM software has been around for nearly 20 years. Many of today’s popular solutions have been built on decade old platforms, layering new functionality in increasingly complex ways. Organizations often realize the importance of properly managing and securing privilege access, but are locked into antiquated solutions with complex and expensive methods.

SbPAM 3.0 continues Stealthbits’ commitment to renovate and simplify PAM. The company approaches PAM from the perspective of the abundance of privileged activities that need to be performed, not a group of privileged admins needing accounts. SbPAM 3.0, available for download beginning October 6, 2020, simplifies PAM and offers a new take on traditional capabilities like Credential Management, Service Account Management and Session Monitoring:

Credential Management – Whether you have 10 or 100,000 systems, built-in accounts can be immediately and easily brought under management via a single click of a button. Through policy inheritance at the platform level, organizations no longer need to define and set accounts on a per-device basis.

Real-Time Service Account Management – To save time, SbPAM produces a list of dependent services and scheduled tasks for each Service Account, along with real-time updates on change status. If errors occur, users are immediately alerted and given the option to pause and roll-back any changes. No more waiting for service failures to understand the status.

Enhanced Live Session Monitoring – In addition to providing live session monitoring capabilities, SbPAM 3.0 also offers the ability to selectively lock and terminate sessions at three different levels, including current session, future sessions on the same resource, or globally, to prevent users from performing any unsanctioned activity.

“The PAM market is ripe for innovation and Stealthbits is continuing to redefine what customers should expect from their Privileged Access Management solution,” said Stealthbits CEO Jim Barkdoll. “Securing privileged access is crucial for security teams in this age of continual cyber-attacks, especially now that so many employees work from home. Stealthbits’ third-generation PAM delivers on our commitment to fill gaps in current PAM technologies, like lowering the cost of ownership, simplifying usability, and providing greater flexibility and choice.”

Stealthbits’ purpose-built solution offers a differentiated approach from more traditional PAM vendors:

Reduce Standing Privileges and Attack Surface – Traditional PAM vendors add to the standing privilege problem, creating multiple privileged accounts per single administrator. Stealthbits focuses on the privileged activity, not the account. Using approaches like ephemeral accounts and activity tokens, SbPAM creates and provisions temporary access to perform a task, then removes and destroys it when task is completed. Access and the account itself ONLY exist while the task is being performed.

Password Vault Options – Nearly all PAM vendors require use of THEIR vault, making switching difficult and expensive. Stealthbits provides vault options: Bring Your Own Vault™ (we’ll integrate with any 3rd party), use ours, or perform vault-less operations… your choice.

Built-in access certification / attestation – All organizations need to check/certify access rights and privileged access is most critical. No one likes big spreadsheets that get passed around with endless rows of system access for review. Stealthbits makes approving your most critical access convenient and less time consuming by enabling electronic workflow and approval directly from the console.

Reduced Total Cost of Ownership – Most PAM vendors charge for high availability, additional databases, proxies, and more including multiple add-on modules. The result is a solution that costs significantly more than anticipated and switching costs prohibit a change. Stealthbits includes everything… no expansion costs for databases, appliances, networking, and add-on modules.

“We looked at several PAM products, many having been around for a number of years, but they often fall very short when it comes to admins and the accounts they use to get access to systems,” admits Craig Larsen, IS Administrator, Eastern Carver County Schools. “What was so intriguing about SbPAM is that we can truly manage the access to our systems to the level of least privilege. The concept of temporary elevation, or just-in-time access, make so much sense as the admin is granted access on the fly and access is removed when no longer needed.”

About Stealthbits Technologies

IDENTIFY THREATS. SECURE DATA. REDUCE RISK.

Stealthbits Technologies, Inc. is a customer-driven cybersecurity software company focused on protecting an organization’s sensitive data and the credentials attackers use to steal that data. By removing inappropriate data access, enforcing security policy, and detecting advanced threats, our highly innovative and infinitely flexible platform delivers real protection that reduces security risk, fulfills compliance requirements, and decreases operational expense.

For more information, visit www.stealthbits.com, email sales@stealthbits.com, or call +1-201-447-9300.

The Stealthbits logo and all other Stealthbits product or service names and slogans are registered trademarks or trademarks of Stealthbits Technologies, Inc. All other trademarks and registered trademarks are property of their respective owners.

