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MedNess: bite-size biopharma and medtech news

10th February
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MedNess This Week
HIGHLIGHTS
COVID Special
Janssen Biotech Inc. submits an application to the FDA requesting the Emergency Use Authorization for their investigational candidate COVID-19 vaccine
Johnson and Johnson and their Janssen Biotech Inc. have submitted a request for the Emergency Use Authorization (EUA) for their candidate COVID-19 vaccine. Their candidate vaccine is a single-dose investigational vaccine. The submission comes right after the release of the safety and efficacy data from the Phase 3 ENSEMBLE trial, where the vaccine met both the primary and secondary key endpoints. The company intends to submit rolling submissions with various health agencies throughout the world. Following the EUA, the company expects to start shipping immediately. The research and development of Janssen’s candidate vaccine has been funded in whole or in part with the federal funds from BARDA, US department of Health and Human Services, in collaboration with NIAID, a part of NIH.
“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
Eli Lilly announces the reduced risk of COVID-19 hospitalizations and death following treatment with their combination of two antibodies
Eli Lilly and company announced that the combination of Bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) each 2800 mg taken together has shown a significantly reduced rate of COVID-19-related hospitalizations and deaths in high-risk patients diagnosed with COVID-19. This results in meeting the primary endpoint of the Phase 3 BLAZE-1 trial. Overall, there was a 70% reduction in the events such as COVID-19-related hospitalization and deaths. The combination antibodies also showed significant improvement in key secondary endpoints. At present Bamlanivimab 700 mg injection is authorized under EUA for the treatment of mild to moderate COVID-19 in high-risk patients. The FDA is currently also reviewing the EUA application from Eli Lilly for the combination use of bamlanivimab and etesevimab in the treatment of mild to moderate COVID-19 for high-risk patients.
"These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S., have reached record highs. These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients. "Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. Bamlanivimab alone is authorized for emergency use as a treatment for high-risk patients with mild to moderate COVID-19 in the U.S. and widely available for use," Skovronsky added.
Click here for more COVID news
Collated by : Esha Sehanobish, PhD
Drug Approvals
FDA approves Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults R/R LBCL
“In TRANSCEND NHL 001, Breyanzi produced sustained responses in a significant proportion of patients with relapsed or refractory large B-cell lymphoma. TRANSCEND also demonstrated feasibility of outpatient administration, which is meaningful for patients, physicians and the healthcare system,” said Jeremy Abramson, M.D., M.M.Sc., director of the lymphoma program at Massachusetts General Hospital and principal investigator for TRANSCEND NHL 001. “With this approval, we now have an important new treatment option for patients with relapsed or refractory large B-cell lymphoma who have undergone at least two prior lines of systemic therapy.”

FDA grants Accelerated Approval to UKONIQ™ (umbralisib) in R/R MZL and FL patients
Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “Today’s approval of UKONIQ marks a historic day for our Company with this being our first approval and we are extremely pleased to be able to bring our novel inhibitor of PI3K-delta and CK1-epsilon to patients with relapsed/refractory MZL and FL. We have built a commercial team with significant experience who will immediately start to engage our customers to educate them on UKONIQ and how to access the product for patients in need and expect to make UKONIQ available to US distributors in the next few days.” Mr. Weiss continued, “We want to thank the patients, physicians, nurses and clinical coordinators for their support and participation in our clinical trials, and the FDA for their collaboration throughout this process. We remain dedicated to patients with B-cell diseases and our mission of developing treatment options for those in need.”
 
FDA Approves TEPMETKO® in mNSCLC patients with METex14 Skipping Alterations
“METex14 skipping occurs in approximately 3% to 4% of NSCLC cases, and patients with this aggressive lung cancer are often elderly and face a poor clinical prognosis,” said Paul K. Paik, M.D., VISION primary investigator and Clinical Director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center. “There is a pressing need for targeted treatments that have the potential to generate durable anti-tumor activity and improve the lives of patients with this challenging disease. TEPMETKO offers an important and welcome new therapeutic option for patients with metastatic NSCLC harboring these genetic mutations.”
Trial Results
FAILED TRIAL: KESTREL Ph III trial of Imfinzi (durvalumab) did not meet the primary endpoint of improving OS vs chemotherapy + cetuximab in 1L PD-L1-high HNSCC patients
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Metastatic head and neck cancer is a complex and challenging disease with a poor prognosis. While we are disappointed by these results, insights from the KESTREL Phase III trial will advance our understanding and application of immunotherapy across our clinical development programme. We will continue to build on the established benefits of Imfinzi in early lung cancer and small cell lung cancer, to bring immunotherapy treatment options to all patients who may benefit.”

