AI-081

Merger expands OncoC4’s wholly owned immunotherapy pipeline and establishes in-house clinical manufacturing capabilities Adds IND-ready AI-081, a PD-1/VEGF bispecific antibody with best-in-class potential and clinical-stage assets including next-generation siglec agonist AI-071 Both companies are co-founded by CEO, Yang Liu and CMO, Pan Zheng and have a similar shareholder base ROCKVILLE, Md., Sept. 25, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, and AcroImmune, a biopharmaceutical company developing immunotherapy drugs for malignant tumor and inflammatory disease, today announced that the companies, which are under common control, have entered into a definitive merger agreement to combine in an all-stock transaction (the Merger). Under the terms of the agreements, OncoC4 will acquire 100% of the outstanding equity interests of AcroImmune. Upon completion of the Merger, the combined company is expected to operate under the name OncoC4, Inc., will be headquartered in Rockville, Maryland, and led by Yang Liu, PhD, Co-Founder, Chief Executive Officer (CEO). Both OncoC4 and AcroImmune were co-founded by Drs. Yang Liu and Pan Zheng and have a similar shareholder base. “This Merger seamlessly bolsters OncoC4’s wholly owned immunotherapy pipeline and adds investigational new drug (IND)-ready PD-1/VEGF bispecific antibody AI-081 with best-in-class potential and clinical stage assets with near-term catalysts including next-generation siglec agonist AI-071,” said Yang Liu, PhD, Co-Founder, CEO and Chief Scientific Officer (CSO) of OncoC4. “Additionally, the Merger will also expand OncoC4’s geographical footprint and establish in-house clinical manufacturing capabilities including R&D, clinical, and manufacturing sites in China.” Dr. Liu continued, “Collectively, these synergies further strengthen the potential of OncoC4 to deliver differentiated and novel immunotherapies spanning multiple modalities for difficult to treat solid tumors and hematological malignancies. We look forward to continued advancement across our innovative pipeline with several upcoming early and late-stage clinical milestones over the next 12 months.” Dr. Pan Zheng, MD, PhD, OncoC4’s Chief Medical Officer (CMO) and cofounder of OncoC4 and AcroImmune added, “A bispecific targeting PD-1 and VEGF holds potential to broaden the horizon of checkpoint therapy across cancers. AI-081 consists of fully owned and high affinity binding motifs to PD-1 and VEGF that are designed to be best in-class among an emerging class of potentially transformative cancer therapies. We are very excited to file an IND application for AI-081 in the fourth quarter of the year.” OncoC4’s Pipeline Programs and Expected Upcoming Milestones Newly Added Wholly Owned Programs AI-081 – A potentially best-in-class bispecific antiboy against PD-1 and VEGF that has demonstrated high potency and in vivo anti-tumor activity in preclinical models IND filing expected in Q4 2024 AI-071 – A Phase 2 ready, next-generation siglec agonist that is designed for broad siglec coverage with potential application across immunotherapy treated indications. Siglec is a novel innate immune checkpoint discovered by OncoC4 founders with broad application for cancer and excessive inflammation. Initiation of Phase 2 trial for acute respiratory failure expected in Q4 2024Initiation of Phase 2 trial for immune related adverse events expected in Q1 2025 Legacy OncoC4 Wholly Owned Programs CD24 Siglec Program – Novel innate immune checkpoint discovered by OncoC4 founders with broad application for the treatment of cancer and excessive inflammation. ONC-841 – First-in-class anti-Siglec 10 mAb designed for broader impact across innate and adaptive immunity in tumor microenvironment Initiated Phase 1 trial in solid tumors in Q3 2024 Cancer Specific CD24 Platform Program – CD24 is a potent ‘don’t eat me’ signal used by tumors to evade innate immune destruction and an oncogene overexpressed in 70% of all human cancers. OncoC4’s cancer-specific mAb targets a neo-CD24 epitope with application across multiple therapeutic modalities. ONC-782 – CAR-T cell therapy for solid and hematological malignancies Initiation of Phase 1 Investigator Initiated Trial in China expected in 2H 2024 ONC-783 – Bispecific mAb for hematological malignancies IND enabling studies initiated in Q2 2024 ONC-784 – ADC for solid tumors IND enabling studies to be initiated in Q1 2025 Partnered Programs Gotistobart (BNT316/ONC392) is a next-generation anti-CTLA-4 antibody candidate in joint late-stage clinical development with BioNTech as a monotherapy and in combination in multiple ongoing solid tumor indications. Designed for improved toxicity and ability to overcome immune suppression in the tumor microenvironment by depleting regulatory T cells to turn immunologically cold tumors hot. About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Its lead clinical candidate is gotistobart (BNT316/ONC-392), a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In March 2023, OncoC4 announced a strategic collaboration with BioNTech to co-develop and commercialize ONC-392 in multiple solid tumor indications. OncoC4 received $200M upfront and is eligible to receive development, regulatory, and commercial milestone payments in addition to double digit royalties. In addition, OncoC4 has a pipeline of first-in-class and best-in-class assetstargeting both novel and well validated oncology targets. For more information, please visit www.oncoc4.com. Investor Contact: Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.com Media Contact: Kristin Politi, Ph.D. LifeSci Communicationskpoliti@lifescicomms.com