Merck to Acquire OncoImmune for $425 Million to Gain First-in-Class CD24Fc with Promising Phase 3 Results in Severe COVID-19

November 23, 2020 /BioValleyBIOON/ -- Merck & Co. and OncoImmune recently announced that they have entered into a definitive agreement. Under the terms of the agreement, Merck will acquire all outstanding shares of OncoImmune through its subsidiary for an upfront cash payment of $425 million. In addition, OncoImmune shareholders will be eligible to receive payments based on sales as well as payments contingent upon the successful achievement of specific regulatory milestones. The acquisition is expected to be completed by the end of 2020, subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

OncoImmune is a privately held, clinical-stage biopharmaceutical company dedicated to the discovery and development of novel biologics for the treatment of cancer and autoimmune diseases. The company’s lead candidate isCD24Fc, a first-in-class recombinant fusion protein that targets a novel immune checkpoint pathway in the innate immune system.

CD24Fc features a novel mechanism of action that modulates immune responses, demonstrating potential for the treatment of various inflammatory diseases. It has shown favorable safety and tolerability in Phase 1 clinical trials involving healthy volunteers, and clinical activity has been observed in Phase 2 trials for the prevention of graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation in leukemia patients, as well as in Phase 3 trials for the treatment of coronavirus disease 2019 (COVID-19). Currently, the pivotal Phase 3 clinical trial for GVHD prevention (NCT04095858) has been initiated.

Under the agreement, prior to the completion of the acquisition, OncoImmune will spin off certain rights and assets unrelated to the CD24Fc project into a new entity owned by OncoImmune’s existing shareholders. Upon completion of the acquisition, MSD will invest $50 million to become a minority shareholder in the new entity.

In addition to CD24Fc, OncoImmune boasts a robust immuno-oncology pipeline, which will be the focus of the new entity. OncoImmune has initiated Phase 1 clinical trials for a novel CTLA-4 antibody candidate.Clinical Trial(NCT04140526), this antibody can selectively eliminateTumorImmunosuppressive regulatory T cells in the microenvironment, while preserving their ability to protect the host fromAutoimmunityPhysiological functions of sexual disorders.

Recently, OncoImmune announced positive results from the interim efficacy analysis of the Phase 3 SAC-COVID clinical trial (NCT04317040) evaluating CD24Fc for the treatment of COVID-19. The data demonstrated that CD24Fc exhibits significant efficacy in treating patients with severe and critical COVID-19.

SAC-COVID was a randomized, double-blind, multicenter, placebo-controlled trial designed to evaluate the safety and efficacy of CD24Fc in hospitalized patients with COVID-19 who required oxygen support (including supplemental oxygen, high-flow oxygen, or mechanical ventilation). In the study, patients were randomly assigned to two groups: one group received standard of care plus a single intravenous infusion of CD24Fc on Day 1, while the other group received standard of care plus placebo on Day 1. The study was initiated in April 2020 and enrolled a total of 243 patients by the time the trial concluded in September 2020.

An interim analysis of 203 subjects (75% of the planned enrollment) showed that,Compared with placebo, patients with severe and critical COVID-19 treated with a single dose of CD24Fc had a 60% higher probability of clinical status improvement and more than a 50% reduction in the risk of death or respiratory failure.The detailed results of this study will be published in a peer-reviewed medical journal.

Since the early stages of the COVID-19 pandemic, MSD has been committed to developing an effective response to COVID-19 and is exploring multiple avenues to enhance understanding of SARS-CoV-2 infection. MSD is collaborating with Ridgeback Biotherapeutics to evaluate molnupiravir, an oral antiviral drug, for the treatment of outpatient and hospitalized patients with COVID-19 in two Phase 2/3 clinical trials. In addition, the company is conductingClinical Trials, evaluating two SARS-CoV-2/COVID-19 candidate vaccines: (1) V590, a vaccine developed in collaboration with IAVI using a recombinant vesicular stomatitisCarrier; (2) V591, which utilizes a measles virus-basedCarrierplatform.

Dr. Roger M. Perlmutter, President of Merck Research Laboratories, stated, “Millions of people worldwide are likely to develop severe or critical COVID-19, creating an urgent need for meaningful new therapies. Recent clinical studies support the view that CD24Fc may provide benefits beyond standard of care for COVID-19 patients requiring oxygen support, thus serving as an important complement to Merck’s investigational drugs and vaccines designed to address the COVID-19 pandemic.”(Bioon.com)

Original Source: Merck to Acquire OncoImmune