Vaccine Info

MK-7110 COVID-19 Therapeutic

Authored by
Staff
Last reviewed
February 26, 2021

MK-7110 COVID-19 Therapeutic Description

The MK-7110 COVID-19 Therapeutic candidate is a first-in-class recombinant fusion protein that targets the innate immune system, an immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive immune response to COVID-19. This overactive response can contribute to the severity of the illness.

MK-7110 (CD24Fc) (Saccovid) comprises the nonpolymorphic regions of CD24 attached to the Fc region of human IgG1.

MK-7110 is a biological immunomodulator in Phase II/III clinical trial stage. Preclinical and clinical studies have demonstrated that CD24Fc effectively addresses the major challenges associated with COVID-19.

MK-7110 COVID-19 Therapeutic History

First, a Phase I clinical trial on healthy volunteers demonstrated the safety of CD24Fc and demonstrated its biological activity in suppressing the expression of multiple inflammatory cytokines.

Second, a Phase II clinical trial in leukemia patients undergoing hematopoietic stem cell transplantation, three doses of CD24Fc effectively eliminated severe (Grade 3-4) acute graft vs. host diseases (GVHD), which is caused by the overreacting immune system and transplanted T cells attacking recipient target tissues.

Third, in preclinical models of HIV/SIV infections, we have shown that CD24Fc ameliorated the production of multiple inflammatory cytokines, reversed T lymphocytes' loss and functional T cell exhaustion, and reduced the leukocyte infiltration of multiple organs.

It is particularly noteworthy that CD24Fc reduced the rate of pneumonia in SIV-infected Chinese rhesus monkeys from 83% to 33%. Therefore, CD24Fc maybe a prime candidate for non-antiviral biological modifiers for COVID-19 therapy, said the company.

Merck acquired CD24Fc (MK-7110) on November 23, 2020, through the acquisition of OncoImmune, a privately held, clinical-stage biopharmaceutical company. Also, Merck announced it has agreed with the United States Government to support the development, manufacture, and initial distribution of an investigational biological therapeutic (CD24Fc, MK-7110) upon approval or Emergency Use Authorization from the U.S. Food and Drug Administration.

“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,” stated Dr. Roger M. Perlmutter, president, Merck Research Laboratories.

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.

MK-7110 COVID-19 Therapeutic Indication

MK-7110 therapeutic candidate is used for the treatment of hospitalized COVID-19 patients. These COVID-19 severe and critical patients either require supplemental oxygen support or high flow oxygen non-invasive ventilation, in addition to ICU patients requiring invasive mechanical ventilation. MK-7110 is a potentially first-in-class recombinant fusion protein that targets the innate immune system.

The MK-7110 is delivered via an intravenous infusion.

MK-7110 COVID-19 Therapeutic News

February 26, 2021 - Merck's recent 10-K report filed with the U.S. Securities and Exchange Commission indicates the regulatory agency is seeking additional data regarding MK-7110 (formerly known as CD24Fc). “Merck received feedback from the FDA that additional data, beyond the study conducted by OncoImmune, would be needed to support a potential EUA application.

February 4, 2021 - Merck Announced Fourth-Quarter and Full-Year 2020 Financial Results. Kenneth C. Frazier, chairman, and chief executive officer, Merck. “Our scientists continue to advance our internal pipeline of promising medicines and vaccines, including in oncology, HIV, and pneumococcal disease, and, more recently, therapeutics for COVID-19. These pipeline developments provide us with increasing line-of-sight to significant potential growth drivers later this decade and into the next.”

January 25, 2021 - Merck announced that the company plans to focus its SARS-CoV-2 / COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. Merck stated in a press release it also continues to evaluate the potential of the measles-virus vector and vesicular stomatitis virus vector-based platforms and pursues broader pandemic-response capabilities.

December 23, 2020 - Merck announced a Supply Agreement with the U.S. Government for Initial Doses of Investigational Biological Therapy for the Treatment of Patients with Severe and Critical COVID-19.  Under the agreement, Merck will receive up to approximately $356 million for manufacturing and supply approximately 60,000-100,000 doses of MK-7110 to the U.S. Government through June 30, 2021. “Our agreement with Merck is the latest example of how industry and government are coming together under Operation Warp Speed to move potential therapeutics all the way from development through to manufacturing, enabling faster distribution,” said HHS Secretary Alex Azar. “More good news about COVID-19 therapeutics is constantly emerging, and President Trump’s commitment to supporting life-saving therapeutics has already helped deliver hundreds of thousands of Operation Warp Speed-supported therapeutics to the frontlines.”

