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OncoC4, Inc.

We are a clinical-stage biotechnology company committed to transforming cutting-edge science into breakthrough therapies. In 2020, our Company was established as a spin-out from OncoImmune, a company previously co-founded by Dr. Liu and Dr. Zheng, after Merck acquired OncoImmune for its CD24Fc program. By leveraging our deep expertise in immuno-oncology and translational medicine, we have internally discovered and advanced a broad pipeline of drug candidates with the potential to be first-in-class or best-in-class therapies designed to improve the current standard of care.

  • 2026

  • 2025

  • 2024

  • 2023

  • 2022

  • 2021

  • 2020

    • BioNTech and OncoC4 Receive FDA Orphan Drug Designation for Gotistobart in Squamous Non-Small Cell Lung Cancer.

    • March 2025, we initiated a Phase 1 clinical trial for AI-081 in the U.S.
    • June 2025, we received IND approval for AI-081 from China’s National Medical Product Administration (NMPA).
    • July 2025, we initiated a Phase 2 clinical trial for AI-081 in the U.S.
    • July 2025, we completed a Phase 1 clinical trial for ONC-841 in the U.S.
    • September 2025, we initiated a Phase 2 clinical trial for ONC-841 in the U.S.
    • September 2025, we completed the Series B Financing in an aggregate amount of US$46.6 million.
    • October 2025, China’s National Medical Product Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for gotistobart (BNT316/ONC392) for the treatment of patients with squamous non-small cell lung cancer (sqNSCLC) who have progressed on prior standard immuno-oncology therapies (IO).
    • December 2025, BioNTech SE (Nasdaq: BNTX) and OncoC4, Inc. presented clinically meaningful Overall Survival benefit data from the non-pivotal dose-confirmation Stage 1 of the global randomized Phase 3 trial PRESERVE-003 (NCT05671510) for gotistobart (BNT316/ONC-392), at the IASLC ASCO 2025 North America Conference on Lung Cancer.
    • April 2024, we received IND clearance for ONC-841 from FDA.
    • August 2024, we initiated Stage 2 portion of the Phase 3 trial of gotistobart (BNT316/ONC-392) in squamous NSCLC with BioNTech SE.
    • August 2024, we initiated a Phase 1 clinical trial for ONC-841 in U.S.
    • November 2024, we completed the acquisition of AcroImmune, adding AI-081 and other preclinical assets to our pipeline.
    • November 2024, we received IND clearance for AI-081 from FDA.

    • 2023, we entered into a global exclusive license and collaboration agreement with BioNTech SE March to develop and commercialize gotistobart (BNT316/ONC-392). OncoC4 will receive a $200 million upfront payment and is eligible to receive development, regulatory and commercial milestone payments and double-digit tiered royalties.

    • June 2023, we initiated a Phase 3 trial of gotistobart (BNT316/ONC-392) in non-small cell lung cancer with BioNTech SE.
    • December 2023, we initiated a Phase 1/2 trial for gotistobart (BNT316/ONC-392) in prostate cancer with BioNTech SE.
    • March 2022, OncoC4, Inc. is recognized by Pharma Tech Outlook as one of the “Top 10 Immunotherapy Solutions Providers – 2022”.
    • March 2022, The CEO Publication, a unique digital platform featuring the industry experts who have created ripples across various areas of expertise, has acknowledged Dr. Yang Liu, Chairman, CEO & CSO of OncoC4 as one among the “Top 20 Dynamic CEOs of 2022″ who is transforming the industry with his unique solutions.
    • April 2022, we received FDA Fast Track designation for gotistobart (BNT316/ONC-392) monotherapy in PD-(L)1-resistant non-small cell lung cancer.
    • April 2022, we completed the issuance of the Convertible Notes in an aggregate amount of US$40.0 million.

    • December 2022, we initiated a Phase 2 clinical trial for gotistobart (BNT316/ONC-392) in Combination with KEYTRUDA®(Pembrolizumab) in Patients with Platinum-Resistant Ovarian Cancer, in collaboration with Merck (NYSE: MRK).

    • In 2021, we continued the enrollment for Phase 1 clinical trial for gotistobart (BNT316/ONC-392) in the U.S.
    • November 2021, OncoC4 reported a summary of preliminary clinical data from the ongoing Phase Ia clinical trial (PRESERVE-001, NCT04140526) evaluating the safety, tolerability and clinical activity of ONC-392 in cancer patients at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting.

    • December 2020, OncoC4, Inc. was incorporated following OncoImmune’s acquisition by Merck Sharp & Dohme Corp. and OncoImmune’s spin-off of oncology assets, including gotistobart (BNT316/ONC-392), a Phase 1 drug candidate, to OncoC4.

    • December 2020, the company completed the Series A financing in an aggregate amount of US $50 million.