OncoC4 and AcroImmune Merge

OncoC4, Inc., a biopharmaceutical company focused on developing innovative cancer treatments, has entered into a definitive merger agreement with AcroImmune, a company specializing in immunotherapy drugs for malignant tumors and inflammatory diseases. This merger, to be executed through an all-stock transaction, will result in OncoC4 acquiring 100% of AcroImmune's outstanding equity interests. The newly combined entity will continue to operate under the OncoC4 name, with its headquarters in Rockville, Maryland, and leadership by Yang Liu, PhD, who serves as the Chief Executive Officer (CEO).

The merger brings together two companies under common control, both co-founded by Drs. Yang Liu and Pan Zheng, and sharing a similar shareholder base. Dr. Liu, also the Chief Scientific Officer (CSO) of OncoC4, highlighted that this merger will significantly enhance OncoC4’s immunotherapy pipeline. Notable additions include AI-081, an investigational PD-1/VEGF bispecific antibody with best-in-class potential, and AI-071, a next-generation siglec agonist.

Dr. Liu emphasized that the merger will expand OncoC4’s geographical footprint and establish in-house clinical manufacturing capabilities, including research and development (R&D) and manufacturing sites in China. This strategic expansion aims to bolster OncoC4's ability to develop novel immunotherapies for hard-to-treat solid tumors and hematological malignancies, with several clinical milestones anticipated over the next year.

Dr. Pan Zheng, Chief Medical Officer (CMO) of OncoC4 and co-founder of both companies, noted that AI-081's bispecific targeting of PD-1 and VEGF has the potential to expand the scope of checkpoint therapy across various cancers. AI-081, which features high-affinity binding motifs to PD-1 and VEGF, is expected to file an Investigational New Drug (IND) application in the fourth quarter of the year.

OncoC4's pipeline includes several promising programs with key milestones expected soon. AI-081 is anticipated to demonstrate high potency and anti-tumor activity in preclinical models, with an IND filing expected in the fourth quarter of 2024. AI-071, a Phase 2-ready siglec agonist, is designed for broad siglec coverage and potential application across multiple immunotherapy-treated indications. Initiation of Phase 2 trials for acute respiratory failure and immune-related adverse events are expected in the fourth quarter of 2024 and the first quarter of 2025, respectively.

The legacy pipeline of OncoC4 includes the CD24 Siglec Program, targeting a novel innate immune checkpoint with broad application for cancer and excessive inflammation. Notably, ONC-841, an anti-Siglec 10 monoclonal antibody, commenced a Phase 1 trial for solid tumors in the third quarter of 2024. The cancer-specific CD24 platform targets a neo-CD24 epitope relevant in numerous therapeutic modalities, showing promise for treating various cancers.

Some of the advanced programs include ONC-782, a CAR-T cell therapy for both solid and hematological malignancies, with a Phase 1 Investigator-Initiated Trial in China expected in the second half of 2024. Additionally, ONC-783, a bispecific monoclonal antibody, and ONC-784, an Antibody-Drug Conjugate (ADC) for solid tumors, are in the IND-enabling study phase, with studies initiated or expected to start in 2024 and 2025.

OncoC4 also collaborates with BioNTech on Gotistobart (BNT316/ONC392), an advanced anti-CTLA-4 antibody candidate undergoing late-stage clinical trials for multiple solid tumor indications. This collaboration aims to leverage improved toxicity profiles and the ability to overcome tumor immune suppression.

Based in Rockville, Maryland, OncoC4 is a privately held company dedicated to discovering and developing innovative biological treatments for cancer. Its leading clinical candidate, gotistobart (BNT316/ONC-392), is designed to balance anti-tumor activity with protection against autoimmune diseases. The company has a robust pipeline targeting both novel and validated oncology targets, positioning it well for future growth and impact in the field of cancer treatment.