Contacts

Media Contact:

Dan Chmielewski

Madison Alexander PR

Office: +1 714-832-8716

Mobile: +1 949-231-2965

dchm@madisonalexanderpr.com

, , {item content}, September 29, 2020

Categories
Healthcare

Merck presents promising new data for three investigational medicines from diverse and expansive oncology pipeline at ESMO Virtual Congress 2020

Researchers Share New Data for Vibostolimab (MK-7684), Merck’s Anti-TIGIT Therapy, as Monotherapy and in Combination With KEYTRUDA® (pembrolizumab); First-Time Results for First-in-Class MK-4830 (Anti-ILT4 Therapy); and Late-Breaking Data for MK-6482 (HIF-2α Inhibitor)

Merck to Initiate Phase 3 Study of Vibostolimab in Non-Small Cell Lung Cancer in First Half of 2021

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of new data for three investigational medicines in Merck’s diverse and expansive oncology pipeline: vibostolimab (MK-7684), an anti-TIGIT therapy; MK-4830, a first-in-class anti-ILT4 therapy; and MK-6482, an oral HIF-2α inhibitor. Data from cohort expansions of a Phase 1b trial evaluating vibostolimab, as monotherapy and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with metastatic non-small cell lung cancer (NSCLC; Abstract #1410P and Abstract #1400P), and first-time Phase 1 data for MK-4830 in patients with advanced solid tumors (Abstract #524O), demonstrated acceptable safety profiles for these two investigational medicines and early signals of anti-tumor activity. Additionally, late-breaking Phase 2 data for MK-6482 showed anti-tumor responses in von Hippel-Lindau (VHL) disease patients with clear cell renal cell carcinoma (RCC) and other tumors (Abstract #LBA26).

“The new data for these three investigational medicines are encouraging and highlight continued momentum in our rapidly expanding oncology pipeline,” Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories. “Over the past five years, KEYTRUDA has become foundational in the treatment of certain advanced cancers. Our broad oncology portfolio and promising pipeline candidates are a testament to our commitment to bring forward innovative new medicines to address unmet medical needs in cancer care.”

Vibostolimab (Anti-TIGIT Therapy): Early Findings in Metastatic NSCLC (Abstract #1410P and Abstract #1400P)

Vibostolimab in combination with KEYTRUDA was evaluated in patients with metastatic NSCLC who had not previously received anti–PD-1/PD-L1 therapy, but the majority of whom had received >1 prior lines of therapy (73%, n=30/41) in Abstract #1410P. In Part B of the first-in-human, open-label, Phase 1 trial (NCT02964013) all patients received vibostolimab (200 or 210 mg) in combination with KEYTRUDA (200 mg) on Day 1 of each three-week cycle for up to 35 cycles. The primary endpoints of the study were safety and tolerability. Secondary endpoints included objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) based on investigator review per RECIST v1.1. In this anti-PD-1/PD-L1 naïve study, vibostolimab in combination with KEYTRUDA had a manageable safety profile and demonstrated promising anti-tumor activity. Treatment-related adverse events (TRAEs) with vibostolimab in combination with KEYTRUDA occurred in 34 patients (83%). The most frequent TRAEs (≥20%) were pruritus (34%), hypoalbuminemia (29%) and pyrexia (20%). Grade 3-5 TRAEs occurred in six patients (15%). No deaths due to TRAEs occurred. Across all patients enrolled, treatment with vibostolimab in combination with KEYTRUDA demonstrated an ORR of 29% (95% CI, 16-46) and median PFS was 5.4 months (95% CI, 2.1-8.2). The median DOR was not reached (range, 4 to 17+ months). Among patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) (n=13), the ORR was 46% (95% CI, 19-75) and median PFS was 8.4 months (95% CI, 3.9-10.2). Among patients whose tumors express PD-L1 (TPS <1%) (n=12), the ORR was 25% (95% CI, 6-57), and median PFS was 4.1 months (95% CI, 1.9-not reached [NR]). PD-L1 status was not available for 16 patients. Median follow-up for the study was 11 months (range, 7 to 18).

Additional data from a separate cohort of the same Phase 1b trial evaluated vibostolimab as monotherapy (n=41) and in combination with KEYTRUDA (n=38) in patients with metastatic NSCLC whose disease progressed on prior anti-PD-1/PD-L1 therapy (Abstract #1400P). In the study, 78% of patients had received >2 lines of prior therapy. In the study, patients received vibostolimab monotherapy (200 or 210 mg) or vibostolimab (200 or 210 mg) in combination with KEYTRUDA (200 mg) on Day 1 of each three-week cycle for up to 35 cycles. The primary endpoints of the study were safety and tolerability. Secondary endpoints included ORR and DOR. Vibostolimab as monotherapy or in combination with KEYTRUDA had a manageable safety profile and demonstrated modest anti-tumor activity in patients whose disease was refractory to PD-1/PD-L1 inhibition, most of whom had previously received several lines of therapy for advanced disease prior to enrollment. Grade 3-5 TRAEs occurred in 15% of patients receiving vibostolimab monotherapy and 13% of patients receiving vibostolimab in combination with KEYTRUDA. The most common TRAEs (≥10% in either arm) were pruritus, fatigue, rash, arthralgia and decreased appetite. One patient died due to treatment-related pneumonitis in the vibostolimab and KEYTRUDA combination arm. The ORR was 7% (95% CI, 2-20) with vibostolimab monotherapy and 5% (95% CI, <1-18) with vibostolimab in combination with KEYTRUDA. The median DOR was 9 months (range, 9 to 9) with vibostolimab monotherapy and 13 months (range, 4+ to 13) with vibostolimab in combination with KEYTRUDA.

