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MedNess: bite-size biopharma and medtech news

5th August, 2020

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HIGHLIGHTS
Our Sponsors
Drug Approvals
FDA Approves Monjuvi + Lenalidomide combination for the Treatment of Adult R/R DLBCL Patients
"We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials," said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. "This approval marks an important step in MorphoSys' transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases."
FDA approved Tecentriq + Cotellic + Zelboraf for the treatment of BRAF V600 mutation-positive advanced melanoma patients
"When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "Today’s FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma."
European Commission grants accelerated approval to NTRK fusion+ve solid tumors and ROS1+ve advanced NSCLC patients
“We are excited to announce the approval of Rozlytrek in Europe for two indications, bringing patients with NTRK and ROS1 gene fusions a new effective treatment even when their cancer has spread to the brain,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This advance represents another important step forward in cancer care by allowing us to treat certain genetic drivers of cancer irrespective of the location of the tumour within the body. Roche is deeply committed to driving personalised healthcare and addressing the high unmet need in patients around the world with rare cancers.”
Regulatory News
FDA accepts BLA for Idecabtagene Vicleucel (Ide-cel, bb2121) for RRMM patients
  • BMS and bluebird bio submitted BLA to FDA for idecabtagene vicleucel (ide-cel; bb2121)
  • Ide-cel is a BCMA-directed CAR-T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma
  • This submission provides further details on the CMC module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from Mar 2020
  • Submission based on results from the Ph 2 KarMMa study evaluating the efficacy and safety of ide-cel in RRMM patients previously treated with an IMiD agent, a PI and an anti-CD38 antibody
  • Results from the study were shared during an oral presentation as part of the ASCO20 Virtual Scientific Program
  • Ide-cel was granted Breakthrough Therapy Designation (BTD) by the FDA, and PRIority MEdicines (PRIME) designation and validation of its Marketing Authorization Application (MAA) by the European Medicines Agency for relapsed and refractory multiple myeloma.
FDA Grants Priority Review to sBLA for KEYTRUDA + Chemotherapy for the Treatment PD-L1+ve mTNBC patients and accepts sBLA for KEYTRUDA for High-Risk Early-Stage TNBC patients
“There is a real need to advance new treatment options for triple-negative breast cancer, an aggressive form of the disease. The FDA’s acceptance of these KEYTRUDA applications for review is an important step toward helping patients with both early-stage and metastatic disease,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These acceptances mark the first U.S. applications for KEYTRUDA in breast cancer, and we look forward to working closely with the FDA to bring these new options to patients as quickly as possible.”
Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer
José Baselga, Executive Vice President, Oncology R&D said: “Patients with early-stage EGFRm lung cancer often experience recurrence even after successful surgery and adjuvant chemotherapy, yet there are currently no approved targeted treatments to improve outcomes. The Phase III ADAURA trial with Tagrisso demonstrated an unprecedented level of clinical benefit in these patients, and we are working closely with the FDA to deliver this potentially curative treatment to patients as quickly as possible.”
Click Here for more on Regulatory News
Trial Results
Positive Topline Results from Ph 3 APOLLO Study of Daratumumab + Pomalidomide and Dexamethasone in RRMM Patients
“We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone. The corresponding intravenous regimen was previously approved by the U.S. FDA based on the Phase1 single-arm EQUULEUS study,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Initial clinical data from Part B of Ph 1/2a study of GEN-009 + checkpoint inhibitor-based regimens (CPI) in advanced solid tumors presented
“We are incredibly encouraged by these initial results,” said Dr. Gillison. “The breadth and magnitude of immune responses validate the complete and partial responses observed in the five patients evaluated. We believe incorporating GEN-009 into standard-of-care immunotherapy regimens may help boost the effectiveness of immune checkpoint inhibitor therapy in patients with advanced disease.”
Trial/Program Status
BET inhibitor ZEN-3694 to be advanced in mCRPC and TNBC, respectively
“Merck, Pfizer, UCSF and Newsoara now form an impressive list of collaborators involved in our development of ZEN-3694 in epigenetic combination therapy programs. We have made significant progress with ZEN-3694 towards multiple registration-enabling studies,” said Donald McCaffrey, President and CEO of Zenith. “I am extremely pleased to report that the newest Phase 2 prostate cancer trial, involving ZEN-3694, is a triple combination clinical study – combining our BET inhibitor, ZEN-3694, Pfizer’s enzalutamide (Xtandi) and Merck’s pembrolizumab (Keytruda), led by UCSF as the principle investigator. This is an exciting novel approach of regulating certain cancer gene expression, addressing targeted therapy resistance and working in concert with the body’s own immune system, respectively. It is clear that our differentiated and leading BET inhibitor, ZEN-3694, is safe and active and able to combine with multiple targeted agents used in today’s precision oncology market.
Click Here for more on Trial/Program Status
Collated by : Richa Tewari, PhD
MedNess Reviews
FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection
The first two COVID-19 serology tests gets the FDA nod of approval. The ADVIA Centaur COV2G and Atellica IM COV2G test, both developed by Siemens are both semi-quantitative tests, that estimates the quantity of patient antibodies developed in response to COVID-19 infection in patients.
Even though, the presence of having antibody against the Covid-19 virus is not a guaranteed to make one immune to future infections or relapse, this tests definitely helps us understand how the the antibody levels are developed and their longevity in affected individuals and may help us understand more about the body’s immune response against the virus.
With an extremely high-specificity (Atellica IM: 99.95%, ADVIA Centaur XP/XPT: 99.89%) these serological tests can certainly rule out false-positive tests in a population with a high level of infection rate.
The semi-quantitative IgG result is crucial also to access an individual’s immunity. Clinicians will have a baseline and have a clearer understanding of an individual’s immune response to the SARS-CoV-2 virus.
Collated by : Tanmoy Samaddar
Medness Business
Onco-News

