IMM2510/AXN-2510 Demonstrates Promising Early Efficacy in First-Line NSCLC

Initial safety and efficacy data from a phase 2 trial (NCT06746870) of the investigational bispecific antibody IMM2510/AXN-2510 (‘2510) in combination with chemotherapy for advanced non–small cell lung cancer (NSCLC) show encouraging activity, particularly within the squamous subtype.¹

Preliminary results from the study, conducted by ImmuneOnco Biopharmaceuticals and noted by Instil Bio, reveal an 80% partial response rate (PRR) in patients with squamous NSCLC, suggesting a potential new avenue for treating this challenging patient population.

“’2510 has demonstrated early but compelling activity in frontline NSCLC patients,” said Caicun Zhou, MD, PhD, director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study, in a press release. “The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for frontline NSCLC, and I look forward to the generation of additional data with ‘2510 in this setting.”

The open-label, multicenter study enrolled patients with front-line advanced NSCLC.² As of the July 1, 2025, data cutoff, 33 patients had received the 10 mg/kg dose of ‘2510, with 21 patients deemed efficacy evaluable. The PRR in this group was 62%. Subgroup analysis further illuminated the compound’s activity, with a PRR of 80% (n = 8/10) observed in patients with squamous NSCLC and a PRR of 46% (n = 5/11) in those with nonsquamous NSCLC. Most of these patients had only 1 tumor assessment at the time of the data cutoff, highlighting the preliminary nature of these findings.¹

The safety profile of ‘2510 also appears to support its continued clinical development. The study reported no dose-limiting toxicities among the 33 safety-evaluable patients. Furthermore, there were no treatment-related adverse events (TRAEs) that led to dose reduction or death, and only a single TRAE resulted in drug discontinuation. The most common grade 3 or higher TRAEs were hematologic, a finding common with chemotherapy-based regimens, and were noted to have "uncommon clinical sequelae." AEs typically associated with VEGF inhibition, such as hypertension and proteinuria, and immune-related adverse events were generally low-grade and infrequent. Infusion-related reactions were also nearly all low-grade.

About ‘2510

IMM2510/AXN-2510 is a bispecific antibody designed to target both the PD-L1 and VEGF pathways, 2 key drivers of tumor growth and immune evasion. The compound is differentiated from other bispecific antibodies in this class by its unique VEGF trap, which binds to multiple VEGF receptor ligands beyond just VEGF-A. The bispecific structure is engineered to anchor to the tumor microenvironment via PD-L1 while also enhancing antibody-dependent cellular cytotoxicity to directly kill PD-L1–positive tumor cells. This multifaceted mechanism of action is hypothesized to provide a synergistic therapeutic effect.

ImmuneOnco, the developer of IMM2510/AXN-2510, is a clinical-stage biotechnology company focused on developing a pipeline of biologics for cancer and other diseases. Instil Bio holds rights to the compound and is advancing its development in the US. ImmuneOnco plans to present more comprehensive and updated safety and efficacy data from the ongoing phase 2 trial at a future medical conference. The preliminary findings, however, provide an early signal that this novel bispecific antibody warrants close observation as it progresses toward a potential phase 3 study.

REFERENCES:

1. 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. Instil Bio. News release. July 31, 2025. Accessed August 4, 2025. https://tinyurl.com/5n6hsmzu

2. A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer. ClinicalTrials.gov. Updated December 24, 2024. Accessed August 4, 2025. https://clinicaltrials.gov/study/NCT06746870