Data from these cohort expansion studies are encouraging and support the continued development of vibostolimab, which is being evaluated alone and in combination with KEYTRUDA across multiple solid tumors, including NSCLC and melanoma. In the ongoing Phase 2 KEYNOTE-U01 umbrella study (NCT04165798), substudy KEYNOTE-01A (NCT04165070) is evaluating vibostolimab in combination with KEYTRUDA plus chemotherapy for the first-line treatment of patients with advanced NSCLC who had not received prior treatment with an anti-PD-1/PD-L1. Merck plans to initiate a Phase 3 study of vibostolimab in NSCLC in the first half of 2021. Ongoing trials in melanoma include the Phase 1/2 KEYNOTE-U02 umbrella study comprised of three substudies evaluating vibostolimab in combination with KEYTRUDA across treatment settings (substudy 02A: NCT04305041, substudy 02B: NCT04305054 and substudy 02C: NCT04303169).

MK-4830 (Anti-ILT4 Therapy): Initial Results in Advanced Solid Tumors (Abstract #524O)

In this first-in-human Phase 1, open-label, multi-arm, multi-center, dose escalation study (NCT03564691), MK-4830, Merck’s first-in-class anti-ILT4 therapy, was evaluated as monotherapy (n=50) and in combination with KEYTRUDA (n=34) in patients with advanced solid tumors. The majority of patients enrolled in the study (51%) had received three or more prior lines of therapy. MK-4830 was administered intravenously at escalating doses every three weeks alone or in combination with KEYTRUDA (200 mg every three weeks). The primary endpoints of the dose escalation part of the study were safety and tolerability; Pharmacokinetics was a secondary endpoint, and exploratory objectives included ORR per RECIST v1.1, evaluation of receptor occupancy and immune correlates of response in blood and tumor.

Findings showed that MK-4830 as monotherapy and in combination with KEYTRUDA had an acceptable safety profile and demonstrated dose-related evidence of target engagement in patients with advanced solid tumors. No dose-limiting toxicities were observed; the maximum-tolerated dose was not reached. Any-grade adverse events were consistent with those associated with KEYTRUDA. Treatment-related AEs occurred in 54% (n=28/52) of patients who received MK-4830 in combination with KEYTRUDA and 48% (n=24/50) of patients who received MK-4830 monotherapy; the majority were Grade 1 and 2. Preliminary efficacy data showed an ORR of 24% (n=8/34) in patients who received MK-4830 in combination with KEYTRUDA. All responses occurred in heavily pretreated patients, including five who had progressed on prior anti-PD-1 therapy (n=5/11). Some patients received more than one year of treatment, and treatment is ongoing in several patients.

These early data support the continued development of MK-4830 in combination with KEYTRUDA in patients with advanced solid tumors. Expansion cohorts of this study include pancreatic adenocarcinoma, glioblastoma, head and neck squamous cell carcinoma (recurrent or metastatic; PD-L1 positive), advanced NSCLC and gastric cancer.

MK-6482 (HIF-2α Inhibitor): Results in VHL-Associated RCC and Non-RCC Tumors (Abstract #LBA26)

In this Phase 2, open-label, single-arm trial, MK-6482 was evaluated for the treatment of VHL-associated RCC (NCT03401788). New data include findings for MK-6482 in VHL patients with non-RCC tumors and updated data in VHL patients with RCC. First-time data in VHL-associated RCC were presented in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. The study enrolled adult patients with a pathogenic germline VHL variation, measurable localized or non-metastatic RCC, no prior systemic anti-cancer therapy, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Patients received MK-6482 120 mg orally once daily until disease progression, unacceptable toxicity, or investigator’s or patient’s decision to withdraw. The primary endpoint was ORR of VHL-associated RCC tumors per RECIST v1.1 by independent radiology review. Secondary endpoints included DOR, time to response, PFS, efficacy in non-RCC tumors, and safety and tolerability.

Promising clinical activity continues to be observed with MK-6482 in treatment-naïve patients with VHL-associated RCC. Among 61 patients, results showed a confirmed ORR of 36.1% (95% CI, 24.2-49.4); all responses were partial responses, and 38% of patients had stable disease. The median time to response was 31.1 weeks (range, 11.9 to 62.3), and median DOR was not yet reached (range, 11.9 to 62.3 weeks). Additionally, 91.8% (n=56) of patients had a decrease in size of target lesions. Median PFS has not been reached, and the PFS rate at 52 weeks was 98.3%. Median duration of treatment was 68.7 weeks (range, 18.3 to 104.7), and 91.8% of patients were still on therapy after a minimum follow-up of 60 weeks.