Preliminary Efficacy Achievement Announces in Ph 2 Combination Trial of PDS0101
“The achievement of this important milestone in this NCI-led Phase 2 clinical trial strengthens the evidence of our novel Versamune® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced and currently untreatable HPV-associated cancers.”
 
Publication of SOPHIA Trial Results for MARGENZA™ in JAMA Oncology Announced
“MARGENZA is the first HER2-targeted therapy to reduce the risk of disease progression in metastatic breast cancer patients over trastuzumab in a head-to-head comparison involving a heavily pretreated patient population,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “These data represent years of research and clinical development at MacroGenics leading to the forthcoming commercialization of this innovative antibody-based therapeutic for the treatment of metastatic HER2-positive breast cancer.”
Trial/Program Status
HERTHENA-Lung01 Ph 2 Study of Patritumab Deruxtecan Initiated in Patients with EGFR-Mutated NSCLC
Our focus is to rapidly and strategically advance the clinical development program of patritumab deruxtecan in cancers where HER3 is frequently overexpressed and is associated with poor prognosis,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “This study will further inform whether targeting HER3 with an antibody drug conjugate may become a potential treatment strategy to overcome diverse mechanisms of EGFR TKI and chemotherapy resistance seen in patients with metastatic EGFR-mutated non-small cell lung cancer.”
AMG 701 (pavurutamab), AMG 673, AMG 596 and AMG 397 programs paused/modified as part of portfolio re-prioritization
  • Enrollment in the Ph 1 study of BCMA-targeting half-life extended BiTE AMG 701 (pavurutamab) paused to define protocol modifications to optimize safety monitoring and mitigation with the FDA (currently enrolled patients demonstrating benefit may continue to receive AMG 701 and the patient enrollment may resume in H1 2021).
  • Clinical development CD33-targeting half-life extended BiTE AMG 673 is paused till further information on the CD33 program through progression of AMG 330.
  • Clinical development of EGFR variant III-targeting BiTE AMG 596 in glioblastoma is stopped.
  • Ph 1 development of the oral MCL-1 inhibitor AMG 397 paused to prioritize the development of MCL-1 inhibitor AMG 176 (currently in Ph 1 for the treatment of hematologic malignancies).
Click here for more Trial Status
Collated by : Richa Tewari, PhD
Medness Plus
FDA approves the marketing of a new device to reduce mild obstructive sleep apnea and snoring in adult patients
FDA authorized the marketing of a new device that will be obtained via prescription and is intended to reduce mild obstructive sleep apnea and reduce snoring. The eXciteOSA device is the first device that can be used while a person is awake unlike the ones that are available so far that are used when the person is sleeping. The use of a device while a person is awake leads to improved tongue muscle function which will hopefully prevent the tongue from collapsing backwards and lead to obstructing the airway during the sleep. The approval for marketing was granted to Signifier Medical Technologies, LLC. The application was reviewed through the De Novo premarket review pathway, which is used for low-to moderate-risk devices that are new. The FDA will also establish special controls for similar devices. This will allow future similar devices to go through the 501(k) premarket notification process by which devices can attain marketing authorization by showing equivalence to a device approved previously.
Roche announces positive results from two global Phase 3 studies for people with neovascular age-related macular degeneration
Roche recently announced results from two of their Phase 3 studies, TENAYA and LUCERNE that evaluate the effectiveness of faricimab in patients with neovascular or “wet” age-related macular degeneration (nAMD). Based on the results from both of the studies, faricimab injections at fixed intervals up to 16 weeks achieved visual sharpness or acuity which was non-inferior to those on aflibercept injections given every eight weeks. Faricimab was also well-tolerated with no new safety signals observed in both the studies.
“These results show the potential of faricimab as a new class of medicine that could extend time between treatments for people living with neovascular age-related macular degeneration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We have now seen positive and consistent results in four phase III studies for faricimab across both neovascular age-related macular degeneration and diabetic macular edema. We look forward to submitting these data to global regulatory authorities, with the aim of bringing this promising treatment option to patients as soon as possible.”
Click here for more MedNess Plus
Collated by : Esha Sehanobish, PhD
Medness @ HealthIT
 
