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Winners announced for ninth annual adolescent immunization awareness contest

New Jersey Middle School and High School Students Promoted Vaccine Awareness in the Annual Protect Me With 3+ Poster and Video Contest

NEWARK, N.J. — (BUSINESS WIRE) — The Partnership for Maternal and Child Health of Northern New Jersey, in collaboration with the New Jersey Department of Health, today announced the winners for the ninth annual Protect Me With 3+ adolescent immunization awareness poster and video contest.

 

The winners and finalists in each category were honored during a virtual awards ceremony on May 12, 2021. The top three winners in the poster and video categories will receive prizes and the opportunity for their artistic creations to be distributed during statewide immunization awareness activities.

 

Middle School Poster Contest Winners:

1st place: Srujana Akella from Woodrow Wilson Middle School

2nd place: Nicole Garcia from Franklin Elementary School

3rd place: Melody Buccieri from Glen Meadows Middle School

 

High School Poster Contest Winners:

1st place: Sanika Godbole from John P. Stevens High School

2nd place: Meghana Akella from John P. Stevens High School

3rd place: Ana Fuentes from Henry Hudson Regional

 

High School Video Contest Winners:

1st place: Chloe Wu from Marlboro High School

2nd place: Anjali Fernandes from Livingston High School

3rd place: Anna Drudy from Academy of Allied Health and Science

Teachers and schools with the most eligible classroom submissions in each category were also acknowledged during the virtual awards ceremony. The winning teachers and schools include:

  • Lisa Hirkaler – Glen Meadows Middle School – Middle School Poster Category
  • Clare Ng – Marine Academy of Science & Technology – High School Poster Category
  • William Werntz – Marlboro High School – High School Video Category

 

The Protect Me With 3+ contest raises awareness about the importance of adolescent immunizations to protect against tetanus, diphtheria, pertussis (Tdap), human papillomavirus (HPV), meningococcal conjugate, and influenza (flu).

 

This year, the contest received poster and video entries from middle school and high school students across the state. The winning creations can be viewed at http://protectmewith3.com/winners.

 

“As the COVID-19 pandemic demonstrates, vaccines are critical to preventing diseases, keeping our communities healthy, and saving lives. The Protect Me With 3+ campaign engages students to share their creativity as advocates for public health,” stated Mariekarl Vilceus-Talty, President and CEO of the Partnership for Maternal and Child Health of Northern New Jersey. “I was amazed by the students’ artistic expression and encouraged by the high number of submissions for this year’s contest. We congratulate this year’s winners and thank all of the students and teachers who make this program a success.”

 

“We greatly appreciate all of the students and teachers who participated in the Protect Me with 3+ contest,” said Dr. Tina Tan, State Epidemiologist and Assistant Commissioner of the New Jersey Department of Health. “The Department of Health is grateful to have the opportunity to educate students on the importance of adolescent immunization through a poster and video contest that allows students to be as creative as possible. We are looking forward to what next year’s contest brings!”

 

New Jersey students in grades 5-8 were eligible to submit posters, and students in grades 9-12 were eligible to submit posters or videos. The public voted for their favorite entries every day from March 22nd through April 11th, 2021.

Contacts

Mike Benedetto

908 616 8355

michael.benedetto@springboardpr.com
Springboard PR

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Science Technology

Diaceutics and LGC SeraCare partnership expands diagnostic commercialization solutions enabled by Global DXRX platform

  • LGC SeraCare joins Diaceutics’ DXRX Network of industry leading service providers to provide end to end solution for development and commercialization of precision medicine diagnostics
  • DXRX platform already provides access to laboratory testing solutions from partners including Targos Molecular Pathology, Histocyte Laboratories, CPQA-ACQP, EMQN CIC, NordiQC, UKNEQAS and Alva10 Dx
  • Partnership introduces additional types of test reference materials and technologies to platform offering including Seraseq™ FFPE Tumor Fusion RNA Reference Material v4 and Seraseq™ FFPE NTRK Fusion RNA Reference Material available in 132 countries
  • Global DXRX platform enables pharmaceutical companies to achieve seamless testing for precision medicines ahead of market launch using best-in-class testing solutions

 

PARSIPPANY, N.J. — (BUSINESS WIRE) — Diaceutics PLC (AIM:DXRX) today announces a new partnership with LGC SeraCare (“SeraCare”), the US-based manufacturer of diagnostic test reference standard controls. The partnership sees LGC SeraCare join the Diaceutics DXRX Network, the world’s first end-to-end digital solution for the development and commercialization of precision medicine diagnostics, expanding the range of test standardization solutions available via the platform.

DXRX has been designed to accelerate diagnostic accuracy to ensure that precision medicines are correctly prescribed to eligible patients at the right time in the treatment journey, securing the best possible outcomes. LGC SeraCare joins a growing network of industry leaders in precision medicine diagnostics who use the platform’s technology to collaborate digitally to enable seamless diagnostic testing for precision medicines, ahead of market launch.

Existing laboratory testing solutions partners on the DXRX platform include Targos Molecular Pathology, Histocyte Laboratories, CPQA-ACQP, EMQN CIC, NordiQC, UKNEQAS and Alva10 Dx. This new partnership introduces additional types of test reference materials and technologies to the platform including Seraseq™ FFPE Tumor Fusion RNA Reference Material v4 and Seraseq™ FFPE NTRK Fusion RNA Reference Material, available in 132 countries.

By providing these critical technologies to the DXRX platform, both LGC SeraCare and Diaceutics will be able to advance their goal of enabling greater adoption of precision medicine by enabling all laboratories to provide consistently high quality testing using reference material to validate their test system, faster.

Alpa Shah, Senior Director Sales, Clinical Genomics – LGC SeraCare commented on the partnership:

“As a provider of innovative technologies that leverage our deep experience and unique perspective to enable the promise of precision medicine, we are delighted to be joining what is a network of true innovators in the industry. Our unwavering commitment to serve and empower clinical and research laboratories, as well as in vitro diagnostics developers is aligned with DXRX as a platform solution which places the laboratory at the centre of a precision medicine network and enables the diagnostic industry to extract more value from Precision Medicine. We look forward to the continued expansion of our offering via the platform and the business development opportunities it brings to SeraCare.”

DXRX Network Advisor, Kenneth J. Bloom, Chief Medical Officer of Advanced Pathology and Genomic Services, Konica Minolta Precision Medicine commented:

“As the post-Covid testing landscape emerges with new complexity, it is now more critical than ever that pharma are collaborating digitally with key stakeholders in the testing supply chain to guarantee diagnostic testing accuracy. It is fantastic to see this collaboration which is an important step in getting every patient the treatment they deserve.”

