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Tevogen Bio to study therapeutic potential of its investigational COVID-19 T cell therapy in long COVID

  • Tevogen’s investigational precision T cell product, TVGN 489, is designed to address the unmet need of COVID-19 patients who are unable to take or unlikely to benefit from currently available prevention or treatment strategies and potentially those with Long COVID, where there are no currently available treatment options
  • Given that no dose limiting toxicities or treatment-related adverse events were observed in the TVGN 489 POC trial, Tevogen intends to explore the potential of this therapy for the treatment of Long COVID
  • Tevogen’s research pipeline includes off-the-shelf, allogeneic genetically unmodified precision CD8+ T Lymphocyte therapeutics for the treatment of immunocompromised patients with COVID-19, patients with other serious viral infections, viral-induced cancers, several non-virally induced common cancers, and neurologic diseases, including multiple sclerosis
  • Tevogen’s inventions are designed to overcome both cost and geography related patient access barriers and aims to transform cancer treatment by developing cell therapies as first-line options

 

WARREN, N.J. — (BUSINESS WIRE) — #COVID19—Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology announced today its intention to study potential therapeutic use of its investigational COVID-19 T cell therapy, TVGN-489, in Long COVID. The finding that none of the patients in the TVGN 489 Proof-of-Concept (POC) trial, treated for their initial COVID infection, developed Long COVID to date is leading Tevogen to explore the potential of TVGN 489 to also treat Long COVID.

“I’m greatly encouraged by the POC trial experience of TVGN 489 and hopeful that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of Long COVID patients.” said Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer.

 

“Anyone that knows someone who has been impacted by this debilitating disease understands the importance of advancing science to alleviate the suffering from Long COVID,” said Tevogen CEO Ryan Saadi, M.D., M.P.H. “I’m hopeful that our innovative T cell technology will eventually offer accessible immunotherapies to millions suffering from viral infections, cancers and other diseases with high unmet need.”

 

TVGN-489 is highly purified cytotoxic CD8+ T lymphocytes (CTLs) designed to detect and kill SARS-CoV-2 infected cells. These allogeneic genetically unmodified CTLs are enriched and expanded in the lab and recognize proteins from across the entire SARS-CoV-2 genome, not just the spike protein.

 

In July 2022, TVGN-489 completed proof-of-concept clinical trial enrollment with zero treatment-related adverse events. Patients treated were infected with a range of all COVID variants at the time, from Delta through Omicron BA.5. Additionally, each patient had co-morbidities rendering them high risk and 50 percent of those additionally met the definition of being immunocompromised.

 

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.

 

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.

 

Tevogen announced the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.

 

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 genome.

 

About Tevogen Bio

Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

 

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company”) and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

Contacts

Tevogen Communications

T: 1 877 TEVOGEN, Ext 714

Communications@Tevogen.com

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Business Culture Environment Lifestyle Science Technology

GrowGeneration announces 60th location at Mount Holly, NJ store opening

DENVER — (BUSINESS WIRE) — GrowGeneration Corp. (NASDAQ: GRWG) (“GrowGen” or “the Company”), the largest chain of specialty hydroponic and organic garden centers in the United States, today announced the opening of the Company’s newest store in Mount Holly, New Jersey on November 21, 2022.


The Mount Holly location represents the Company’s 60th store and officially expands operations into 16 states. The new store is 7,700 square feet and will include vertical farming demonstrations and educational support for growers to build and maintain state-of-the-art grow operations to maximize their yields.

 

Darren Lampert, Co-Founder and Chief Executive Officer of GrowGen said, “We are excited to open our first store in New Jersey and increase our reach and operations into a fast-growing and strategically important market. We expect New Jersey to be highly active in the coming years, with a strong medical patient base, over 800 conditional licenses that have been issued, microenterprise and social equity licenses, as well as a pending law to allow for home cultivation.”

 

Mr. Lampert continued, “As we expand our footprint in the Northeastern United States, we are excited to continue our efforts in cooperation with Harvest 360 to support our national program with education and training for Social Equity License holders. The program focuses on delivering top-notch support and solutions to operators and their communities. To date, we have 30 holders of micro licenses who are active in the program within the New York and New Jersey markets.”