In patients with non-RCC tumors, results in those with pancreatic lesions (n=61) showed a confirmed ORR of 63.9% (95% CI, 50.6-75.8), with four complete responses and 35 partial responses. Additionally, 34.4% had stable disease. In those with central nervous system (CNS) hemangioblastoma (n=43), results showed a confirmed ORR of 30.2% (95% CI, 17.2-46.1), with five complete responses and eight partial responses. Additionally, 65.1% had stable disease. In patients with retinal lesions (n=16), 93.8% of patients had improved or stable response.

In this Phase 2 study, TRAEs occurred in 98.4% of patients, and there were no Grade 4-5 TRAEs. The most common all-cause adverse events (≥20%) were anemia (90.2%), fatigue (60.7%), headache (37.7%), dizziness (36.1%) and nausea (31.1%). Grade 3 all-cause adverse events included anemia (6.6%), fatigue (4.9%) and dyspnea (1.6%). One patient discontinued treatment due to a TRAE (Grade 1 dizziness).

As announced, data spanning more than 15 types of cancer will be presented from Merck’s broad oncology portfolio and investigational pipeline at the congress. A compendium of presentations and posters of Merck-led studies is available here. Follow Merck on Twitter via @Merck and keep up to date with ESMO news and updates by using the hashtag #ESMO20.

About Vibostolimab

Vibostolimab is an anti-TIGIT therapy discovered and developed by Merck. Vibostolimab binds to TIGIT and blocks the interaction between TIGIT and its ligands (CD112 and CD155), thereby activating T lymphocytes which help to destroy tumor cells. The effect of combining KEYTRUDA with vibostolimab – blocking both the TIGIT and PD-1 pathways simultaneously – is currently being evaluated across multiple solid tumors, including NSCLC and melanoma.

About MK-4830

MK-4830 is a novel antibody directed against the inhibitory immune checkpoint receptor immunoglobulin-like transcript 4 (ILT4). Unlike current T cell-targeted antibodies (e.g., anti-PD1, anti-CTLA-4), anti-ILT4 is believed to attenuate immunosuppression imposed by tolerogenic myeloid cells in the tumor microenvironment. MK-4830 is currently being evaluated alone and in combination with KEYTRUDA across multiple solid tumors as part of ongoing Phase 1 and 2 trials.

About MK-6482

MK-6482 is an investigational, novel, potent, selective, oral HIF-2α inhibitor that is currently being evaluated in a Phase 3 trial in advanced RCC (NCT04195750), a Phase 2 trial in VHL-associated RCC (NCT03401788), and a Phase 1/2 dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738). Proteins known as hypoxia-inducible factors, including HIF-2α, can accumulate in patients when VHL, a tumor-suppressor protein, is inactivated. The accumulation of HIF-2α can lead to the formation of both benign and malignant tumors. This inactivation of VHL has been observed in more than 90% of RCC tumors. Research into VHL biology that led to the discovery of HIF-2α was awarded the Nobel Prize in Physiology or Medicine in 2019.

About KEYTRUDA® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA® (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

  • solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
  • colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Contacts

Media Contacts:

Pamela Eisele

(267) 305-3558

Justine Moore

(908) 740-6449

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

Read full story here

Categories
For Edit

Trump scorns his own scientists over virus data

A public scolding of the C.D.C. chief was only the latest but perhaps the starkest instance when the president has rejected not just the policy advice of his public health officials but the facts and information that they provided.

 

— NYT: Peter Baker

Categories
Local News

Dodge Momentum Index inches up in August

HAMILTON, N.J.–(BUSINESS WIRE)–The Dodge Momentum Index increased 1.8% in August to 126.5 (2000=1000) from the revised July reading of 124.2. The Momentum Index, issued by Dodge Data & Analytics, is a monthly measure of the first (or initial) report for nonresidential building projects in planning, which have been shown to lead construction spending for nonresidential buildings by a full year. In August, the commercial component rose 3.3%, while the institutional component moved 1.2% lower.


The August increase in the overall Momentum Index is the second consecutive rise and a further sign that the construction sector continues to post a modest recovery following the large declines in April and June. This recovery, though, is uneven. The commercial component has risen 9% from its June low and is just 13% below its 2018 peak fueled by increased planning activity for warehouse and office projects. The institutional component, however, has declined for five consecutive months and has yet to hit bottom. The institutional component is now 34% below its recent peak. The public side of the building market is suffering as state and local government revenues have declined, creating budget cuts across the country. This has led to a significant pullback in education projects entering planning, placing substantial downward pressure on the institutional component of the Momentum Index.

In August, 11 projects each with a value of $100 million or more entered planning. The leading commercial projects were a $262 million UPS distribution facility in Mebane NC and a $200 million Amazon distribution center (Project Star) in San Antonio TX. The leading institutional projects were the $150 million BayCare South Florida Baptist Hospital in Plant City FL and the $125 million second phase of the Veterans Memorial Arena in Binghamton NY.

