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MedNess: bite-size biopharma and medtech news

31st March, 2020
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MedNess This Week
HIGHLIGHTS
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Drug Approvals
Imfinzi approved in the US for 1L ES-SCLC based on positive results from Ph 3 CASPIAN trial
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options. Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease.”
ENHERTU® Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer
“Our researchers in Japan have worked diligently on our ADC technology and we are excited to bring ENHERTU®, the first of many ADCs we have in development, to patients with HER2 positive metastatic breast cancer in Japan. Results seen with ENHERTU® are impressive as most women benefited from treatment with durable responses lasting a median duration of more than 14 months,” said Wataru Takasaki, PhD, Corporate Officer, Head of Oncology Function and Head of R&D Division in Japan, Daiichi Sankyo. “ENHERTU® also represents the second innovative treatment to be approved in Japan from our oncology pipeline within the past year, a milestone we are extremely proud of as we work to transform science into meaningful treatments for patients with cancer.”
MHLW (Japan) approves TEPMETKO®* (tepotinib) for the treatment of unresectable, advanced or recurrent NSCLC patients with METex14 skipping alterations
“With TEPMETKO, we are pleased to offer the first approved MET inhibitor in Japan, and a new option that can change the course of treatment for non-small cell lung cancer harboring METex14 skipping alterations,” said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany. “With a focus on identifying these alterations in NSCLC patients with flexibility and precision, the companion diagnostic to TEPMETKO offers both liquid and tissue biopsy testing capabilities to best support the delivery of this targeted therapy to the patients who may benefit.”
Regulatory News
Fast Track Designation granted to IPI-549 + Opdivo Combination for the Treatment of Advanced Urothelial Cancer
“Receiving Fast Track designation is an important recognition of the significant unmet need in advanced urothelial cancer and reflects the potential for IPI-549, in combination with Opdivo, to improve outcomes for these patients,” said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. “A retrospective analysis of Bristol Myers Squibb’s Checkmate-275 accelerated approval study of Opdivo monotherapy in patients with urothelial cancer revealed an important association between high baseline levels of myeloid derived suppressor cell (MDSC) and poor overall survival. These data, combined with our MARIO-1 data that showed IPI-549, both as a monotherapy and in combination with Opdivo treatment, is associated with a reduction in blood MDSC levels, inspired our MARIO-275 study with the goal of improving outcomes for urothelial cancer patients.”
Trial Results
Venclexta/Venclyxto Combination Improved OS in 1L AML Patients in Ph 3 VIALE-A study
“Acute myeloid leukaemia remains a challenging blood cancer, with particularly low median survival rates in patients who cannot tolerate intensive chemotherapy given their age or underlying health,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These data validate the benefit that this Venclexta/Venclyxto-based combination can bring to patients and we look forward to discussing the results with health authorities.”
OVATION 1 trial of GEN-1 in Ovarian Cancer Shows Strong PFS Treatment Effect Utilizing Medidata Synthetic Control Arm
“Acorn AI, by Medidata, is proud to partner with Celsion to create a Synthetic Control Arm for this important clinical trial in advanced ovarian cancer patients with unmet medical needs,” said Ruthie Davi, Ph.D., vice president, Data Science at Acorn AI, by Medidata. “This could have game-changing implications for patients, the medical community, and the industry. As demonstrated with the SCA for the OVATION I Study, we now have the opportunity to gain early scientific clarity to expedite the development of potentially life-saving treatments.”
Click Here for more Trial Results
Trial/Program Status
> 75% Patients enrolled in Ph 3 AVENGER 500 of CPI-613 ️ (devimistat) in Metastatic Pancreatic Cancer patients
'We are continuing to enroll patients ahead of schedule, as the patients in our trials suffer from life-threatening diseases and are in dire need of treatment; patient safety is our top priority,' said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. 'In order to support our clinical trial sites and enrolled patients during this unsettling and unprecedented time, we have established a COVID-19 task force to closely monitor our clinical trials and make changes as needed. We want to express our deepest gratitude to all of the principal investigators, nurses, hospital staff, patients and their families for their continued support and cooperation.'
AXL receptor tyrosine kinase (RTK) inhibitor, dubermatinib (TP-0903), Added to Ph 1b/2 Beat AML Umbrella Trial
"We believe the Beat AML Master Clinical Trial is changing the treatment paradigm for AML as well as for clinical trials more broadly across cancer types," said Amy Burd, Ph.D., Vice President of Research Strategy, The Leukemia & Lymphoma Society. "Through this trial, we have taken a tailored approach to treatment based on patients' unique genomic profile, with the ultimate goal of identifying safe and effective targeted therapies for patients who previously had limited options. LLS is pleased that Tolero Pharmaceuticals is joining this unprecedented collaboration of top cancer centers and scientists, several top pharmaceutical companies, the U.S. Food and Drug Administration and a leading-edge genomics company to bring novel targeted therapies to patients faster."
Click Here for more Trial/Program Status
Collated by : Richa Tewari, PhD
COVID-19 special
Diagnostics
FDA issues Emergency Use Authorization (EUA) for oral formulations for two anti-malarial drugs
FDA has issued an EUA for the emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19. This authorization will be limited to product supplied from the Strategic National Stockpile (SNS) to health authorities pursuant to section 564 of the Federal Food, Drug and Cosmetic Act. Pursuant to section 564 of the Act, the secretary of HHS determined that this was a public health emergency and that circumstances exist that justify the emergency use of the drugs during the pandemic. Both these drugs have not been FDA-approved for the treatment of COVID-19. Some versions of these drugs shown effectiveness in the treatment of diseases such as malaria. As of now there are anecdotal and limited in vitro data for chloroquine phosphate and hydroxychloroquine sulfate use in COVID-19.
FDA approves Emergency Use Authorization for point-of-care COVID-19 diagnostic
FDA recently issued the first EUA (Emergency Use Authorization) for Cepheid Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for COVID-19 caused by SARS-CoV-2 virus. This diagnostic test will be used in high-and moderate-complexity, CLIA-certified laboratories, along with certain patient care settings. Cepheid will be able to provide for this point-of-care testing by March 30th. By targeting multiple regions of the viral genome, the tests will make use of their current Xpert®Xpress Flu/RSV cartridge technology. The test intends to provide results in approximately 45 minutes with the preparation time for the samples being less than 1 minute. This will help in performing large number of tests that are required at the moment.
 

