OncoC4 Initiates Phase 1/2 Trial of BNT316/ONC-392 for Advanced Prostate Cancer Patients

OncoC4, Inc. has initiated a Phase 1/2 clinical trial for patients suffering from metastatic castration-resistant prostate cancer (mCRPC), dosing the first participant with the anti-CTLA-4 antibody candidate BNT316/ONC-392 in conjunction with radioligand therapy lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). This development is a collaborative effort between BioNTech and OncoC4, who are working together on the advancement of BNT316/ONC-392 for various solid tumor treatments.

Prostate cancer ranks as the most frequently diagnosed cancer in men and is a leading factor in cancer-related mortality. It is estimated that 10-20% of patients with prostate cancer will progress to castration-resistant prostate cancer, which is associated with a significantly poor prognosis and a median survival rate of approximately two years for those at the metastatic stage. There is an urgent need for innovative treatments that can enhance survival rates for mCRPC patients.

The ongoing trial, directed by David R. Wise, M.D., Ph.D., from NYU Langone Health, is an open-label, randomized study designed to evaluate the safety and efficacy of the combination therapy in mCRPC patients who have seen disease progression despite treatment with an androgen receptor pathway inhibitor. The trial, known as PRESERVE-006 (NCT05682443), plans to enroll 144 patients across 20 sites in the United States. It will initially focus on the safety of the combination therapy and will then determine the optimal dosage. The second phase will assess the therapy's impact on progression-free survival compared to the current standard of care.

BioNTech and OncoC4 entered into a strategic partnership in March 2023, which includes the joint development of BNT316/ONC-392 for a variety of solid tumor types. BioNTech retains exclusive worldwide commercialization rights for the product candidate, which is currently under evaluation in several clinical trials for advanced solid tumors, including a Phase 3 trial for non-small cell lung cancer.

BNT316/ONC-392, also known as gotistobart, is a next-generation anti-CTLA-4 antibody. CTLA-4 is an immune checkpoint receptor that suppresses T cell activity, a mechanism that cancer cells exploit to evade the immune system. BNT316/ONC-392 is designed to block CTLA-4 while maintaining the recycling of CTLA-4 and the function of immunosuppressive T cells in peripheral tissues, potentially leading to fewer adverse effects.

OncoC4, located in Rockville, Maryland, is a clinical-stage biopharmaceutical company dedicated to discovering and developing novel biologics for cancer treatment. Their lead candidate, BNT316/ONC-392, is in late-stage development for use as monotherapy or in combination with other treatments for various cancers. The company also has a pipeline of preclinical candidates targeting the CD24-Siglecs cancer immune evasion pathway.