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MedNess: bite-size biopharma and medtech news

25th August, 2020
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HIGHLIGHTS
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Onco I-Analyse
BMS to acquire Forbius, adding Forbius’ lead TGF-β asset to its portfolio
On 24th August, BMS announced that it has entered into a definitive agreement to acquire Forbius, a privately held, clinical-stage protein engineering company developing biotherapeutics for the treatment of cancer and fibrotic diseases.
The deal which includes an undisclosed, upfront payment and future success-based milestone payments is expected to close by Q4 2020. Under the agreement, BMS will acquire Forbius’ TGF- β program, including the program’s lead investigational asset, AVID200. Forbius’ non-TGF- β assets will be spinned-off into a newly formed private company, owned by Forbius’ existing shareholders before the close of acquisition.
AVID200, a highly potent and isoform-selective TGF-β inhibitor, neutralizes TGF- β1 and - β3 with picomolar potency and is currently in phase I development for advanced or metastatic solid malignancies. TGF-β is implicated in the inhibition of anti-cancer immunity in the tumor microenvironment via its profound local immunosuppressive and immunoexclusion effects and in the promotion of metastases due to epithelial-to-mesenchymal transition. Research links these effects to resistance to anti-PD-(L)1 therapies and the failure of immune checkpoint inhibitors (CHKPTi) in several tumors. Selective inhibition of TGF-β1 & 3 is considered to enhance the anti-tumor efficacy by acting synergistically with immunotherapies, with a potential to treat patients who “may not respond to immunotherapy”, including BMS’ Opdivo.
The potential of TGF- β pathway to improve outcomes in cancer patients has drawn attention of other big pharma players as well. Notably, some of these agents targeting the pathway, include Merck’s bintrafusp alfa (bifunctional fusion protein immunotherapy targeting PD-L1 and TGF-β RII), Pfizer’s PF-06952229 (TGF-β1 inhibitor), Novartis’ (TGF-β1 inhibitor) in clinical development across solid tumors. This widespread interest showcases an untrapped commercial opportunity by promising response in CHKPTi-resistant/non-responsive patient population.
Just barely a week ago, BMS acquired Dragonfly’s IL-12 immunotherapy program, including DF6002 to advance the R&D in oncology and hematology. With these acquisitions, BMS is bolstering its oncology pipeline to address areas of high unmet need.
Collated by :Shilpa Rawal, PhD
COVID19 Special
FDA issues an Emergency Use Authorization (EUA) for convalescent plasma as a potential treatment for COVID-19
FDA issued an EUA for the use of investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients. Based on the data available so far, the FDA has concluded that convalescent plasma may be useful in treating COVID-19 and the potential benefits outweigh the potential risks of the product. Although further research will be needed to determine the full spectrum of its effectiveness as a treatment.
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus,” said Stephen M. Hahn, M.D., FDA Commissioner

Roche and Regeneron announce their collaboration to increase the global supply of an investigational antibody cocktail for COVID-19
Roche and Regeneron recently announced their collaboration to significantly increase an antibody cocktail for COVID-19 called REGN-COV2. This antibody cocktail is presently in the late-stage clinical trials for COVID-19 treatment and prevention. Due to this collaboration, the overall number of doses that will be available to the patients globally, will increase since the overall supply of REGN-COV2 is expected to increase by atleast two to three times the current capacity. Based on the collaboration agreement, Roche will distribute the antibody cocktail outside the US, whereas Regeneron will be responsible for distributing within the country.
"Regeneron has progressed the REGN-COV2 research and development program at record speed and worked tirelessly to maximize our in-house manufacturing capacity," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the globe." "We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN-COV2 could be a critical line of defense against the COVID-19 pandemic," said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. "We're committing our manufacturing expertise and capacity, and our global distribution network, to bring Regeneron's potential antibody combination to as many people around the world as we possibly can."
Click Here for more COVID19 special
Collated by :  Esha Sehanobish, PhD
Drug Approvals
Imfinzi approved in Japan for the treatment of ES-SCLC based on Ph 3 CASPIAN trial data
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “This approval of Imfinzi provides an important new immunotherapy option in Japan for patients with extensive-stage small cell lung cancer. These patients have an especially poor prognosis, with only two per cent surviving beyond five years. Imfinzi, in combination with chemotherapy, delivers a sustained survival benefit and prolonged treatment response with a convenient dosing regimen given every four weeks during maintenance.”
FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for RRMM Patients based on Ph 3 CANDOR & Ph 1b EQUULEUS studies
“The significant increase in progression-free survival (PFS) seen among patients receiving the DKd regimen supports the use of this new combination for patients with relapsed and refractory multiple myeloma. We continue to advance effective regimens for the most critical patients who have already relapsed,” said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Atrium Health’s Levine Cancer Institute, and principal investigator of the CANDOR study. "The DKd regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug-based therapy, such as lenalidomide-containing regimens, and therefore new therapeutic options are needed."
