View this email in your browser

MedNess: bite-size biopharma and medtech news

14th July, 2020
Subscribe here
MedNess This Week
HIGHLIGHTS
Our Sponsors
News Today
Biogen completes submission of BLA  for aducanumab as a treatment for alzheimer’s disease
“Alzheimer’s disease remains one of the greatest public health challenges of our time. It robs memories, independence and eventually the ability to perform basic tasks from the people we love,” said Michel Vounatsos, Chief Executive Officer at Biogen. “The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease. We are committed to driving progress for the Alzheimer’s disease community and look forward to the FDA’s review of our filing.”
Collated by :  Ananda Ghosh, PhD and Nisha Peter PhD 
COVID19 Special
Gilead announces additional data on remdesivir for the treatment of COVID-19
Gilead Inc. earlier this week announced additional results on remdesivir, an investigational antiviral drug that is currently under analysis as a potential treatment for COVID-19. The data was presented from a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with the severe form of COVID-19.
“We are working to broaden our understanding of the full utility of remdesivir. To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These data presented at the Virtual COVID-19 Conference shed additional light on the use of remdesivir in specific patient populations, including those that may be susceptible to higher rates of COVID-19 infection, as well as others that are particularly vulnerable, including children and pregnant and postpartum women.” “This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” said Susan Olender, MD, Columbia University Irving Medical Center. “While not as vigorous as a randomized controlled trial, this analysis importantly draws from a real-world setting and serves as an important adjunct to clinical trial data, adding to our collective understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic.”
FDA issues Emergency Use Authorization for Point of Care Antigen Test
FDA recently issue an Emergency Use Authorization (EUA) for the use of a COVID-19 antigen diagnostic test called the BD (Becton Dickinson) Veritor System for the detection of SARS-CoV-2. The EUA will allow the test to be used for as long as the emergency conditions are considered to exist.
“Expanding America’s testing capabilities is the result of partnership and ingenuity between the federal government, private sector and academia. Today’s authorization is another achievement of that work. Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly,” said FDA Commissioner Stephen M. Hahn, M.D.
Click Here for more COVID19 special
Collated by :  Esha Sehanobish, PhD
Drug Approvals
FDA and Health Canada approve INQOVI® (decitabine and cedazuridine) tablets for intermediate and high-risk MDS and CMML
“Intravenous or subcutaneous administered hypomethylating agents have been the cornerstone for the treatment of patients with MDS and CMML since the mid-2000s,” said Guillermo Garcia-Manero, MD, Professor and Chief of Section of Myelodysplastic Syndromes, Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas, and Principal Investigator of the ASCERTAIN clinical study. “The FDA’s approval of INQOVI builds on the proven therapeutic utility of hypomethylating agents in these diseases and offers a new orally administered option that offers patients an alternative to five consecutive days of IV infusions every month during a treatment period that can extend to several months.”
LYNPARZA® (olaparib) Approved in the EU for gBRCA-mutated Metastatic Pancreatic Cancer based on Ph 3 POLO trial results
Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “Patients with metastatic pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and few treatment advances have been made over the last few decades. In the POLO trial, LYNPARZA nearly doubled median progression-free survival versus placebo after first-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer. This approval underscores the importance of testing all patients for germline BRCA mutations at the time of diagnosis to help inform personalized treatment options for patients in the EU.”
Regulatory News
FDA issues CRL regarding applications seeking accelerated approval of LENVIMA + KEYTRUDA in 1L unresectable HCC patients based on Ph 1b Study 116/KEYNOTE-524 trial data
  • FDA has issued a Complete Response Letter (CRL) regarding Eisai’s and Merck’s applications seeking accelerated approval of LENVIMA + KEYTRUDA for the 1L treatment of patients with unresectable hepatocellular carcinoma (HCC)
  • The applications were based on data from the Phase 1b Study 116/KEYNOTE-524 trial, which showed clinically meaningful efficacy in the single-arm setting.
