BioNTech and OncoC4 Collaborate on Phase 3 Trial for BNT316/ONC-392 Program in Metastatic NSCLC
Friday, June 30, 2023
BioNTech SE (Nasdaq: BNTX) and OncoC4, Inc. have jointly announced the initiation of a Phase 3 clinical trial for their novel anti-CTLA-4 antibody candidate, BNT316/ONC-392 (gotistobart). The trial aims to evaluate the effectiveness and safety of BNT316/ONC-392 as a standalone therapy compared to standard chemotherapy (docetaxel) in patients with metastatic non-small cell lung cancer (NSCLC) who have previously undergone treatment with PD-(L)1 inhibitors.
The Phase 3 trial, named PRESERVE-003 (NCT05671510), is an open-label, randomized study that will be conducted in two stages. It is expected to enroll approximately 600 patients across various clinical sites in the United States, Europe, and other countries, including Belgium, Germany, Italy, Spain, and Türkiye. The primary endpoint of the trial will be overall survival, while secondary endpoints will include overall response rate, progression-free survival, and adverse event profile. BNT316/ONC-392 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in 2022, recognizing its potential as a promising CTLA-4-targeting therapy.
Prof. Özlem Türeci, Chief Medical Officer and Co-Founder at BioNTech, expressed optimism about the investigational treatment, believing it has the potential to offer a new treatment option for late-stage NSCLC patients with a poor prognosis. Additionally, the unique treatment approach may have the ability to synergistically combine with other immunotherapeutic modalities, providing benefits to a broader range of patients.
Dr. Pan Zheng, Chief Medical Officer and Co-Founder at OncoC4, highlighted the importance of the Phase 3 trial in addressing the existing challenges faced by CTLA-4-targeting cancer therapeutics. Dr. Zheng expressed hope that the trial's outcomes would build upon the positive responses observed in the ongoing Phase 1/2 study (NCT04140526) involving BNT316/ONC-392 as a monotherapy and in combination with pembrolizumab for advanced solid tumors.
The initiation of the Phase 3 trial marks a significant milestone in the strategic collaboration between BioNTech and OncoC4, which began in March 2023. Under the collaboration agreement, OncoC4 received an upfront payment of $200 million and is eligible for additional payments upon achieving development, regulatory, and commercial milestones, as well as double-digit tiered royalties. Both BioNTech and OncoC4 will collaborate on the development of BNT316/ONC-392 as a monotherapy and in combination with anti-PD-(L)-1 antibodies for various solid tumor indications until regulatory authorization is obtained. Development costs for these studies will be shared equally between the two companies. BioNTech will hold exclusive worldwide commercialization rights for these products, with OncoC4 participating in certain markets to be determined.
BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly developed by BioNTech and OncoC4. It is currently undergoing late-stage clinical development as a standalone therapy or in combination with other treatments for various cancer indications. The antibody works by blocking CTLA-4, an immune checkpoint receptor that inhibits T cell immune response, thereby allowing cancer cells to evade elimination by the immune system. By blocking CTLA-4, BNT316/ONC-392 aims to enhance T cell activity and promote anti-tumor effects. The antibody has been designed to minimize immune-related adverse effects and ensure a favorable safety profile. Ongoing clinical trials, including the Phase 1/2 trial (PRESERVE-001) and the Phase 3 trial (PRESERVE-003), are assessing the efficacy of BNT316/ONC-392 in patients with advanced solid tumors and NSCLC resistant to immunotherapy. Additionally, a Phase 2 trial is evaluating the combination of BNT316/ONC-392 with pembrolizumab for platinum-resistant ovarian cancer.
