On October 19, 2026 OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, reported that the China National Medical Products Administration (NMPA) has accepted two new Investigational New Drug (IND) applications (CXSL2601129 and CXSL2601130) to evaluate cesalatamig (AI-081), the company’s differentiated PD-1/VEGF bispecific antibody, in novel combination regimens for patients with advanced solid tumors.
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The INDs 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 studies represent an important expansion of OncoC4’s strategy to establish cesalatamig as a foundational immuno-oncology backbone with the potential to enhance activity across multiple therapeutic modalities.
"The acceptance of these new IND applications in China marks an important milestone in the evolution of our cesalatamig development strategy," said Dr. Pan Zheng, Co-founder and Chief Medical Officer of OncoC4. "We believe the dual targeting of PD-1 and VEGF may provide a highly complementary platform for combination approaches. By integrating cesalatamig with next-generation ADCs and precision oncology therapies such as RAS pathway inhibitors, we aim to unlock new treatment options for patients whose cancers remain difficult to treat with current standards of care."
Cesalatamig is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immune responses through dual blockade of VEGF and PD-1. OncoC4 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 tumors1-2. These studies will assess whether concurrently targeting tumor-intrinsic signaling and the tumor microenvironment can produce deeper and more durable clinical responses in biomarker-selected patient populations.
"Having obtained clinical proof-of-concept data demonstrating the activity of cesalatamig monotherapy in several challenging cancer indications, as well as its combinability with chemotherapy, we are now advancing rational combinations with precision therapies," said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. "These INDs expand our ability to evaluate cesalatamig in high-priority combinations and advance our vision of precision immuno-oncology."
Patient enrollment is expected to begin following NMPA approval and completion of site activation activities.
About Cesalatamig
Cesalatamig (AI-081) is a differentiated PD-1/VEGF bispecific antibody designed to promote stronger cooperative interaction between PD-1 and VEGF blockade through high affinity to PD-1 and substantially higher VEGF-binding affinity than bevacizumab-based PD-(L)1/VEGF bispecific antibodies. As a result, cesalatamig shows best-in-class potential that favors its action in a PD-1 and VEGF-rich tumor microenvironment. Cesalatamig also has more effective Fc-silencing modifications to avoid the depletion of PD-1-positive effector T cells. The U.S. FDA granted cesalatamig Fast Track Designation for the treatment of non-small cell lung cancer (NSCLC) that progressed after concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy in September 2026.
(Press release, OncoC4, OCT 19, 2026, View Source [SID1234673585])