Regulatory News
FDA awards Fast Track Designation to Paxalisib For Glioblastoma
Kazia CEO, Dr James Garner, commented, “in awarding Fast Track Designation to paxalisib, FDA has recognised the drug’s potential to meaningfully improve outcomes for patients with glioblastoma. This is a very powerful acknowledgement. The opportunities that Fast Track Designation creates, as we move towards an NDA filing, are of great value and have the potential to substantially accelerate the commercialisation of paxalisib. In particular, the ‘rolling review’ process enables Kazia to complete and submit substantial sections of our NDA filing in advance, saving time and reducing risk for the product. We look forward to working closely with FDA as we move into the final stage of development for paxalisib.”
MAA Submitted to EMA for Glioblastoma Immunotherapy, SITOIGANAP 
Apostolos Stathopoulos, MD, PhD, President and CEO of ERC Worldwide commented, “We are excited to see such strong results from SITOIGANAP, especially the high number of patients going into remission. The beneficial advantage that we are bringing to patients suffering from this orphan disease like GBM is groundbreaking, especially being able to help those patients who have advanced to a stage without alternative therapeutic options.”
Click here for more Regulatory News
Trial Results
KEYTRUDA® + Chemo Significantly Improved OS & PFS vs chemo in Locally Advanced or 1L Metastatic Esophageal Cancer
“Esophageal cancer is a devastating malignancy with a high mortality rate and few treatment options in the first-line setting beyond chemotherapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “In this pivotal study, KEYTRUDA plus chemotherapy resulted in superior overall survival compared with the current standard of care in the full study population and across all patient groups evaluated. These results build upon our research reinforcing the survival benefits of KEYTRUDA, and we look forward to engaging regulatory authorities as quickly as possible.”
FAILED TRIAL: Ph 3 COMBI-i trial of spartalizumab (PDR001) + Tafinlar® + Mekinist® in advanced BRAF V600-mutated melanoma patients did not meet primary endpoint of PFS improvement
“While the COMBI-i trial did not reach its primary endpoint, the study’s findings give us valuable insights into the role the investigational immunotherapy spartalizumab may play in future cancer therapy combinations and underscore the previously established importance of Tafinlar + Mekinist for these patients,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “Novartis remains committed to melanoma patients through ongoing research, and we continue to deliver the approved combination therapy Tafinlar + Mekinist to patients around the world. We extend our gratitude to the patients and investigators who participated in the COMBI-i study. Their partnership has expanded our understanding of spartalizumab and its potential role in future cancer treatments.”
Click here for more Trial Results
Trial/Program Status
Ph 2 ARTISTRY-3 trial of ALKS 4230 monotherapy initiated in a variety of advanced, malignant solid tumors
"Early clinical data from our ARTISTRY program showed that ALKS 4230 selectively expanded cancer-fighting immune cells in the periphery, with negligible effects on regulatory T cells (Tregs)," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "Data from the ARTISTRY-3 clinical trial will provide a deeper understanding of the effects of ALKS 4230 on immunologic activity in the tumor microenvironment across a variety of tumor types. Findings from this trial may help us answer important mechanistic questions and identify the tumor types for which ALKS 4230 could offer the most clinical benefit, thereby helping to inform a potential registration strategy." 
Click here for more Trial Progress
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
Leveraging big data to reopen schools
Reopening schools in a safe manner has been a nationwide concern during the COVID-era. The leaders in the school system have proposed a big data-centric dashboard to monitor the spread of virus among students, faculty and staffs. While it remains as a state of the art, still to be implemented system, Boston University has gone live by testing and implementing a data visualization resource that allows users to track the number of tests conducted, as well as the number of negative, positive, or inconclusive cases, which will be updated daily to include the cumulative vs. day-to-day counts. Heat maps will also be constructed to indicate hot spots (cluster of positive tests) within the campus. West Virginia University (WVU) have taken a similar approach launched since August 3rd and is combining the use of a dashboard, social media platforms and newsletter to alert the people in the university. WVU students testing positive will be contacted by their local health departments to get advice on symptom onset, recommendations for isolation and testing, and for conduct contact tracing.
Deep learning techniques to differentiate COVID19 from the other flu-related lung injuries
During the initial period of outbreak, CT scans were a decisive readout for the initial evaluation of COVID19-affected lungs in the patients, a trend widely used in Wuhan China and northern Italy. However, soon it was realized that CT evaluation cannot distinguish between COVID19 vs. other influenza-associated pneumonias due to similar radiographic presentation. Therefore, clinicians are now discouraged from using these medical images for coronavirus diagnosis. On the other hand, need of a supplemental technique that can distinguish between these pathological types is ever increasing to strengthen support toward use of CT in diagnostic settings. A collaborative team between NIH and NVIDIA worked on developing a deep learning algorithm to detect COVID-19 on chest CT and used data from a globally diverse, multi-institutional dataset: from hospitals of China, Italy, and Japan, to capture a wide variety in clinical timing and practice for CT during the outbreak. By using 2,724 scans from 2,619 patients, they identified two models (full 3D vs. hybrid 3D) for identification of a COVID-lung, each of which yielded an accuracy rate of 91.7 and 92.4%, respectively. While this combination of classical medical tool with AI is going to be instrumental during the COVID-era, researchers are hopeful that the implication of this model can be utilized in future as well.
