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MedNess: bite-size biopharma and medtech news

14th April, 2020
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HIGHLIGHTS
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COVID Special
Johnson and Johnson announce the selection of a lead candidate for COVID-19
Johnson and Johnson recently announced the selection of a lead vaccine candidate for COVID-19. The company has been working on a wide range of these constructs since January 2020. The company has been working in collaboration with BARDA (Biomedical Advanced Research and Development Authority) to screen Janssen’s library of antiviral molecules in order to develop a potential vaccine for coronavirus.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “We greatly value the U.S. government’s confidence and support for our R&D efforts. Johnson & Johnson’s global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities. We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”
FDA issues an emergency use Authorization for a blood purification system to treat adult COVID-19 patients
“We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies,” said FDA Commissioner Stephen M. Hahn, M.D. “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease. Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”
FDA issues a second emergency use authorization to decontaminate N95 or N-95 equivalent respirators
“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” said HHS Secretary Alex Azar. “Thanks to rapid work by the men and women of the FDA and President Trump’s vision for an all-of-America response, innovators are giving our healthcare warriors new tools nearly every day to fight the COVID-19 pandemic.” “This EUA is another game changer. It will allow hospitals to decontaminate compatible N95 respirators using vaporized hydrogen peroxide sterilizers that are readily available in approximately 2,000 U.S. hospitals,” said FDA Commissioner Stephen M. Hahn, M.D. “It’s another important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by health care personnel on the front lines of the COVID-19 pandemic.”
Gilead Sciences announce results from a study of a cohort of COVID-19 patients who were treated with the investigational antiviral remdesivir
“While the outcomes observed in this compassionate use analysis are encouraging, the data are limited,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Gilead has multiple clinical trials underway for remdesivir with initial data expected in the coming weeks. Our goal is to add to the growing body of evidence as quickly as possible to more fully evaluate the potential of remdesivir and, if appropriate, support broader use of this investigational drug.” “Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful," said Jonathan D. Grein, MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
 
Click Here for more details and updates on COVID19
Drug Approvals
FDA approves BRAFTOVI® (encorafenib) + cetuximab (ERBITUX®) combination for the treatment of adult mCRC patients with BRAFV600E mutation based on results from Ph 3 BEACON CRC trial
“We are pleased by the FDA’s approval of BRAFTOVI in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We are grateful to the patients and study investigators who participated in the Phase 3 BEACON CRC trial and are proud to now be able to offer a targeted treatment option for people with BRAFV600E-mutant metastatic CRC who have received prior therapy. Looking ahead, we’re committed to continuing to investigate this treatment regimen across earlier lines of therapy.”
Regulatory News
Priority Review from FDA to KEYTRUDA® (pembrolizumab)’s sBLA based on Biomarker, Regardless of Tumor Type
“From the start, biomarker research has been a critical aspect of our clinical program evaluating KEYTRUDA monotherapy,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “TMB has been an area of scientific interest to help identify patients most likely to benefit from KEYTRUDA. We look forward to working with the FDA throughout the review process to help bring KEYTRUDA monotherapy to patients with cancer in the second-line or higher treatment setting, where options remain limited.”
Fast Track Designation Granted to Sacituzumab Govitecan for Metastatic Urothelial Cancer
“Coming in the wake of a recent unanimous recommendation by the independent Data Safety Monitoring Committee for the ASCENT study to stop the trial due to compelling evidence of efficacy in metastatic triple-negative breast cancer, it is gratifying to learn of the FDA’s recognition of sacituzumab govitecan’s potential in urothelial cancer, an important second indication for our lead antibody-drug conjugate. With the upcoming maturation of the data from the 100-patient cohort with prior platinum-based and PD-1 or PD-L1 inhibitor therapies, and based on the Fast Track designation, we will actively seek guidance from the FDA on a potential accelerated approval pathway,” said Loretta M. Itri, M.D., Chief Medical Officer at Immunomedics.
Click Here for more Regulatory News
Trial Results
Positive Topline Results Announced from Interim Analysis of Ongoing Ph 2 Trial of STP705 in Cutaneous Squamous Cell Carcinoma in situ (isSCC) Patients
“It is very exciting to unveil the results from the interim analysis from our first clinical oncology study. This marks a significant milestone as evidenced by the large portion of the patients treated with STP705 for isSCC meeting the primary endpoint with a dose dependent manner. This interim clinical readout not only demonstrates the potential of RNAi therapeutics in the oncology application, but also illustrates the potential safety and efficacy of polypeptide nanoparticle delivery for siRNA therapeutics. In addition, the profound therapeutic efficacy further validates TGF-β1 and COX-2 as an important cancer drug target and our dual-targeting strategy for novel RNAi cancer therapeutics,” said Patrick Lu, Ph.D., President and CEO of Sirnaomics. “These efficacy and safety results from the interim report stalwartly demonstrates our leadership position at the forefront of RNAi cancer therapeutics.”
Updated data announced from ongoing Ph 2 1L GBM trial of AV-GBM-1
“Although treatment and monitoring of patients is ongoing, we are very encouraged by these interim results,” said Dr. Robert O. Dillman, AIVITA Chief Medical Officer. “We completed accrual to the trial ahead of schedule, thanks to the engagement of our clinical site principal investigators and a truly outstanding manufacturing success rate at AIVITA.”
Trial/Program Status
Ph 3 ASCENT trial of sacituzumab govitecan in mTNBC patients to be stopped for compelling efficacy
“We want to thank the members of the DSMC for their guidance,” said Loretta M. Itri, MD, Chief Medical Officer of Immunomedics. “This strengthens our resolve to complete the analysis and reporting of the final study results, thereby allowing these data to become available to physicians caring for the TNBC community in a timely fashion.”
Tagrisso Phase III ADAURA trial to be unblinded early after overwhelming efficacy in the adjuvant treatment of EGFR-mutated NSCLC patients
José Baselga, Executive Vice President, Oncology R&D, said: "We are thrilled by the recommendation to unblind the Phase III ADAURA trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure."
Click Here for more Trial/Program Status
Collated by : Richa Tewari, PhD
MedNess Plus
FDA approves Sevenfact for the treatment of adults and adolescents with hemophilia A or B with inhibitors
“Based on a comprehensive analysis of the scientific evidence, the FDA determined that the rDNA construct inserted in the rabbit’s genomic DNA is safe for the animal and for the people handling the rabbits, and is effective in causing Human Factor VII (hFVII) protein to be expressed in the rabbits’ milk,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “The FDA has also determined under the National Environmental Policy Act that approval of the application will have no significant impact on the environment.”
FDA issues an announcement to withdraw all prescription and over-the-counter ranitidine drugs from the market effective immediately
“The FDA is committed to ensuring that the medicines Americans take are safe and effective. We make every effort to investigate potential health risks and provide our recommendations to the public based on the best available science. We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”
Click Here for more on MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

