BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO
MAINZ, Germany, and ROCKVILLE, Maryland, USA, June 2, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), today announced positive preliminary data from the ongoing Phase 1/2 trial with the companies’ anti-CTLA-4 antibody candidate, BNT316/ONC-392 (gotistobart), in a patient cohort with metastatic, PD-(L)1-resistant non-small cell lung cancer (“NSCLC”). The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile. The data will be presented in a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting by Kai He, M.D., Ph.D., Pelotonia Institute for Immuno-Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, Ohio, USA.
The results featured at the ASCO Annual Meeting include a total of 27 patients with metastatic, PD-(L)1-resistant NSCLC, available for tumor response assessment who have received at least two doses of 10 mg/kg of BNT316/ONC-392. At data cut-off, the overall response rate (“ORR”) among evaluable patients was 29.6%, with a disease control rate (“DCR”) of 70.4%, including 1 complete response, 7 partial responses and 11 patients with stable disease. BNT316/ONC-392 continues to be well tolerated with a manageable safety profile. Immune-related adverse events (irAE) of Grade 3 and 4 were observed in 10 patients (30%), which is considered lower than what was reported for similar drugs.
“Metastatic NSCLC has a very poor prognosis with a 5-year survival rate of only 9%2. These new data highlight the potential of BNT316/ONC-392 to provide a new approach to leveraging CTLA-4 as an effective target to address advanced, hard-to-treat tumors, further broadening our oncology toolkit,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. “Our goal is to accelerate the development of this program in NSCLC towards pivotal Phase 3 evaluation in line with our mission of providing the optimal therapeutic strategy for each cancer patient.”
“The clinical activity and safety profile validate the improved therapeutic index of BNT316/ONC-392,” said Pan Zheng, M.D., Ph.D. Chief Medical Officer and Co-Founder at OncoC4. “We are especially encouraged by the readouts from the PD-(L)1-resistant NSCLC. Responses were observed regardless of PD-L1 status, and among those who failed multiple lines of immunotherapy and chemotherapy, including PD-1 and CTLA-4 combination therapy.”
Lung cancer remains one of the most commonly diagnosed malignant cancer types and the leading cause of cancer deaths worldwide, with NSCLC1 making up approximately 85% of all lung cancers. The new data further support the initiation of a pivotal Phase 3 study with BNT316/ONC-392 as monotherapy for immunotherapy-resistant NSCLC, for which the candidate received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) in 2022. The Phase 3 trial, PRESERVE-003 (NCT05671510), is planned to start in Q3 2023.
For more information, please visit www.BioNTech.com.
Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Its lead clinical candidate is ONC-392, a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has a pipeline of first-in-class preclinical product candidates focusing on the CD24-Siglecs cancer immune evasion pathway.
More information: www.oncoc4.com.
BioNTech Forward-Looking Statements
For a discussion of these and other risks and uncertainties, see BioNTech’s Quarterly Report on Form 6-K for the quarter ended March 31, 2023, filed with the U.S. Securities and Exchange Commission (“SEC”) on May 8, 2023, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
1 CA Cancer J Clin. 2021 May;71(3):209-249
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