About Dodge Data & Analytics: Dodge Data & Analytics is North America’s leading provider of commercial construction project data, market forecasting & analytics services and workflow integration solutions for the construction industry. Building product manufacturers, architects, engineers, contractors, and service providers leverage Dodge to identify and pursue unseen growth opportunities that help them grow their business. On a local, regional or national level, Dodge empowers its customers to better understand their markets, uncover key relationships, size growth opportunities, and pursue specific sales opportunities with success. The company’s construction project information is the most comprehensive and verified in the industry. Dodge is leveraging its more than 125-year-old legacy of continuous innovation to help the industry meet the building challenges of the future. Learn more at www.construction.com.

Contacts

Media Contact: Nicole Sullivan | AFFECT Public Relations & Social Media | +1-212-398-9680,

nsullivan@affectstrategies.com

Categories
Business

Majesco enters into amended agreement to be acquired by Thoma Bravo

Majesco shareholders to receive $16.00 in cash per share

Transaction provides a significant cash premium to Majesco shareholders

Transaction Expected to Close by the End of 2020

MORRISTOWN, N.J.–(BUSINESS WIRE)–Majesco (NASDAQ: MJCO), a global leader of cloud insurance software solutions for insurance business transformation, today announced that it has signed an amended definitive agreement to be acquired by Thoma Bravo, L.P., a leading private equity firm focused on the software and technology-enabled services sectors, in a transaction valuing the company at $729 million. Following the closing of the transaction, Majesco will operate as a privately held company.

Under the amendment, Thoma Bravo will acquire all of Majesco’s outstanding shares for $16.00 per share. The price represents a premium of approximately 113% over Majesco’s average closing price of $7.52 during the 30-trading day period ended July 17, 2020.

The proposed merger is subject to the approval of Majesco shareholders and the approval of the shareholders of Majesco’s parent company, Majesco Limited. Majesco’s and Majesco Limited’s Boards of Directors have unanimously approved the merger and recommend that their respective shareholders approve the merger. Majesco Limited’s promoter shareholders have entered into a voting agreement to vote in favor of a transaction with Thoma Bravo and against a competing transaction, which remains in place for a 7-month period following any termination of the transaction documents. Majesco will solicit written consents from its shareholders to approve the Merger Agreement and expects to distribute the consent solicitation statement in August 2020.

The increased offer from Thoma Bravo and the amendment followed Majesco’s receipt of an unsolicited acquisition proposal from an unaffiliated third party.

Completion of the merger is not subject to a financing condition but is subject to the accuracy of the representations and warranties, performance of the covenants and other agreements included in the Merger Agreement and customary closing conditions for a transaction of this type, including regulatory approvals in the US and India. Assuming satisfaction of those conditions, the Company expects the merger to close by the end of 2020.

Nomura Securities International, Inc. is acting as financial advisor to Majesco, and Sheppard, Mullin, Richter & Hampton LLP and Khaitan & Co are acting as legal advisors to Majesco and Majesco Limited, respectively. Kirkland & Ellis LLP and Trilegal are acting as legal advisor to Thoma Bravo.

About Majesco

Majesco (NASDAQ: MJCO) provides technology, expertise, and leadership that helps insurers modernize, innovate and connect to build the future of their business – and the future of insurance – at speed and scale. Our platforms connect people and businesses to insurance in ways that are innovative, hyper-relevant, compelling and personal. Over 200 insurance companies worldwide in P&C, L&A and Group Benefits are transforming their businesses by modernizing, optimizing or creating new business models with Majesco. Our market-leading solutions include CloudInsurer® P&C Core Suite (Policy, Billing, Claims); CloudInsurer® LifePlus Solutions (AdminPlus, AdvicePlus, IllustratePlus, DistributionPlus); CloudInsurer® L&A and Group Core Suite (Policy, Billing, Claims); Digital1st® Insurance with Digital1st® Engagement, Digital1st® EcoExchange and Digital1st® Platform – a cloud-native, microservices and open API platform; Distribution Management, Data and Analytics and an Enterprise Data Warehouse. For more details on Majesco, please visit www.majesco.com.

About Thoma Bravo

Thoma Bravo is a leading private equity firm focused on the software and technology-enabled services sectors. With a series of funds representing more than $45 billion in capital commitments, Thoma Bravo partners with a Company’s management team to implement operating best practices, invest in growth initiatives and make accretive acquisitions intended to accelerate revenue and earnings, with the goal of increasing the value of the business. The firm has offices in San Francisco and Chicago. For more information, visit www.thomabravo.com.

Cautionary Language Concerning Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Majesco’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Majesco’s Annual Report on Form 10-K, as amended by its Quarterly Reports on Form 10-Q.

Important factors that could cause actual results to differ materially from those described in forward-looking statements contained in this press release include, but are not limited to: the incurrence of unexpected costs, liabilities or delays relating to the merger; the failure to satisfy the conditions to the merger, including regulatory approvals; and the failure to obtain the requisite approval by the shareholders of Majesco Limited.