 

About GrowGeneration Corp:

GrowGen owns and operates specialty retail hydroponic and organic gardening centers. Currently, GrowGen has 60 stores across 16 states, which include 22 locations in California, 6 locations in Colorado, 6 locations in Michigan, 5 locations in Maine, 5 locations in Oklahoma, 4 locations in Oregon, 3 locations in Washington, 1 location in Arizona, 1 location in Florida, 1 location in Massachusetts, 1 location in Mississippi, 1 location in Missouri, 1 location in New Jersey, 1 location in New Mexico, 1 location in Rhode Island, and 1 location in Virginia. GrowGen also operates an online superstore for cultivators at growgeneration.com. GrowGen carries and sells thousands of products, including organic nutrients and soils, advanced lighting technology and state of the art hydroponic equipment to be used indoors and outdoors by commercial and home growers.

Contacts

Investor Contact
ICR, Inc.

GrowGenIR@icrinc.com

Categories
Business Healthcare Science

Blue Earth Diagnostics highlights presentations on Axumin® (Fluciclovine F 18) at upcoming RSNA® 2022 Annual Meeting

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced presentations on Axumin® (fluciclovine F 18) at the upcoming Radiological Society of North America (RSNA) 108th Scientific Assembly and Annual Meeting, to be held in Chicago, Ill., from November 27 to December 1, 2022. Details of selected oral and poster presentations are listed below.

Two presentations from Emory University will discuss additional analyses from EMPIRE-1, the first prospective, randomized controlled trial to demonstrate that 18F-fluciclovine PET/CT-guided radiation therapy improved event-free survival rates in men with biochemical recurrence of prostate cancer. Another presentation compares the diagnostic performance of bone scintigraphy with 18F-fluciclovine in detecting bone metastases in men with prostate cancer at various PSA levels. Details of selected oral and poster presentations by Blue Earth Diagnostics’ collaborators are listed below.

 

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment.

 

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Oral presentation

Thursday, December 1, 2022

Title:

Failure-free Survival of Prostate Cancer Patients After Conventional Imaging Versus 18F-fluciclovine PET-guided Salvage Radiotherapy Stratified by Serum PSA Level: A Secondary Sub-group Analysis of a Randomized Control Trial

Presenter:

Ismaheel Lawal, MD, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, Ga.

Session Type:

Oral Scientific Session

Session Title:

Science Session with Keynote: Nuclear Medicine/Molecular Imaging (Prostate Cancer Imaging)

Presentation Time:

1:30 – 2:30 PM CT

Location:

S402, McCormick Place

Presentation No.:

R-6-SNMMI 08-1

Poster presentations

Tuesday, November 29, 2022

Title:

Bone Scan versus F-18 Fluciclovine PET/CT at Different PSA Levels: A Single Center Comparison Study

Presenter:

Hatice Savas, MD, Associate Professor, Feinburg School of Medicine, Northwestern University, Chicago, Ill.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion

Presentation Time:

9:00 – 9:30 AM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T2-SPNMMI-1

Title:

Impact of 18F-fluciclovine PET/CT on Failure-free Survival in Biochemical Recurrence of Prostate Cancer Following Salvage Radiation Therapy

Presenter:

Charles Marcus, MBBS, Assistant Professor, Department of Imaging and Radiology Sciences, Emory University School of Medicine, Atlanta, Ga.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion – A

Presentation Time:

12:15 – 12:45 PM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T5A-SPNMMI-2

 

Axumin® (fluciclovine F 18) presentations

Blue Earth Diagnostics invites participants at RSNA 2022 to attend the presentations above. For full session details and scientific presentation listings, please see the RSNA 2022 online program here.

