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MedNess: bite-size biopharma and medtech news

18th November, 2020
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HIGHLIGHTS
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COVID Special
Pfizer and BioNTech announces positive results from the first Interim analysis of the Phase 3 study of their vaccine candidate against COVID-19 
Pfizer Inc. and BioNTech SE recently announced the results from their first interim analysis of the Phase 3 study of their COVID-19 vaccine candidate, BNT162b2. Based on the interim analysis, the mRNA-based vaccine candidate showed evidence of efficacy against the disease in individuals without prior SARS-CoV-2 infection. The results were obtained from an interim analysis that was performed by an independent Data Monitoring Committee (DMC).
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
Moderna announces positive results from the first interim analysis of the Phase 3 trial of their candidate vaccine to treat COVID-19 
Moderna on Monday announced positive results from the first interim analysis of the Phase 3 trial of their candidate COVID-19 vaccine, mRNA-1273. The analysis was performed by an independent, NIH-appointed Data Safety Monitoring Board that analyzed the data and concluded that the trial has met the primary efficacy point and that the candidate vaccine was able to achieve an efficacy of 94.5%. The COVE study has enrolled more than 30,000 individuals in the US.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, Chief Executive Officer of Moderna. 
Click here for more COVID news
Collated by : Esha Sehanobish, PhD
Drug Approvals
FDA grants accelerated approval to KEYTRUDA® (pembrolizumab) + Chemotherapy for Patients With Locally Recurrent Unresectable or mTNBC Whose Tumors Express PD-L1 (CPS ≥10)
“Approximately 15-20% of patients with breast cancer are diagnosed with triple-negative breast cancer, which is a difficult-to-treat and aggressive cancer,” said Dr. Hope Rugo, director of Breast Oncology and Clinical Trials Education, University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. “Notably, in KEYNOTE-355, KEYTRUDA was combined with three different chemotherapy regimens: paclitaxel, nab-paclitaxel or gemcitabine and carboplatin. The approval of KEYTRUDA in combination with chemotherapy gives physicians an important new option for appropriate patients.”
Calquence approved in the EU for the treatment of CLL based on positive results from 2 Ph 3 trials, ELEVATE-TN (in 1L CLL) and ASCEND (in R/R CLL)
Paolo Ghia, MD, Director, Strategic Research Program on CLL, Università Vita-Salute San Raffaele in Milan, and investigator of the ASCEND Phase III trial, said: “One of our biggest hurdles in treating chronic lymphocytic leukaemia is finding tolerable treatment options that manage the disease long term, which typically impacts older patients with comorbidities. Today’s news marks great progress for patients in Europe, as the Phase III clinical trials for Calquence showed a significant improvement in comparison with current standard treatments.”
Regulatory News
FDA Fast Track Designation Granted to SRF388 to Treat HCC
“Liver cancer is the most rapidly increasing type of cancer in both men and women in the U.S., with incidences tripling since 1980.1 2 There is a significant need to expedite the development of new therapies to treat liver cancer as the five-year survival for patients with unresectable or metastatic liver cancer is less than five percent,”2 said Rob Ross, M.D., chief medical officer. “SRF388 targets IL-27, an immuno-suppressive cytokine that has been found to be elevated in patients with liver cancer, as well as kidney cancer, and we believe SRF388 has the potential to be an effective treatment option for these patients, as monotherapy or in combination with anti-PD-1 therapies.”
FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer
“Receiving Fast Track designation is a significant milestone in our fight against pancreatic cancer,” said Sanjeev Luther, President and CEO of Rafael. “This designation further stresses the severe unmet need in treatment options for this aggressive and devastating disease. We are truly thankful to the doctors, researchers, the FDA and all of our supporters who have made this possible. And most of all, we are grateful to the patients involved in our trials; the patients are the inspiration and driving force behind all of our efforts.”  
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Trial Results
FAILED TRIAL: Ph 3 KEYNOTE-598 trial of KEYTRUDA® + Ipilimumab vs KEYTRUDA Monotherapy in 1L PD-L1+, EGFR/ALK WT NSCLC patients to stop for futility; Patients to discontinue Ipilimumab
“We conducted KEYNOTE-598 in order to explicitly explore whether combining our anti-PD-1 therapy, KEYTRUDA, with ipilimumab provided additional benefits beyond treatment with KEYTRUDA alone in the metastatic non-small cell lung cancer setting,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. KEYTRUDA monotherapy remains a standard of care for the treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1.”