FDA approves Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test from Abbott to detect the novel coronavirus
FDA recently announced the approval of EUA for Abbott’s new and presently the fastest available point-of-care test for the detection of the presence of the novel coronavirus causing COVID-19. The test is known as Abbott ID NOW COVID-19 test.This test intends to generate positive results within 5 minutes and negative results within 13 minutes. The other advantage of this test is that it can be performed outside the confines of the hospital or clinics. Another advantage is that it is small in size hence can be used in different places without any problem and can fit in variety of locations. 

FDA releases a statement to alert consumers about fraudulent COVID-19 test kits
FDA recently released a statement to alert consumers about existing fraudulent COVID-19 test kits. FDA warns that at this time, they have not approved or authorized the use of any test that is available to purchase for testing at home by yourself for COVID-19. This is a part of FDA’s constant monitoring of the products in the market that falsely claim to be effective in detection, treating and preventing COVID-19. These fraudulent claims are extremely detrimental for the health and well-being of people during this pandemic. In case of symptoms, FDA has reminded consumers to refer to their healthcare practitioners who will then guide them to proper steps, instead of trying to look for unauthorized home testing kits. FDA has already released warning letters to many companies who have made false claims about treating and preventing COVID-19 and has asked consumers to report to the FDA if they see such fraudulent test kits.
Vaccine and antibody development

Pfizer and BIONTECH to jointly develop a potential COVID-19 vaccine
At present various pharmaceutical and biotechnology companies are collaborating to develop vaccines for COVID-19. Pfizer Inc. and Biopharmaceutical New Technologies (BioNTech) (a next-generation immunotherapy company) recently announced that they would co-develop and distribute a potential mRNA-based coronavirus vaccine to prevent COVID-19 infection. The distribution will exclude China. The companies at present have executed a Material Transfer and Collaboration Agreement to allow both the companies to start working together, immediately. The collaboration will build and extend on the collaboration into which Pfizer and BioNTech entered in 2018, to develop mRNA-based influenza vaccine.