 

Indication and Important Safety Information About Axumin

INDICATION

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

 

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

 

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. Visit: www.braccoimaging.com.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0)1865 784186

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business

Cenntro to exhibit full logistar EV line and All Electric iChassis at CES 2023

Press Event to Unveil Production iChassis on January 4, 2023

Booth Meetings with Management Available for Institutional Investors, Sell-Side and Industry Analysts

 

FREEHOLD, N.J. — (BUSINESS WIRE) — Cenntro Electric Group Limited (NASDAQ: CENN), a leading EV technology company with advanced, market-validated electric commercial vehicles, today announced that it will showcase its vehicles at the upcoming 2023 Consumer Electronics Show (CES®), one of world’s largest technology trade shows taking place January 5-8, 2023 in Las Vegas. In conjunction with CES, the Company will also hold a press event on January 4th to unveil its production version of the iChassis and hold investor meetings at its booth to provide an overview of Cenntro and discuss the future of Mobility.

“CES is the world’s leading event for showcasing the future of sustainable transportation and technology, and we are looking forward to presenting our fleet and iChassis to attendees,” said Peter Wang, Chairman and CEO of Cenntro. “Cenntro is dedicated to delivering Electric Vehicle solutions that municipalities and corporate fleets, both large and small, can utilize to reduce emissions without sacrificing performance. Our purpose-built ECVs are designed to support urban logistics and services, last-mile delivery and other commercial applications purpose-built for the demands of the city.

 

“Technology has become an integral differentiator in EV vehicles and transportation, and CES® is the most influential tech tradeshow worldwide to unveil Cenntro’s iChassis. The iChassis opens the promise of automated and autonomous driving to new applications and businesses today, moving beyond the roads and bringing autonomy to everyday commercial functions from warehouses to surveillance to mobile vending and delivery. We believe these functions are the sweet spot for adoption of automated and autonomous vehicles and will drive new innovation for the implementation of autonomy,” concluded Wang.

 

Cenntro Exhibit at Booth 5840

Cenntro’s exhibit at Booth 5840 in the West Hall will be an almost 10,000 square feet display of its complete All Electric Commercial product line. The exhibit will include the full Logistar line which features the versatile, compact cargo van, the LS100, the multi-purpose LS200 available in van or box truck configurations, the segment defining LS260 van and the Class 4 LS400 purpose-built for last mile delivery and urban services. Cenntro will also showcase its Off-Road Vehicle offerings, the TeeMak, and the Antric One, an auto grade four wheeled e-cargo bike purpose-built for delivery services and general cargo transport.

 

Press Event for All Electric iChassis

Cenntro’s production version, state of the art All Electric iChassis, will make its world premiere at a press conference on Tuesday, January 4, 2023 at 12:00 pm at the Mandalay Bay Hotel, the venue for CES Press Conferences. The open-platform, fully programmable iChassis has been designed for automated and autonomous driving. The iChassis opens innovation to third-parties to develop their own software and design hardware to control and maneuver the vehicle and to develop new applications that are unique to their needs.

 

Investor Meetings & Mobility Dinner

Cenntro’s executive team will hold meetings with institutional investors, sell-side and industry analysts to learn more about the Company and its products at booth 5840 in the West Hall of the Las Vegas Convention Center January 5-8, 2023.

 

For more information or to request a booth meeting, please contact: ir@cenntroauto.com

 

About Cenntro Electric

Cenntro Electric Group Ltd. (or “Cenntro”) (NASDAQ: CENN) is a leading designer and manufacturer of electric light and medium-duty commercial vehicles. Cenntro’s purpose-built ECVs are designed to serve a variety of organizations in support of city services, last-mile delivery, and other commercial applications. Cenntro has committed to lead the transformation of commercial fleets to zero-emissions vehicles and develop a full line of zero-emission commercial vehicles through scalable, decentralized production, and smart driving solutions empowered by the Cenntro iChassis. For more information, please visit Cenntro’s website at: www.cenntroauto.com.

