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.
'Meaningful new therapeutic options are desperately needed for possibly millions of people around the world who will develop severe or critical COVID-19 disease,' said Dr.
Interim analysis of data from 203 participants (75% of the planned enrollment) reported by OncoImmune indicated that patients with severe or critical COVID-19 treated with a single dose of CD24Fc showed a 60% higher probability of improvement in clinical status, as defined by the protocol, compared to placebo. The risk of death or respiratory failure was reduced by more than 50%. Detailed results will be submitted for publication in a peer-reviewed medical journal.
'Outstanding work by the OncoImmune team has provided compelling evidence regarding the use of CD24Fc in patients with severe and critical COVID-19 in our Phase 3 Trial,' said
Under the agreement, prior to the completion of the acquisition, OncoImmune will spin-out certain rights and assets unrelated to the CD24Fc program to a new entity to be owned by the existing shareholders of OncoImmune. In connection with the closing of the acquisition,
The closing of the acquisition, which is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, is expected before the end of 2020.
OncoImmune was represented by
About SAC-COVID Phase 3 Trial
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 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 CD24Fc via an intravenous infusion on Day 1 or standard of care plus placebo on Day 1. The multi-center trial was initiated in
About CD24Fc
OncoImmune's lead product is CD24Fc, a first-in-class recombinant fusion protein that targets the innate immune system. Prior to the Phase 3 clinical trial for COVID-19 patients, CD24Fc 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.
About
About OncoImmune
OncoImmune is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biopharmaceuticals for the treatment of cancer and autoimmune disease.
The company's lead therapeutic candidate CD24Fc has a novel mechanism of action that has potential applications to a number of inflammatory diseases and has shown good safety and tolerability in a Phase 1 clinical trial in healthy volunteers. Clinical activity has been observed in two Phase 2 trials in GVHD and the Phase 3 trial in COVID-19. In addition to CD24Fc, OncoImmune has a rich pipeline of immuno-oncology candidates that will be the focus of the new spinout. OncoImmune has initiated a Phase 1 clinical trial evaluating a novel CTLA-4 antibody candidate that selectively eliminates immune suppressive regulatory T cells in the tumor microenvironment while preserving their physiological function to protect host against autoimmune diseases (NCT04140526).
About
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