These forward-looking statements should not be relied upon as predictions of future events and Majesco cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Majesco or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. Majesco disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Important Additional Information:

In connection with the proposed merger, Majesco will file a consent solicitation statement and other relevant documents concerning the proposed merger with the SEC. The consent solicitation statement and other materials filed with the SEC will contain important information regarding the merger, including, among other things, the recommendation of Majesco’s board of directors with respect to the merger. SHAREHOLDERS ARE URGED TO READ THE CONSENT SOLICITATION STATEMENT AND OTHER CONSENT MATERIALS THAT MAJESCO FILES WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE MERGER AND RELATED MATTERS. You will be able to obtain the consent solicitation statement, as well as other filings containing information about Majesco, free of charge, at the website maintained by the SEC at www.sec.gov. Copies of the consent solicitation statement and other filings made by Majesco with the SEC can also be obtained, free of charge, by directing a request to Majesco, 412 Mount Kemble Ave., Suite 110C, Morristown, NJ 07960, Attention: Corporate Secretary.

Participants in the Solicitation:

Majesco and its executive officers and directors may be deemed, under SEC rules, to be participants in the solicitation of consents from Majesco’s shareholders with respect to the proposed merger. Information regarding the executive officers and directors of Majesco and their respective ownership of Majesco common stock is included in the Proxy Statement for Majesco’s 2020 Annual Meeting of Stockholders (the “2020 Proxy Statement”), filed with the SEC on July 29, 2020. To the extent that holdings of Majesco’s securities have changed since the amounts printed in the 2020 Proxy Statement, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. More detailed information regarding the identity of the potential participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in the consent solicitation statement and other materials to be filed with SEC in connection with the proposed merger.

Contacts

Media:
Laura Tillotson

Director, Marketing Communications and Creative Services

+ 201 230 0752

Laura.Tillotson@majesco.com

Categories
Business

New data from HouseCanary reveals COVID-19’s resurgence is creating an attractive ‘seller’s market’ for homeowners

Despite Resurgent Homebuyer Demand, New Listing Volume Dropped 12% on a Week-Over-Week Basis and Net New Listings are Down 17.5% Compared to the Same Point in 2019

Sustained Supply Constraints Throughout the Spring and Summer Have Kept Listing Prices Above Pre-Pandemic Levels Across 29 States

Outlook for a V-Shaped Housing Market Recovery in 2020 Remains Dim as a Result of Recessionary Concerns, Election Cycle Uncertainty and the Current Year-Over-Year Drop in New Listings

SAN FRANCISCO–(BUSINESS WIRE)–HouseCanary, Inc. (“HouseCanary”), a leading provider of residential real estate data and home valuations, today released its latest Market Pulse report, covering 22 listing-derived metrics and comparing data between the week ending July 24, 2020 and the week ending March 13, 2020. The Market Pulse is an ongoing review of proprietary data and insights from HouseCanary’s nationwide platform.


Jeremy Sicklick, Co-founder and Chief Executive Officer of HouseCanary, commented: “The resurgence of COVID-19 has solidified a bona fide seller’s market across more than half of the country. While pandemic uncertainty appears to be sidelining a growing number of prospective home sellers, pent-up demand on the buy-side remains quite strong due to attractive borrowing terms and a surge in first-time homebuyers. Several large states, ranging from California to Florida, have seen their median home price listings rise rather significantly since mid-March. The question that remains is whether this market environment will be able to persist beyond. Our data continues to suggest the probability of a V-shaped housing market recovery remains dim given recessionary concerns, election year uncertainty and the overall decline in listing activity.”

Select findings from this week’s Market Pulse are below. Be sure to review the Market Pulse in full for extensive state-level data.

Weekly New Listing Volume (Single-Family Detached Homes):

  • New listing volume is down 12.2% week-over-week
  • New listing volume is down 21.1% nationwide compared to the week ending March 13, when most COVID-19 measures were implemented
  • Decline in new listing activity since the week ending March 13, broken down by home price:
    • $0-$200k: (-24.9%)
    • $200k-$400k: (-23.4%)
    • $400k-$600k: (-19.3%)
    • $600k-$1mm: (-14.1%)
    • >$1mm: (-7.6%)
  • New listing volume is up 24.1% from its lowest point in mid-April

Total Net New Listings:

  • Since the week ending March 13, there have been 1,146,138 net new listings placed on the market, representing a 17.5% decrease relative to the same period in 2019
  • For the week ending July 24, there were 55,192 net new listings placed on the market, representing a 14.0% decrease compared to the previous week
  • Percentage of total net new listings since March 13, broken down by home price:
    • $0-$200k: 22.5%
    • $200k-$400k: 45.0%
    • $400k-$600k: 17.7%
    • $600k-$1mm: 10.0%
    • >$1mm: 4.8%

Median Listing Price Activity (Single-Family Detached Homes):

  • The median price for new listings has risen in 29 states since the start of COVID-19 in March
  • Several states heavily impacted by the pandemic have seen material listing price growth since the onset of the pandemic:
    • California: +14.7%
    • Kentucky: +12.7%
    • Florida: +7.2%
    • New Jersey: +6.1%
    • Texas: +3.0%