  • These data were recently presented at the 2020 ASCO meeting
  • Data also supported a Breakthrough Therapy designation (BTD) granted by the FDA in July 2019.
  • CRL stated that the applications do not provide evidence that KEYTRUDA in combination with LENVIMA represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced diseases
  • Since the applications for Study 116/KEYNOTE-524 no longer meet the criteria for accelerated approval, Eisai & Merck plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial
FDA lifts the partial clinical hold on pivotal Ph 2 trial of camidanlumab tesirine in R/R HL Patients
“The ADC Therapeutics team worked diligently to provide a thorough and prompt response to the FDA following its request for information about our pivotal Phase 2 clinical trial of Cami,” said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. “During the partial clinical hold we continued to treat patients benefiting from Cami, and now look forward to resuming the enrollment of new patients in the trial as soon as possible.”
FDA Places Clinical Hold on MELANI-01 Study of UCARTCS1A in RRMM Patients
“We share the FDA’s commitment to patient safety and are working collaboratively with the agency and the investigators to resolve this clinical hold,” said Carrie Brownstein, MD, Chief Medical Officer, Cellectis. “The safety of patients enrolled in our clinical trials is our utmost priority and we at Cellectis remain committed to safely resuming the clinical development of UCART product candidate targeting CS1 for patients with multiple myeloma and unmet medical need.”
iDMC recommends stopping Ph 3 OPTIMA Study of ThermoDox® + RFA in HCC patients as trial considered unlikely to meet primary endpoint of OS improvement
“We are surprised and disappointed that the OPTIMA Study results were not found to be more robust at this analysis. Nonetheless, we intend to follow the advice of the DMC and will consider our options either to stop the study or continue to follow patients after a thorough review of the data, and an evaluation of our probability of success. Timing for this decision is made less urgent by the fact that the OPTIMA Study has been fully enrolled since August 2018 and that the vast majority of the trial expenses have already been incurred,” stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer.
Click here for more Regulatory News
Trial Results
FAILED TRIAL: Ph 3 IMagyn050 study of Tecentriq® + Avastin®, paclitaxel and carboplatin did not meet primary endpoint of PFS improvement in 1L ovarian cancer patients
“Ovarian cancer remains one of the most aggressive cancers and is difficult to treat in its advanced stages,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “While we are disappointed by these results, we remain committed to improving outcomes for women living with this disease and are pleased that Avastin remains a key component in the treatment of front-line ovarian cancer.”
Significant PFS & OS Improvement Announced from Ph 3 ASCENT Study of TRODELVYTM in mTNBC Patients
“The results of the global Phase 3 ASCENT study confirm our initial observations that sacituzumab govitecan has the potential to change the standard management of mTNBC. Based on these data, sacituzumab govitecan has set a new benchmark in scientific and clinical innovation for patients with mTNBC by offering a novel alternative to the common drugs currently in clinical practice. Importantly, the ASCENT topline data also validate the manageable safety profile of sacituzumab govitecan, rendering it a good partner candidate for combination with other therapies, including immunotherapy,” stated the study principal investigator, Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Mass General Cancer Center and Assistant Professor of Medicine at Harvard Medical School.
Analysis of Crossover Population from Ph 3 INVICTUS trial of QINLOCK™ (ripretinib) in 4L GIST Patients Presented
“On the heels of QINLOCK’s recent approval in the U.S. and Canada in patients with fourth-line GIST, we are excited to add to the body of evidence supporting its potential as a new standard of care in this setting,” said Matthew L. Sherman, MD, Executive Vice President and Chief Medical Officer of Deciphera. “GIST is a highly complex disease for which we specifically designed QINLOCK and we are committed to ensuring it is able to reach as many appropriate patients as possible.”
Trial/Program Status
Last Patient Enrolled in Ph 2 HEPANOVA Trial of TTFs + Sorafenib in Advanced Liver Cancer
“Tumor Treating Fields therapy has demonstrated efficacy in in vitro and in vivo models of hepatocellular carcinoma,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We believe that Tumor Treating Fields’ mechanism of action is broadly applicable to solid tumor cancers. We look forward to seeing results from the HEPANOVA trial and further exploring the potential of Tumor Treating Fields as a treatment for advanced liver cancer.”