Contacts

Enquiries:
Alma PR
Caroline Forde

Robyn Fisher

Kieran Breheny

+44 (0)20 3405 0205

diaceutics@almapr.co.uk

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Science Technology

Velodyne Lidar launches breakthrough Intelligent Infrastructure Solution

Rutgers University Selects Velodyne’s Solution as Cornerstone Technology for New Jersey Department of Transportation Smart City Project

 

SAN JOSE, Calif. — (BUSINESS WIRE) — #VelodyneLidar—Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today launched its Intelligent Infrastructure Solution designed to solve some of the most challenging and pervasive infrastructure problems. This new solution combines Velodyne’s award-winning lidar sensors and Bluecity’s powerful artificial intelligence (AI) software to monitor traffic networks and public spaces. It generates real-time data analytics and predictions, helping to improve traffic and crowd flow efficiency, advance sustainability and protect vulnerable road users.


The Intelligent Infrastructure Solution is available now exclusively from Velodyne. It is already deployed in multiple North America cities, including in Quebec and British Columbia, with upcoming installations in New Jersey and more deployments expected across the United States.

Velodyne also announced a sales agreement with Rutgers Center for Advanced Infrastructure and Transportation (CAIT) to deploy its Intelligent Infrastructure Solution equipped with Velodyne’s Alpha Prime™ lidar sensors. CAIT will install the solution at multiple intersections in New Brunswick, New Jersey as part of the Middlesex County – Smart Mobility Testing Ground (MC-SMTG) project in collaboration with the New Jersey Department of Transportation (NJDOT). The project will serve as a testbed for mobility data-gathering, analysis and sharing technologies that will help implement connected and autonomous vehicle systems in the future. CAIT selected the Velodyne solution after a rigorous vetting process, in which they tested other sensor solutions and competitive lidar systems.

“The acquisition and analysis of mobility data is crucial to integrating autonomous vehicles, and creating a safer pedestrian and cycling environment,” said Dr. Ali Maher, professor and director, Rutgers Center for Advanced Infrastructure and Transportation. “Velodyne’s Intelligent Infrastructure Solution captures data on various traffic activity including vehicles, pedestrians and bicyclists in all types of environmental conditions. We envision the solution as playing a critical role in helping us create a safer environment for all road users.”

“There is a growing commitment by governments worldwide to rebuild outdated transportation infrastructure systems. Leading the way is the 2.25 trillion-dollar proposal by the Biden Administration to invest in the modernization of vehicles, roads and transit systems. As Velodyne looks at a world with connected and autonomous vehicles, we know that infrastructure will play a critical role in moving this industry forward,” said Anand Gopalan, Chief Executive Officer, Velodyne Lidar. “Our solution, powered by Bluecity’s AI-powered traffic monitoring software platform, will be key in the efforts to transform our roads and transportation infrastructure into smart cities, paving the way for a more sustainable, safer future.”

Velodyne’s Solution Transforming Infrastructure

Velodyne’s Intelligent Infrastructure Solution creates a real-time 3D map of roads and intersections, providing precise traffic monitoring and analytics. It reliably collects data in any lighting or weather condition, supporting 24/7, 365 days a year operation. The solution advances safety through multimodal analytics that detect various road users including, vehicles, pedestrians and cyclists. It can predict, diagnose and address road safety challenges, helping municipalities and other customers make informed decisions to take corrective action.

The Intelligent Infrastructure Solution is more cost-effective and easier to install than radar- and camera-based systems. This lower price point is because a single lidar sensor installed on a traffic pole can cover an entire intersection or highway section compared to radar- and camera-based systems that typically need multiple sensors to cover the same area. The solution works with Velodyne’s Alpha Prime, Ultra Puck™, Puck™ and Velarray sensors. Velodyne’s lidar sensors do not identify individuals’ facial characteristics, a growing concern for civic applications. Lidar has an advantage in privacy over camera-only systems because lidar does not record details like hair and skin color.

“Rogers collaborated with Velodyne and Bluecity on a traffic monitoring system in Kelowna, B.C., which was Canada’s first 5G smart city project,” said Neel Dayal, Senior Director, Innovation and Partnerships at Rogers Communications. “The initiative showed how this lidar-based solution can track near-misses of accidents at problematic intersections. By using the solution’s data, municipalities can do the critical work of improving roadway safety in a cost-effective and efficient way.”

“We are excited to partner with Velodyne in order to bring to market this breakthrough solution that collects and analyzes detailed traffic data about road users while preserving anonymity and trust,” said Asad Lesani, CEO at Bluecity. “We believe that Velodyne sensors are best-in-class and this solution will be a game changer for the smart city industry.”

Addressing Critical Transportation Infrastructure Challenges

Velodyne Lidar’s Intelligent Infrastructure Solution can be used for:

Safety Analytics. Velodyne’s Intelligent Infrastructure Solution near-miss analytics can be used to predict, diagnose and address road safety challenges before the next collision happens. Today’s camera-based solutions require several cameras per intersection or identified public area, which typically take longer processing times to get the final analysis. Traffic studies aren’t complete if they operate only at certain hours or under certain conditions.

Traffic Efficiency and Sustainability. Velodyne’s Intelligent Infrastructure Solution delivers reliable real-time traffic data to optimize traffic light timing based on congestion and throughput in all types of weather and lighting conditions. The solution can cover various road users, including vulnerable pedestrians and cyclists, whereas current technologies generally provide data for vehicles only. Also, lidar doesn’t require any interaction with a person’s cell phone, enabling it to accurately track people in crowded areas while preserving privacy.

Crowd Analytics. The solution can enable businesses and cities to improve revenue and infrastructure by providing foot traffic data analytics to learn about traffic patterns, congregation areas, congestion points and more. Knowing how people flow through a building and where they stop along the way is useful to designers, architects and city planners.

Vehicle to Everything (V2X) Communication. Velodyne’s Intelligent Infrastructure Solution uses extracted trajectory road user data around intersections to predict potential collisions, which can be used to warn connected vehicles via V2X communications. Vehicle manufacturers can leverage the solution’s analytics in combination with their on-board safety systems to reduce accident probability.

Emergency Services. Velodyne’s Intelligent Infrastructure Solution detects collisions and near-miss incidents in real time to provide data to emergency response services for faster dispatch in both urban and rural environments.

Environmental Protection. Velodyne’s IIS can detect wildlife crossings and help prevent collisions that often result in substantial personal, environmental and economic losses, including human injuries, fatalities, loss of wildlife and vehicle damage.

About Bluecity

Bluecity is a software company that combines artificial intelligence and lidar sensors to provide accurate, real-time traffic data for the Intelligent Transportation Systems (ITS) industry. Built by and for transportation engineers, Bluecity’s solution uses deep learning to transform raw lidar data into actionable road usage and safety information. From turning movement counts, to analysis of near misses between vehicles, pedestrians, and cyclists, their system reliably detects all road users in any weather or lighting condition. With their innovative, turnkey solution, Bluecity makes cities safer and smarter. Visit bluecity.ai for more information.

