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

A clinical trial is currently underway to evaluate the combination treatment of BNT316/ONC-392, an anti-CTLA-4 antibody, with lutetium (177Lu) vipivotide tetraxetan (Pluvicto®), a form of radioligand therapy, for patients with metastatic castration-resistant prostate cancer (mCRPC) who have seen disease progression after treatment with an androgen receptor (AR) pathway inhibitor. This Phase 1/2 study aims to determine the safety and efficacy of this combined approach and is anticipated to include 144 participants across various clinical sites in the United States.
The collaboration between BioNTech and OncoC4 is driving the development of BNT316/ONC-392 for use in a variety of solid tumor types. Prostate cancer, a leading cancer in men worldwide, often progresses to castration-resistant disease, which has a median survival rate of about two years for those with metastatic disease. There is a significant need for new treatments that can improve survival rates for these patients.
David R. Wise, M.D., Ph.D., the Director of the Perlmutter Cancer Center at NYU Langone Health and the principal investigator of the trial, expressed optimism about the potential of BNT316/ONC-392 in combination with radioligand therapy to enhance patient outcomes.
The trial, known as PRESERVE-006 (NCT05682443), is an open-label, randomized study that will initially focus on the safety of the combined treatment before determining the optimal dosage. The second phase will assess if the treatment can improve progression-free survival over the current standard of care for mCRPC patients with PSMA-positive scans who have not responded to previous AR targeted therapies and have not been previously treated with lutetium (177Lu) vipivotide tetraxetan.
BioNTech and OncoC4 entered into a strategic collaboration in March 2023, which includes sharing development costs for BNT316/ONC-392 across various solid tumor indications. 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 patients with metastatic, immunotherapy-resistant non-small cell lung cancer (NSCLC).
BNT316/ONC-392, also known as gotistobart, is a next-generation anti-CTLA-4 antibody designed to enhance T cell activity against cancer cells while maintaining the immunosuppressive function of regulatory T cells in peripheral tissues, potentially leading to fewer immune-related adverse effects.
Prostate cancer, which is often driven by androgens, can become castration-resistant, spreading to other parts of the body and ceasing to respond to androgen-blocking therapy. The PSMA biomarker is expressed on prostate cancer cells and is a target for radioligand therapy. Approximately 30% of men with prostate cancer develop castration-resistant prostate cancer (CRPC) within five years, with the majority presenting with metastatic disease at the time of CRCP diagnosis.
OncoC4, based in Rockville, Maryland, is a clinical-stage biopharmaceutical company focused on developing novel biologics for cancer treatment, with BNT316/ONC-392 as its lead clinical candidate. The company also has a pipeline targeting the CD24-Siglecs cancer immune evasion pathway.

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