OncoImmune Launches First-in-human Clinical Trial for ONC-392 – The anti-CTLA-4 Antibody that Preserves CTLA4 Recycling for Safer and More Effective Immunotherapy
- Category: Antibodies
- Published on Wednesday, 23 September 2020 18:49
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ROCKVILLE, MD, USA I September 23, 2020 I OncoImmune, Inc. announced today that it has dosed the first patient in the first-in-human clinical trial of ONC-392, its novel, next generation anti-CTLA-4 antibody, at the University of California (UC) Davis Comprehensive Cancer Center on September 16, 2020. This is a Phase 1A/1B clinical trial designed to assess the safety, pharmacokinetics, and clinical activity of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care therapy in Non-Small Cell Lung Cancer. In Phase IA, patients with solid tumors that are refractory to available therapies will be recruited. Cancer patients enrolled in the trial will receive increasing doses of ONC-392 based on his/her tolerance to the drug and anti-tumor effect of the immunotherapy.
ONC-392 was developed based on decades of fundamental research on CTLA-4 biology and immunotherapy by OncoImmune’s Founders, Drs. Yang Liu and Pan Zheng who proposed a new theory to improve both the efficacy and safety of immunotherapy drugs. Unlike other anti-CTLA-4 antibodies that induce CTLA-4 degradation and thus weaken immune tolerance and cause immunotherapy-associated adverse events (irAE), ONC-392 preserves the CTLA-4 immune checkpoint for safer and more effective immunotherapy.
OncoImmune is enormously grateful to Dr. Tianhong Li, a leading medical Oncologist and associate professor at UC Davis, for her wealth of experience in immunotherapy, especially in lung cancer, and her colleagues at the UC Davis Comprehensive Cancer Center for being the first site to open the trial. “CTLA-4 is an important but challenging immunotherapeutic target. This study is important as we look at this new generation anti-CTLA-4 antibody, which potentially could benefit all cancer patients who are candidates for cancer immunotherapy,” said Dr. Li.
About OncoImmune, Inc.
OncoImmune (www.oncoimmune.com) is a privately-held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for COVID-19, 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. It is being tested in a Phase III clinical trial for the treatment of COVID-19 (https://www.clinicaltrials.gov/ct2/show/NCT04317040). OncoImmune recently announced the progress of the trial (https://www.businesswire.com/news/home/20200614005028/en/OncoImmune-Reports-Progress-Phase-III-Clinical-Trial).
CD24Fc has also 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 Phase III study for the prevention of aGVHD is being initiated nationwide.