Click here for more Trial/Program Status
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
COVID Contact tracing leveraged by campus Wi-fi
The campus’s Wi-Fi connectivity is under consideration to build a COVID-19 contact tracing application at the University of California, Irvine. Donald Bren School of Information & Computer Sciences at the UCI has received a rapid funding grant from the National Science Foundation for the project to build and deploy an app designed to provide situational awareness to participants while preserving their anonymity. The project utilizes physical infrastructure, such as, sensors to collect data on activities in classrooms, offices, common areas, and conference rooms and middleware that incorporates privacy technologies in a policy-driven framework. The app will seek individuals’ permission to collect and use their location data. The app-development platform also includes a social distancing compliance tool employing anonymized Wi-Fi connectivity datasets to create occupancy profiles on entire buildings and different floors or zones within them, such as lecture halls, laboratories, and conference rooms
Precision medicine in tackling COVID19
The San Antonio Partnership for Precision Therapeutics (SAPPT) has announced a plan to fund three projects that will accelerate treatments for COVID-19 using precision medicine principles. SAPPT was created by four leading San Antonio research organizations: Southwest Research Institute, Texas Biomedical Research Institute, The University of Texas Health Science Center at San Antonio, and The University of Texas at San Antonio: launched in 2019. SAPPT has awarded $600,000 dedicated to fund these projects, with the support obtained from USAA’s $1 million to organizations combating COVID-19. SAPPT organized and issued a call for proposals and had selected three projects to fund through a rapid response. The San Antonio Area Foundation also committed close to $100,000 to SAPPT to advance their efforts to understand, treat, and prevent COVID-19. Each is a collaborative effort among the four research institutions with promising early milestones. For example, the team at Texas Biomed will study the role of the protein FURIN in COVID-19 and its impact on individual responses to the virus. Researchers at UT Health San Antonio will be uncovering how COVID-19 evades our innate immune system and blocks the body’s ability to quickly detect the virus to mount an antiviral response. The third funded project will be led by researchers from UT Health San Antonio studying how COVID-19 evades the human immune system by mimicking the host RNA and grows inside the body. According to Taylor Eighmy, president of UTSA, “These three additional projects support a strong foundation of transformative COVID-19 research happening in San Antonio. From better understanding the virus and applying custom therapies to developing drug treatments and vaccines, our partnership is in the unique position to make a real difference in the global impact of this pandemic.”
Collated by :  Debarati Banik
MedNess Reviews
Philips and BioIntelliSense's integrate for remote monitoring and telehealth
In an effort to support its telehealth and remote patient monitoring programs, Philips announced plans to integrate BioIntelliSense’s health-tracking sticker in these programs.
BioIntelliSense’s FDA-cleared multisensory patch named BioSticker, that debuted this past January, is capable of logging vital signs and symptoms such as sneezes, coughs and vomiting and has a 30-day battery life.
Philips plans to use the company’s BioSticker, to help monitor people with chronic conditions such as diabetes, cancer and heart failure and for telehealth. This would also include keeping clinicians connected with COVID-19 patients who may not require hospitalization.
By monitoring signs such as skin temperature, pulse, respiratory rate, overall activity level and the frequency of coughs, Philips hopes the system can trigger earlier interventions in people quarantined at home with the coronavirus.
The BioSticker will first be used by the U.S. service provider Healthcare Highways across seven monitoring programs, including one aimed at COVID-19 monitoring. The other programs focus on focus on heart failure, high blood pressure, diabetes, total joint replacement, cancer and asthma. Meanwhile, Philips also announced a 10-year contract worth up to $100 million with the U.S. Department of Veterans Affairs, to expand its tele-ICU and connected critical care programs, as well as work in diagnostic imaging, sleep solutions and remote patient monitoring.