About Velodyne Lidar

Velodyne Lidar (Nasdaq: VLDR, VLDRW) ushered in a new era of autonomous technology with the invention of real-time surround view lidar sensors. Velodyne is the first public pure-play lidar company and is known worldwide for its broad portfolio of breakthrough lidar technologies. Velodyne’s revolutionary sensor and software solutions provide flexibility, quality and performance to meet the needs of a wide range of industries, including autonomous vehicles, advanced driver assistance systems (ADAS), robotics, unmanned aerial vehicles (UAV), smart cities and security. Through continuous innovation, Velodyne strives to transform lives and communities by advancing safer mobility for all. For more information, visit www.velodynelidar.com.

Forward Looking Statements

This press release contains “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995 including, without limitation, all statements other than historical fact and include, without limitation, statements regarding Velodyne’s target markets, new products, development efforts, competition. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “can,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Velodyne’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include uncertainties regarding government regulation and adoption of lidar, the uncertain impact of the COVID-19 pandemic on Velodyne’s and its customers’ businesses; Velodyne’s ability to manage growth; Velodyne’s ability to execute its business plan; uncertainties related to the ability of Velodyne’s customers to commercialize their products and the ultimate market acceptance of these products; the rate and degree of market acceptance of Velodyne’s products; the success of other competing lidar and sensor-related products and services that exist or may become available; uncertainties related to Velodyne’s current litigation and potential litigation involving Velodyne or the validity or enforceability of Velodyne’s intellectual property; and general economic and market conditions impacting demand for Velodyne’s products and services. Velodyne undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Velodyne Investor Relations
InvestorRelations@velodyne.com

Media
Codeword

Liv Allen

velodyne@codeword.com

Categories
Business Science

Datopotamab Deruxtecan late-breaking data at ESMO Breast shows promising preliminary response and disease control in patients with metastatic triple negative breast cancer

  • Oral presentation highlighting first results from TROPION-PanTumor01 in patients with triple negative breast cancer shows preliminary clinical activity

 

TOKYO & MUNICH & BASKING RIDGE, N.J. — (BUSINESS WIRE) — New data from Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC), showed preliminary response and disease control in patients with metastatic triple negative breast cancer (TNBC) with disease progression following standard treatment.

These preliminary data from the TNBC cohort of the TROPION-PanTumor01 phase 1 study were presented as a late-breaking mini oral presentation (Abstract #LBA4) at the 2021 European Society of Medical Oncology (ESMO) Breast Cancer Virtual Congress (#ESMOBreast21).

TNBC accounts for approximately 10 to 15% of breast cancer cases and is associated with higher disease recurrence and worse prognosis compared to other breast cancer subtypes.1,2,3 It is estimated that only 12.2% of patients with metastatic TNBC survive five years and median overall survival is generally less than two years.2,3

The preliminary objective response rate (ORR), assessed by blinded independent central review, was 43% in 21 evaluable patients treated with datopotamab deruxtecan [6 mg/kg (n=19) or 8 mg/kg (n=2)]. Five confirmed complete or partial responses (CR/PRs) were seen, with four additional CR/PRs awaiting confirmation at the time of data cut-off of January 8, 2021. A disease control rate of 95% was observed.

“There are currently limited treatment options for patients with previously treated metastatic triple negative breast cancer, historically a very difficult-to-treat subtype of breast cancer,” said Aditya Bardia, MD, MPH, Director of Breast Cancer Research, Mass General Cancer Center, Harvard Medical School. “These initial safety and efficacy results of datopotamab deruxtecan in patients with triple negative breast cancer are encouraging and warrant further development for patients with breast cancer.”

The safety profile of datopotamab deruxtecan seen in the TNBC cohort is consistent with safety that has been previously reported in the non-small cell lung cancer (NSCLC) cohort of TROPION-PanTumor01. No patients discontinued treatment due to adverse events (AEs); however, dose reductions due to AEs occurred in six patients (25%) and were most commonly due to stomatitis (13%) and mucosal inflammation (8%). Grade 3 or higher treatment emergent adverse events (TEAEs) regardless of causality occurred in 33% of patients. TEAEs grade 3 or higher included stomatitis (13%), fatigue (4%) and anemia (4%) with no grade 3 or higher TEAEs of diarrhea or neutropenia. The most common TEAEs overall in ≥25% of patients were stomatitis, nausea, fatigue, vomiting, and alopecia. No cases adjudicated as drug-related interstitial lung disease (ILD) were observed.

“These preliminary results provide proof-of-concept that targeting TROP2 with datopotamab deruxtecan may be an effective treatment strategy for patients with previously treated metastatic triple negative breast cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “We are encouraged by the early tumor responses and disease control seen in these patients and we will continue to explore the potential of datopotamab deruxtecan in several types of breast cancer, including triple negative breast cancer.”

“Triple negative breast cancer is known to be particularly aggressive and fast growing, and after treatment the risk of recurrence is faster and higher than in any other breast cancer subgroup,” said Cristian Massacesi, Senior Vice President, Head of Late Stage Development Oncology R&D, AstraZeneca. “The preliminary results for datopotamab deruxtecan in this cohort of pretreated patients are encouraging for this high-potential targeted ADC.”

Patients were treated with a median of four prior lines of therapy (range, 1-9, including prior lines of therapy in the [neo]adjuvant or metastatic setting) with a majority (88%) receiving more than two previous lines of treatment, including a taxane (83%), platinum-based chemotherapy (50%), immunotherapy (33%), sacituzumab govitecan (8%) and a PARP inhibitor (4%). As of data cut-off on January 8, 2021, 75% of patients remained on treatment with datopotamab deruxtecan.

Summary of TROPION-PanTumor01 Results

Efficacy Measure

Total Evaluable in TNBC Cohort (N=21)i, ii

ORR, %iii, iv

43% (n=9)

CR/PR (confirmed)

n=5

CR/PR (pending confirmation)

n=4

DCR, %v

95% (n=20)

PD, %

5% (n=1)

CR, complete response; DCR, disease control rate; ORR, objective response rate; PD, progressive disease; PR, partial response

i Includes response evaluable patients who had ≥1 postbaseline tumor assessment or discontinued treatment. Postbaseline tumor assessments were not yet available for 3 patients at the data cutoff. One patient was not confirmed to have a target lesion per BICR and therefore had a best overall response of non-CR/non-PD.

ii Includes 2 patients that received 8 mg/kg datopotamab deruxtecan prior to selection of the 6-mg/kg dose for dose expansion.

iii Includes patients with a best overall response of CR, PR, stable disease, or non-CR/non-PD.

iv ORR is CR+PR; Responses are confirmed (CRs/PRs; n=5) plus those ongoing CRs/PRs too early to be confirmed (n=4).

v DCR is CR+PR+SD.

