News Releases
OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors
- ONC-841 is a potential first-in-class SIGLEC 10 antibody designed to block an innate and potentially adaptive immune checkpoint and prevent cancer evasion of immune cells
- Anti-tumor T cells, NK cells and macrophages can be rejuvenated within the tumor microenvironment following ONC-841 treatment
- Preliminary Phase 1 data on safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected 2H 2025
ROCKVILLE, Maryland, USA, April 23, 2024 –– OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced that the United States Food and Drug Administration (“FDA”) has cleared the investigational new drug (“IND”) application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors.
OncoC4 Expands Scientific Advisory Board with Appointment of Heather A. Wakelee, MD, FASCO
- Wakelee is a world-renowned expert in the research and treatment of lung cancer
- OncoC4’s SAB now includes 6 distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy
ROCKVILLE, Maryland, USA, April 2, 2024 — OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced the appointment of thoracic medical oncologist Heather A. Wakelee, MD, FASCO to the OncoC4 Scientific Advisory Board (SAB) made up of distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy. Dr. Wakelee, currently a Professor of Medicine and Chief of the Division of Oncology at Stanford University, and Deputy Director of the Stanford Cancer Institute, brings over 20 years of experience in clinical strategy.
OncoC4 Announces First Patient with Advanced Prostate Cancer Dosed in Phase 1/2 Trial of BioNTech-partnered BNT316/ONC-392 Program
- The Phase 1/2 trial will assess the efficacy and safety of BNT316/ONC-392 in combination with the radioligand therapy lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with metastatic castration resistant prostate cancer (“mCRPC”) who have progressed on an androgen receptor (“AR”) pathway inhibitor.
- The trial is expected to enroll 144 patients at clinical trial sites in the United States
- The study is in furtherance of the strategic collaboration between BioNTech and OncoC4 which includes joint development BNT316/ONC-392 in a range of solid tumor indications
ROCKVILLE, Md., Feb. 22, 2024 (GLOBE NEWSWIRE) — OncoC4, Inc. (“OncoC4”) today announced that the first patient with metastatic castration resistant prostate cancer (“mCRPC”) has been dosed in a Phase 1/2 trial evaluating the anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) in combination with radioligand therapy, lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). BNT316/ONC-392 is being jointly developed by BioNTech and OncoC4.
OncoC4 to Present at the 42nd Annual J.P. Morgan Healthcare Conference
ROCKVILLE, Md., USA, Jan 04, 2024 (GLOBE NEWSWIRE) — OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, today announced its participation in the 42nd Annual J.P. Morgan Healthcare Conference being held in San Francisco, California. Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4 will present an overview of the company and its pipeline at 11 a.m. Pacific Time on Thursday, January 11, 2024, in the Mission Bay Room (32nd Floor) of The Westin St. Francis Hotel.
OncoC4 Strengthens Leadership Team with the Appointment of Abid Ansari as Chief Financial Officer
ROCKVILLE, Md., USA, Sept 28, 2023 (GLOBE NEWSWIRE) — OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, today announced the appointment of Abid Ansari as Chief Financial Officer (CFO), effective immediately. Abid brings over 20 years of expertise in financial strategy and business development for public and private life science companies to OncoC4. He will lead the company’s finance, business development, investor relations, and public relations functions.
BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC
- Initiation of pivotal Phase 3 trial in non-small cell lung cancer (NSCLC) marks the first landmark in BioNTech’s and OncoC4’s strategic collaboration initiated in March 2023 with the aim to evaluate BNT316/ONC-392 in various solid tumor indications
- The randomized Phase 3 trial is expected to enroll approximately 600 patients with metastatic, immunotherapy-resistant NSCLC at clinical trial sites initially in the United States, followed by Europe and other countries and regions
- The trial initiation follows the FDA Fast Track Designation granted in 2022, based on Phase 1/2 safety and efficacy data for the monotherapy in metastatic, immunotherapy-resistant NSCLC
- BNT316/ONC-392 is entering the pivotal clinical evaluation as part of BioNTech’s strategy to initiate multiple trials with registrational potential in 2023 and 2024
MAINZ, Germany, and ROCKVILLE, Maryland, USA, June 29, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced that the first patient with non-small cell lung cancer (NSCLC) has been treated in a pivotal Phase 3 trial evaluating the companies’ next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart). The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024.