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.
ONC-392 was developed based on the research of OncoImmune’s Founders, Drs. Yang Liu and Pan Zheng, who proposed a new theory to improve both the efficacy and safety of immunotherapy drugs. The theory calls for preservation of the CTLA-4 immune checkpoint for safer and more effective immunotherapy. (https://www.sciencedirect.com/science/article/pii/S0165614719302639). This groundbreaking research was published in three papers in Cell Research in 2018 and 2019. The two 2018 papers were recognized with the Sanofi-Cell Research Outstanding Paper Award of 2018 (https://www.nature.com/articles/s41422-019-0248-2).
"ONC-392 is OncoImmune’s second drug product candidate and the approval of this IND is an important milestone for OncoImmune," said Yang Liu, President and CEO of OncoImmune. "Unlike other anti-CTLA-4 antibodies that cause lysosomal degradation of CTLA-4, ONC-392 preserves CTLA-4 recycling and thus maintains CTLA-4 function outside of the tumor microenvironment while allowing more effective CTLA-4-targeted depletion of regulatory T cells within the tumor. The truly novel and differentiated mechanism of action of this drug has the potential to improve therapeutic outcomes while significantly reducing toxicity."
"We are very excited to test the potential of this novel antibody in cancer patients," said Pan Zheng, Chief Medical Officer of OncoImmune, Inc.
The CMC development and GMP manufacturing of the drug substance and drug product were performed by WuXi Biologics, a leading global open-access biologics technology platform for the ONC-392 program. "Throughout the development program from DNA to IND, we were very impressed by WuXi Biologics’ expertise and professionalism, and we could not have picked a better partner for this project," said Martin Devenport, OncoImmune’s Chief Operating Officer.
About OncoImmune, Inc.
OncoImmune (www.oncoimmune.com) is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases. OncoImmune is based in Rockville, Maryland.
OncoImmune’s lead product, CD24Fc, is a novel therapeutic that regulates host inflammatory response to tissue injuries and which has broad implications in the pathogenesis of cancer, autoimmune disease, metabolic syndrome and graft-versus-host disease (GvHD). CD24Fc has completed a Phase IIa trial for the prophylactic treatment of acute Graft versus Host Disease (GvHD) in leukemia patients undergoing hematopoietic stem cell transplantation (HSCT) and resulted in a significant improvement in 180 Day Grade III-IV GVHD Free Survival, the Phase III primary endpoint. CD24Fc prophylaxis also resulted in a reduced relapse 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 very well. A Phase III study is anticipated to start in early 2020.