Researchers have been working furiously to identify medications to combat the novel coronavirus that causes COVID-19.
While there are no definitive answers yet, the Food and Drug Administration (FDA) has authorized emergency use of the experimental drug remdesivir.
That move came days after the early, unpublished results of a clinical trial showed that hospitalized patients who took the antiviral were discharged faster than those taking a placebo—in 11 days vs. 15.
This emergency authorization will make remdesivir more widely available for the treatment of severe COVID-19, even as the agency noted there is still limited information about its safety and effectiveness.
A recent article on the matter stated: “Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept,” Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), said on April 29, in a brief talk with the press.
Investigators will soon look at whether remdesivir in combination with another medication may offer more robust effects, Fauci said.
Researchers around the world are continuing to explore a number of other possible treatments.”
Active biotech companies with recent developments include: Nascent Biotech, Inc., Moderna, Inc., Vir Biotechnology, Inc., Pfizer Inc., Novavax, Inc.
The article continued: “The Infectious Diseases Society of America (IDSA) recently released guidelines outlining which therapies are worth testing as potential treatments for this new disease that many doctors are still trying to understand.
“We’re learning a lot quickly—more so than we have with any other virus,” says Paul Goepfert, M.D., professor of medicine and microbiology and director of the Alabama Vaccine Research Clinic at the University of Alabama at Birmingham… But it will take more rigorous studies before scientists truly know what will work best.”
Nascent Biotech, Inc. BREAKING NEWS: Nascent Biotech’s CEO Provides Corporate Updates on Phase I Brain Cancer Trial and COVID-19 Development Initiative on SNN Network
Nascent Biotech (the “Company” or “Nascent”) is pleased to provide a corporate update and summary with a recent interview the Company’s CEO, Sean Carrick, presented on SNN Network.
Mr. Carrick indicates, “As the Company moves forward with execution of its active 2020 agenda, key strategic initiatives will bring increased shareholder value to the Company.
These include Nascent’s landmark Phase 1 studies on its Pritumumab (PTB) antibody for brain cancer, COVID-19 in vitro studies, and the virus vaccine program.”
During the interview Mr. Carrick updated the audience on a series of milestones completed by the Company including:
- The Company has performed all necessary U.S. preclinical work and developed successful manufacturing techniques for PTB and is now ready to begin Phase 1 Brain Cancer studies.
- Nascent is ahead of the curve as the Company’s PTB monoclonal Antibody due to its clear clinical and regulatory pathway for the treatment of deadly brain cancers with PTB.
- Studies published by independent third parties, including an article in The Journal of Biological Medicine (Yu et al. Journal of Biomedical Science (2016) 23:14 DOI 10.1186/s12929-016-0234-7) identifying a means of infection by the Coronavirus’ use of cell surface vimentin for cell entry, has launched Nascent’s timely research. Specifically, the article mentioned cell surface vimentin as a potential target in the treatment of conditions related to the Coronavirus. The Company’s PTB antibody targets the cell surface vimentin structure, which may serve to effectively block the virus ability to enter the cells.
- The Company’s response to COVID-19, indicating that Nascent is awaiting results from in vitro testing prior to the next step in its study of PTB and its use against viruses.
- Collaboration with Manhattan BioSolutions Inc. in developing vaccines to be used against viruses around the world. The vaccine program employs a recombinant Bacillus Calmette-Guerin (rBCG), genetically engineered to express selected SARS-CoV-2 proteins. Based on preclinical experience with rBCG candidates for oncology indications and its safe track record as a tuberculosis vaccine, Nascent has the reason to believe that rBCG based vaccine against SARS-CoV-2 may be possible to develop.
- Nascent expects to apply for grants based on the outcomes of in vitro studies and confirms that the company has requested a pre-IND meeting with the FDA to accelerate trials for the SARS-CoV-2 indications.
Other industry developments from around the markets include:
Moderna, Inc. a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, recently announced that the first participants in each age cohort have been dosed in the Company’s Phase 2 study of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
This Phase 2 study, being conducted by Moderna under its own Investigational New Drug (IND) application, will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300).
Each participant will be assigned to receive placebo, a 50 μg or a 100 μg dose at both vaccinations.
Participants will be followed through 12 months after the second vaccination.
Given the 25 μg and 100 μg dose levels in the Phase 1 study showed neutralizing antibody titers at or above convalescent sera and were generally well tolerated, the Company has decided not to pursue the 250 μg dose level in the Phase 2 study.
Vir Biotechnology, Inc. recently announced that is has finalized a process development and manufacturing agreement with Biogen Inc. based on the letter of intent that the companies announced in March.
Under the agreement Biogen will perform process development activities and specified manufacturing and process transfer services to enable commercial supply of Vir’s SARS-CoV-2 monoclonal antibodies.
“Biogen’s world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximize the yield of each manufacturing batch produced.
The willingness of both Vir and Biogen to begin work before the definitive agreement was in place exemplifies our shared commitment to working in unconventional ways in the interest of the public good, and mutual recognition that bringing these therapies to people at the speed and scale that is needed requires the combined resources of multiple collaboration partners and significant manufacturing capacity.” said Michael Kamarck, Ph.D., Chief Technology Officer of Vir.
Pfizer Inc. recently announced the establishment of the Pfizer Breakthrough Growth Initiative, through which Pfizer will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs.
“There has never been a more important moment to pursue new collaborations in our industry.
The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients.” said John Young, Pfizer’s Chief Business Officer.
Novavax, Inc. a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced the acquisition of Praha Vaccines a.s., part of the Cyrus Poonawalla Group, in an all cash transaction of approximately $167 million.
The acquisition includes a biologics manufacturing facility and associated assets in Bohumil, Czech Republic.
The facility is expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021 for NVX–CoV2373, Novavax’ COVID-19 vaccine candidate.
NVX–CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix–M™ adjuvant.
“Manufacturing capacity is a critical component of our strategy to deliver a vaccine for the COVID-19 pandemic.
This acquisition provides the vital assets required to produce more than 1 billion doses per year.
In parallel with ramping up production at Bohumil, we will continue efforts to expand antigen capacity in the U.S. and Asia, and increase production of Matrix-M to match antigen capacity at multiple sites globally.” said Stanley C. Erck, President and Chief Executive Officer of Novavax.
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