It is all about coronavirus treatments and vaccines for the biotech sector at the moment. A slew of biotechs is evaluating their pipeline drugs and vaccines for the treatment of COVID-19. The World Health Organization has now declared the outbreak of COVID-19 to be a pandemic, given the alarming levels of spread and severity. Thereafter, the focus is on companies, which have promising candidates to combat this disease.
Recap of the Week’s Most Important Stories:
Moderna Gains As it Progresses With Coronavirus Study: Shares of clinical-stage biotechnology company, Moderna, Inc., (MRNA - Free Report) surged after it announced that the first participant has been dosed in the phase I study of mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This phase I study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application. The phase I study is evaluating three doses of mRNA-1273 — 25, 100 and 250 micrograms — which are being administered on a two-dose vaccination schedule, given 28 days apart, for safety and reactogenicity. The study will enroll 45 healthy adults who will be observed for 12 months following the second vaccination.
Although the study design suggests that it may take at least 12 months to come out with top-line data, Moderna is actively preparing for a phase II study to evaluate mRNA-1273.
Regeneron Up on Identification of Antibodies for Coronavirus: Regeneron Pharmaceuticals (REGN - Free Report) announced that it has identified antibodies, which can possibly treat COVID-19.
The company is developing a novel multi-antibody cocktail that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as a treatment for those already infected. Regeneron has now isolated hundreds of virus-neutralizing, fully-human antibodies from its VelocImmune mice, which have been genetically-modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19 to maximize the pool of potent antibodies.
The company plans to select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein as well as other desirable qualities. A positive outcome will be a great boost for Regeneron and is much needed, given the widespread outbreak. The company is producing hundreds of thousands of prophylactic doses per month and hopes to have smaller quantities available for initial clinical testing at the beginning of summer.
Regeneron currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioNTech Surges on Deal With Pfizer for Coronavirus Treatment: Shares of BioNTech (BNTX - Free Report) surged significantly after it announced a collaboration deal with large-cap pharma, Pfizer, to develop a vaccine for COVID-19. Both companies will jointly develop BioNTech’s mRNA-based vaccine candidate, BNT162, to prevent COVID-19 infection. The collaboration aims to accelerate the global development of BNT162, leveraging the expertise and resources of both companies. BNT162 is expected to enter clinical testing by the end of April 2020.
Vaxart Collaborates With Emergent BioSolutions: Clinical-stage biotechnology company, Vaxart, Inc. (VXRT - Free Report) , announced that it has entered into an agreement with Emergent BioSolutions Inc. Per the agreement, Emergent will deploy its molecule-to-market contract development and manufacturing (CDMO) services to help develop and manufacture Vaxart’s experimental oral vaccine candidate for COVID-19. Further, development services will begin immediately. Once Vaxart elects a candidate, Emergent is expected to produce bulk cGMP vaccine allowing the former to initiate a phase I study in the second half of 2020.
Vir Collaborates With Biogen for COVID-19 Treatment: Vir Biotechnology, Inc. (VIR - Free Report) announced that it has signed a letter of intent with biotech bigwig, Biogen Inc. (BIIB - Free Report) , for the development and clinical manufacturing of human monoclonal antibodies for the potential treatment of COVID-19. Biogen would continue cell-line development, process development and clinical manufacturing activities in order to advance the development of Vir’s proprietary antibodies subject to the completion of a definitive agreement. Vir has identified a number of monoclonal antibodies that bind to SARS-CoV-2, which were isolated from individuals who had survived a SARS (Severe Acute Respiratory Syndrome) infection.
DBV Technologies Suffers a Setback: DBV Technologies (DBVT - Free Report) announced that the FDA has identified questions regarding efficacy, including the impact of patch-site adhesion, in its ongoing review of the Biologics License Application (BLA) for investigational Viaskin Peanut. Consequently, the Allergenic Products Advisory Committee (APAC) meeting to discuss the BLA will no longer take place as previously scheduled on May 15, 2020. Nevertheless, the company is in discussions with the FDA regarding the potential submission of additional information on patch-site adhesion from its clinical program as well as long-term efficacy results from the three-year, open-label extension study, PEOPLE, to answer FDA’s questions, as part of the ongoing BLA review.
The Nasdaq Biotechnology index lost 10.28% in the last five trading sessions. Among the biotech giants, Regeneron gained 3.51% during this period. Over the past six months, shares of Regeneron have gained 70.65%. (See the last biotech stock roundup here: Biotech Stock Roundup: NVAX, CANF Up on Coronavirus Treatment Updates & More)
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19.
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