Bemarituzumab + Chemotherapy Demonstrates Significant PFS and OS Benefit Compared to Placebo + Chemo in 1L Advanced Gastric and GEJ Cancer in Ph 2 FIGHT trial
“These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade,” said Helen Collins, M.D., Five Prime’s Executive Vice President and Chief Medical Officer. “Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance the development of bemarituzumab, the first and only investigational treatment targeting FGFR2b+. Five Prime is grateful to the patients and investigators who participated in our clinical trials, and we look forward to discussing next steps with health authorities worldwide.”
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Trial/Program Status
Milestone payment of $10M triggered with the advancement of MK-4830 into a Ph 2 trial
“Novel myeloid cell targeting antibodies have the potential to treat patients who currently do not benefit from primary checkpoint antibodies,” said Garo Armen, Chairman and CEO of Agenus. “We are excited about the progress of MK-4830 and look forward to delivering our own wholly-owned novel myeloid tuning agent to the clinic next year.”
Ph 2 VERSATILE-002 Trial of PDS0101-KEYTRUDA® in Recurrent/Metastatic Head and Neck Cancer Initiated
“The launch of the VERSATILE-002 Phase 2 trial demonstrates our commitment to developing a safe and effective treatment option that builds upon the current standard of care for patients with this aggressive cancer and further strengthens our collaboration with Merck,” commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Though the COVID-19 pandemic impacted our initial timeline, we are pleased to open up this trial to patients.”
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Collated by : Richa Tewari, PhD
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Medness Plus
Amgen and AstraZeneca announces positive results from their Phase III trial for Tezepelumab in patients with severe, uncontrolled asthma 
Amgen and AstraZeneca recently announced positive results from the NAVIGATOR Phase III trial which involves studying a potential new medicine Tezepelumab in the treatment of patients with severe and uncontrolled asthma. This is a part of the collaboration that started in 2012 between the two companies and was updated recently. Amgen continues to lead manufacturing and AstraZeneca continues to lead development and both the companies will continue to share the costs and profits equally after AZ pays a mid-single-digit royalty to Amgen. The commercialization will be done jointly by Amgen and AstraZeneca.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Tezepelumab works differently from any other asthma biologic medicine and targets multiple inflammatory pathways that contribute to asthma symptoms and exacerbations. Building on the broad efficacy previously seen with tezepelumab, these are exciting data that bring us one step closer to delivering a medicine to severe asthma patients, including those with low eosinophil counts.” “Due to the complex nature of severe asthma, many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. Today’s ground-breaking results show that tezepelumab has the potential to transform care for a broad population of severe asthma patients who are underserved today, including those without an eosinophilic phenotype,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.
Click here for more MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness Reviews

NightWare receives FDA approval for marketing the medical device to reduce sleep disorder in PTSD patients
Post-traumatic stress disorder (PTSD) is a clinical condition that develops afterward exposure to extremely traumatic events such as combat experience or life-threatening accidents etc. Symptoms of PTSD range from flashback memories of the stressful event, nightmares, to hypervigilance. Sleep disturbance because of the nightmare is one of the hallmark symptoms of PTSD and it affects their daily life severely. Minneapolis based company NightWare has constructed a medical device which can reduce sleep disturbances associated with nightmares in PTSD patients. On 6th November, NightWare got the final approval from the FDA to market its digital therapeutic. This De Novo clearance will allow NightWare to use their App in Apple watch and iPhone App. Briefly, their App will function via the Apple watch sensors by tracking the heart rate and movement of the users during their sleep. The machine learning algorithm is capable of detecting abnormal heart rate or bodily movement presumably caused by episode of nightmare. The application then vibrates the smartwatch to disrupt the dream without affecting the sleep cycle. This breakthrough device has been studied in a 30-day randomized trial with 70 patients. The outcome of that study indicated that the active group showed greater improvement than the sham regarding their sleep quality. NightWare app could be installed with a doctor’s prescription.
“Today’s authorization offers a new, low-risk treatment option that uses digital technology to provide temporary relief from sleep disturbance related to nightmares,” - Carlos Peña, Ph.D., director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.