 

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts. Such statements may be, but need not be, identified by words such as “may,” “believe,” “anticipate,” “could,” “should,” “intend,” “plan,” “will,” “aim(s),” “can,” “would,” “expect(s),” “estimate(s),” “project(s),” “forecast(s)”, “positioned,” “approximately,” “potential,” “goal,” “strategy,” “outlook” and similar expressions. Examples of forward-looking statements include, among other things, statements regarding assembly and distribution capabilities, decentralized production, and fully digitalized autonomous driving solutions. All such forward-looking statements are based on management’s current beliefs, expectations and assumptions, and are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the results expressed or implied in this communication. For additional risks and uncertainties that could impact Cenntro’s forward-looking statements, please see disclosures contained in Cenntro’s public filings with the SEC, including the “Risk Factors” in Cenntro’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 25, 2022 and which may be viewed at www.sec.gov.

Contacts

Investor Relations Contact:

Chris Tyson

MZ North America

CENN@mzgroup.us
949-491-8235

Company Contact:

PR@cenntroauto.com
IR@cenntroauto.com

Categories
Business Lifestyle Science

inTEST Corporation to participate in the 11th Annual NYC Summit

MT. LAUREL, N.J. — (BUSINESS WIRE) — inTEST Corporation (NYSE American: INTT), a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, security, and semiconductor (“semi”), today announced that Nick Grant, President & CEO, and Duncan Gilmour, Chief Financial Officer, will participate in the 11th Annual NYC Summit, being held Tuesday, December 13th at Mastro’s New York.

 

The inTEST presentation is scheduled to begin at 9:30 a.m. Eastern Time, in a “round-robin” format consisting of small group meetings with company management teams. The presentation material utilized during the NYC Summit will be accessible on the events page of the Company’s website https://ir.intest.com.

 

Attendance at the NYC Summit is by invitation only and is available solely to accredited investors and publishing research analysts. During the event, investors and analysts will have the opportunity to meet with the majority of the 12 management teams during the small group meeting sessions, as well as opportunities to meet with management during the breakfast and lunch networking sessions.

 

The 12 management teams collectively hosting the 11th Annual NYC Summit 2022 include: ACM Research (ACMR), Advanced Energy (AEIS), Aehr Test (AEHR), Alpha & Omega Semiconductor (AOSL), Axcelis (ACLS), FormFactor (FORM), Ichor Systems (ICHR), inTEST (INTT), Intevac (IVAC), Kulicke & Soffa (KLIC), Onto Innovation (ONTO), and SkyWater Technology (SKYT). Both Cowen and Stifel are sponsors of the conference.

 

About inTEST Corporation

inTEST Corporation is a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, and security, as well as both the front-end and back-end of the semiconductor manufacturing industry. Backed by decades of engineering expertise and a culture of operational excellence, inTEST solves difficult thermal, mechanical, and electronic challenges for customers worldwide while generating strong cash flow and profits. inTEST’s strategy leverages these strengths to grow organically and with acquisitions through the addition of innovative technologies, deeper and broader geographic reach, and market expansion. For more information, visit www.intest.com.

Contacts

inTEST Corporation

Duncan Gilmour

Chief Financial Officer, Treasurer and Secretary

(856) 505-8999

Investors:

Deborah K. Pawlowski

Kei Advisors LLC

dpawlowski@keiadvisors.com
(716) 843-3908

Categories
Business Science

Blue Earth Diagnostics highlights upcoming presentation of results from Phase 3 LIGHTHOUSE study of investigational PET imaging agent 18F-rhPSMA-7.3 in newly diagnosed prostate cancer

− First presentation of results to be made at 23rd Annual Scientific Meeting in Urologic Oncology (SUO) −

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced presentations on investigational rhPSMA compounds and Axumin® (fluciclovine F 18) at the upcoming 23rd Annual Scientific Meeting in Urologic Oncology (SUO), to be held in San Diego, Calif., from November 30 to December 2, 2022. They include the first presentation of key results from Blue Earth Diagnostics’ completed Phase 3 LIGHTHOUSE trial (NCT04186819) investigating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer. 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. An rhPSMA presentation from Blue Earth Diagnostics’ sister company, Blue Earth Therapeutics, will report on its ongoing Phase 1/2 trial investigating the use of 177Lu-rhPSMA-10.1 for treatment in metastatic castrate-resistant prostate cancer. In addition, a further presentation will report findings from experiments designed to better understand PSMA regulation in castrate-resistant and neuroendocrine prostate cancer and the potential role of 18F-fluciclovine PET imaging when these tumors have low PSMA expression.

