President Donald Trump and executives discuss progress and needs in advancing vaccines and treatments against coronavirus; also, news from Takeda and Vir Biotechnology.

White House Meets with Pharma Executives to Advance Coronavirus Treatments and Vaccines

President Donald Trump and members of the White House Coronavirus Task Force met this week (March 2, 2020) with pharmaceutical industry executives to discuss progress in developing vaccines and treatments against the coronavirus (COVID-19).

At the meeting from the large pharmaceutical companies were: Emma Walmsley, CEO of GlaxoSmithKline (GSK); John Shiver, Senior Vice President of Global Vaccine R&D at Sanofi Pasteur, the vaccines arm of Sanofi; Daniel O’Day, Chairman and CEO of Gilead Sciences; Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical, Pfizer; and Paul Stoffels, Vice Chairman and Chief Scientific Officer, Johnson & Johnson.  

Also attending were: Leonard S. Schleifer, CEO and President, Regeneron Pharmaceuticals; Stéphane Bancel.  CEO of Moderna, a Cambridge, Massachusetts-based clinical stage biotechnology company specializing in messenger RNA (mRNA) therapeutics and vaccines; J. Jim Kim, President, CEO and Director of Inovio Pharmaceuticals, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company; Stanley C. Erck, President and CEO, Novavax, a clinical-stage vaccine company headquartered in Gaithersburg, Maryland;  and Dan Menichella, CEO of CureVac, a Tübingen, Germany-based biopharmaceutical company developing therapies based on messenger RNA.

“We are meeting with the pharmaceutical and biotechnology companies—the biggest in the world, most prestigious, the ones that get down to the bottom line very quickly—to discuss how the federal government can accelerate the development of vaccines and therapeutic treatments for the coronavirus,” said President Trump in his remarks at the meeting.

“We’re here working with the pharmaceutical company leaders on three key issues: how do we speed vaccines, how do we speed therapeutics, and what are the supply-chain challenges that we may be facing for pharmaceutical products here in the United States,” said US Secretary of Health and Human Services Alex Azar and a member of the White House Coronavirus Task Force at the meeting. “With regard to therapeutics and vaccines, we want to know how we can not get in their way but rather speed that development process along.”

See related stories: “Gilead Sciences, GSK, Moderna Advance Treatments Against Coronavirus,” “Sanofi, Regeneron, Other Pharma Companies Advance Coronavirus Treatments,” “HHS, Janssen Join To Develop Coronavirus Vaccine,” and “Coalition CEPI and GSK To Collaborate and Develop Coronavirus Vaccine.”

 Source: White House

Takeda Initiates Research and Development of COVID-19 Treatments

Takeda Pharmaceutical has initiated the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) to treat high-risk individuals with coronavirus (COVID-19)

SARS-CoV-2 is the virus that causes COVID-19.

Hyperimmune globulins are plasma-derived therapies that have previously been shown to be effective in the treatment of severe acute viral respiratory infections and may be a treatment option for COVID-19. Takeda says it has the experience to research, develop, and manufacture a potential anti-SARS-CoV-2 polyclonal H-IG, which Takeda is referring to as TAK-888.

Takeda is currently in discussions with multiple national health and regulatory agencies and health care partners in the US, Asia, and Europe to expeditiously move the research into TAK-888 forward. This requires access to source plasma from people who have successfully recovered from COVID-19 or who have been vaccinated, once a vaccine is developed. These convalescent donors have developed antibodies to the virus that could potentially mitigate severity of illness in COVID-19 patients and possibly prevent it.

H-IG works by concentrating the pathogen-specific antibodies from plasma collected from recovered patients or vaccinated donors in the future. By transferring the antibodies to a new patient, it may help that person’s immune system respond to the infection and increase their chance of recovery. Because the plasma needed for TAK-888 is unlikely to come from current plasma donors, Takeda will initially produce the therapy in a segregated area within its manufacturing facility in Georgia, and development and production of it should not negatively impact Takeda’s ability to produce its other plasma-derived therapies, the company says.

In addition, Takeda is exploring whether select marketed therapies and molecules in its drug library could be viable candidates for the effective treatment of COVID-19. Takeda says these efforts are at an early stage. The company says an internal working group of in-house experts in public health, vaccines, plasma-derived therapies, and research and development will continue to seek opportunities to leverage the company’s network of global partners to address COVID-19.

To date (March 4, 2020), there are no approved vaccines or therapies to prevent or treat COVID-19.                                    

Source: Takeda Pharmaceutical

Vir Biotechnology, Alnylam Partner for RNAi Therapeutics for Coronavirus

Vir Biotechnology, a San Francisco-based biopharmaceutical company, and Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based pharmaceutical company specializing in RNA interference (RNAi) therapeutics, have expanded their existing collaboration to include the development and commercialization of RNAi therapeutics targeting SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19).

Under the agreement, the companies will use Alnylam’s recent advances in lung delivery of novel conjugates of siRNA–the molecules that mediate RNAi–together with Vir’s infectious-disease expertise and capabilities, to bring forward one or more siRNAs to treat SARS-CoV-2 and potentially other coronaviruses as well. The collaboration will focus on development of siRNAs that Alnylam recently identified that target highly conserved regions of coronavirus RNAs.

Alnylam has designed and synthesized over 350 siRNAs targeting all available SARS-CoV and SARS-CoV-2 genomes, which will be screened in in vitro potency assays. Potent siRNA lead candidates will be further evaluated by scientists at Vir for in vitro and in vivo anti-viral activity, leading to the selection of a development candidates.

Vir will lead all development and commercialization of any selected development candidates. At clinical proof of concept, Alnylam will have an option to share equally in the profits and losses associated with the development and commercialization of the coronavirus program. Alternatively, Alnylam may elect to earn development and commercialization milestones and royalties on net sales of products resulting from the collaboration in amounts agreed upon for the coronavirus program. This new program expands the companies’ existing licensing agreement announced in 2017 to now develop up to six novel siRNAs to treat infectious diseases.

Source: Vir Biotechnology and Alnylam Pharmaceuticals