On September 25, 2024 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, reported that the companies, which are under common control, have entered into a definitive merger agreement to combine in an all-stock transaction (the Merger) (Press release, OncoC4, SEP 25, 2024, View Source [SID1234655989]). 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.
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"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 antibody 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 2024
Initiation of Phase 2 trial for immune related adverse events expected in Q1 2025
Legacy OncoC4 Wholly Owned Progams
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.