On September 9, 2025, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as "ImmuneOnco", stock code: 01541.HK) announced that at the 2025 World Conference on Lung Cancer (WCLC), the company presented the Phase I clinical study progress of palverafusp alfa (IMM2510) for advanced squamous non-small cell lung cancer (SQ-NSCLC) that had been treated with immune therapy, in the form of a poster. This presentation highlights ImmuneOnco's innovative strength and research achievements in the field of tumor treatment.

IMM2510, an Anti-PD-L1/VEGF Bispecific Antibody Fusion Protein for Advanced IO-treated SQ-NSCLC: A Phase I Study

Presentation Format: Poster

Presentation Abstract Number: 4792

Session: P3.12 - Metastatic Non-Small Cell Lung Cancer - Targeted Therapy

Key Points:

Study Type: A multicenter, open-label, dose-escalation and cohort expansion Phase I clinical trial.

This study first reports the preliminary efficacy and safety data of IMM2510 in patients with advanced squamous non-small cell lung cancer (SQ-NSCLC), with data derived from the dose-escalation and cohort expansion phases of the Phase I clinical study.

Efficacy Results:

• As of August 6, 2025, among 17 evaluable SQ-NSCLC patients with a median follow-up time of 3.75 months, the objective response rate (ORR) was 35.3% (6/17), and the disease control rate (DCR) was 76.5% (13/17).

• The median duration of response (DoR) was 7.59 months (95% CI: 4.07–NA), and the median progression-free survival (PFS) was 9.4 months (95% CI: 1.87–NA).

• Enrollment in the SQ-NSCLC cohort and further pharmacodynamic/pharmacokinetic (PD/PK) analyses are ongoing.

Key Safety Features:

• As of June 13, 2025, among 23 enrolled patients, common treatment-related adverse events (TRAEs) of grade ≥3 included thrombocytopenia (8.7%), lymphopenia (8.7%), and infusion-related reactions (8.7%).

• The safety profile of single-agent IMM2510 is manageable.

Future Research Directions:

• Based on these encouraging results, an application for a Phase III registration clinical trial to assess IMM2510  for SQ-NSCLC after IO treatment failure will be submitted in the near future.

• Additionally, Immuneon is actively advancing clinical trials of IMM2510 in combination with chemotherapy, IMM27M (an ADCC-enhanced CTLA-4 antibody), IMM01 (a CD47-targeted drug), and ADCs in various solid tumor indications, aiming to bring hope to more patients.

Dr. Tian Wenzhi, founder, chairman, CEO, and CSO of Immuneon, said:

"The data presented at WCLC 2025 further validate the clinical value of IMM2510 in patients with squamous NSCLC who have failed prior immunotherapy. Currently, treatment options for this population in later-line settings are limited, with conventional chemotherapy such as docetaxel demonstrating modest efficacy and poor tolerability. By extending median PFS to 9.4 months and achieving a 40% ORR in docetaxel-resistant patients, IMM2510 has successfully overcome existing therapeutic barriers through its dual-target mechanism (simultaneous PD-L1 and VEGF inhibition) and engineered ADCC activity. Building on these encouraging results, we will accelerate the global clinical development of IMM2510. We firmly believe IMM2510 has the potential to provide a novel, more effective treatment option for patients with advanced squamous NSCLC worldwide, reshaping the therapeutic landscape for advanced lung cancer."

‌Dr. Wu Zhuli, Chief Medical Officer of Immuneon, said:

"The data obtained by IMM2510 in patients with advanced SQ-NSCLC who have failed IO treatment are very exciting. The impressive clinical efficacy and good safety profile have exceeded our expectations, which makes us very confident about its future potential. At present, there are limited options for NSCLC patients who have failed IO treatment, and there is a huge unmet clinical need. We will spare no effort to actively promote the conduct of key clinical studies and accelerate the drug registration process. We look forward to IMM2510 becoming a solid new choice for a large number of cancer patients as soon as possible, bringing them more treatment hope and survival benefits."