BNT-161b1

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020. News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays. FDA Actions COVID-19 Drug Shortages Response : The FDA has updated its webpage to provide information on in-use time for certain drugs during the COVID-19 pandemic. Warning Letter : The FDA and the FTC issued a warning letter to MMSTabs.com for selling fraudulent COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19. EUAs : The FDA issued EUAs for the following: Impella Left Ventricular (LV) Support Systems ( Abiomed ) SARS-Co-V-2 Assay ( Cleveland Clinical Robert J. Tomsich Pathology and Laboratory Medicine Institute ) Poplar SARS-CoV-2 TMA Pooling Assay ( Poplar Healthcare ) COVID-19 PCR Test ( Wren Laboratories, LLC ) SARS-CoV-2 MALDI-TOF Assay ( Ethos Laboratories ) Diagnostics Update : To-date the FDA has authorized 203 individual EUAs, which include 166 molecular tests, 35 antibody tests and 2 antigen tests. Testing Therapies, Antivirals and Vaccines Novavax is yet another biopharma company reporting promising early-stage data for a potential COVID-19 vaccine. The company announced data from Phase I of its Phase I/II placebo-controlled trial of its vaccine with and without Matrix-M adjuvant. The trial was conducted in healthy adults 18 to 59 years of age. In early July, Regeneron Pharmaceuticals , with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), announced they were launching Phase III trials of REGN-COV-2, the company’s two-antibody cocktail to treat and prevent COVID-19. Although those results of those trials are still pending, the company issued a scientific article , not yet peer-reviewed, that shows the cocktail was able to “almost completely block the establishment of virus infection,” in rhesus macaques and hamsters. Revive Therapeutics Ltd. will advance a Phase III study to evaluate the safety and efficacy of rheumatoid arthritis drug Bucillamine in patients with mild-moderate COVID-19. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19. BioNTech and Fosun Pharma announced the initiation of a Phase I clinical trial in China for BNT162b1, an mRNA-based COVID-19 vaccine candidate. Veru confirmed in an in vitro study that VERU-111 has anti-inflammatory action against the key cytokines involved in the cytokine storm triggered by COVID-19. VERU-111 is an oral, first-in-class microtubule depolymerization agent that has possible antiviral and anti-inflammatory dual-action. ANA Therapeutics ’ IND application for ANA001 (niclosamide capsules) for COVID-19 received the go-ahead from the FDA. The trial will enroll at least 400 patients with COVID-19 at 10 centers in the U.S. Biophytis received approval from the Brazilian Health Regulatory Agency (ANVISA) to begin its clinical development program COVA in Brazil. The COVA Phase II/III clinical program will evaluate the efficacy and safety of Sarconeos (BIO101) for respiratory deterioration in COVID-19 patients. Sarconeos is a small molecule, oral drug in Phase IIb trials for sarcopenia in the U.S. and Europe. Eli Lilly initiated a Phase III trial of LY-CoV555 for the prevention of COVID-19 at long-term care facilities in partnership with NIAID. LY-CoV555 is a monoclonal antibody against SARS-CoV-2. FDA issued a EUA for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are receiving ECMO treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed . Johns Hopkins University researchers are initiating a trial to learn whether plasma from recovered COVID-19 patients can treat those with a virus infection or prevent those who are at higher risk. Two clinical trials will enroll 1,100 people nationally and is funded by a $35 million grant from the US Department of Defense. Company Actions/Announcements Moderna will be using a tiered pricing system for its experimental COVID-19 vaccine. Moderna’s CEO said that it will charge between $32 and $37 per dose for its coronavirus vaccine. However, this is for some “low volume” customers. Partner Therapeutics entered into a $35 million milestone-based Firm Fixed Price agreement with the U.S. Department of Defense to fund two Phase II trials of inhaled Leukine (sargramostim) in COVID-19 patients with acute hypoxemia. The studies will begin this month at sites across the U.S. and will supplement data from more than 60 patients who have completed treatment with Leukine in the SARPAC study underway in Belgium. Leukine may aid the production of antibodies against COVID-19 and help restore lung cells damaged by the pathogen, potentially improving lung function in COVID-19 patients and reducing long-term complications. They are expected to launch in August 2020 in the U.S. under an IND application approved by the FDA in May. Adaptive Biotechnologies which partnered with Microsoft to decode the immune response to COVID-19, launched immunoSEQ T-MAP COVID, a proprietary research product and data analysis service to accurately and reproducibly measure the T-cell immune response to vaccines in development and track the persistence of that response over time. J&J announced Janssen Pharmaceutical Inc. has an agreement with the U.S. government for the manufacturing and delivery of 100 million doses of Ad26.COV2.S, a COVID-19 investigational vaccine, following approval or EUA by the FDA. Pfizer Canada and BioNTech SE announced an agreement with the Canadian government to supply their BNT162 mRNA-based COVID-19 vaccine candidate. Deliveries are planned over the course of 2021. The agreement is part of their commitment in the fight against the pandemic. Other Industry News Minority groups, such as blacks and Latinos, are typically less likely to participate in clinical trials, even though they are more likely to be most severely affected by COVID-19. Polls show this is consistent in COVID-19 trials as well. They have found that Americans expressing interest in participating in the COVID-19 trials tend to be young, white and healthy. But in order for it to be proven that the vaccine is safe and effective most broadly, clinical trials need to be conducted that include a range of ethnicities, races and age groups, especially in populations most at risk of catching the disease. According to a study published in the journal Science Advances on July 24, an international team of researchers led by neuroscientists at Harvard Medical School has uncovered which olfactory cell types are most vulnerable to infection by SARS-CoV-2, which causes COVID-19. Reported by Kaiser Health News , there is reason to believe obesity could undermine a COVID-19 vaccine and make it less effective similar to influenza, hepatitis B, tetanus and rabies vaccines.