November 23, 2020 - Merck announced it would acquire OncoImmune. Merck stated it would accelerate the development of CD24Fc, a candidate for treating patients with severe and critical COVID-19.

September 24, 2020 - OncoImmune’s SACCOVID™ (CD24Fc) Exhibits Superb Therapeutic Efficacy—A Potential Breakthrough in Treating Severe and Critical COVID-19. “The interim analysis shows safety and outstanding therapeutic efficacy of SACCOVIDTM. The results indicate that patients who received SACCOVIDTM had a 60% better chance to achieve clinical recovery than those who received placebo (P=0.005). The median time to recovery was 6 days for patients treated with SACCOVIDTM compared with 10 days in the placebo group. Also, the risk of death or respiratory failure is reduced by more than 50%,” said Dr. Pan Zheng, MD, Ph.D., Chief Medical Officer, and co-founder of OncoImmune.

MK-7110 COVID-19 Therapeutic Clinical Trial

Clinical Trial NCT04317040: CD24Fc as a Non-antiviral Immunomodulator in COVID-19 Treatment (SAC-COVID). Last Update Posted: November 24, 2020.

The Phase 3 study is designed as a randomized, placebo-controlled, double-blind, multicenter trial to compare two COVID-19 treatment regimens in hospitalized adult subjects diagnosed with severe and critical COVID 19.

Arm A: CD24Fc/Best Available Treatment; Arm B: placebo/ Best Available Treatment. CD24Fc will be administered as a single dose of 480 mg via IV infusion on Day 1. A total of 270 subjects will be enrolled and randomized in a 1:1 ratio to receive CD24Fc or placebo. All subjects will be treated with the best available treatment. The follow-up period is 28 days.

First, although the new coronavirus (SARS-CoV-2) infect lung and intestine, many patients suddenly take a turn for the worse even when the viral replication appears to be under control. Second, patients with serious or critical clinical symptoms show remarked T cell lymphopenia that is more severe and more acute than human immunodeficiency virus (HIV) infection. Functional exhaustion of T cells is suggested by high expression of T-cell exhaustion markers, which again appears more acute than in HIV patients. Third, multiple cytokines are elevated among patients with severe clinical symptoms, potentially explaining the multiple organ failure associated with COVID-19.

For these reasons, treatment of COVID-19 likely requires a combination of both antivirals and non-antivirals-based approaches.

CD24Fc is a biological immunomodulator in Phase II/III clinical trial stage. CD24Fc comprises the nonpolymorphic regions of CD24 attached to the Fc region of human IgG1. We have shown that CD24 is an innate checkpoint against the inflammatory response to tissue injuries or danger-associated molecular patterns (DAMPs). Preclinical and clinical studies have demonstrated that CD24Fc effectively addresses the major challenges associated with COVID-19. First, a Phase I clinical trial on healthy volunteers demonstrated the safety of CD24Fc and demonstrated its biological activity in suppressing the expression of multiple inflammatory cytokines.

Second, in Phase II clinical trial in leukemia patients undergoing hematopoietic stem cell transplantation (HCT), three doses of CD24Fc effectively eliminated severe (Grade 3-4) acute graft vs. host diseases (GVHD), which is caused by the overreacting immune system and transplanted T cells attacking recipient target tissues.

Third, in preclinical models of HIV/SIV infections, we have shown that CD24Fc ameliorated the production of multiple inflammatory cytokines, reversed T lymphocytes' loss and functional T cell exhaustion, and reduced the leukocyte infiltration of multiple organs. It is particularly noteworthy that CD24Fc reduced the rate of pneumonia in SIV-infected Chinese rhesus monkeys from 83% to 33%.

Therefore, CD24Fc maybe a prime candidate for non-antiviral biological modifiers for COVID-19 therapy. The phase III trial will involve 270 patients randomized into blinded placebo and CD24Fc arms, with time to clinical improvement from critical or severe to mild to the primary endpoint.