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Merck has largely stayed out of the COVID-19 battle, but exploded into it with three major deals and collaborations today.
First, Merck is buying Austria-based Themis, a vaccines and immune-modulation therapies company focused on infectious diseases and cancer. Merck hasn’t disclosed financial details, except that it is a cash deal to buy all outstanding Themis shares.
Themis has a pipeline of vaccine candidates and immune-modulatory therapies that it has built using its measles virus vector platform. The vector was originally developed by researchers at the Institut Pasteur and licensed exclusively to Themis for specific viral indications. In March, the company joined a consortium with the Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh, which is supported by monies from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine candidate against COVID-19.
“Building on the pioneering work of the Institute Pasteur, the Themis team has established specialized expertise that complements Merck’s own capabilities in the discovery, development, manufacturing and global distribution of vaccines,” said Roger M. Perlmutter, president, Merck Research Laboratories. “We are eager to combine our strengths both to develop an effective COVID-19 vaccine in the near term and to build a pandemic preparedness capability directed toward emerging agents that pose a future epidemic threat.”
The company expects to begin vaccinating volunteers “within weeks.” The company is already manufacturing doses of the vaccine in France for clinical trials.
Secondly, Merck is collaborating with IAVI, a nonprofit scientific research organization focused on global health challenges. They are partnering to develop a vaccine against COVID-19. The vaccine candidate uses the recombinant vesicular stomatitis virus (rVSV) technology that was used for Merck’s Ebola Zaire virus vaccine, ERVEBO. Merck has also entered an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HSS).
“We believe an rVSV-based vaccine strategy represents a promising approach to combating the novel coronavirus pandemic and look forward to implementing an accelerated development program, together with Merck, to evaluate the potential of our vaccine candidate against SARS-CoV-2,” said Mark Feinberg, IAVI president and chief executive officer.
The company indicates it plans to begin human clinical trials with the vaccine sometime this year. Merck expects to launch production of the vaccine in a facility in Pennsylvania.
And third, Merck signed a collaboration pact with Miami, Florida-headquartered Ridgeback Biotherapeutics to develop EIDD-2801, an orally available antiviral candidate for COVID-19. Under a subsidiary, Merck gains exclusive worldwide rights to develop and commercialization EIDD-2801 and related molecules. Again, no financial details were released. Merck is paying Ridgeback an upfront payment along with milestones and net proceeds. Merck will handle clinical development, regulatory filings and manufacturing.
The drug is an investigational, oral form of a potent ribonucleoside analog that inhibits replication of multiple RNA viruses, including SARS-CoV-2. In animal studies, the drug improved pulmonary function, decreased body-weight loss and decreased the amount of virus in the lung for both SARS-CoV-1, the coronavirus that caused SARS, and another coronavirus that causes MERS, Middle Eastern Respiratory Syndrome.
“Since the start of the COVID-19 pandemic we have worked closely with our network of esteemed collaborators to advance EIDD-2801 into the clinic,” said Wendy Holman, chief executive officer of Ridgeback. “This agreement with Merck, a leader in infectious disease therapeutics, positions us to harness the full potential of EIDD-2801 and, if approved, deliver it to the patients that need it globally.”
The company indicates it is similar to Gilead Sciences’ remdesivir, which has emergency use authorization for COVID-19, but can be taken as a pill, rather than as a transfusion.
In an interview with Reuters, Merck’s chief executive officer Ken Frazier indicated that the company was waiting for therapies with proven track records before moving deeply into the COVID-19 arena.
“We wanted to be in a position where we could choose things that have the right kind of characteristics to make a contribution for a virus that’s likely to be with us for some time,” he told Reuters.
One consideration, apparently, is that both vaccine candidates are designed for a single dose, which is both easier and requires less manufacturing and distribution efforts.
Another likely consideration is that both vaccine candidates utilize proven technology, unlike some of the other vaccines under development, notably Moderna and the U.S. National Institute of Allergy and Infectious Disease, and Pfizer and Germany’s BioNTech, both of which leverage messenger RNA technology. No vaccine using mRNA has yet to be approved for the market.
Francis Collins, director of the National Institutes of Health (NIH), announced last week that Merck’s vaccine, as well as vaccine candidates from Johnson & Johnson and Sanofi are running about a month, possibly two months, before Moderna’s, but may be included in large efficacy trials this summer.
“I think we’ll be in a position to participate,” Frazier said.
To date, Merck hasn’t signed any deals with the U.S. government to distribute either the vaccine to Americans first. Frazier indicated the company is committed to making its vaccine available globally and affordably.