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MedNess: bite-size biopharma and medtech news

16th June, 2020
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HIGHLIGHTS
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COVID19 Special

Regeneron Starts Clinical Trails for COVID-19 Antibody Cocktails
Regeneron has started  clinical development of its anti-SARS-CoV-2 antibody combination REGN-COV2, kicking it off with two trials, one in hospitalized patients and another in non-hospitalized patients. In the first part of the trial, Regeneron will look at virologic and safety endpoints before adding clinical endpoints into the mix in Phase 2. The Phase 1 and 2 trials will inform the design and size of Phase 3 studies in each population.
Although Eli Lilly was the first company to get an anti-SARS-CoV-2 antibody candidate into humans, Regeneron has closely followed suit by hitting its mid-June target. Regeneron has emerged as one of the front-runners in the race to develop antibodies against the coronavirus, having validated the application of its platform to infectious diseases with an Ebola drug. Amgen, AstraZeneca, GlaxoSmithKline and Lilly are among the other drug developers working on antibodies that could have therapeutic and preventive applications against SARS-CoV-2.
Regeneron has settled on a combination of two antibodies that target different areas of the receptor-binding domain on the spike protein. In explaining its decision to go with a two-drug combination, Regeneron cited research, which is set to be published in Science, into the potential for viruses to escape treatment through mutation. As Regeneron sees it, hitting the virus with a one-two antibody punch lessens the risk that a mutant, drug-resistant form will emerge and become the dominant strain. 
Regeneron looked for antibodies to include in its combination in the blood of patients who had recovered from COVID-19 and in mice genetically modified to have human immune systems. By casting its net wide, Regeneron thinks it has hit upon potent antibodies against the virus. 
**Watch this space for more updates**
Drug Approvals
FDA Approves Opdivo® (nivolumab) in Advanced ESCC patients After Prior Fluoropyrimidine- and Platinum-based Chemo based on Ph 3 ATTRACTION-3 trial data
“Many cases of esophageal cancer are diagnosed at the advanced stage, when the disease could have a significant impact on a patient’s health. Treatment options can be limited once patients with advanced esophageal squamous cell carcinoma progress,” said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb. “The approval of Opdivo as a new treatment option for previously treated patients with advanced esophageal squamous cell carcinoma, regardless of PD-L1 expression, highlights our commitment to providing new options to address the unmet needs of patients and brings us another step closer to understanding the full potential of immunotherapy for gastrointestinal cancers.”
Regulatory News
FDA grants Orphan Drug Designation of DKN-01 for the Treatment of Gastric and GEJ Cancer
"Orphan Drug Designation for DKN-01 in gastric and gastroesophageal junction cancer is another significant milestone in our DKN-01 development program and underscores the need for new treatment options for these indications," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We believe DKN-01 has the potential to be an important new therapy for this patient population that remains an area of high unmet medical need."
Expanded Access Program Announced for Onvansertib in KRAS-Mutated mCRC as Follow-On to Fast Track Designation
"We are excited to offer expanded access to our investigational drug for patients with KRAS-mutated mCRC who may benefit from treatment with onvansertib, but may not be able to participate in our clinical trial," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "The granting of Fast Track Designation coupled with the initiation of our Expanded Access Program underscores the medical need for a new therapeutic option to treat these patients who are facing a devastating prognosis. We are dedicated to advancing the clinical development of onvansertib so that many more patients will have access to treatment in our ongoing trials and through our compassionate use program."
Trial Results
FAILED TRIAL: Ph 3 KEYNOTE-361 Trial of KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy fails to meet dual primary endpoints of PFS/OS improvement in advanced/Metastatic Urothelial Carcinoma patients
“In this study, KEYTRUDA in combination with chemotherapy in previously untreated patients with advanced or metastatic bladder cancer was rigorously tested against an active control of the current standard of care chemotherapy combination regimen,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “While we are disappointed in these study results, KEYTRUDA has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease. We are grateful to the patients and investigators for their participation in this study.”
EHA 2020: AbbVie announced positive results from Ph 3 VIALE-A (M15-656) trial of venetoclax (VENCLEXTA® or VENCLYXTO®) plus azacytidine in 1L chemo-ineligible AML patients
"Patients living with AML may be too sick to endure chemotherapy, and they face one of the most aggressive types of blood cancer," said Neil Gallagher, M.D., Ph.D., chief medical officer, AbbVie. "The positive results from the VIALE-A study underscore the significant impact venetoclax plus azacitidine can have on improved survival and complete response in a previously-untreated patient population."
Click here for more Trial Results
Trial/Program Status
First Patient dosed in Ph 1/2 trial of Selinexor + SoC Therapy for 1L or rGBM Patients
“While selinexor has been most extensively studied in patients with hematologic malignancies, there is increasing evidence that selinexor may also play an important role in the treatment of a variety of solid tumors, including patients with GBM,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “We were highly encouraged by the results from our previous Phase 2 KING study, which evaluated selinexor as a single agent in patients with recurrent GBM and demonstrated clear anti-cancer activity. We now look forward to assessing selinexor’s activity in combination with currently used standard of care treatments where we hope it will prove to be synergistic and even more effective.”
Ph 3 CONTACT-01 Trial of Cabozantinib + Atezolizumab initiated in Previously Treated mNSCLC patients
“Survival rates for patients with metastatic non-small cell lung cancer are low, and since more than half of these patients are diagnosed at an advanced stage, the patient community is in need of new treatment options, especially for those who progress following immunotherapy and chemotherapy,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We were pleased to see the positive results from cohort 7 of the COSMIC-021 trial further supporting the growing body of preclinical and clinical evidence that cabozantinib may promote a more immune-permissive environment potentially resulting in additive or synergistic effects with immune checkpoint inhibitors such as atezolizumab. We look forward to forthcoming findings for the combination in this disease in CONTACT-01, as well as in other difficult-to-treat cancers in planned phase 3 studies.”
Target Enrollment completed In Ph 3 ATHENA Trial in 1L Advanced Ovarian Cancer patients requiring maintenance treatment
“The completion of target patient enrollment in the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step toward developing additional therapeutic options for women with advanced ovarian cancer,” said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. “This was a tremendous effort by trial investigators, our collaborators and our dedicated Clovis team to complete target enrollment in this 1,000-patient study in under two years. Most important, we are grateful to all of the patients who participated in this study.”
Collated by : Richa Tewari, PhD
MedNess @ HealthIT
COVID19 vs. Social Determinants of Health
According to the team of researchers at the MIT Sloan School of Management, COVID19-suseptibility is correlated with socioeconomic factors related to social determinants of health (SDH), in addition to age and race. Analyzing the daily county-level COVID-19 death rates from April 4 to May 27, this team came to the similar conclusion of African Americans and older people to be more likely to die from the virus compared to Caucasians and individuals under age 65. However, they did not find correlations between obesity rates, ICU beds per capita, or poverty rates. This study controlled for patients’ income, weight, diabetic and smoking status, and failed to find a correlation. No correlation between exposure to air pollution was found either, although a commute via public transportation is associated with more deaths. Counties with higher home values, higher temperature summers, and lower temperature winters were found to be more likely to die from the virus than patients from lower home values, cooler summer weather, and warmer winter weather. To shed lights on African Americans being more susecptible to death, Christopher R. Knittel, the George P. Shultz Professor of Applied Economics at MIT Sloan, suggests that after ruling out income, weight & overall health status, “We must examine other possibilities, such as systemic racism that impacts African Americans’ quality of insurance, hospitals, and healthcare, or other underlying health conditions that are not in the model, and then urge policymakers to look at other ways to solve the problem.” Read the full report here.
Collated by :  Debarati Banik
MedNess Reviews

