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ImmuneOnco Announced Preliminary Safety & Efficacy Data from the Clinical Trial Studying IMM2510/AXN-2510, a PD-L1xVEGF Bispecific Antibody, in Combination with Chemotherapy in Front-line NSCLC in China
2025-07-31
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● Partial responses observed in 80% of squamous NSCLC front-line patients and in 46% of non-squamous NSCLC front-line patients

● Safety profile supports further clinical development, with no dose-limiting toxicities observed in patients with front-line NSCLC

● ImmuneOnco expects to present updated safety and efficacy data at a future medical conference





SHANGHAI, July 31, 2025 (GLOBE NEWSWIRE) ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, “ImmuneOnco”), today is pleased to announce preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China.




As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable).  Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the IMM2510 chemotherapy combination trial in front-line NSCLC at a future medical conference.


The IMM2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients.  In these patients, there were no treatment-related adverse events (TRAE) leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae.  Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.


Professor Caicun Zhou, M.D., Ph.D., director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study of IMM2510 in 1L NSCLC said:

“IMM2510 has demonstrated early but compelling activity in front-line NSCLC patients. The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with IMM2510 in this setting.”


Dr. Wenzhi Tian, CEO of ImmuneOnco said:

“We are delighted to witness the progress of IMM2510 in front-line non-small cell lung cancer (NSCLC). This data paves the way for its advancement into Phase 3 clinical studies and provides valuable insights to support further research across multiple indications.”


Bronson Crouch, CEO of Instil said:

“We are pleased with the preliminary clinical results of the combination of IMM2510/AXN-2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class. We look forward to further public updates from ImmuneOnco on these data, as well as the initiation of our previously announced US phase 1 clinical trial before the end of this year.”


About Instil Bio

Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil's lead asset,  IMM2510/AXN-2510, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors. For more information, visit www.instilbio.com.





About ImmuneOnco

ImmuneOnco is a clinical-stage biotech company focused on discovery and development of biologics to treat cancers, autoimmune diseases and metabolic diseases. With 10+ assets all originated in-house and the most advanced asset in phase III right now, ImmuneOnco is pursuing innovative therapies to improve patients’ health. For more information visit www.immuneonco.com .