Merck (NYSE:MRK), known as MSD outside the United States and Canada, has moved into the race to develop COVID-19 treatments, including vaccines and a possible therapy the company announced in press releases today. Starting with two agreements to develop potential vaccines against SARS-CoV-2 and a research collaboration to advance the development of a novel antiviral candidate, the COVID-19 drug development race gets more interesting by the week.
Merck’s entry into the COVID-19 drug development race includes:
- Merck acquisition of Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious disease, including COVID-19
- IAVI and Merck’s collaboration to develop a COVID-19 vaccine
- Merck and Ridgeback Bio’s collaboration to advance development of an oral antiviral candidate for COVID-19 known as EIDD-2801
Merck chairman and chief executive officer Kenneth Frazier reported, “With our singular legacy and expertise in vaccines and anti-infective medicines, we know Merck as a responsibility to engage in the scientific community’s efforts to find new medicines and vaccines to bring this pandemic to an end.”
TrialSite News will break down this imminent news.
Who is Themis and why will Merck buy them?
As Merck reported, Merck, via a subsidiary, will acquire privately-held Themis, a biotech with a broad pipeline of vaccine candidates and immune-modulatory therapies developing its innovative measles virus vector platform based on a vector originally developed by scientists at the Institut Pasteur—a world-leading European vaccine research institute. Themis holds an exclusive license from Institut Pasteur for select viral indications. The two parties already were collaborating in the joint development of vaccine candidates involving the measles virus vector platform.
Why is Themis latest activity relevant to COVID-19?
Just recently, Themis joined a consortium together with Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh, supported by the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine candidate targeting SARS-CoV-2 for the prevention of COVID-2.
How has this led to more value at Themis?
The Themis team has been able to build on the innovative and pioneering work of the Institut Pasteur—in the process developing specialized expertise and intellectual property know-how that can greatly complement Merck. Moreover, CEPI has made direct investments advancing the Themis technology platform and associated programs. Hence, Merck looks forward to continued collaboration with CEPI and other international organizations involved in the pursuit of vaccines and therapies targeting SARS-CoV-2.
What is the timeline for a vaccine moving forward?
The vaccine candidate is in pre-clinical development, and clinical studies are planned to start later in 2020.
Who is IAVI?
IAVI are a nonprofit scientific research organization dedicated to addressing urgent and unmet global health challenges.
What is the goal of the Merck and IAVI alliance?
The two parties have agreed to join forces to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19.
What is the joint vaccine candidate?
This vaccine candidate will use recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine called ERVEBO® (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans.
Why is rVSV a promising candidate?
Merck believes this approach is promising to combat SARS-CoV-2—along with the powerful synergies of the two organizations collaborating. The partnership is attracting federal government funding.
Where has the IAVA team been working on the vaccine candidates?
IAVI’s rVSV vaccine preclinical development, including the work on the SARS-CoV-2 vaccine candidate, is done by scientists at IAVI’s Design and Development Laboratory (DDL) in Brooklyn, New York. This is part of a long-standing effort to develop rVSV vaccines for HIV and other infectious diseases under the leadership of Dr. Swati Gupta, head of Emerging Infectious diseases and Scientific Strategy.
What is the core basis of the deal?
Under this deal, IAVI and Merck will collaborate to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate engineered by IAVI scientists.
How does U.S. Government funding fit into this deal?
Moving forward, Merck will receive support via an agreement they just signed with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response with an agency of the United States Department of Health and Human Services. BARDA has invested $1+ billion into AstraZeneca for its Oxford vaccine partnership and over $480 million into Moderna for its mRNA-1273-based vaccine effort. Now BARDA will help fund Merck’s vaccine effort, thanks to the partnership with IAVI.
What is the status of the vaccine candidate?
Presently, the candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead the effort for regulatory filings globally. Both organizations will collaborate to develop the vaccine and make it accessible and affordable worldwide.
Ridgeback Bio Partnership
What is special about EIDD-2801?
EIDD-2801 is an orally available antiviral candidate currently in early state development for the treatment of patients with COVID-19. Importantly, Dr. Roger M. Perlmutter, president of Merck Research Laboratories, reported, “In addition to our efforts to develop potential vaccines to SARS-CoV-2, we have also been evaluating our own anti-viral assets and those from external sources for their potential to treat individuals with COVID-19.”
What is special about EIDD-2801?
According to Dr. Perlmutter, “Clinical evaluation of EIDD-2801 in COVID-19 patients is just beginning, now that Phase I studies have demonstrated that the compound is well-tolerated. Since preclinical studies demonstrated that EIDD-2801 has potent antiviral properties against multiple coronavirus strains including SARS-CoV-2, we are eager to advance the next phase of clinical studies as rapidly and responsibly as possible.”
What are the deal terms?
Merck secures worldwide exclusive rights to develop and commercialize EIDD-2801 and related molecules. Merck will pay Ridgeback an undisclosed upfront payment, specified milestone, and a share of the net proceeds of EIDD-2801 and related molecules, if approved. Merck will be responsible for clinical development and regularly filings as well as manufacturing. The parties are committed to making joint products accessible and economical worldwide.