Collated by :  Rinki Saha 
Conference Coverage - SITC 2020 
ABSTRACTS
  1. Adaptimmune presented data from dose escalation cohorts of Ph 1 SURPASS trial of ADP-A2M4CD8
  2. Advaxis Presents Updated Data from Ongoing ADXS-503 Ph 1/2 Lung Cancer Trial
  3. Alkermes Presents New Data on ALKS 4230
  4. ALX Oncology Announces New Data from ASPEN-01, the Ph 1b Study of ALX148, Showing Promising Initial Clinical Responses in Patients with Advanced Solid Tumors
  5. Amgen Presents First Clinical Data for AMG 757
  6. BerGenBio presents Ph 2 bemcentinib + pembrolizumab BGBC008 trial data in advanced NSCLC patients
  7. Checkpoint Therapeutics Announces Presentation of Updated Cosibelimab Lung Cancer Results
  8. Iovance Biotherapeutics Presents Clinical Data in Head and Neck Cancer
  9. IMV’s T Cell Therapy Demonstrates 86% ORR in Combination with Merck’s Keytruda® in PD-L1 Positive Patients with r/r DLBCL
  10. I-Mab Reports Phase 1 Clinical Trial Data of Highly Differentiated Anti-CD47 Monoclonal Antibody Lemzoparlimab
  11. Infinity Pharmaceuticals Presents New MARIO-1 Phase 1/1b Clinical Data
  12. Moderna presents Interim data from Ph 1 dose expansion cohort of mRNA-4157 + pembrolizumab
  13. OncoSec Announces Positive Interim Data from KEYNOTE-695 Trial in Anti-PD-1 Checkpoint Refractory Metastatic Melanoma
  14. Sensei Biotherapeutics Presents Additional Data from Phase 1/2 Clinical Trial of SNS-301
  15. Xencor Presents Updated Data From the DUET-2 Ph 1 Study of XmAb20717
Medness Business
Onco-News
Daiichi Sankyo Creates New Business Unit to Unify Major Oncology Markets into One Streamlined Organization Dedicated to Patients with Cancer
“Daiichi Sankyo will accelerate one of the boldest strategies we have embarked upon – to realize our 2025 Vision “Global Pharma Innovator with competitive advantage in Oncology,” said Sunao Manabe, President and CEO, Daiichi Sankyo Company, Ltd. “With our oncology portfolio putting this vision within reach, we must evolve our global management structure into one that will usher us into a successful long-term business dedicated to improving patients’ lives.” 
Curis enters a CRADA with NCI for joint development of CA-4948 as an anti-cancer agent under the NCI Experimental Therapeutics Program (NExT)
"In addition to expanding the reach of this important clinical program, we believe this CRADA will provide powerful validation of our target-specific approach to developing impactful novel therapeutics for patients suffering from devastating cancers," said James Dentzer, President and Chief Executive Officer of Curis. We look forward to working closely alongside the team at the NCI and utilizing their tremendous expertise and resources as we advance CA-4948 through the clinical process." 
Xencor, MorphoSys and Incyte Enter into Global Development Collaboration for Tafasitamab in Combination with Plamotamab
‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20xCD3 XmAb(R) bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma," said Bassil Dahiyat, Ph.D., President and Chief Executive Officer at Xencor. "Plamotamab, which redirects T cells to tumors, and tafasitamab, a CD19-directed XmAb antibody, combine powerful and distinct immune pathways, and this collaboration is designed to enable us to generate new clinical insights and accelerate development timelines for patients who may need additional therapeutic options. It builds upon many years of partnership between Xencor and MorphoSys following MorphoSys' in-licensing of tafasitamab in 2010."
Collated by : Richa Tewari, PhD
Editors' Desk
Richa Tewari, PhD
Oncology News
Esha Sehanobish, PhD
MedNess Plus
Arundithi Ananthanarayanan
MedNess Reviews
Divyaanka Iyer
BioPharma News
Shilpa Rawal, PhD
Onco I-Analyse
Debarati Banik
HealthIT
Rinki Saha
BioPharma News
Abhi Dey
Consulting Editor
Nisha Peter, PhD
Managing Editor
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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 Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
Concept and Design: Ananda Ghosh and Nisha Peter
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