About TROPION-PanTumor01

TROPION-PanTumor01 is a first-in-human, open-label, two-part, multicenter phase 1 trial designed to evaluate the safety, tolerability and preliminary efficacy of datopotamab deruxtecan in patients with advanced solid tumors refractory to or relapsed from standard treatment or for whom no standard treatment is available, including NSCLC, TNBC and hormone receptor positive (HR+) breast cancer.

The dose escalation part of the study assessed the safety and tolerability of increasing doses of datopotamab deruxtecan to determine the maximum tolerated dose and/or recommended dose for expansion in patients with unresectable advanced NSCLC. The dose expansion part of the study further assessed the safety and tolerability of datopotamab deruxtecan at selected dose levels (4 mg/kg, 6 mg/kg and 8 mg/kg) in patients with NSCLC. Based on the preliminary efficacy and safety, the 6 mg/kg dose has been identified as the recommended dose for the NSCLC cohort.

The TNBC cohort was added in July 2020 and is currently evaluating patients with metastatic TNBC receiving datopotamab deruxtecan (6 mg/kg) with disease relapse or progression with standard treatment. The HR positive/HER2 negative cohort was added in March 2021 and is currently evaluating patients with metastatic HR positive/HER2 negative breast cancer receiving datopotamab deruxtecan (6 mg/kg) with disease relapse or progression with standard treatment.

Safety endpoints include dose limiting toxicities and serious adverse events. Efficacy endpoints include ORR, DCR, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetic, biomarker and immunogenicity endpoints also are being evaluated.

About TROP2 in Triple Negative Breast Cancer

TROP2 (trophoblast cell-surface antigen 2) is a transmembrane glycoprotein that is overexpressed in several types of solid tumors, including breast cancer.4 Research indicates that high TROP2 expression is associated with cancer cell growth and proliferation and poor patient survival.4,5 While TROP2 is expressed across all breast cancer subtypes, it is overexpressed in approximately 80% of patients with TNBC, making it a promising molecular target for therapeutic development.5

Approximately 10 to 15% of patients with breast cancer are considered triple negative because the tumors test negative for estrogen, progesterone hormone receptors (HRs) and human epidermal growth factor 2 receptor (HER2).1,2,6 An estimated 260,000 new cases of TNBC were reported globally in 2018 with it being more common in younger women and those who are Black.1,2,7 Compared to patients with other breast cancer subtypes, prognosis for patients with metastatic TNBC is generally worse and the disease is more likely to recur following treatment with initial chemotherapy.1,3 Five-year survival of metastatic TNBC is estimated at 12.2% and median overall survival is generally less than two years.2,3

About Datopotamab Deruxtecan (Dato-DXd)

Datopotamab deruxtecan (Dato-DXd) is a TROP2 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, datopotamab deruxtecan is one of three lead ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform.

A comprehensive development program called TROPION is underway globally with trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple solid tumors, including NSCLC, TNBC and HR+ breast cancer. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of datopotamab deruxtecan.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit www.daiichisankyo.com.

__________________________________________

References

1 American Cancer Society. Triple-negative breast cancer. Accessed April 19, 2021.

2 Sharma P. Oncologist. 2016;21:1050-1062.

3 National Cancer Institute. SEER cancer stat facts: female breast cancer subtypes. Accessed April 19, 2021.

4 Goldenberg D, et al. Oncotarget. 2018;9(48): 28989-29006.

5 Zaman S, et al. Onco Targets Ther. 2019;12:1781-1790.

6 Bianchini G, et al. Nat Rev Clin Oncol. 2016;13:674-690.

7 Bray F, et al. CA Cancer J Clin. 2018;68:394-424.

Contacts

Media Contacts:

Global/US:
Victoria Amari

Daiichi Sankyo, Inc.

vamari@dsi.com
+1 908 900 3010 (mobile)

EU:
Lydia Worms

Daiichi Sankyo Europe GmbH

lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)

+49 176 11780861 (mobile)

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Categories
Local News Science

NJ Bio moves headquarters to Princeton, New Jersey

PRINCETON, N.J. — (BUSINESS WIRE) — #adc—NJ Biopharmaceuticals LLC (d/b/a NJ Bio), an expert provider of chemistry and biopharmaceutical services specializing in bioconjugation, custom synthesis, flow chemistry, and process development, announced the move of its headquarters from North Brunswick to Princeton, New Jersey.


The 35,000-square-foot, state-of-the-art laboratory space will be located at 350 Carter Road, at a site formerly occupied by Bristol Myers Squibb. Over time, the company plans to expand further within the same location. Current staff will move from North Brunswick to Princeton, and the facility will be fully operational by July 1, 2021. NJ Bio will continue to operate its facility in Bristol, PA, with plans for future growth at that site, including GMP manufacturing capabilities for small molecules as well as bioconjugation.

“On behalf of the board of directors and senior management at NJ Bio, I am excited to announce this move,” said Nareshkumar Jain, Ph.D., President and CEO of NJ Bio. “Our expansion to this advanced facility demonstrates the rapid growth of NJ Bio in just over two years. This new location, well-equipped with the latest instruments, and staffed by exceptional scientists, will ensure that NJ Bio continues to remain an outstanding partner to our clients, delivering high value and results for their most challenging research and development needs.”

About NJ Bio

NJ Bio is an integrated chemistry service provider with expertise in bioconjugation, payload-linker synthesis, nucleotide chemistry, and application of BioNMR to drug discovery programs, including protein degraders. NJ Bio also offers expertise in flow chemistry and process development and provides innovative solutions for large-scale continuous manufacturing needs. NJ Bio’s clients range from large pharmaceutical and biotechnology companies to start-ups.

For additional information, visit www.njbio.com.

Contacts

Media Contact
Reva Raghupathi, PhD, MBA

Vice-President, Strategic Alliances, NJ Bio

Email: info@njbio.com

Categories
Healthcare Science

LEO Pharma presents long-term safety and efficacy data for tralokinumab in adults with moderate-to-severe atopic dermatitis at AAD VMX 2021

  • Interim analysis at 56 weeks from ECZTEND, an open-label extension trial, demonstrates sustainable and durable efficacy of tralokinumab in adult patients1
  • Patients enrolled in ECZTRA 1 and 2 parent trials who continued into ECZTEND have now been treated with tralokinumab for two years1
  • The overall safety profile of tralokinumab was consistent with that observed in the parent trials1

BALLERUP, Denmark, & MADISON, N.J. — (BUSINESS WIRE) — LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.

Tralokinumab is a high affinity, human monoclonal antibody that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.2,3 It is an investigational therapy in clinical development, and its safety and efficacy are currently being evaluated by regulatory authorities.