Details of selected presentations by Blue Earth Diagnostics and its collaborators are listed below.

 

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

 

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

SUO has designed this year’s meeting to feature all presentations in digital poster format, presented in scheduled blocks and available in the online poster gallery.

Thursday, December 1, 2022

Investigational rhPSMA

18F-rhPSMA-7.3

Title:

Diagnostic Performance and Safety of 18F-rhPSMA-7.3 PET in Patients with Newly Diagnosed Prostate Cancer: Results from a Phase 3, Prospective, Multicenter Study (LIGHTHOUSE)

Presenter:

Brian Chapin, MD, Assistant Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, on behalf of the LIGHTHOUSE Study Group

Time:

2:00 −3:00 PM PT

Number:

134

177Lu-rhPSMA-10.1

Title:

The Safety, Tolerability, Radiation Dosimetry and Efficacy of 177Lu-rhPSMA-10.1 for Metastatic Castrate-resistant Prostate Cancer: A Phase 1/2 Trial in Progress

Presenter:

Koby Amankwah, Weill Cornell Cancer Center, New York, NY

Time:

9:00 – 10:00 AM PT

Number:

73

Axumin® (fluciclovine F 18)

Title:

Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer with 18F-Fluciclovine PET Imaging

Presenter:

Himisha Beltran, MD, Associate Professor, Medical Oncology, Dana-Farber Cancer Institute, Boston, Mass.

Time:

9:00 − 10:00 AM PT

Number:

72

Blue Earth Diagnostics invites participants at the SUO 23rd Annual Meeting to attend the presentations above and to learn more about the company at its Medical Affairs educational booth. For session details and scientific presentation listings, please see the SUO online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

Indication and Important Safety Information About Axumin

INDICATION

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. Visit: www.braccoimaging.com.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0)1865 784186

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business

AM Best affirms credit ratings of Definity Financial Corporation and its subsidiary

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has affirmed the Long-Term Issuer Credit Rating (Long-Term ICR) of “bbb-” (Good) of Definity Financial Corporation (Definity Financial) (Ontario, Canada). Concurrently, AM Best has affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term ICR of “a-” (Excellent) of Definity Insurance Company (Definity Insurance). Both companies are domiciled in Ontario, Canada. The outlook of these Credit Ratings (ratings) is stable.

 

The ratings reflect Definity Insurance’s balance sheet strength, which AM Best assesses as very strong, as well as its marginal operating performance, neutral business profile and appropriate enterprise risk management.

The rating affirmations also reflect improved operating performance, partially due to refinement of underwriting practices and expansion into commercial lines, as well as a tempering of the group’s expense ratio, which historically was elevated due to scaling of its digital platform and expenses associated with its recent demutualization and IPO. Risk-adjusted capitalization is expected to be maintained at a level that is supportive of strong business growth as the group executes its business strategy. As a newly formed public entity, the group’s balance sheet is presently unlevered. However, going forward, AM Best expects that financial leverage and interest coverage will be maintained at levels commensurate with its current ratings.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Michael Buckley
Financial Analyst
+1 908 439 2200, ext. 5658
michael.buckley@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Rosemarie Mirabella
Director
+1 908 439 2200, ext. 5892
rosemarie.mirabella@ambest.com

Al Slavin
Communications Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business

AM Best revises outlooks to stable for Western Pacific Mutual Insurance Company, A Risk Retention Group

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has revised the outlooks to stable from negative and affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Rating of “a-” (Excellent) of Western Pacific Mutual Insurance Company, A Risk Retention Group (WPMIC) (Littleton, CO).

The Credit Ratings (ratings) reflect WPMIC’s balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management.