Stanford Researchers Turn to CRISPR Gene-Editing To Fight COVID-19
Adding on to the number of approaches to fight the COVID-19 infection, bioengineers at Stanford University have developed a technique based on CRISPR gene-editing to address the disease. The team was earlier working on a CRISPR gene-editing technology to fight the flu when the COVID-19 pandemic emerged. They quickly pivoted to address the new disease.
The Stanford team, along with with researchers at the Department of Energy's Lawrence Berkeley National Laboratory have now reported a technique called prophylactic antiviral CRISPR in human cells, that they have nicknamed PAC-MAN. The technology disables viruses by scrambling their genetic code. They researchers were also able to test the PAC-MAN system by delivering them into lung cells.
The PAC-MAN system combines a guide RNA with the virus-killing enzyme Cas13. The RNA directs Cas13 to destroy certain nucleotide sequences in the SARS-CoV-2 genome, effectively neutralizing it. For efficiently delivering the PAC-MAN system into lung cells, the researchers turned to Berkeley Lab's Molecular Foundry, which has been working on lipitoids, synthetic peptides that can deliver DNA and RNA into cells.
When the researcher packaged their COVID-targeting PAC-MAN with the lipitoids and delivered it into lung epithelia cells, they were able to reduce the amount of SARS-CoV-2 virus by 90%. They are now planning animal trials with collaborators at New York University and Karolinska Institute in Sweden. The Stanford researchers are confident their PAC-MAN system will also prove useful for fighting influenza and other coronavirus infections. However, the current system has not been tested in in-vivo models of the disease.
The potential for using CRISPR to eliminate viruses has already generated some enthusiasm in the research community. Last year, Excision BioTherapeutics licensed a technology from Temple University that uses CRISPR, combined with antiretroviral therapy, to eliminate HIV.
Medness Business
Onco-News

AbbVie and Genmab to jointly develop and commercialize three of Genmab's next-generation bispecific antibody products, including epcoritamab
"This transformative collaboration will allow us to accelerate, broaden and maximize the development of some of our promising early-stage bispecific antibodies, including epcoritamab, with the ultimate goal of bringing these potential therapies much faster to cancer patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Today's announcement marks the beginning of a new journey for Genmab that combines our world-class knowledge in antibody biology and deep expertise in truly innovative next-generation antibody technology platforms, with AbbVie's R&D prowess and their leadership position in hematological cancers."
DelMar to Acquire Adgero Biopharmaceuticals, Expands Late-Stage Oncology Pipeline
"The acquisition of Adgero by DelMar positions the combined company for long-term corporate growth and increased shareholder value by bringing together DelMar's oncology therapeutic candidate, VAL-083, and Adgero's REM-001 photodynamic therapy with a lead indication in CMBC," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar. "This acquisition is the result of an extensive search for a suitable oncology therapy and provides the combined company with a diversified, late-stage oncology pipeline. During the next 12-18 months, we expect to achieve significant clinical milestones, driven by a seasoned leadership team that will bolster our oncology drug development expertise."
Click here for more on 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
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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