Zai Lab to develop and exclusively commercialize REGN1979 in oncology in mainland China, Hong Kong, Taiwan and Macau
"Zai Lab is an ideal collaborator for us, with an established and respected track record that aligns with our mission to use the power of science to repeatedly bring new medicines to patients with serious diseases," said Israel Lowy, M.D., Ph.D., Senior Vice President and Head of Clinical and Translational Sciences for Oncology at Regeneron. "Zai's support will not only help bolster enrollment into global REGN1979 trials, but will also enable this promising investigational medicine to reach patients faster in this key region, if approved."
T-cure Bioscience and NCI to develop T cell receptor therapy for treatment of solid tumors
“We are extremely excited to work with Dr. Hinrichs and his team at NCI to advance this novel TCR product candidate through preclinical and clinical development,” stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. “Dr. Hinrichs’ extensive experience in the discovery and development of novel adoptive T-cell therapies for cancer will be invaluable as we advance this program. Of note, the TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to an immunotherapy without any toxicities. As a result, we believe it holds great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without harming healthy tissue.”
Collated by : Richa Tewari, PhD
Bio-Pharma and MedTech

Gilead collaborates with Second Genome for microbiome-based solutions to drug development for inflammatory diseases
Gilead Sciences, Inc. (Gilead; HQ Foster City, CA) has inked a potential $1.5 billion deal with Second Genome, Inc. (Second Genome; San Francisco, CA) on April 6th 2020. Second Genome, a clinical-stage company, will be working towards finding microbiome-based biomarkers and drug candidates to inflammatory diseases like inflammatory bowel disease (IBD) and fibrosis. “There is a growing body of evidence that the microbiome plays an important role in disease progression and treatment response in inflammatory diseases,” said William Lee, PhD, Executive Vice President of Research, Gilead Sciences.
Pandion Therapeutics raises $80 million in series B funding for bispecific antibodies to immune system disorders
Pandion Therapeutics (Pandion, Boston MA) is a start-up making bispecific antibodies to cure autoimmune disorders. Pandion has technological platforms that can create combinations for the effector and tether modules, taking into account the stoichiometry and geometry for good arrow head binding and functional screens for tissue specific tether.
Pandion is collaborating with Astellas for developing pancreas specific tissue tethers, for autoimmune type-1 diabetes. The company is further looking to expand its disease portfolio to inflammatory bowel disease, autoimmune liver and skin diseases. For these plans, Pandion has raised $80 million in series B funding (1st April 2020) from investors including Access Biotechnology, Boxer Capital, RA capital and OrbiMed.
OraSure Technologies bags BARDA funding to develop in-home rapid detection test kit for COVID-19
Orasure Technologies (OraSure; BETHLEHEM, Pa) has received funding of $710,310 from U.S. federal government’s Biomedical Advanced Research and Development Authority (BARDA) for fast tracking its in-house rapid detection system for SARS-CoV2. The announcement was made on 6th April 2020. The in-house self-test kit is based on oral fluid sample collection; and detects antigens of SARS-CoV2 and other coronaviruses which could cause severe respiratory disease such as the strain of the 2000 SARS outbreak. The stick test takes 20 minutes to produce results that would show 2 bands (control and test) in case of positive infection, akin to the readout of standard over the counter pregnancy tests. The goal envisioned by OraSure and BARDA is for asymptomatic carriers of SARS-CoV2 to be able to easily and painlessly detect their carrier status so as to enable quarantine and follow up measures. The company anticipates rolling out the tests to scale in 4 to 6 months’ time.
Click Here for more 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
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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