 

The revised outlooks to stable from negative are based on AM Best’s expectation that WPMIC will see a stabilization in its key underwriting metrics as a result of the higher levels of net premiums earned that are anticipated in the coming years. The expected growth in earned premiums, which is based on the earnings schedule of the company’s 10-year home warranties, should help stabilize some of the recent volatility that has been displayed in the company’s loss and loss adjustment expense (LAE) ratio. In 2019 and 2020, the company saw increases in underwriting losses and reported pre-tax operating losses for the year as well, prompting AM Best to revise the company’s outlooks to negative from stable. The volatility in the company’s loss and LAE ratio is not only attributed to the lower amounts of earned premiums in those years, but also is associated with a higher number of losses in those years originating from Western’s national builders deductible program. Timing issues related to reimbursements for the deductibles from the builders in the deductible program have helped contribute to the deterioration in loss experience in recent calendar years. However, despite the volatility in 2019 and 2020, results have improved in 2021 and have been favorable through the first nine months of 2022. Prospectively, AM Best expects the company to maintain an adequate level of operating performance, as historically has been the case, and to maintain the supportive risk-adjusted capitalization needed for its current book of business.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Robert Gabriel
Financial Analyst
+1 908 439 2200, ext. 5725
robert.gabriel@ambest.com

Fred Eslami
Associate Director
+1 908 439 2200, ext. 5394
fred.eslami@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Al Slavin
Communications Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Environment Lifestyle

Altus Power unveils new app to connect residential customers to local clean energy

STAMFORD, Conn. — (BUSINESS WIRE) — Altus Power, Inc. “(Altus Power” or the “Company)” (NYSE: AMPS) today announced it has launched its digital platform for Community Solar and it is now available on the Apple App Store and on its website. Altus Power’s Community Solar program matches individuals and communities with solar projects built locally. These programs offer customers a discount on their monthly energy bills and adds clean power to their community by displacing more carbon-intensive utility power. Customers can complete the signup process in under a minute on the new app. It’s like a dating app for the planet that saves you money.

 

Energy is part of almost every aspect of our lives, but it comes with a price. Altus Power is changing the way people can go green by providing access to solar energy delivered directly to the customers utility bill. The new app makes it easy to join thousands of others who are going green with Altus Power’s Community Solar programs.

 

Today Altus Power solar arrays cover 22 states—almost half of the states in the country—and are increasing their reach with community solar rapidly. Upcoming launches in Maryland, Hawaii, New Jersey and New York will provide enough electricity to power tens of thousands of homes annually, and Altus Power is working on additional locations as well. “Providing easy-to-use technology to reach people who benefit most from lowering their electricity bills will be a game-changer,” said Julia Sears, Chief Digital Officer of Altus Power. “People shouldn’t need an electrical engineering degree to figure out how to gain access” added Sears.

 

Solar electricity is no longer restricted to those with the resources and space to install panels on their rooftop. Altus Power’s Community Solar allows anyone in an eligible area who receives an electric bill from their utility to join the solar community. Altus Power is aiming to reach any customers who are interested in supporting clean energy and the climate while receiving discounts on their electricity bills. Altus Power is proud to offer power generated from the sun to all eligible communities, including customers who rent their homes or apartments, and low-to-moderate income households who, in some places, can qualify for greater savings when they join.

 

Utility bills are the least affordable they’ve been in years, driven by a steady rise in utility rates. In the U.S., one-third of the population spends almost 20% of their income on their electricity. When individuals sign up for community solar, they reduce their community’s need for traditional power and receive credits on their power bills, supporting the planet and their wallet.

 

Once enrolled, our platform will help customers take control of their energy use, reach their sustainability goals, and track their growing savings. And they can stay updated as new opportunities become available.

 

Altus Power also offers a referral program that incentivizes local building owners to spread the word about community solar and enable tenants to enroll. Reach out to the Altus team at hello@altuspower.com if interested.

 

Start saving money and help your community get clean energy with the new Apple mobile app or our online version and coming soon on the Google Play store.

 

About Altus Power, Inc.

Altus Power, based in Stamford, CT, is the premier commercial-scale clean electrification company serving commercial, industrial, public sector and community solar customers with an end-to-end solution. Altus Power originates, develops, owns and operates locally-sited solar generation, energy storage and charging infrastructure across the nation. Visit www.altuspower.com to learn more.