Translate Bio and Sanofi will collaborate to develop a potential mRNA vaccine candidate against COVID-19
Sanofi Pasteur and Translate Bio recently entered into a collaboration to develop a novel mRNA-based vaccine for COVID-19. Translate Bio is a clinical-stage mRNA therapeutics company and Sanofi Pasteur is the vaccines global business unit of Sanofi. Their collaboration is an extension of an already existing agreement between the two companies from 2018 to develop mRNA vaccines targeted for infectious diseases. Sanofi has already announced its collaboration with BARDA (Biological Advanced Research and Development Authority to develop a novel vaccine for COVID-19. It will be a protein-based vaccine. The collaboration with Translate Bio is the second one for COVID-19, for Sanofi.

Johnson and Johnson and Beth Israel Deaconess Medical Center enter into collaboration to accelerate the development of COVID-19 vaccine
Janssen Pharmaceutical company announced its collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to advance the development of a vaccine for COVID-19. They are now carrying out preclinical testing of multiple vaccine in order to identify a potential candidate for further clinical trials. Janssen will use their AdVac® and PER.C6® technologies to develop the vaccine and rapidly increase the production. Along with venturing out into vaccine development, Janssen is also working with its global strategic partners to screen its library of antiviral molecules. This will be done to obtain a potential treatment for COVID-19.
Eli Lilly and AbCellera will collaborate to develop antibody therapies for COVID-19 treatment
Eli Lilly and Company and AbCellera have entered into a collaboration to co-develop antibody therapies for the prevention and treatment of COVID-19. The initial development costs of the product will be shared equally by the two companies. Following this, Eli Lilly will be responsible for the development, manufacturing and distribution. The collaboration will make use of AbCellera’s rapid pandemic response platform developed under DARPA Pandemic Prevention Platform (P3) Program and Lilly’s ability for fast development and processing of therapeutic antibodies.
Click Here for more updates on COVID19 global efforts
Collated by :  Esha Sehanobish, PhD
Medness Plus
FDA approves a supplemental application for Epclusa for the treatment of hepatitis C in children
FDA recently approved a supplemental application for a combination for the treatment of hepatitis C virus (HCV) in pediatric patients 6 years and older or those who weigh at least 17 kg and is effective in any of the six strains of HCV.
“This approval will provide additional treatment options for children and adolescents with HCV,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”
FDA issues a complete response letter for the sNDA for 2.5 mg of empagliflozin as adjunct to insulin for patients with type 1 diabetes
The FDA recently issued a complete response letter for the supplemental New Drug Application (sNDA) for 2.5 mg of empagliflozin as an adjunct to insulin for adult patients with type 1 diabetes. This medication is being developed by Eli Lilly and Company and Boehringer Ingelheim.
“The challenges of managing blood sugar levels for those with type 1 diabetes, and the desire for new treatment options, reveal important unmet needs in the diabetes community,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “We remain committed to the continued study of therapies that may improve outcomes for adults with cadiorenal metabolic conditions, including diabetes.”
Click Here for more on MedNess Plus
Collated by :  Esha Sehanobish, PhD
Medness Business
Onco-News