Predictive analytics algorithms to screen suicidal teen population
According to the global database of WHO, the suicide rate among young people (aged between 15-19) is at a staggering 7.4/100,000. In the US alone, the rate shows an upward trend with 62% increase since 2000, being the second leading cause of death amongst teens. The challenge for healthcare providers therefore remains the unpredictability of the mental health need to the at-risk youths. A screening tool, called the Computerized Adaptive Screen for Suicidal Youth (CASSY), can now be combined to be used in emergency rooms, when an adolescent or teen is admitted for any reason: psychiatric complaint or something unrelated. The tool prompts them to complete a questionnaire on a digital device. The occurrence of follow-up questions is based on answers and tailored to the individual patient. The questions asked by CASSY encompasses about suicidal thoughts as well as other risk indicators, such as, sleep disturbance, trouble focusing, agitation, depression and hopelessness, family-issues and school connectedness. The score for their suicidal risk level is determined by the combination of risk factors. The predictive analytics algorithm is developed from data from multiple centers participating in the Emergency Department Screen for Teens at Risk for Suicide, funded by the National Institutes of Mental Health. Cheryl King and her team from Michigan Medicine C.S. Mott Children's Hospital and member of the University of Michigan Injury Prevention Center has played an instrumental role in developing this tool.

Google’s cloud solutions for vaccine availability and public health
The new data analytics solutions launched by Google clouds, called Intelligent Vaccine Impact solution, is a set of data analytics technologies that will come to aid the regional and local governments to ensure vaccine availability and deliver successful COVID-19 public health strategies. According to the blog recently published by Mike Daniels, vice president of the global public sector at Google Cloud, “Google has supported communities and public health organizations throughout the pandemic through research grants, telehealth support, and more. And as the global challenge to immunize millions of people continues to rise, we’re proud to extend our commitment by today announcing Google Cloud’s Intelligent Vaccine Impact solution”. The machine learning approach combines AI and epidemiology to COVID-19 forecasting and analysis. To quote Daniels, “We also developed an AI-driven ‘what-if’ model to be used for COVID-19 response and other infectious disease policy intervention decision-making, using our Application Modernization platform with Anthos, Kubernetes, and BigQuery”. BigQuery will help the state epidemiologists and public health officials to aggregate the results of data models with both public and private datasets to drive better policy decisions. Read the news on Twitter here.
Medness Reviews

CureVac teams up with U.K. Government to Develop Vaccine Against COVID-19 Variants
The German biotech CureVac is joining forces with the U.K. government to tackle the next new variants of the SARS-CoV-2 virus, with the government securing 50 million doses of any successful shot.
According to a statement released by CureVac, the company will work with the U.K. Vaccines Taskforce under an agreement to study multiple emergent variants of the virus and develop vaccine candidates against selected variants, CureVac and the government will expedite clinical trials in the U.K. to get vaccines through emergency or conditional authorizations as quickly as possible.
If approved, any vaccines that come out of the deal will be distributed in the U.K. and its overseas and dependent territories. The move extends the country’s investment in Covid-19 prevention as Britain races ahead of the European Union in vaccinations.
Amid a global scramble for supplies, vaccine makers and governments are already turning their focus to combating mutated strains of the virus amid growing concern about the threat posed by variants that emerged in South Africa, Brazil and the U.K. However, clinical trials run by Pfizer, Moderna and the University of Oxford ended before the emerging variants started to account for a significant proportion of COVID-19 cases in the countries where those trials took place.
CureVac is forging partnerships in a bid to accelerate the development and roll out of its experimental messenger-RNA Covid vaccines, which are similar to the ones already being administered to tens of millions of people from Pfizer Inc. and BioNTech SE, along with Moderna Inc.

