ROCKVILLE, Maryland, October 29, 2026
OncoC4, Inc., a late clinical-stage biopharmaceutical company developing innovative medicines for cancer and immunological diseases, has announced that clinical findings from its global Phase 1/2 studies of cesalatamig (AI-081) have been selected for a late-breaking oral presentation at the 41st Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2026). The presentation will focus on the safety and efficacy of cesalatamig as a monotherapy in patients with PD-(L)1-resistant or refractory non-small cell lung cancer (NSCLC). The scientific meeting will take place in Phoenix, Arizona, with the presentation scheduled for November 7, 2026, during Clinical Oral Abstract Session 2, beginning at 1:45 PM Mountain Standard Time. The research will provide clinical findings from the ongoing global BiPAVE-001 programme and represents an important milestone in the development of OncoC4’s investigational immunotherapy portfolio. The late-breaking abstract has been assigned Abstract Number 1187 and will be presented by Dr. Kai He, the U.S. principal investigator of the BiPAVE-001 trials and Director of Thoracic Oncology at the University of Texas Health San Antonio Mays Cancer Center.
Cesalatamig Advances as a Novel PD-1/VEGF Bispecific Antibody
Cesalatamig (AI-081) is an investigational bispecific antibody designed to simultaneously target two important biological pathways involved in cancer progression: programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF). PD-1 is an immune checkpoint protein that can suppress the activity of T cells, allowing cancer cells to evade immune recognition. VEGF is a signalling protein that promotes the formation of new blood vessels and supports tumour growth. By targeting both pathways through a single antibody, cesalatamig is designed to combine immune checkpoint inhibition with VEGF blockade. According to OncoC4, the molecule has been engineered with high affinity for PD-1 and substantially higher VEGF-binding affinity than bevacizumab-based PD-(L)1/VEGF bispecific antibodies. Its design also incorporates enhanced Fc-silencing modifications intended to prevent depletion of PD-1-positive effector T cells. These characteristics are intended to support cooperative biological activity within the tumour microenvironment, where immune suppression and abnormal blood vessel formation can contribute to cancer progression. The investigational therapy is being developed to address advanced solid tumours, including NSCLC patients who have experienced disease progression following previous immunotherapy.
Global BiPAVE-001 Trials Evaluate Safety and Efficacy
The upcoming presentation will feature clinical findings from the monotherapy arms of the ongoing BiPAVE-001 Phase 1/2 clinical development programme. The programme includes two global studies: BiPAVE-001 (NCT06635785), conducted in the United States, and BiPAVE-001 CN (CTR20253261), conducted in China. Both studies are investigating cesalatamig in patients with advanced solid tumours. The first part of the programme involves a first-in-human Phase 1 dose-escalation and dose-expansion investigation designed to assess safety, tolerability, pharmacokinetics and preliminary antitumour activity. The Phase 2 portion includes dose-optimization studies evaluating cesalatamig as a single agent or in combination with standard-of-care treatments in selected cancer indications. The November 7 presentation will specifically address its monotherapy performance in patients with PD-(L)1-resistant or refractory NSCLC. Detailed clinical results will be released in accordance with SITC’s scientific meeting embargo policy, meaning the full efficacy and safety findings are not included in the October 29 announcement. The presentation is expected to provide further information about the clinical development of this investigational antibody in a patient population with significant unmet treatment needs.
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FDA Fast Track Designation Supports NSCLC Development
In September 2026, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to cesalatamig for the treatment of NSCLC that has progressed following concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy. Fast Track designation is intended to facilitate the development and expedite the review of investigational medicines addressing serious conditions with unmet medical needs. It may provide opportunities for more frequent interactions with the FDA and eligibility for certain expedited regulatory pathways, subject to applicable requirements. The designation does not represent FDA approval or establish that the medicine is effective. For patients with advanced NSCLC whose disease progresses after checkpoint inhibitor-based treatment and platinum chemotherapy, additional therapeutic approaches remain an important research priority. OncoC4 is investigating cesalatamig as part of its broader oncology pipeline, which also includes antibody-based programmes targeting CTLA-4, SIGLEC-10 and CD24.
The selection of cesalatamig for a late-breaking oral presentation at SITC 2026 represents an important scientific milestone for OncoC4 and its global clinical development programme. The upcoming findings will contribute to research into bispecific antibody approaches that combine immune checkpoint inhibition and VEGF targeting. If supported by further clinical evidence, this strategy could offer another investigational approach for patients with difficult-to-treat solid tumours. However, cesalatamig remains an investigational medicine and has not received marketing approval. Additional clinical studies will be required to establish its safety, efficacy and potential role in cancer treatment.
Source: OncoC4 press release