The interim analysis at 56 weeks in the ECZTEND trial (NCT03587805) showed tralokinumab 300 mg every other week plus optional topical corticosteroids (TCS) demonstrated long-term improvements in itch, sleep, and in atopic dermatitis signs and symptoms.1 Patients who had enrolled in pivotal Phase 3 trials ECZTRA 1 and 2 who continued into ECZTEND were on treatment for at least two years.1

“Atopic dermatitis is a complex, chronic skin disease that can have devastating and lasting impacts due to the unpredictable nature of the disease. Since patients can live with atopic dermatitis for decades, clinicians are looking for new treatment options that provide predictable long-term results,” said Andrew Blauvelt, MD, MBA, President of Oregon Medical Research Center in Portland, Oregon, and lead investigator for ECZTEND. “We are encouraged by the sustained improvements seen over time in patients treated with tralokinumab in the ECZTEND trial, showing great potential for a promising new treatment option for adults living with uncontrolled moderate-to-severe atopic dermatitis.”

The ongoing 268-week open-label extension trial is investigating the long-term safety and efficacy of tralokinumab 300 mg every other week in patients who previously participated in parent trials ECZTRA 1-8 and TraSki investigator-initiated study.1 The primary endpoint was defined as the number of adverse events during the treatment period from baseline up to Week 268.1

Interim analysis at Week 56 included patients from parent trials ECZTRA 1, 2, ECZTRA 3 and ECZTRA 5. Interim efficacy results at Week 56 were based on the Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).1

IGA 0/1 (% of

patients [n/N])

EASI

Score

(Median)

EASI % Change

From Parent Trial

Baseline (Median)

EASI-50

(% of

patient [n/N])

EASI-75

(% of

patients [n/N])

EASI-90

(% of

patient [n/N])

EASI ≤7

(% of

patients [n/N])

Pruritus

NRS Worst

Weekly

Score

(Mean

[SD])

Eczema-

related

Weekly Sleep

NRS Score

(Mean [SD])

Week 56

49.7 (255/513)

1.8

-93.6

95.1 (488/513)

82.8 (425/513)

61.0 (313/513)

79.7 (409/513)

3.3 (2.6)

2.0 (2.4)

Participants included 1,174 patients from ECZTEND at data cut-off.1 Observed outcomes for all patients enrolled 60 weeks prior to data cut-off (n=513) were analyzed at Week 56.1 At parent-trial baseline, ECZTEND baseline, and Week 56, median EASI score was 26.6, 4.7, and 1.8, respectively.1 At Week 56, IGA and EASI response rates were 49.7% (IGA 0/1), 95.1% (EASI-50), 82.8% (EASI-75), 61.0% (EASI-90), and 79.7% (EASI ≤7). An EASI score of ≤7 corresponds to mild atopic dermatitis.1

At the same 56-week data cut-off, measurements of itch and sleep disruptions due to itch were also reported.1 At Week 56, the mean worst weekly pruritus (i.e. itch) numeric rating scale (NRS) score was 3.3 (parent-trial baseline was 7.7) while the mean eczema-related weekly sleep NRS score was 2.0 (parent-trial baseline was 6.9).1

In the two-year cohort of patients who completed 52 weeks of tralokinumab treatment in parent studies (ECZTRA 1 and 2) and at least 56 weeks in ECZTEND (n=291), observed EASI response rates were 93.8% (EASI-50), 82.5% (EASI-75), and 59.8% (EASI-90), demonstrating sustained efficacy after two years of treatment.1 The efficacy and response rates demonstrated by this two-year cohort were consistent with that of the overall group at data cut-off (56 weeks).1These results indicate patients receiving long-term treatment with tralokinumab sustained the response rates and improvements in itch and sleep achieved in the parent trials.1

The long-term safety of tralokinumab treatment were also assessed.4 By the data cut-off, 11.8% of patients had withdrawn from the study, and discontinuation rates due to an adverse event were low (1.6%).4

In the safety analysis set (n=1,174), from the start of the ECZTEND trial to data cut-off, 71.9% of patients experienced an adverse event; most were mild or moderate in severity.4 The most frequently reported adverse events (≥5% of patients receiving tralokinumab) included viral upper respiratory tract infection (mainly reported as common cold; 21.3%), atopic dermatitis (13.5%), and upper respiratory tract infection (7.1%). Conjunctivitis was reported in 5.9% of patients.4

“Atopic dermatitis is a condition that can impact patients over decades, which is why we are very encouraged by these long-term study results that show the potential of tralokinumab over time,” said Jörg Möller, Executive Vice President, Global Research and Development, LEO Pharma. “Tralokinumab is currently being evaluated by health authorities around the world, and we hope to introduce this targeted treatment option soon.”

LEO Pharma recently received a positive opinion for tralokinumab from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on April 23, 2021.

Additional data will be presented by LEO Pharma at AAD VMX, including a sub-analysis of the pivotal Phase 3 trial, ECZTRA 1, that showed the impact of tralokinumab on skin barrier abnormalities.

About tralokinumab

Tralokinumab is a human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Tralokinumab specifically binds to the IL-13 cytokine with high affinity, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).2,3

About the ECZTEND – Long-Term Extension (LTE) Trial

ECZTEND is a Phase 3, long-term (up to 268 weeks), open-label, single-arm, extension trial to evaluate the safety and efficacy of tralokinumab in patients with atopic dermatitis who participated in the previous tralokinumab monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy tralokinumab plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), and the oral cyclosporine A trial (ECZTRA 7), the combination therapy tralokinumab plus TCS trial in Japanese subjects (ECZTRA 8), and the tralokinumab monotherapy skin barrier function trial (TraSki).5

About ECZTRA 1, 2, ECZTRA 3 and ECZTRA 5 Trials

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the efficacy and safety of tralokinumab (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.6

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the efficacy and safety of tralokinumab (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.7

ECZTRA 5 (ECZema TRAlokinumab trial No. 5) was a randomized, double-blind, placebo-controlled, 30-week, Phase 2 trial which included 215 adult patients with atopic dermatitis to evaluate the effect of tralokinumab (300 mg) on vaccine antibody responses (Tdap and meningococcal vaccines) in adults with moderate-to-severe atopic dermatitis who are candidates for systematic therapy. Patients were treated with either tralokinumab or placebo for 16 weeks. The safety, efficacy, and tolerability of tralokinumab when administered with the studied vaccines was also assessed.8

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.9 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.10 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.2

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million. For more information please visit www.LEO-Pharma.com.

