KENILWORTH, N.J., & ROCKVILLE, Md.--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and OncoImmune, a privately-held, clinical-stage biopharmaceutical company, today announced that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of OncoImmune for an upfront payment of $425 million in cash. In addition, OncoImmune shareholders will be eligible to receive sales-based payments and payments contingent on the successful achievement of certain regulatory milestones. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating its lead therapeutic candidate CD24Fc for the treatment of patients with severe and critical COVID-19.

OncoImmune, Inc. announced today that its Investigational New Drug (“IND”) application for ONC-392, its novel, next generation anti-CTLA-4 antibody, has been approved by the U.S. Food and Drug Administration (“FDA”). The IND approval enables OncoImmune to begin a Phase 1A/1B clinical trial of ONC-392 that is designed to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer. This open label trial is expected to begin in early 2020.