The U.S. government continues to inject capital into novel therapeutics development as part of the battle against COVID-19. Now the federal government has entered into an agreement with Merck, known as MSD outside of North America, to develop and manufacture as well as fund initial distribution of an investigational biological therapeutic called MK-7110 (CD24Fc) if the product can reach the Emergency Use Authorization (EUA) milestone from the U.S. Food and Drug Administration (FDA). Merck acquired MK-71100 as part of its acquisition of Oncolmmune, a privately held clinical-stage biotech company. As TrialSite has urged, although both vaccines and new biologics are critical during this pandemic, so is the exploration of existing drugs that could be repurposed for early stage treatment. Several such compounds have been identified. Novel drug development is incredibly expensive as well as risky, and the federal government needs to bolster its strategy to diversify approaches to ensure the highest probability of gaining low cost choice options for a healthy marketplace if possible. Perhaps Merck’s novel product can compete with the existing monoclonal antibody products already authorized under EUA, should MK-71100 get approved for emergency use.
As Operation Warp Speed now spends over $2 billion on novel biological therapeutics alone, a number of pleas out in the market cry for funds for more study of repurposing existing, FDA-approved drugs. TrialSite reported on the ReFRAME initiative created by Calibr, the drug discovery division of Scrips Research, for example. Its leader, Peter Shultz, PhD, received ongoing support form the Bill & Melinda Gates Foundation and the candidates have been distributed broadly to nonprofit collaborators and used to identify repurposing opportunities for a range of disease including COVID-19.
For example, TrialSite reported on July 26 that Sanford Burnham Prebys discovered 21 drugs that could potentially treat COVID-19.
Just recently, TrialSite reported on important progress from Washington University School of Medicine St. Louis and the the fluvoxamine findings—this study has been sponsored by the COVID-19 Early Treatment Fund (CETF) dedicated to repurposing existing drugs for early onset treatment of COVID-19.
Of course, there are a number of other initiatives and the mounting evidence that the antiparasitic drug Ivermectin actually inhibits SARS-CoV-2 in what is now dozens of study results (case series, observational and randomized controlled trial)—albeit most of them have been done overseas.
By September 2020, Oncolmmune reported that topline findings from an interim efficacy analysis of a Phase 3 study investigating MK-7100 for the treatment of patients with severe and critical COVID-19 showed results. More specifically, the interim analysis revealed that form a total of 203 patients (75% of the planned enrolment) that those hospitalized with COVID-19 and treated with a single dose of MK-7110 evidenced a 60% higher probability of improvement in clinical status compared to placebo, as defined by the protocol. Importantly, the risk of death or respiratory failure was purportedly reduced by over 50%. This study is ongoing.
Under this agreement Merck will receive up to $356 million for manufacturing and supply of approximately 60,000-100,000 doses of MK-7110 to the U.S. government through June 30, 2021 to meet the government’s Operation Warp Speed goals. This approach is intended to expedite the delivery of MK-7110 to the American people as quickly as possible should the early stage candidate somehow get approved. Merck will also expand production capacity to increase the supply of the investigational product.
Ongoing Phase 3 Clinical Trial
The SAC-COVID Phase 3 clinical trial (NCT04317040) is a randomized, double blind, placebo-controlled trial designed to evaluate the safety and efficacy of CD24Fc/MK-7110 in hospitalized patients with COVID-19 requiring oxygen support, including those requiring supplemental oxygen, high flow oxygen, and mechanical ventilation. Participants were randomly assigned into two arms receiving either standard of care plus a single dose of MK-7110 via an intravenous infusion on Day 1 or standard of care plus placebo on Day 1. The multi-center trial was initiated in April 2020 and had enrolled 243 patients when the trial was closed due to full enrollment in September 2020.
About Operation Warp Speed
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
About MK-7110 (CD24Fc)
MK-7110 is a potentially first-in-class recombinant fusion protein that targets the innate immune system. In addition to the Phase 3 clinical trial for COVID-19 patients, MK-7110 has been studied for safety in healthy volunteers and in Phase 2 clinical trials for the prevention of graft versus host disease (GVHD) following hematopoietic stem cell transplantation in patients with leukemia. A pivotal Phase 3 clinical trial (NCT04095858) for prophylaxis of GVHD has been initiated nationwide.
About Merck’s Ongoing Commitment to COVID-19
Merck has been committed to developing an effective response to COVID-19 since the early stage of the pandemic and is exploring multiple paths to advance the understanding of SARS-CoV-2 infection. In addition to the development of MK-7110, in collaboration with Ridgeback Biotherapeutics Merck is evaluating molnupiravir, an investigational orally available anti-viral agent being evaluated in two Phase 2/3 trials for the treatment of patients with COVID-19 in both the outpatient and hospital settings. The company is also conducting clinical trials to evaluate two SARS-CoV-2/COVID-19 vaccine candidates: V590, being developed through a collaboration with IAVI, which utilizes a recombinant vesicular stomatitis vector, and V591 which uses a measles virus vector-based platform.
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.