Weekly Contract Volume (Single-Family Detached Homes):

  • Weekly contract volume is down 6.4% week-over-week
  • Percent change in contract volume week-over-week, broken down by home price:
    • $0-$200k: (-4.6%)
    • $200k-$400k: (-6.7%)
    • $400k-$600k: (-8.0%)
    • $600k-$1mm: (-4.9%)
    • >$1mm: (-8.6%)
  • Weekly contract volume is up 19.2% nationwide compared to the week ending March 13, when most COVID-19 measures were implemented
  • Percent change in weekly contract volume since the week ending March 13, broken down by home price:
    • $0-$200k: +5.3%
    • $200k-$400k: +16.0%
    • $400k-$600k: +29.3%
    • $600k-$1mm: +44.8%
    • >$1mm: +51.4%
  • Weekly contract volume is up 85.8% from its lowest level in mid-April

Total Listings Under Contract:

  • Since the week ending March 13, 1,299,238 properties have gone into contract across 41 states, representing a 2.2% decrease relative to the same period in 2019
  • For the week ending July 24, there were 75,662 listings that went under contract nationwide
  • Percentage of total contract volume since the week ending March 13, broken down by home price:
    • $0-$200k: 24.8%
    • $200k-$400k: 45.3%
    • $400k-$600k: 16.9%
    • $600k-$1mm: 9.0%
    • >$1mm: 4.0%

As a nationwide real estate broker, HouseCanary’s broad multiple listing service (“MLS”) participation allows us to evaluate listing data and aggregate the number of new listings as well as the number of new listings going into contract for all single-family detached homes observed in the HouseCanary database. Using this data, HouseCanary continues to track listing volume, new listings, and median list price for 41 states and 50 individual Metropolitan Statistical Areas (“MSAs”).

About HouseCanary:

Founded in 2013, valuation-focused real estate brokerage HouseCanary provides software and services to reshape the real estate marketplace. Financial institutions, investors, lenders, mortgage investors, and consumers turn to HouseCanary for industry-leading valuations, forecasts, and transaction-support tools. These clients trust HouseCanary to fuel acquisition, underwriting, portfolio management, and more. Learn more at www.housecanary.com.

Contacts

Denise Dunckel

press@housecanary.com

Categories
Business

Majesco implements Oracle Cloud HCM to further its digital transformation journey

Leading cloud software company for insurance carriers improves organizational productivity and increases employee engagement

MORRISTOWN, N.J.–(BUSINESS WIRE)–Majesco, a global leader of cloud insurance software, today announced the implementation of Oracle Cloud HCM to help meet its long-term strategic and operational goals. With a growing customer list of more than 200 major clients across Product & Casualty, Life & Annuity and Group insurance, Majesco will use Oracle Cloud Human Capital Management (HCM) to make informed, real-time business decisions that will help expand its global footprint.

“We’re excited about the advanced capabilities Oracle Cloud HCM brings to our employees. This new, modern cloud system marks an important step in our transformation journey and will be critical to how we run our business,” notes Adam Elster, CEO of Majesco. “With Oracle HCM, we will leverage data-driven insights in real-time to help us manage all of our talent needs.”

Majesco’s cloud-based solutions help insurers modernize, innovate and transform their business to meet the demands of today’s digital customer. Whether it’s an insurer creating a new startup or greenfield, modernizing a legacy business or optimizing existing operations, Majesco helps insurers take on the future of insurance.

In order to meet growing demand, Majesco replaced its old legacy system with Oracle’s unified, cloud-based platform that is built to breakdown organizational silos, standardize processes and improve the overall efficiency of HR operations.

“We’re excited to have helped Majesco take this next step in the digital transformation journey by improving and maximizing employee engagement,” said Chris Leone, senior vice president, applications development, Oracle. “With Oracle Cloud HCM, Majesco will be better prepared to support its customers and take hold of this new era of insurance.”

In addition to Oracle Cloud HCM’s Core HR, which provides a foundation to support the entire worker life cycle, Majesco is also deploying Oracle Cloud Workforce Compensation and Oracle Cloud Recruitment, which leads with innovation to engage and identify the best talent for the organization’s needs.

“Oracle’s scalable and flexible solution provides our employees with an intuitive, personalized HR system that can manage personal and employment information easily and securely, while providing insights into the entire worker lifecycle to enable effective talent management,” commented Melissa Blankenbaker, CHRO of Majesco.

