Making History: OncoC4 Inaugurates First Patient in New Clinical Trial Combining ONC-392 and KEYTRUDA® for Platinum-Resistant Ovarian Cancer

Building on the promising results of its monotherapeutic activity in a previous clinical trial, ONC-392 is now entering Phase 2 of a multicenter, open-label combination trial. This groundbreaking study offers tremendous potential to improve outcomes and quality of life for those suffering from a wide range of diseases.

OncoC4, Inc., a clinical-stage biopharma company pioneering innovative immunotherapies for cancer, is proud to announce that the first patient has been dosed in their Phase 2 combination study of ONC-392 and KEYTRUDA® (pembrolizumab). This groundbreaking study is being conducted to evaluate the efficacy of their nextgen target-preserving anti-CTLA-4 antibody and Merck’s anti-PD-1 therapy in patients with platinum-resistant ovarian cancer (PROC). The trial (PRESERVE-004, NCT05446298) is an important step towards making a difference in the lives of those affected by this disease.

The Women’s Cancer Care Associates, LLC in Albany, New York, is the site of a groundbreaking clinical trial, sponsored by OncoC4, Inc. in collaboration with Merck (known as MSD outside the US and Canada) and the GOG Foundation Inc. Dr. Joyce Barlin is the Principal Investigator of the study and is responsible for dosing patients involved in the trial. This is a major development in the effort to fight cancer and improve the lives of those affected.

Excitement is in the air as we embark on a Phase 2 clinical trial of an innovative immunotherapy combination to address the unmet need in platinum-resistant ovarian cancer. It is an honor to serve as Co-PI alongside esteemed Dr. Bradley Monk, and we are thrilled to dose the first patient at our institution. This is a momentous occasion in the world of immunotherapy clinical trial research, and we are eager to see the results of this groundbreaking treatment.

We are delighted to have made progress on our ONC-392 clinical program with the dosing of our first patient in the PRESERVE-004 trial in the combination arm with KEYTRUDA. We have already seen promising results with ONC-392 as monotherapy, and we are hopeful that the results of the PRESERVE-004 trial will further bolster our progress. We are thankful to our partners Merck and the GOG Foundation for their support of the PRESERVE-004 trial, and we look forward to providing more data as they become available.

KEYTRUDA® – the revolutionary immunotherapy drug from Merck Sharp & Dohme LLC – is revolutionizing cancer treatment. Developed by the pharmaceutical giant Merck & Co., Inc., this cutting-edge therapy has been proven to be a powerful weapon in the fight against cancer. With its ability to target and eliminate cancer cells, KEYTRUDA® is a beacon of hope for cancer patients around the world.

About ONC-392

OncoC4’s lead product candidate, ONC-392, is in late-stage clinical development and has been granted fast-track-designation from the FDA as a monotherapy for immunotherapy-resistant non-small cell lung cancer (NSCLC). Unlike other anti-CTLA-4 mAbs, ONC-392 has the unique ability to interact strongly with CTLA-4 at a pH typical of normal tissues and the tumor microenvironment. In addition, when the pH drops below 6.0, ONC-392 rapidly disassociates from its target, preserving the normal life cycle of CTLA-4 and avoiding antibody-induced lysosomal degradation. This feature not only reduces toxicity, but also increases therapeutic efficacy, resulting in a better therapeutic index and allowing for sufficient dosing to tap into the immunotherapeutic potential of anti-CTLA-4 antibodies.

About PRESERVE-004 Trial (NCT05446298)

The PRESERVE-004 Study, also known as Merck study MK3475-E24 or GOG study GOG-3081, is a Phase 2 Randomized Open-label Multicenter Study conducted by OncoC4 as the sponsor under the FDA IND 160987. Patients with Platinum Resistant Ovarian Cancer (PROC) who meet the eligibility criteria will be enrolled in one of the two experimental arms to receive either 3 mg/kg or 6 mg/kg of ONC-392, in combination with a fixed dose of 200 mg of pembrolizumab, for up to 24 months at the prespecified interval of once every 3 weeks. The primary endpoints of this trial are to assess the efficacy and safety of this combination through measuring the objective response rate per RECIST1.1 and evaluating treatment related adverse events (TRAEs) and immune related adverse events (irAEs).

About OncoC4, Inc.

OncoC4 is a cutting-edge biopharmaceutical company based in Rockville, Maryland, at the forefront of discovering and developing innovative treatments for cancer. Our lead candidate, ONC-392, is a revolutionary anti-CTLA-4 antibody that combines the power of immune protection against autoimmune diseases with enhanced anti-tumor activity. We also have a robust, first-in-class pipeline of preclinical products targeting the CD24-Siglecs cancer immune evasion pathway. Our mission is to develop life-saving treatments that can change the course of cancer.

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