JStone/Shutterstock “Hopefully the approval process will go very quickly, and we think we have a winner here,” Trump told White House reporters on Wednesday. JStone/Shutterstock After the U.S. Department of Health and Human Services (HHS) and the Department of Defense’s Operation Warp Speed program cut a $1.95 billion deal with Pfizer and BioNTech for production of their experimental COVID-19 vaccines, President Donald Trump referred to it as “a historic agreement.” “Hopefully the approval process will go very quickly, and we think we have a winner here,” Trump told White House reporters on Wednesday. “We also think we have other companies right behind that are doing very well on the vaccines, long ahead of schedule.” Operation Warp Speed (OWS) has a goal of delivering 300 million doses of a safe and effective vaccine against COVID-19 by January 2021. It is a partnership between HHS, the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD). The project’s website says, “OWS engages with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.” The Pfizer and BioNTech deal is just the latest of several that Operation Warp Speed has funded. These include: • March 30: $456 million in support of Johnson & Johnson’s candidate vaccine. • April 16: $483 million for Moderna’s COVID-19 vaccine, which is in development with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). • May 21: $1.2 billion for AstraZeneca’s vaccine in partnership with the University of Oxford. Operation Warp Speed made an announcement on May 15, noting it had selected 14 promising candidates from more than 100 vaccine candidates, and those 14 were being narrowed down to about seven. Large-scale clinical trials were being launched for those trials. In terms of manufacturing production, OWS, in addition to the Pfizer/BioNTech deal, also included production agreements with AstraZeneca, Moderna, and J&J, as well as a June 1 announcement with Emergent BioSolutions to increase domestic manufacturing capabilities and capacities for both COVID-19 vaccines and therapeutics. That deal was worth approximately $628 million. If and when these vaccines are considered viable, Operation Warp Speed also is developing plans for widespread distribution efforts. They include a May 12 contract announcement worth $138 million with ApiJect for more than 100 million prefilled syringes by the end of this year as well as a production goal of more than 500 million in 2021; a June 9 domestic manufacturing capacity deal for vials for vaccines, with $204 million going to Corning with an a $143 million contract to SiO2 Materials Science to scale up capacity to manufacture glass-coated plastic containers. The Pfizer-BioNTech will pay out $1.95 billion for 100 million doses of the experimental COVID-19 vaccine, with an agreement to buy up to 500 million more doses. Two weeks ago, on July 13, the two companies reported that two of their four vaccine candidates received Fast Track designation from the FDA. The two are BNT162b1 and BNT162b2 and are both currently in Phase I/II clinical trials in the U.S. and Germany. Each of the four experimental vaccines are a unique combination of messenger RNA format and target antigen. The two Fast-Tracked are nucleoside modified RNAs formulated in lipid nanoparticles, which basically means they are engineered pieces of mRNA that are contained in a fat particle that is used as a delivery vector. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen. The two companies also reported a week later initial data from the German Phase I/II trial. It is published on the online preprint server at medRxiv and is currently being peer-reviewed for possible publication. This data is on BNT1621b1. The companies indicate the preliminary data supported and expands on early results from the recently disclosed early data from the US trial of BNT162b1. The vaccine produced high, dose level-dependent neutralizing antibodies against SARS-CoV-2 and RBD-binding IgG concentrations after the second date. The titers of neutralizing antibodies were comparable to a group of convalescent antibody titers from patients who recovered from COVID-19. The companies stated, “Furthermore, sera of vaccinated subjects displayed broadly neutralizing activity in pseudovirus neutralization assays across a panel of sixteen SARS-CoV-2 RBD variants represented in publicly available SARS-CoV-2 sequences and against the newly dominant D614G strain.” They also showed induction of high levels of CD4+ and CD8+ T cell responses. They found the strength of the T cell responses varied between patients and there was no clear dose level dependence between the level of doses, suggesting that that stimulation and robust expansion of T cells might be stimulated at low mRNA dose levels.