OncoC4 and BioNTech Announce $200M Strategic Collaboration to Advance Phase 3 Trial of Next-Gen Anti-CTLA-4 Antibody ONC-392
On March 20, 2023, BioNTech and OncoC4 announced the signing of a strategic collaboration agreement, under which BioNTech acquired global rights to ONC-392, OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate featuring a novel mechanism of action.OncoC4 will receive a $200 million upfront payment and is eligible for R&D, regulatory, and commercialization milestone payments, as well as double-digit tiered royalties on sales.Subject to the satisfaction of closing conditions and regulatory approvals, both parties expect to complete the transaction in the first half of 2023. ONC-392 is planned to initiate Phase III clinical trials in 2023.
OncoC4 is a renownedDr. Yang Liu, Chinese immunologist, and Dr. Pan Zheng, Fellow of the American Institute for Medical and Biological Engineering (AIMBE)Co-founded. OncoC4’s predecessor, OncoImmune, was wholly acquired by the multinational pharmaceutical company Merck & Co. in November 2020, with an upfront payment of $425 million for the transaction. This collaboration with BioNTech,agreements reached by OncoImmune, its spin-off OncoC4, or Guangzhou Angke Immunology with multinational pharmaceutical companiesThe second high-down-payment authorized transaction.
Dr. Yang Liu and Dr. Pan Zheng
On November 23, 2020, Merck (NYSE: MRK, known as MSD outside the United States and Canada) and OncoImmune reached an acquisition agreement. Merck acquired all issued shares of OncoImmune to obtain global rights to one of OncoImmune’s investigational assets in its pipeline (CD24Fc). The global rights (excluding Greater China) and Greater China rights to OncoImmune’s remaining investigational pipeline assets were spun off into the newly established U.S. company OncoC4 and Guangzhou OncoImmune, respectively.
The upfront payment for the aforementioned transaction amounts to $425 million, and existing shareholders of OncoImmune, including HM CAPITAL, are eligible to receive future milestone payments from Merck & Co. as well as sales royalties following the drug’s commercial launch. Meanwhile, Merck & Co. invested $50 million to become a shareholder in OncoC4.Previously, HM Capital led OncoImmune’s Series B financing round in September 2020, which was the most recent round of funding prior to the acquisition by Merck & Co.
On March 20, 2023, BioNTech and OncoC4 announced a strategic collaboration to jointly develop and commercialize ONC-392, an anti-CTLA-4 monoclonal antibody.Previously, HM CAPITAL led the Pre-B convertible note financing round for OncoC4 in April 2022, which was also the most recent funding round prior to BioNTech’s transaction.
ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody with a novel mechanism of action. Through unique molecular design, it preserves the CTLA-4 receptor recycling mechanism and selectively depletes immunosuppressive T cells (regulatory T cells, “Tregs”) within the tumor microenvironment.With its superior safety and efficacy, ONC-392 has yielded encouraging clinical data in the treatment of various solid tumors.
ONC-392 has received Fast Track Designation from the U.S. Food and Drug Administration (“FDA”) as a monotherapy for non-small cell lung cancer (NSCLC) that is resistant to prior immunotherapy. Existing clinical data support the initiation of a randomized, double-blind, controlled Phase 3 clinical trial of ONC-392 monotherapy in patients with PD-1-resistant NSCLC (NCT05671510). Additionally, a Phase 2 clinical trial evaluating ONC-392 in combination with the PD-1 inhibitor Keytruda for the treatment of patients with platinum-resistant ovarian cancer has been initiated (NCT05446298).
BioNTech and OncoC4 will jointly develop ONC-392 as a monotherapy and in combination with PD-1 inhibitors for the treatment of various solid tumor indications. All other combination regimens, particularly those involving drugs from BioNTech’s pipeline, will be developed solely by BioNTech.
Dr. Ugur Sahin, CEO and Co-Founder of BioNTech“Although CTLA-4 has emerged as a prominent target over the past decade, we believe that existing anti-CTLA-4 agents have yet to fully realize the therapeutic potential of this target in the field of cancer immunotherapy. Clinical data from OncoC4 demonstrate that ONC-392 exhibits encouraging safety and efficacy profiles across multiple solid tumors. We are confident that ONC-392, whether used as monotherapy or in combination with BioNTech’s personalized immunotherapies, represents a valuable addition to combination regimens in cancer immunotherapy.”
Dr. Yang Liu, Co-founder, CEO, and Chief Scientist of OncoC4stated: “Based on its unique biological mechanism, we believe ONC-392 has the potential to expand the therapeutic scope of anti-CTLA-4 agents in cancer immunotherapy. We are also highly enthusiastic about collaborating with BioNTech to develop ONC-392 for the treatment of various solid tumors, thereby addressing unmet medical needs.”
HM CAPITAL led the investment rounds on two separate occasions: once before Merck & Co. completed its acquisition of OncoImmune, and again before BioNTech finalized its strategic collaboration with OncoC4. As the lead investor in OncoC4’s latest financing round and the sole institutional shareholder in this round, HM CAPITAL looks forward to ONC-392 and OncoC4’s other pipeline candidates continuing to make significant contributions to human health.