References

  1. Blauvelt A, et al. Long-term Improvements Observed in Tralokinumab-treated Patients With Moderate-to-severe Atopic Dermatitis: An ECZTEND Interim Analysis. American Academy of Dermatology Association Virtual Meeting Experience (AAD VMX); April 23-25, 2021. On-demand video oral presentation 29393.
  2. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020; 75:54-62.
  3. Popovic B, et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017; 429:208–19.
  4. Blauvelt A, et al. Long-term Safety, Efficacy, and Adherence to Tralokinumab Treatment in Moderate-to-severe Atopic Dermatitis for up to 3 Years: Interim Readout of ECZTEND, a Phase 3, Long-term Extension Trial. American Academy of Dermatology Association Virtual Meeting Experience (AAD VMX); April 23-25, 2021. E-poster 27697.
  5. ClinicalTrials.gov. National Library of Medicine (U.S.). Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials – ECZTEND. Identifier NCT03587805. https://clinicaltrials.gov/ct2/show/NCT03587805.
  6. Wollenberg A, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021; 437-449.
  7. Silverberg JI, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate‐to‐severe atopic dermatitis: results from the double‐blind, randomized, multicentre, placebo‐controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021; 450-463.
  8. Merola J, et. al. Tralokinumab Does Not Impact Vaccine-induced Immune Responses: Results From a 30-week, Randomized, Placebo-controlled Trial in Adults With Moderate-to-severe Atopic Dermatitis. (EZCTRA 5) J Am Acad Dermatol. 2021.
  9. Weidinger S, et al. Atopic dermatitis. Lancet. 2016; 387:1109-1122.
  10. Boguniewicz M, et al. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev 2011;242(1):233-46.

April 2021 MAT-42680

Contacts

Linda Mayer
Global Product Communications

+1 973 908 7924

limay@leo-pharma.com

Henrik Kyndlev
Global External Communications

+45 3140 6180

hdtdk@leo-pharma.com

Categories
Local News Science Technology

Asana BioSciences to present additional efficacy data from chronic hand eczema phase 2b trial of oral SYK/JAK inhibitor gusacitinib at AAD VMX late-breaking session

LAWRENCEVILLE, N.J. — (BUSINESS WIRE) — Asana BioSciences, a clinical stage biopharmaceutical company, announced that it will present additional positive results from a Phase 2b study evaluating the efficacy and safety of its investigational oral Janus kinase family (JAK) and spleen tyrosine kinase (SYK) inhibitor gusacitinib (ASN002) in adult patients with moderate-to-severe chronic hand eczema (CHE) in a late-breaking research program at the American Academy of Dermatology Virtual Meeting (AAD VMX 2021), to be held April 23 – 25, 2021.

The details of the presentation are as follows:

Study Title: Efficacy, Patient Reported Outcomes and Safety of Gusacitinib (ASN002) in Chronic Hand Eczema: Results of a Phase 2b, Randomized, Double-blind, Placebo-Controlled Study.

Presenter: Howard Sofen, M.D., Associate Clinical Professor of Medicine/Dermatology and Pediatrics, University of California, Los Angeles, and Chief of Dermatology at LA County/Olive View Medical Center United States

Session: Late Breaking Abstracts

Date/Time: 24th April 2021 /2:00 – 3:00 PM US EDT

Chronic hand eczema is often debilitating and affects approximately 10% of the U.S. population and millions of people worldwide. The Phase 2b study was a randomized, double-blind, placebo-controlled, parallel-group study evaluating oral gusacitinib (40 mg or 80 mg once daily) in moderate to severe CHE patients for up to 32 weeks, with the primary endpoint of mean modified total lesion severity score (mTLSS) at week 16 (NCT03728504). The physician global assessment (PGA) and pruritus were among the key secondary endpoints studied.

Howard Sofen, MD, the presenting and one of the lead investigators said, “The results of this trial are very impressive and provide evidence that gusacitinib may be an effective once-daily, oral treatment option for CHE patients who are unable to achieve adequate control with topical corticosteroids and other unapproved treatments. Gusacitinib showed a significant effect on mTLSS, PGA, pain, and pruritus at week 16. Rapid improvements in primary and secondary endpoints were observed during the first 2 weeks of treatment, and effects were sustained over the 32-week study. In addition, gusacitinib was effective in patients with chronic foot eczema and atopic dermatitis (as measured by vIGA in CHE patients who also had AD involvement) in this study. The most common treatment-emergent adverse events were upper respiratory tract infection, headache, nausea, and nasopharyngitis. No pulmonary embolism, opportunistic infections, malignancies, major adverse cardiovascular events, or deaths were reported in the study,” Dr. Sofen said.

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.

ASN003 is in Phase 1 development for BRAFV600 mutated metastatic melanoma, metastatic colorectal and advanced non-small cell lung cancer, and advanced solid tumors with PI3K pathway alterations (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 planned for the first half of 2021.

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.

ASN009 is 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

Louis Denis

Asana BioSciences

997 Lenox Drive, Suite 220

Princeton Pike Corporate Center

Lawrenceville, NJ 08648

Ph: +1(860) 941-5029

Louis.Denis@AsanaBio.com

Categories
Science Technology

Investigational combination of Aliqopa® (copanlisib) and rituximab significantly increases progression-free survival in patients with relapsed indolent non-Hodgkin’s Lymphoma

  • In the Phase III trial CHRONOS-3 of 458 patients with indolent non-Hodgkin’s Lymphoma (iNHL), the investigational combination of Aliqopa and rituximab was statistically significant in delaying disease progression or death (HR=0.52, 95% CI 0.39, 0.69) compared to rituximab and placebo, with a median progression-free survival (PFS) of 21.5 months (95% CI 17.8, 33.0) versus 13.8 months (95% CI 10.2, 17.5)1
  • The CHRONOS-3 trial included several prespecified iNHL subgroups including follicular lymphoma (FL; n=275), marginal zone lymphoma (MZL; n=95), small lymphocytic lymphoma (SLL; n=50), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM; n=38)1
  • Bayer is discussing the data from CHRONOS-3 with health authorities worldwide

Abstract: CT001

WHIPPANY, N.J. — (BUSINESS WIRE) — Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant improvement in progression-free survival (PFS) with the investigational combination of Aliqopa® (copanlisib) and rituximab given intravenously in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL) compared to the combination of rituximab and placebo. After a median follow-up of 19.2 months, patients treated with this combination had a median PFS of 21.5 months (95% CI 17.9, 33.0) versus 13.8 months in patients treated with rituximab and placebo (95% CI 10.2, 17.5), (HR=0.52, p=0.000002). No new safety signals were identified for Aliqopa in the combination arm of the study.1 The data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 and simultaneously published in The Lancet Oncology.

CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether Aliqopa in combination with rituximab is superior to placebo plus rituximab in extending PFS in patients with relapsed iNHL following at least one prior rituximab-containing therapy. Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included.2

In 2017, Aliqopa was approved for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies based on the results of a single-arm, multicenter, Phase II clinical trial (CHRONOS-1).3 Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

“In clinical practice, we have seen an overall improvement in the prognosis of iNHL patients, yet relapsed disease is still a prominent treatment challenge,” said Matthew J. Matasar, M.D., Medical Oncologist, Regional Care Network Medical Site Director, Memorial Sloan Kettering Cancer Center (MSK) Bergen. “The results reported with the combination of copanlisib and rituximab suggest a potential advancement for patients with these diverse types of cancers.”

“Bayer is committed to putting patients’ needs first and delivering innovative treatment options that address areas of high unmet need, and clinical research is the first step in that process,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer. “These data highlight the potential of Aliqopa and rituximab as a new strategy for treating these patients and we look forward to advancing regulatory discussions.”

Bayer is in discussions with health authorities worldwide regarding the data from CHRONOS-3.

Additional CHRONOS-3 Data Being Presented at AACR

In addition to the primary endpoint of PFS, data on the secondary endpoints of ORR and complete response rate (CRR) will also be presented. Best ORR for the combination of Aliqopa and rituximab was 80.8% (95% CI 76, 85) versus 47.7% (95% CI 40, 56) for rituximab and placebo (p<0.0001), with 33.9% and 14.6% of patients achieving CR, respectively. Of the relapsed iNHL patients included in the trial, 60% had FL, 20.7% marginal zone lymphoma (MZL), 10.9% small lymphocytic lymphoma (SLL) and 8.3% lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). Analysis of the subtypes will be presented at AACR and published in The Lancet Oncology.1

All-grade treatment-emergent adverse events (TEAEs) observed with the Aliqopa and rituximab combination that occurred in more than 20% of the patients included hyperglycemia (69.4%), hypertension (49.2%), diarrhea (33.6%), neutropenia (20.8%), nausea (22.5%) and pyrexia (20.5%). Discontinuation due to all-grade TEAEs in CHRONOS-3 for Aliqopa and rituximab was 32% versus 8% for rituximab and placebo.1

Aliqopa is an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant activity against alpha and delta isoforms the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.4 Aliqopa is approved in the U.S. under the accelerated approval pathway for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Accelerated approval was granted for this indication based on an ORR of 59% (n=61/104; 95% CI 49, 68), including 14% (15/104) of CRs from the open-label, single-arm multicenter, Phase II clinical trial (CHRONOS-1), in a total of 142 subjects, which included 104 subjects with follicular B-cell non-Hodgkin’s Lymphoma who had relapsed disease following at least two prior treatments. In the updated two-year follow-up analysis conducted on data until 16 weeks after the last patients eligible for full analysis started treatment, Aliqopa ORR was 59% (n=61; 95% CI 49, 68), including 20% CR (n=21).5 Tumor response was assessed according to the International Working Group response criteria for malignant lymphoma. Efficacy based on ORR was assessed by an Independent Review Committee.

Disclosure: This study was sponsored by Bayer AG. Dr. Matasar has received honoraria from Bayer AG and subsidiaries of Bayer AG for advising and related activities. Bayer AG also provides research funding for Dr. Matasar through Memorial Sloan Kettering Cancer Center (MSK). In addition, Dr. Matasar has received honoraria from Roche/Genentech for advising and related activities, and the company also provides research funding for him through MSK.

About Aliqopa® (copanlisib) Injection3

Aliqopa (copanlisib) is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Aliqopa is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3K-α and PI3K-δ isoforms expressed in malignant B cells. Aliqopa has been shown to induce tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.

IMPORTANT SAFETY INFORMATION FOR ALIQOPA® (copanlisib)

Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection.

Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients treated with ALIQOPA monotherapy. Before initiating treatment with ALIQOPA, consider PJP prophylaxis for populations at risk. Withhold ALIQOPA in patients with suspected PJP infection of any grade. If confirmed, treat infection until resolution, then resume ALIQOPA at previous dose with concomitant PJP prophylaxis.

Hyperglycemia: Grade 3 or 4 hyperglycemia (blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients treated with ALIQOPA monotherapy. Serious hyperglycemic events occurred in 2.8% of patients. Treatment with ALIQOPA may result in infusion-related hyperglycemia. Blood glucose levels typically peaked 5 to 8 hours post-infusion and subsequently declined to baseline levels for a majority of patients; blood glucose levels remained elevated in 17.7% of patients one day after ALIQOPA infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment.

Of the twenty patients with diabetes mellitus treated in CHRONOS-1, seven developed Grade 4 hyperglycemia and two discontinued treatment. Patients with diabetes mellitus should only be treated with ALIQOPA following adequate glucose control and should be monitored closely.

Achieve optimal blood glucose control before starting each ALIQOPA infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hyperglycemia.

Hypertension: Grade 3 hypertension (systolic 160 mmHg or greater or diastolic 100 mmHg or greater) occurred in 26% of 317 patients treated with ALIQOPA monotherapy. Serious hypertensive events occurred in 0.9% of 317 patients. Treatment with ALIQOPA may result in infusion-related hypertension. The mean change of systolic and diastolic BP from baseline to 2 hours post-infusion on Cycle 1 Day 1 was 16.8 mmHg and 7.8 mmHg, respectively. The mean BP started decreasing approximately 2 hours post-infusion; BP remained elevated for 6 to 8 hours after the start of the ALIQOPA infusion. Optimal BP control should be achieved before starting each ALIQOPA infusion. Monitor BP pre- and post-infusion. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of hypertension.

Non-infectious Pneumonitis: Non-infectious pneumonitis occurred in 5% of 317 patients treated with ALIQOPA monotherapy. Withhold ALIQOPA and conduct a diagnostic examination of a patient who is experiencing pulmonary symptoms such as cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam. Patients with pneumonitis thought to be caused by ALIQOPA have been managed by withholding ALIQOPA and administration of systemic corticosteroids. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of non-infectious pneumonitis.

Neutropenia: Grade 3 or 4 neutropenia occurred in 24% of 317 patients treated with ALIQOPA monotherapy. Serious neutropenic events occurred in 1.3%. Monitor blood counts at least weekly during treatment with ALIQOPA. Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of neutropenia.

Severe Cutaneous Reaction: Grade 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients treated with ALIQOPA monotherapy respectively. Serious cutaneous reaction events were reported in 0.9%. The reported events included dermatitis exfoliative, exfoliative rash, pruritus, and rash (including maculo-papular rash). Withhold, reduce dose, or discontinue ALIQOPA depending on the severity and persistence of severe cutaneous reactions.

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ALIQOPA can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of copanlisib to pregnant rats during organogenesis caused embryo-fetal death and fetal abnormalities in rats at maternal doses as low as 0.75 mg/kg/day (4.5 mg/m2/day body surface area) corresponding to approximately 12% the recommended dose for patients. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least one month after the last dose.

