OncoC4 Receives NMPA Approval for Cesalatamig Combination Studies

ROCKVILLE, Md., Oct. 19, 2026 /CourierPR/ -- OncoC4 Inc., a late clinical-stage biopharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted two new Investigational New Drug (IND) applications to evaluate its PD-1/VEGF bispecific antibody, cesalatamig (AI-081), in novel combination regimens for patients with advanced solid tumors. The IND applications, CXSL2601129 and CXSL2601130, will support clinical studies evaluating cesalatamig in combination with antibody-drug conjugates (ADCs) across selected solid tumors and with pan-RAS inhibitors in molecularly defined patient populations.

The company's strategy aims to establish cesalatamig as a foundational immuno-oncology backbone, potentially enhancing activity across multiple therapeutic modalities.

Cesalatamig is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immune responses through dual blockade of VEGF and PD-1. The company is evaluating cesalatamig across multiple tumor types in ongoing clinical studies in the United States and China. In September 2026, cesalatamig received U.S. FDA Fast Track Designation for non-small cell lung cancer (NSCLC) that progressed after concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

The ADC combination program is intended to evaluate the potential for cesalatamig to enhance anti-tumor activity through complementary mechanisms of action, leveraging the targeted cytotoxic activity of ADCs together with immune activation and vascular normalization associated with dual PD-1/VEGF blockade. The precision medicine program will evaluate cesalatamig in combination with inhibitors of the RAS signaling pathway, one of the most frequently dysregulated oncogenic pathways across solid tumors.

In addition to cesalatamig, OncoC4's pipeline includes Tasafustobart (ONC-841), a first-in-class anti-SIGLEC-10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. The company has also initiated a first-in-human trial of ONC-783, a first-in-class T cell engager targeting a novel CD24 epitope selectively expressed across a broad spectrum of human cancers, including solid tumors and hematological malignancies, in the United States.

OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer.

The company's ongoing efforts to expand the clinical applications of cesalatamig and its other pipeline assets underscore its commitment to advancing precision immuno-oncology strategies.