On April 25, 2022 OncoC4, Inc., a clinical stage biopharma company developing novel immunotherapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC-392, the Company’s next-gen anti-CTLA-4 monoclonal antibody (mAb) that preserves the CTLA-4 immune checkpoint function, as a single agent for the treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) who have had disease progression on prior anti-PD-(L)1 therapy (Press release, BioNTech, APR 25, 2022, View Source [SID1234655987]).

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"We are grateful for the Fast Track designation for ONC-392, which underscores the unmet need for new treatment options for patients with PD(L)-1-resistant NSCLC," said Yang Liu, PhD, co-founder, CEO and Chief Scientific Officer of OncoC4. "We look forward to more frequent interactions with the FDA to accelerate our clinical development path as we seek to bring this promising drug candidate to patients as expeditiously as possible. Our Phase 1b dose expansion study is ongoing for multiple indications, including PD(L)1-resistant NSCLC, with pivotal studies being planned in the near term."

Fast Track designation is intended to facilitate the development and expedite the review of new therapeutics for the treatment of serious or life-threatening conditions where there is an unmet medical need. The ONC-392 program may be eligible for more frequent meetings with the FDA to discuss the drug’s development plan ensuring collection of appropriate data needed to support approval, and more frequent written communications with the FDA regarding topics such as the design of the proposed clinical trials. Fast Track programs also have eligibility for rolling review as well as eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

ONC-392 is currently in Phase 1 clinical testing to evaluate safety, pharmacokinetics, and efficacy as monotherapy and in combination with anti-PD-1 standard of care in advanced solid tumors and NSCLC (PRESERVE-001; NCT04140526). In recently completed Parts A and B of the study, OncoC4 observed promising clinical activity of ONC-392 in PD(L)1-resistant cancer, including NSCLC.

About NSCLC: Lung cancer, of which 84% are NSCLC, accounts for 25% of all cancer deaths, more than any other cancer, in the United States. Immunotherapy targeting PD(L)1 has been transformative for NSCLC in terms of lives saved. Unfortunately, most lung cancer remains resistant to PD(L)1-targeting therapy, and PD(L)1-resistant NSCLC is one of the biggest challenges for cancer immunotherapy and a huge unmet medical need. CTLA-4 is another clinically validated target although no CTLA-4-targeting drug has been approved as monotherapy for lung cancer.

About ONC-392: Based on decades of research led by OncoC4 co-founders, Drs. Yang Liu and Pan Zheng, OncoC4 is developing ONC-392, a nextgen anti-CTLA-4 mAb that most effectively and selectively eliminates regulatory T cells, a major culprit of immune evasion, in the tumor microenvironment. Unlike traditional anti-CTLA-4 antibodies, ONC-392 does not cause lysosomal degradation of CTLA-4 and thus preserves the immune tolerance checkpoint function of CTLA-4 in the rest of the body. As a result, ONC-392 has a much-improved therapeutic index compared to other CTLA-4-targeting drugs.

About the PRESERVE-001 Trial (NCT04140526): The trial is conducted to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer and other solid tumors. The study consists of three linked parts: Part A is a dose-finding rapid titration study of ONC-392 as a single agent in patients with advanced solid tumors of various histologies to define the recommended Phase II dose for ONC-392 monotherapy (RP2D-M); Part B is dose-finding for combination with standard dose of pembrolizumab (Part B) to define the Recommended Phase II dose for ONC-392 combination therapy (RP2D-C); and Part C comprises expansion cohorts of ONC-392 in monotherapy and in combination therapy with pembrolizumab to determine safety and initial efficacy.