Congratulating a clearance
WuXi Biologics applauds OncoImmune over FDA clearance of IND application for ONC-392
SHANGHAI—WuXi Biologics recently put out a press release congratulating its partner, OncoImmune, Inc., on the U.S. Food and Drug Administration (FDA) clearance of OncoImmune’s Investigational New Drug (IND) application for ONC-392, a novel, next-generation anti-CTLA-4 antibody.
“It has been our great pleasure working with WuXi Biologics on our ONC-392 program,” said Yang Liu, Ph.D., founder and CEO of OncoImmune. “The clearance of ONC-392 IND by the FDA is an important milestone for OncoImmune. WuXi Biologics’ state-of-the-art and full-service biologics platform enabled us to complete a solid CMC package in support of our IND submission and clearance. We are excited about the potential of this next generation anti-CTLA-4 antibody with its novel and differentiated mechanism of action to improve therapeutic outcomes while significantly reducing toxicity.”
As part of the collaboration, WuXi Biologics provided comprehensive and integrated services for the ONC-392 program, including CMC development and GMP manufacturing of the drug substance and drug product, through the company’s development and manufacturing capacities and capabilities.
“Congratulations to OncoImmune on reaching this milestone for the ONC-392 program. We are glad to enable OncoImmune to accelerate the development of biologics from DNA to IND. We wish the program a great success to benefit more patients suffering from cancers,” added Dr. Chris Chen, CEO of WuXi Biologics. “WuXi Biologics will continue empowering global partners to provide more life-saving treatments to meet health challenges.”
ONC-392 is OncoImmune’s second biological product to reach clinical testing. A Phase 1a/1b clinical trial of ONC-392, 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, is expected to begin in early 2020.
OncoImmune also has its lead product, CD24Fc, in trials currently. CD24Fc is a novel therapeutic that regulates host inflammatory response to tissue injuries. OncoImmune says that CD24Fc has broad implications in the pathogenesis of cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GvHD). CD24Fc has completed a Phase 2a trial for the prophylactic treatment of acute GvHD in leukemia patients undergoing hematopoietic stem cell transplantation (HSCT). CD24Fc treatment resulted in a significant improvement in 180 day Grade III-IV GVHD-free survival, which is the Phase 3 primary endpoint.
CD24Fc prophylaxis also resulted in reduced relapse rates and, compared to match controls, CD24Fc demonstrated improvement in overall survival, non-relapse mortality and relapse-free survival. A dose-dependent reduction in severe (Grade > 3) mucositis was also observed. A 20 patient open label dose expansion cohort at the recommended clinical dose is fully enrolled, and the drug continues to perform well. OncoImmune anticipates that the CD24Fc Phase 3 study will begin in early 2020 as well.