BioNTech and Regeneron to Advance FixVac and Libtayo® (cemiplimab) Combination in Melanoma
“Despite recent treatment advances with anti-PD-1 therapies for patients with melanoma, most patients fail to obtain a durable benefit. The combination of Libtayo and BNT111 FixVac has the potential to augment the immune system’s ability to effectively recognize melanoma in multiple ways and hopefully improve immune targeting to control the cancer,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational Science and Oncology, at Regeneron.

Cytovia Therapeutics Acquires Worldwide Rights to CytoImmune Therapeutics’ EGFR Dual-targeting CAR for NK Cell Treatment of GBM & Other Solid Tumors
Dr. Daniel Teper, Chairman and CEO of Cytovia added: “We are honored to collaborate with Dr. Caligiuri, a pioneer in translating biological research on NK cells into impactful therapeutics. He has published solid data with intracranial injection of EGFR CAR NK cells to support their clinical development in glioblastoma. Additionally, EGFR is a clinically validated target which will allow us to expand the use of NK cellular therapy in multiple solid tumors.”
Strata Oncology Announces Partnership with BioMed Valley Discoveries to Accelerate Enrollment in ERK Inhibitor Study
“This partnership with BioMed Valley Discoveries supports our commitment to improving the lives of patients with cancer by providing local access to promising investigational therapies,” said Dan Rhodes, Ph.D., CEO of Strata Oncology. “We are confident our network of health system partners, standardized on the Strata Trial, will help drive rapid enrollment of this important study.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech
$249 million worth of contracts handed to seven diagnostic companies by NIH for their COVID-19 testing platforms
News came in on July 31st 2020, that National Institute of Health’s (NIH) Rapid acceleration diagnosis program (RADx) has handed out $248.7 million worth of contracts across seven diagnostic companies, after evaluating them in a competitive bidding for funding. Together, these companies should expand the daily COVID-19 testing capacity by 2%- covering 6 million people, a leap from the current 823000 tests administered daily.
Mesa Biotech: will use a palm sized detector for testing COVID-19 from nasal swabs, within 30 minutes, using reverse transcription-polymerase chain reaction (RT-PCR). Award amount: $15.4 million.
Quidel Corporation: will use nasal swab material in a 15 minutes collection to results testing for COVID-19 using immunofluorescence-based lateral flow immunoassay identifying SARS-CoV 2 nucleocapsid proteins (Sofia SARS Antigen FIA test kit). Another platform delivers results from 50 samples within an hour (The Read Now or Batch Test Mode). Award amount: $71 million.
Talis Biomedical Corporation: will return test results within 30 minutes using isothermal amplification of viral RNA and an optical detection system, that stores generated data on cloud. Award amount: $25 million.
Ginkgo Bioworks: will use NGS based viral DNA/RNA screening and can scale up to 50,000- 100,000 tests per day, providing results by 24-48 hours from sample collection. Award amount: $40 million.
Helix OpCo: will scale daiy test numbers to 100,000/ day by bulk shipping samples to public healthcare departments and relevant healthcare systems to obtain results within 24-48 hours. Its own testing platform includes real-time RT-PCR for SARS-CoV2 nucleic acid detection. Award amount: $33.4 million.
Fluidigm Corporation: will upscale its microfluidics technology in COVID-19 testing, covering 6000 samples in 24 hours. Award amount: $37 million.
Mammoth Biosciences: will upscale its CRISPR-based COVID-19 detection system (called DETECTR test), to enable commercial labs across US to be able to use its technology for COVID-19 testing. Award amount: undisclosed.
Sanofi-GSK collaboration gains $2.1 billion warp speed funding to provide free 100 million doses to the US of their COVID-19 vaccine
On July 31st 2020, Sanofi and GSK announced their COVID-19 vaccine collaboration received $2.1 billion federal backing to support the program through clinical trials, manufacturing upscale and delivering the first 100 million doses- free of charge- to the US government. Majority of the funding is mobilized towards Sanofi’s recombinant protein based COVID-19 vaccine development. The US government has a further option to procure additional 500 million doses in the future.
“The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone…From the beginning of the pandemic, Sanofi has leveraged its deep scientific expertise and resources to help address this crisis, collaborating with the U.S. Department of Health and Human Services to unlock a rapid path toward developing a pandemic vaccine and manufacturing at large scale. With our partner GSK, we expect our Phase 1/2 study for the recombinant adjuvanted approach to start in September.”- Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.

 
Click Here for more news and details on mergers, acquisitions and business updates
Collated by : Divyaanka Iyer
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Tanmoy Samaddar
MedNess Reviews
Divyaanka Iyer
BioPharma News
Debarati Banik
HealthIT
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing 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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Content Editors: Richa Tewari , Esha SehanobishDivyaanka Iyer, Arundithi AnanthanarayananDebarati BanikTanmoy SamaddarMayur Vadhvani and Abhinav Dey 
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