Instil Bio Announces ImmuneOnco’s Presentation of ‘2510 Monotherapy Data in Patients with 2L+ Squamous NSCLC at the 2025 World Conference on Lung Cancer (WCLC)

Rhea-AI Summary

Instil Bio (NASDAQ:TIL) announced that ImmuneOnco presented promising preliminary data for their '2510 therapy in treating squamous non-small cell lung cancer (sq-NSCLC) at the 2025 World Conference on Lung Cancer. The Phase 1 study showed an objective response rate (ORR) of 35.3% in 17 evaluable patients who had previously failed PD-(L)1 inhibitor and platinum-doublet chemotherapy.

The study evaluated different dose levels (3, 6, 10, or 20 mg/kg Q2W), with most patients receiving the 20 mg/kg Q2W dose. The therapy demonstrated efficacy across PD-L1 TPS scores, with majority of responses in negative and low PD-L1 TPS scores. The treatment was generally well-tolerated, with mainly manageable low-grade infusion reactions and two Grade 3 VEGF-related adverse events.

Positive

• Achieved 35.3% objective response rate in previously treated sq-NSCLC patients
• Demonstrated efficacy across PD-L1 TPS scores, particularly in negative and low scores
• Generally well-tolerated safety profile with manageable adverse events

Negative

• Two Grade 3 VEGF-related adverse events (proteinuria and bleeding) reported
• Study limited to 17 efficacy evaluable patients

Insights

Oncology Clinical Trial Expert

ImmuneOnco's '2510 shows promising 35.3% response rate in previously treated lung cancer patients, suggesting potential differentiation from competing bispecifics.

The preliminary data for ImmuneOnco's '2510 (IMM2510/AXN-2510) presents an intriguing efficacy signal in a difficult-to-treat patient population. The 35.3% objective response rate in squamous NSCLC patients who failed prior PD-(L)1 inhibitor plus platinum-doublet chemotherapy is noteworthy, particularly because responses were observed across PD-L1 TPS scores with the majority in negative and low expressors.

The bispecific antibody's unique design combines a VEGF trap (for broader neutralization of VEGF ligands) with ADCC enhancement (for direct tumor killing), potentially differentiating it from other PD-(L)1xVEGF bispecifics. This dual mechanism theoretically addresses both immune suppression and angiogenesis pathways simultaneously.

Safety data appears manageable with mostly low-grade infusion reactions, though two Grade 3 VEGF-related adverse events (proteinuria and bleeding) were observed in the squamous subset. This safety profile is consistent with the mechanism of action of VEGF inhibition.

The continued enrollment at the 20 mg/kg Q2W dose level suggests investigators have identified a potentially optimal dose with acceptable safety. However, it's important to note this remains early Phase 1 data with only 17 efficacy-evaluable patients, and durability of response - a critical measure of clinical benefit - hasn't yet been established as "most patients remain on treatment."

ORR of 35% in previously treated squamous NSCLC patients with responses across PD-L1 TPS scores

Differentiated structure of ‘2510 potentially results in best-in-class monotherapy activity in 2L+ NSCLC for PD-(L)1xVEGF bispecifics

DALLAS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today announced that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK) (“ImmuneOnco”) presented preliminary efficacy and safety data of ‘2510 (IMM2510/AXN-2510) as monotherapy in a Phase 1 study of patients in China with previously treated squamous non-small cell lung cancer (sq-NSCLC) at the 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain on September 9, 2025.

ImmuneOnco reported that 23 patients with sq-NSCLC had been treated with monotherapy ‘2510 as of June 13, 2025. All patients had failed previous PD-(L)1 inhibitor plus platinum-doublet chemotherapy, and 6 patients had previously received VEGF-directed therapy. Patients were treated with ‘2510 at different dose levels (3, 6, 10, or 20 mg/kg Q2W), with the majority of patients treated at the 20 mg/kg Q2W dose level. In the 17 efficacy evaluable patients, the objective response rate (“ORR”) was 35.3%, with the majority of responses seen in patients with negative and low PD-L1 TPS scores. Most patients remain on treatment with the opportunity for additional tumor assessments, including multiple patients currently with stable disease. In general, ‘2510 was safe and well tolerated across the Phase 1 trial, with mostly manageable low grade infusion reactions in the first cycle as previously reported. In the squamous subset there were two Grade 3 VEGF-related adverse events of proteinuria and bleeding. Enrollment is continuing at the 20 mg/kg Q2W dose level in this study.

“’2510 was designed for potential best-in-class activity with a VEGF trap for broader neutralization of VEGF ligands and ADCC enhancement for direct tumor killing,” said Jamie Freedman, M.D., Ph.D., Chief Medical Officer of Instil. “ImmuneOnco’s promising preliminary monotherapy data for ‘2510 in patients with sq-NSCLC who have failed prior therapies compares favorably with other molecules in the PD-(L)1xVEGF bispecific class.”

About Instil Bio

Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil's lead asset, 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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “future,” “intends,” “may,” “plans,” “potentially,” “targets” and “will” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include express or implied statements regarding our expectations with respect to the therapeutic potential ‘2510, the strategic position of ‘2510 and its safety and efficacy profile, the clinical development of ‘2510 including enrollment of clinical trials and the generation of clinical data therefrom, and other statements that are not historical fact. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements, including risks and uncertainties associated with the costly and time-consuming drug product development process, the uncertainty of clinical success, including the risk that preliminary or interim results of clinical trials will not be indicative of final results, and other risks and uncertainties affecting us and our plans and development programs, including those discussed in the section titled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 filed with the SEC, as well as our other filings with the SEC. Additional information will be made available in other filings that we make from time to time with the SEC. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

Contacts:
Investor Relations:
1-972-499-3350
investorrelations@instilbio.com
www.instilbio.com

FAQ

What were the key results of Instil Bio's '2510 therapy in squamous NSCLC patients?

The Phase 1 study showed an objective response rate of 35.3% in 17 evaluable patients who had previously failed PD-(L)1 inhibitor and platinum-doublet chemotherapy treatments.

What dose levels were tested in the Instil Bio TIL '2510 Phase 1 trial?

The study tested dose levels of 3, 6, 10, and 20 mg/kg Q2W, with the majority of patients treated at the 20 mg/kg Q2W dose level.

What were the safety results for Instil Bio's '2510 therapy?

The therapy was generally well-tolerated with mostly manageable low-grade infusion reactions in the first cycle, though two Grade 3 VEGF-related adverse events of proteinuria and bleeding were reported in the squamous subset.

How many patients were treated in the Instil Bio TIL '2510 Phase 1 study?

23 patients with squamous NSCLC were treated, of which 17 were evaluable for efficacy as of June 13, 2025.

What type of cancer patients were included in the Instil Bio '2510 trial?

The trial included previously treated squamous non-small cell lung cancer (sq-NSCLC) patients who had failed prior PD-(L)1 inhibitor plus platinum-doublet chemotherapy, with 6 patients having received prior VEGF-directed therapy.