Researchers identify new SARS-CoV-2 neutralizing antibodies in the fight against COVID-19
Researchers from the Cologne University Hospital and the German Center for Infection Research studied the antibody response to the SARS-CoV-2 virus and were able to pinpoint the antibodies with the strongest neutralizing effect on the virus. They reported the findings of the study in the journal Cell. Together with Boehringer Ingelheim, they are currently characterizing and developing the antibodies further.
The team focused on decoding the “humoral immune response” that the virus causes, which is the process by which B cells are activated to fight pathogens. They studied the response in 12 people who recovered from the virus, as well as in immune cells from 48 healthy people collected before the pandemic. They then isolated 255 antibodies specific to the SARS-CoV-2 response, reconstructed them in the lab, and then tested their ability to neutralize the coronavirus.
Out of the 255 antibodies, they finalized on 28 antibodies as they were not only able to potently neutralize the virus but also showed low levels of mutations over time.
Comparing B cells from COVID-19 survivors to those of the 48 healthy individuals helped the team identify the top antibody candidates. Interestingly, they discovered precursors of potent SARS-CoV-2-neutralizing antibodies in the blood samples taken pre-pandemic for every single individual, suggesting that the immune systems of healthy people may already be primed to ramp up the production of COVID-19 neutralizing antibodies in response to treatment with the drug candidates they identified. The findings from the study prompted the researchers to suggest that the COVID neutralizing antibodies they identified may be useful in both fighting active infections and preventing them in people who have come in contact with patients fighting the disease. They have predicted clinical trials of the top antibody candidates could begin by the end of the year.
Medness Plus
FDA approves Rukobia for the treatment of HIV for patients who have unsuccessfully tried to use multiple HIV medications
FDA recently approved Rukobia (fostemsavir) a novel antiviral medication for the treatment of adult patients with HIV. This new medication is expected to be effective in patients who have tried multiple treatment options for HIV but have had unsuccessful results and those who have resistance or intolerance to other available treatment options.
“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” said Jeff Murray, M.D., deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection—helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives.”
FDA approves Fintepla for the treatment of seizures in Dravet syndrome
In the end of June, FDA approved a Schedule IV controlled substance called Fintepla (fenfluramine), for the treatment of seizures in Dravet syndrome. It was approved for patients aged 2 years and older.
“Dravet syndrome is a debilitating disease that takes a tremendous toll on both patients and their families,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome. The FDA will continue to work with companies on drug development for Dravet syndrome and other types of epilepsy.”
Click here for more MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Business
Onco-News

Amgen Announces Additional Investment of approximately $421M in BeiGene
Amgen announced an additional investment of approximately $421 million in BeiGene's registered direct offering of ordinary shares, which maintains Amgen's current pro rata ownership of BeiGene at approximately 20.3%.This additional investment reflects Amgen's confidence in the progress the companies are making in their ongoing oncology collaboration in China, the world's second largest pharmaceutical market.  
Zymeworks grants Merck license to develop additional multispecific antibody therapeutic candidates using Zymeworks’ Azymetric™ and EFECT™ platforms
“It is an exciting time for the field of bispecific and multispecific therapeutics with candidates like ZW25 demonstrating great promise in clinical trials,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “We are very proud that oncology leaders like Merck recognize the value of our therapeutic platforms and continue to return for expanded access to our technology. We look forward to continuing our relationship with Merck as they advance additional multispecific candidates towards the clinic.”
Click here for more mergers , acquisitions and business news
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
Nisha Peter, PhD
Managing Editor
Ananda Ghosh, PhD
Founder
Share Share
Tweet Tweet
Forward Forward
Subscribe
Disclaimer
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.
Copyright © 2019 MedNess , All rights reserved.
You are receiving this MedNess Newsletter as a subscriber on the list.

Cover Image : Pixabay
Images : Twitter , Unsplash.com
Content Editors: Richa Tewari , Esha Sehanobish , Mayur Vadhvani and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
Our mailing address is:
MedNess
2160 Matthews Avenue 
Bronx 10462, NY 
NY

Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.