Merck, known as MSD outside the United States and Canada, announced it has entered into an agreement with the United States Government to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Merck acquired MK-7110 through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company.
“Building upon the promising clinical findings to date for MK-7110, Merck is pleased to be collaborating with the U.S. Government to advance the manufacture and distribution of this candidate for patients with serious COVID-19 disease,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.
Under the agreement, Merck will receive up to approximately $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 delivery of MK-7110 to the American people as quickly as possible, following potential EUA or FDA approval. Merck is also investing to expand its manufacturing capacity to increase supply of MK-7110.
In September 2020, OncoImmune reported topline findings from an interim efficacy analysis of a Phase 3 study evaluating MK-7110 for the treatment of patients with severe and critical COVID-19. An interim analysis of data from 203 participants (75% of the planned enrollment) indicated that hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared to placebo, as defined by the protocol. The risk of death or respiratory failure was reduced by more than 50%. The study is ongoing.
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.
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.
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.
Source: Company Press Release