Contacts

For Community Solar Inquiries:

Hello@altuspower.com

For Media Inquiries:

Chris Shelton

Head of Investor Relations

InvestorRelations@altuspower.com

Categories
Business Culture Lifestyle Science

B&G Foods to partner with America’s Grow-a-Row to provide over 1 million servings of fresh produce to those in need

PARSIPPANY, N.J. — (BUSINESS WIRE) — B&G Foods, Inc. (NYSE: BGS) announced today a philanthropic partnership with America’s Grow-a-Row (AGAR), a not-for-profit organization that grows and gleans fresh, healthy fruits and vegetables that are donated to those suffering from hunger or living in areas that lack reliable access to fresh, affordable produce. In 2023, B&G Foods will donate $250,000 to AGAR, which will result in the planting, growing, harvesting and distribution of 1.25 million servings of fresh produce to communities in need across the United States.

B&G Foods is guided by philanthropic principles adopted earlier this year that include promoting food security, supporting local communities where B&G Foods employees live and work, and accelerating diversity in the culinary arts. Its partnership with AGAR, an organization based in B&G Foods’ home state of New Jersey, provides a new opportunity for its NJ-based employees to volunteer locally. Employees will be given the opportunity to help harvest produce that will go on to be donated to other areas of the country where B&G Foods has manufacturing or distribution facilities, creating an opportunity for a full circle donation experience and providing an opportunity for B&G Foods employees throughout the country to get involved.

 

“Partnering with AGAR is an opportunity to use our passion for food to make a real impact in communities, especially food deserts,” said Casey Keller, President and Chief Executive Officer of B&G Foods. “By providing 1.25 million servings of produce to those who are in need, we are making it easier for families to eat healthy, nourishing foods.”

 

Through the partnership B&G Foods will also help fund educational programs for adults and children. These programs range from ‘day on the farm’ experiences for kids in underserved communities to healthy cooking demonstrations, and more.

 

“We are very grateful to B&G Foods for the generous donation that will do so much to further our mission,” said Chip Paillex, President & Founder, America’s Grow-a-Row. “Each year, we donate 2.5 million pounds of produce and corporate donors like B&G Foods help us give even more to those in need.”

 

For more information about B&G Foods’ philanthropic and other corporate social responsibility efforts, including the company’s environmental, sustainability and DEI efforts, please visit www.bgfoods.com/about/responsibility/.

 

About B&G Foods, Inc.

Based in Parsippany, New Jersey, B&G Foods and its subsidiaries manufacture, sell and distribute high-quality, branded shelf-stable and frozen foods across the United States, Canada and Puerto Rico. With B&G Foods’ diverse portfolio of more than 50 brands you know and love, including Back to Nature, B&G, B&M, Bear Creek, Cream of Wheat, Crisco, Dash, Green Giant, Las Palmas, Le Sueur, Mama Mary’s, Maple Grove Farms, New York Style, Ortega, Polaner, Spice Islands and Victoria, there’s a little something for everyone. For more information about B&G Foods and its brands, please visit www.bgfoods.com.

 

About America’s Grow-a-Row

America’s Grow-a-Row’s mission is to positively impact as many lives as possible through a volunteer effort of planting, picking, rescuing, and delivering free fresh produce. As part of its mission, AGAR educates people of all ages about the hunger crisis, nutrition and healthy eating, and agriculture. AGAR impacts more than 100,000 people each year through its hunger relief and education programs. AGAR is celebrating 20 years of service to those in need in 2022 and has donated more than 17 million pounds, or 68 million servings, of fresh produce since its beginning. AGAR’s nourishing produce is distributed to food banks, soup kitchens, and food pantries in New Jersey, New York City, Philadelphia and eastern Pennsylvania. In addition, produce reaches food banks from Maine to Virginia through a Feeding America mixing center in Philadelphia. Expansion plans in 2022/2023 include distributing fresh, healthy fruits and vegetables to southeastern and mid-western states.

Contacts

B&G Foods:

Kristin Berlew

kristin.berlew@bgfoods.com
908.601.1407