The collaboration of AstraZeneca and BenevolentAI enters a new milestone as AI-generated drug target for chronic kidney disease is being added to AstraZeneca’s portfolio
Since 2015, the Biopharma industry slowly increasing collaboration with artificial intelligence companies to keep up with the pace of producing drugs in a short period along with a better profit rate. Leading pharmaceutical companies such as Pfizer, Takeda, AstraZeneca, Novartis, Bristol Myers Squibb (BMS), Roche, Janssen, Merck KGaA, Boehringer Ingelheim, Bayer, GSK have already made a step forward by making the partnership with AI-based companies to advance their portfolios. The power of AI in generating drug targets are being recognized in pressing times as well. For example, UK based start-up BenevolentAI came up with six promising approved drugs for the treatment of Covid-19. Last year September Recursion Pharma, an AI-based company inked a 239M strategic deal with Bayer for the drug development of Fibrotic Diseases.
In 2019, AstraZeneca entered a strategic deal with breakthrough tech company BenevolentIP to identify new targets in two therapeutic areas: Idiopathic Pulmonary Fibrosis (IPF) and Chronic Kidney Disease (CKD). Currently, CKD is a major health problem affecting approximately 13% of the United States population. It is a complex disease as the progression of CKD is associated with several serious complications, including increased incidence of cardiovascular disease, hyperlipidemia, anemia, and metabolic bone disease. While there are treatments available for those manifestations but it’s not optimal which creates the need for a better solution. Enriched biomedical datasets along with extensive expertise from AstraZeneca and high-end machine learning and artificial intelligence platform from BenevolentIP, finally managed to produce a novel drug target for CKD.
“Complex diseases like CKD have defied conventional research efforts. Together, we are steadily closing the gap between AI, data, and biology, and we are excited to continue collaborating on our shared goal of discovering and developing vital new treatments for patients,” said Dr. Anne Phelan, Chief Scientific Officer of BenevolentAI.
 
Medness Business
“AFM24 is a first-in-class innate cell engager that we believe has the potential to bring benefit to a broad set of patients as monotherapy and in combination with other I/O therapies to address disease states where co-activation of the innate and adaptive immune systems is beneficial,” said Dr. Adi Hoess, CEO of Affimed. “This collaboration with Roche is an important step in our continued execution of AFM24’s clinical development strategy. Importantly, preclinical and clinical studies indicate that ICE® and PD-(L)1 checkpoint inhibition therapy could act synergistically, which drives our optimism about the combination of AFM24 with atezolizumab and its promise as a possible treatment option for patients with EGFR expressing solid tumors.”

Lilly backs chronic pain relief in a $410 million licensing deal with Asahi Kasei
As announced on 29th January 2021, Eli Lilly and Company (Lilly; Indianapolis) has entered a licensing deal with Asahi Kasei Pharma Corporation (Asahi Kasei, Tokyo) over its chronic pain relief molecule AK1780. AK1780 is an orally bioavailable P2X7 receptor antagonist. P2X7 belongs to a purinogen receptors that signals for cell death and inflammation upon binding high ATP concentrations. P2X7 I implicated in driving chronic pain in inflammatory bowel disease and neuroinflammation. AK1780 recently completed Phase I clinical trials for single and multiple dosing and safety.
According to the terms of the licensing agreement, Eli Lilly will pay $20 million in upfront cash, with a potential of giving $210 million more to Asahi Kasei in potential development and regulatory milestones. Upon commercialization Asahi Kasei will receive further sales milestone payments to the tune of $180 million, along with tiered royalties in mid-single to low-double digits. In return for its investment, Lilly will hold the exclusive rights global commercialization and distribution rights to AK1780 barring Japan and China where Asahi Kasei will retain promotion rights.
This deal fits in well with Lilly’s sustained efforts in its pain relief portfolio. Lilly is invested in osteoarthritic pain relief drugs as well.
Click here for more business news
Collated by : Richa Tewari, PhD and Divyaanka Iyer
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
Consulting Editor
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Content Editors: Richa Tewari , Esha Sehanobish , Rinki Saha ,  Shilpa Rawal, PhD ,  Debarati Banik  , Divyaanka Iyer , Arundithi Ananthanarayanan and Abhinav Dey 
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