Merck Halts Development of MK-7110 (CD24Fc, Saccovid) for COVID-19 Amid Global Cases Surpassing 138 Million

April 15, 2021 / BIOON -- Currently, the COVID-19 epidemic overseas continues to spread rapidly. According to Baidu's "Real-time Big Data Report on the Novel Coronavirus Pneumonia Epidemic," as of 20:00 on April 15, 2021, the global cumulative number of confirmed cases exceeded 130 million (138.9 million), with more than 2.98 million deaths.

Recently, Merck & Co. announced that it will halt the development of MK-7110 (formerly known as CD24Fc, also known as Saccovid) for the treatment of hospitalized patients with COVID-19. MK-7110 is an intravenous immunomodulator currently in Phase III clinical development. The drug was acquired by Merck through its $425 million purchase of OncoImmune in December 2020.

MK-7110 is an immunomodulator targeting the innate immune system. It is a first-in-class recombinant fusion protein that targets a novel immune pathway checkpoint in the innate immune system.

MK-7110 has a novel mechanism of action that modulates immune responses, showing potential for treating various inflammatory diseases. Prior to its development for COVID-19, the drug was being studied for the prevention of graft-versus-host disease (GVHD) in leukemia patients following hematopoietic stem cell transplantation, and Phase 3 clinical trials for this indication have been initiated.

The Role of CD24 and Siglecs in Immunity and Cancer Biology

In September 2020, two months prior to its acquisition by Merck Sharp & Dohme (MSD), OncoImmune reported positive results from an interim efficacy analysis of a Phase III clinical trial. The study demonstrated thatCompared with placebo, patients with severe or critical COVID-19 who received a single dose of MK-7110 were 60% more likely to show improvement in clinical status and had a more than 50% reduced risk of death or respiratory failure.. The interim data were released based on 75% of the planned enrollment in the study. The full study results announced in early February this year were consistent with those of the interim analysis. MSD had previously expected to supply MK-7110 to the U.S. government in the first half of this year.

In late February this year, Merck & Co., Inc. received feedback from the U.S. Food and Drug Administration (FDA) indicating that, in addition to the studies conducted by OncoImmune, Inc., more data are needed to support a potential Emergency Use Authorization (EUA) application for MK-7110 in the treatment of COVID-19.

The Broad Therapeutic Potential of MK-710

Given the need for additional studies—including new clinical trials and research related to large-scale manufacturing—MK-7110 was not expected to reach the market until the first half of 2022. In light of this timeline, the associated technical, clinical, and regulatory uncertainties, the availability of multiple therapies for hospitalized COVID-19 patients, and the need to concentrate Merck’s resources on accelerating the development and manufacturing of the most viable therapeutic candidates and vaccines, Merck has decided to discontinue the development of MK-7110 for COVID-19. The company will instead focus its efforts in response to the COVID-19 pandemic on advancing molnupiravir, an oral antiviral agent, and on producing Johnson & Johnson’s COVID-19 vaccine.

Dr. Roy Baynes, Chief Medical Officer, Senior Vice President, and Head of Global Clinical Development at MSD Research Laboratories, stated: “From the outset of the COVID-19 pandemic, MSD has been committed to deploying our expertise and capabilities where they can have the greatest impact. MSD is currently advancing the development of molnupiravir as an oral outpatient therapy, representing a promising potential new approach, while also working to accelerate the production of Johnson & Johnson’s COVID-19 vaccine.” (Bioon.com)

Original Source: Merck to Discontinue Development of MK-7110 for COVID-19