About Majesco

Majesco (NASDAQ: MJCO) provides technology, expertise, and leadership that helps insurers modernize, innovate and connect to build the future of their business – and the future of insurance – at speed and scale. Our platforms connect people and businesses to insurance in ways that are innovative, hyper-relevant, compelling and personal. Over 200 insurance companies worldwide in P&C, L&A and Group Benefits are transforming their businesses by modernizing, optimizing or creating new business models with Majesco. Our market-leading solutions include CloudInsurer® P&C Core Suite (Policy, Billing, Claims); CloudInsurer® LifePlus Solutions (AdminPlus, AdvicePlus, IllustratePlus, DistributionPlus); CloudInsurer® L&A and Group Core Suite (Policy, Billing, Claims); Digital1st® Insurance with Digital1st® Engagement, Digital1st® EcoExchange and Digital1st® Platform – a cloud-native, microservices and open API platform; Distribution Management, Data and Analytics and an Enterprise Data Warehouse. For more details on Majesco, please visit www.majesco.com.

Cautionary Language Concerning Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Majesco’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Majesco’s Annual Report on Form 10-K, as amended by its Quarterly Reports on Form 10-Q.

Important factors that could cause actual results to differ materially from those described in forward-looking statements contained in this press release include, but are not limited to: the adverse impact on economies around the world and our customers of the current COVID-19 pandemic; our ability to achieve increased market penetration for our product and service offerings and obtain new customers; our ability to raise future capital as needed; the growth prospects of the property & casualty and life & annuity insurance industry; the strength and potential of our technology platform and our ability to innovate and anticipate future customer needs; our ability to compete successfully against other providers and products; data privacy and cyber security risks; technological disruptions; our ability to successfully integrate our acquisitions and identify new acquisitions; the risk of loss of customers or strategic relationships; the success of our research and development investments; changes in economic conditions, political conditions and trade protection measures; regulatory and tax law changes; immigration risks; our ability to obtain, use or successfully integrate third-party licensed technology; key personnel risks; and litigation risks.

These forward-looking statements should not be relied upon as predictions of future events and Majesco cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Majesco or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. Majesco disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Contacts

Laura Tillotson

Director, Marketing Communications and Creative Services

+ 201 230 0752

laura.tillotson@majesco.com

Categories
Digital - AI & Apps

Software giant creates company culture by giving back

With a “people promise” to its employees and community, a prominent software company, in Tinton Falls, N.J., demonstrates it has a big heart.

Commvault Cares volunteers make sandwiches for the homeless at Asbury Park homeless shelter Wednesday.
— Provided photo

Commvault, New Jersey’s largest software company, reflects its “people promise” or, its corporate social responsibility (CSR), when it launched a volunteerism and charitable program called Commvault Cares in August three years ago.

Commvault Vice President and Chief Resources Officer Jesper Helt, said they initiated the social program because of “how we perceive our responsibility in the community where we are present…an organization that needs to give back and enrich the community that we are part of.”

Commvault Cares started in August 2017 with volunteers that have grown from about 850 volunteers last year, and is expected to exceed more than 1000 this year.

“We are early in August (now). We’ll get in above the goal we’ve set,” said Helt.

The company expects to surpass its past volunteering and charitable efforts for this year’s third annual Commvault Cares events.

From Aug. 1 through Aug. 27, the company’s calendar is full of events for Commvault Cares CSR within Monmouth County.

Commvault Cares events include the company’s collaboration with Ronald McDonald House, where volunteers cook for families in need; ice-cream social at Arbor Terrace; lunchbreak, where volunteers feed local community members; volunteers also organize costumes at Count Baise Theater; they help garden at Oasis Farms; beach cleanup at Sandy Hook National Park; they make sandwiches for the homeless at Asbury and Hoboken homeless shelters; among other community volunteering and charitable events.

“We do a diverse set of charities and volunteer activities that are done within and outside the office,” said Helt.

He also said that the company does similar activities throughout the year and globally, but Commvault Cares is specifically for August.

“We do many things throughout the year because it is meaningful and important to our company that we are engaged in that way,” said Helt.

He also said the company’s CSR is focused on “sustainability as it concerns the environment, children and health.”

Last year, Commvault Cares received the Horizon Hero Award for its volunteer work, he added.

Helt also said Commvault volunteers because it is entirely dependent on the talent that makes up the company, and that they are responsive to how employees feel when they are at work, and what it takes to make them productive and creative.

Volunteers from Commvault make meals for the needy at Ronald McDonald House in Monmouth County.
— Provided photo

He said that in order to attract and retain talent, the company has to care about the employees’ lifestyles that include work and leisure time.

“We as a company need to cater to your lifestyle…to represent many of the things that you care about as an employee. Part of that is giving back to the community, and getting involved in the community,” said Helt.

He said that Commvault wants to be a force for those in need and for the communities around them.

Commvault wants its employees to have the freedom to make an impact together in the local communities with their community partners during and after work hours, he said.

“It’s at the very core of how we as a company try to create a culture, an employee experience that is attractive and meaningful,” explains Helt.

The volunteers are from among Commvault’s more than 2,500 employees.

Commvault is the largest of its kind in New Jersey, making an impact locally and globally.

This worldwide company delivers backup and recovery software for enterprises and large organizations that need to manage their data.

Click these links to learn more about Commvault’s history and products.

Follow @Michelle_Dryden on Twitter.