Collated by :  Debarati Banik
MedNess Reviews
FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment
The FDA has granted an emergency use authorization(EUA) for investigational convalescent plasma for the treatment of COVID-19 patients. Based on on-going scientific experimental results, FDA had concluded the convalescent plasma therapy as an effective and treatment strategy with potential benefits that outweigh the potential risks of the product.
The EUA authorizes the distribution and administration of COVID-19 plasma by health care providers in the U.S. The FDA’s Center for Biologics Evaluation and Research claimed that the statutory criteria for issuing an EUA was met based on all scientific evidence.
After an initial traditional clinical trials and emergency single-patient investigational new drug (IND) application was successful, an Expanded Access Program for convalescent plasma was initiated in early April. With a growing demand for single patient IND requests, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. 
The EUA remains in effect and may be revised or revoked if it is determined that the  EUA no longer meets the statutory criteria for issuance.
Collated by :  Dr. Tanmoy Samaddar
Medness Plus
FDA approves treatment for neuromyelitis optica spectrum disorder, a rare condition affecting optic nerves and the spinal cord
FDA recently approved Enspryng (satralizumab-mwge) for the treatment of a rare neurological disease called neuromyelitis optica spectrum disorder (NMOSD) in adults that affects the optic nerves and the spinal cord. It is third to be approved for NMOSD. It is mainly effective for patients who are aquaporin-4 antibody positive. Enspryng received a fast track designation and an orphan drug designation.
“Until last year, there were no FDA-approved treatments for patients with this rare, debilitating and sometimes fatal disease. Now there are three,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Enspryng highlights the FDA’s commitment to rapidly advancing safe and effective therapies for NMOSD and other neurological diseases.”
Johnson and Johnson will acquire Momenta Pharmaceuticals, to expand its leadership into autoimmune diseases
Johnson and Johnson announced its agreement to acquire Momenta Pharmaceuticals, Inc. The latter is a company that specializes in developing treatments for immune-mediated diseases. The approximate cash transaction was for $6.5 billion. Janssen will retain the presence of Momenta in Cambridge, MA.
“Nipocalimab, and the rest of Momenta’s pipeline, built over many years by outstanding scientists who have turned important insights into actionable biology, expands and complements our portfolio by giving us clinical-stage and discovery-stage compounds in autoantibody biological pathways. Combining Momenta’s discoveries with our 20-year heritage in immunology, global scope, and scientific and medical expertise, we see a real opportunity to create an entire ‘pipeline in a pathway,’” said Mathai Mammen, M.D., Ph.D., Global Head of Janssen Research & Development, Johnson & Johnson. “We are excited about the significant potential to expand on Momenta’s excellent progress in rare diseases, and to increase our impact on patients both within and beyond our current focus areas.”
Click here for more MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

Gilead Sciences and Tango Therapeutics to Expand Strategic Oncology Collaboration
“Since we signed the original agreement two years ago, we have been very pleased with the productivity of the collaboration and with the quality of scientific discovery that has come from this partnership,” said William A. Lee, PhD, Executive Vice President of Research at Gilead Sciences. “We are looking forward to working with Tango to run additional cancer context dependent screens to identify a broader set of targets based on our immuno-oncology strategy.”
Lilly and Innovent Announce Global Expansion of TYVYT Licensing Agreement
"We are thrilled to expand on our successful China TYVYT collaboration with Lilly to now include markets outside of China. This agreement also marks the first solid step in getting Innovent's innovative portfolio into the global market," said Michael Yu, Ph.D., Founder, Chairman and CEO of Innovent. "We are confident that pairing Lilly's global commercial expertise with TYVYT's clinical profile will further accelerate our mission, benefitting patients globally."
Junshi Biosciences and Impact Therapeutics to Develop Senaparib (IMP4297) in China
“Impact Therapeutics is a leader among domestic targeted anti-tumor drug discovery companies. We are excited to have the opportunity to partner with Impact to bring domestic innovation to benefit patients in China and beyond. Data showed that Senaparib (IMP427) has superior safety and has the potential to be the best-in-class, which means that IMP427 has great potential as a monotherapy as well as in combination with other agents,” said Ning Li, M.D., Ph.D., Chief Executive Officer of Junshi Biosciences.
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Tanmoy Samaddar
MedNess Reviews
Divyaanka Iyer
MedNess Reviews
Debarati Banik
HealthIT
Abhi Dey
Consulting Editor
Shilpa Rawal, PhD
Onco I-Analyse
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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