CytomX Therapeutics and Astellas to Develop Probody® T-Cell Engaging Bispecific Therapies for Treatment of Cancer
“This collaboration with Astellas leverages CytomX’s deep expertise in targeting multiple antibody modalities to the tumor microenvironment,” said Sean McCarthy, D. Phil., President, Chief Executive Officer and Chairman of CytomX. “We are excited about the use of our technology to assist Astellas in unlocking the potential of T-cell engaging bispecifics in the treatment of solid tumors, building on the growing proof of concept we have established for our platform.”
Agios Provides Update on 2016 Collaboration Agreement with Celgene (Bristol Myers Squib)
“We are grateful to Celgene, and now Bristol Myers Squibb, for their longstanding partnership, which has enabled important research and clinical development focused on the advancement of potential innovative treatment approaches for patients with cancer,” said Jackie Fouse, Ph.D., chief executive officer at Agios. “We are now evolving our relationship to enable both companies to advance our respective priorities with full strategic flexibility.”
Alphamab Oncology Announces Clinical Supply Collaboration with Pfizer on KN026 + Ibrance® (palbociclib) Combination
Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, “Through the collaboration with Pfizer, we are on the right track to investigate the combination of KN026 and a CDK4/6 inhibitor for patients with HER2-positive breast cancer as a chemo-free regimen. By combining KN026 with palbociclib , we believe it has the potential to provide more effective treatment options for patients with HER2 positive breast cancer.”
Collated by : Richa Tewari, PhD
BioPharma and MedTech

After COVID-19, Roche sets sight on Gram negative superbugs inking a $190.5 million deal with LpxC antibiotic maker Forge Therapeutics
On 25th May 2020, Roche signed a $190.5 million deal with Forge therapeutics (Forge) to license its FG-LpxC LUNG, a novel compound that inhibits Lipid A formation in antibiotic-resistant, Gram-negative bacteria including Pseudomonas aeruginosa.
“We look forward to combining our novel approach and innovative chemistry with Roche's proven drug development and commercialization expertise to provide a truly new class of antibiotic for people suffering from serious antibiotic-resistant infections.”- Zachary Zimmerman, Ph.D., CEO of Forge.

AstraZeneca and Silence Therapeutics collaborate over a $60 million deal to advance siRNA treatments to multiple organs
AstraZeneca and Silence Therapeutics (Silence) announced a collaboration to advance targeted siRNA treatments developed by the latter into disease areas spanning cardiovascular, renal, metabolic and lung diseases (25th March 2020).
 "This collaboration with Silence adds an exciting new modality, siRNA, into our drug discovery toolbox. Importantly we can apply this drug modality across our key therapy areas in cardiovascular, renal and metabolism and respiratory to target novel pathways not amenable to more traditional drug discovery approaches."- Mene Pangalos, EVP BioPharmaceuticals R&D, AstraZeneca.
Redpin Therapeutics secures $15.5 million in series A funding for its molecular switch-controlled chemogenetic treatments
Redpin Therapeutics (Redpin, New York), a pre-clinical chemogenetics company, has an interesting gene therapy platform conferring high specificity to target cells.
“We sort of the do the opposite of what has been done in the pharmaceutical industry for decades and decades. Instead of making small molecules for a biologic target or receptor, we pick a drug and then we make a very, very specific receptor for it. As long as these two molecules, the receptor and the small molecule, engage, you will have an effect on the neuron” – Elma Hawkins, CEO, Redpin.
Click Here for more details on these technologies, mergers and acquisitions
Collated by :  Divyaanka Iyer
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Debarati Banik
HealthIT
Divyaanka Iyer
MedNess Reviews
Nisha Peter, PhD
Managing Editor
Mayur Vadhvani, PhD
Consulting Editor
Abhi Dey
Consulting Editor
Ananda Ghosh, PhD
Founder
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The editors take care to share authentic information.  In case of any discrepancies please write to medness.newsletter@gmail.com
The sponsors do not have any influence on the nature or kind of the news/analysis reported in MedNess. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Medness. Examples of analysis performed within this article are only examples. They should not be utilized in real-world analytic products as they are based only on very limited and dated open source information. Assumptions made within the analysis are not reflective of the position of anyone volunteering or working for Medness. This blog is strictly for news and information. It does not provide medical advice, diagnosis or treatment nor investment suggestions. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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