Adverse Drug Reactions: Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most frequently observed adverse drug reactions (≥20%) in ALIQOPA-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased general strength and energy (36%), hypertension (35%), neutropenia (32%), nausea (26%), thrombocytopenia (22%), and lower respiratory tract infections (21%).

Drug Interactions: Avoid concomitant use with strong CYP3A inducers. Reduce the ALIQOPA dose to 45 mg when concomitantly administered with strong CYP3A inhibitors.

Lactation: Advise women not to breastfeed. Advise a lactating woman not to breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose.

For important risk and use information about Aliqopa, please see the full Prescribing Information.

About CHRONOS-3

CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Aliqopa in combination with rituximab versus placebo in combination with rituximab in patients with relapsed indolent NHL who have received at least one or more lines of prior rituximab-containing therapy. Histological subtypes included in the trial were follicular lymphoma (FL), small lymphocytic lymphoma (SLL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), and marginal zone lymphoma (MZL). Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included (NCT02367040). The study enrolled 458 participants.2

About non-Hodgkin’s Lymphoma

Non-Hodgkin’s Lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the eleventh most common cancer worldwide, with nearly 510,000 new cases diagnosed in 2018. It accounted for nearly 249,000 deaths worldwide in 2018.6,7

Indolent NHL consists of multiple subtypes, including follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM). While the disease is typically slowly growing, it can become more aggressive over time. Despite treatment advances, there remains a need for improved treatment options for the relapsed or refractory stage of the disease. After response to initial therapy, response rates and duration of response decline with subsequent lines of therapy, underscoring the need for patients whose disease has already progressed.

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

© 2021 Bayer

BAYER, the Bayer Cross and Aliqopa are registered trademarks of Bayer.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

______________________________________________________________________________

References

  1. Matasar, M., Capra, M., Özcan, M., et.al. CHRONOS-3: randomized Phase III study of copanlisib plus rituximab vs rituximab/placebo in relapsed indolent non-Hodgkin lymphoma (iNHL) CT001. In: Proceedings of the 112th Annual Meeting of the American Association for Cancer Research; 2021 April 10-15. Philadelphia (PA): AACR; 2021. Abstract CT001
  2. ClinicalTrials.gov. Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin’s Lymphoma (iNHL) (CHRONOS-3). Available online: https://clinicaltrials.gov/ct2/show/NCT02367040. Last Accessed: March 2021.
  3. Aliqopa (copanlisib) for injection [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; November 2020.
  4. Scott, W.J., Hentemann, M.F., Rowley, R.B., et al. ChemMedChem 2016, 11, 1517-1530. Discovery and SAR of novel 2,3-dihydroimidazo[1,2-c]quinazoline PI3K inhibitors: Identification of copanlisib (BAY 806946).
  5. Dreyling, M., Santoro, A., Mollica, L., et al. J. Hematol. 2020, 95, 362-371. Long-term safety and efficacy of the PI3K inhibitor copanlisib in patients with relapsed or refractory indolent lymphoma: 2-year follow-up of the CHRONOS-1 study.
  6. World Cancer Research Fund. Worldwide cancer data: Global cancer statistics for the most common cancers. Available online: https://www.wcrf.org/dietandcancer/cancer-trends/worldwide-cancer-data. Last Accessed: March 2021
  7. Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R.L., Torre, L.A. and Jemal, A. (2018), Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68: 394-424. https://doi.org/10.3322/caac.21492

PP-ALI-US-0689-1 04/21

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Aliens must be out there

Why aren’t we looking for them?

 

— NYT: Top Stories

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Science

Chinese spacecraft enters Mars’ orbit, joining Arab ship

In this undated photo released by the China National Space Administration, a view of the planet Mars is captured by China’s Tianwen-1 Mars probe from a distance of 2.2 million kilometers (1.37 million miles). A Chinese spacecraft appears poised to enter orbit around Mars on Wednesday, Feb. 10, 2021, one day after an orbiter from the United Arab Emirates did so, and about a week ahead of an American attempt to put down another spacecraft on the surface of the red planet. (CNSA/Xinhua via AP)

 

BEIJING (AP) — A Chinese spacecraft went into orbit around Mars on Wednesday on an expedition to land a rover on the surface and scout for signs of ancient life, authorities announced in a landmark step in the country’s most ambitious deep-space mission yet.

The arrival of Tianwen-1 after a journey of seven months and nearly 300 million miles (475 million kilometers) is part of an unusual burst of activity at Mars: A spacecraft from the United Arab Emirates swung into orbit around the red planet on Tuesday, and a U.S. rover is set to arrive next week.

China’s space agency said the five-ton combination orbiter and rover fired its engine to reduce its speed, allowing it to be captured by Mars’ gravity.

“Entering orbit has been successful … making it our country’s first artificial Mars satellite,” the agency announced.

The mission is bold even for a space program that has racked up a steady stream of achievements and brought prestige to China’s ruling Communist Party.

If all goes as planned, the rover will separate from the spacecraft in a few months and touch down safely on Mars, making China only the second nation to pull off such a feat. The rover, a solar-powered vehicle about the size of a golf cart, will collect data on underground water and look for evidence that the planet may have once harbored microscopic life.

Tianwen, the title of an ancient poem, means “Quest for Heavenly Truth.”

Landing a spacecraft on Mars is notoriously difficult. Smashed Russian and European spacecraft litter the landscape along with a failed U.S. lander. About a dozen orbiters missed the mark. In 2011, a Mars-bound Chinese orbiter that was part of a Russian mission didn’t make it out of Earth orbit.

Only the U.S. has successfully touched down on Mars — eight times, beginning with two Viking missions in the 1970s. An American lander and rover are in operation today.

China’s attempt will involve a parachute, rocket firings and airbags. Its proposed landing site is a vast, rock-strewn plain called Utopia Planitia, where the U.S. Viking 2 lander touched down in 1976.

Before the arrival this week of the Chinese spacecraft and the UAE’s orbiter, six other spacecraft were already operating around Mars: three U.S., two European and one Indian.

All three of the latest missions were launched in July to take advantage of the close alignment between Earth and Mars that happens only once every two years.

A NASA rover called Perseverance is aiming for a Feb. 18 landing. It, too, will search for signs of ancient microscopic life, collecting rocks that will be returned to Earth in about a decade.

China’s secretive, military-linked space program has racked up a series of achievements. In December, it brought moon rocks back to Earth for the first time since the 1970s. China was also the first country to land a spacecraft on the little-explored far side of the moon in 2019.

China is also building a permanent space station and planning a crewed lunar mission and a possible permanent research base on the moon, though no dates have yet been proposed.

While most contacts with NASA are blocked by Congress and China is not a participant in the International Space Station, it has increasingly cooperated with the European Space Agency and countries such as Argentina, France and Austria. Early on, China cooperated with the Soviet Union and then Russia.

 

— Associated Press