Company News
2025-05-22
38Phase 3 trial of IMM2510/AXN-2510 in combination with chemotherapy in first-line NSCLC anticipated to start in mid-2026 in China, subject to regulatory discussions
Monotherapy US dose optimization Phase 1b/2 trial of IMM2510/AXN-2510 in relapsed/refractory solid tumors, intended to bridge the doses to the ongoing China trials, replaces the previously planned US trial
SHANGHAI and DALLAS,TX, May 22, 2025 (GLOBE NEWSWIRE) – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, “ImmuneOnco”) and Instil Bio, Inc. (Nasdaq: TIL, "Instil") , today announced clinical trial updates of IMM2510/AXN-2510 and NSCLC clinical development strategy.
“Our collaboration on IMM2510/AXN-2510 has achieved meaningful progress. We are actively conducting a Phase 2 clinical trial of IMM2510/AXN-2510 in combination with chemotherapy in patients with first-line NSCLC. The data generated to date underscore its best-in-class potential within the promising PD-(L)1xVEGF class. We anticipate sharing further clinical data in the second half of 2025.”
“We are delighted with the significant clinical advancements by our collaborator, ImmuneOnco, with IMM2510/AXN-2510 for NSCLC in China. We are confident that IMM2510/AXN-2510 has the potential to emerge as a leading PD-(L)1xVEGF bispecific antibody, and we look forward to the initial results from the ongoing first-line chemotherapy combination trial in China. In parallel, we are advancing preparations to initiate U.S. clinical development later this year, and we look forward to bringing this potential important new medicine to patients globally.”
Phase 2 Trial of IMM2510/AXN-2510 in Combination with Chemotherapy in Front-Line NSCLC
●ImmuneOnco expects to complete enrollment of approximately 60 patients in Q3 2025 in its Phase 2 trial of IMM2510/AXN-2510 in combination with chemotherapy in patients with NSCLC in the first-line setting in China.
● Among more than 30 NSCLC patients enrolled(including the safety run-in), more than 20 first-line NSCLC patients have been treated since the end of March.
●ImmuneOnco anticipates sharing initial safety and efficacy results from this Phase 2 trial in the second half of 2025.
IMM2510/AXN-2510 Monotherapy Data in Relapsed/Refractory NSCLC (China)
●The objective response rate(ORR)is similar to datasets from competitor PD-(L)1xVEGF bispecific antibodies at a similar stage of development in patients with previously treated NSCLC, showing ORR of 23%(efficacy evaluable n=13).
●The updated clinical safety from the full IMM2510/AXN-2510 monotherapy trial(n=106)and efficacy data in NSCLC are further detailed in a new corporate deck posted on ImmuneOnco’s investor relations webpage at :
http://cn.immuneonco.com/investor/promote/index.html#JInformation.
Other IMM2510/AXN-2510 Clinical and Preclinical Updates
● Instil’s Phase 1b/2 trial of IMM2510/AXN-2510 in the United States is expected to be initiated before the end of 2025, assuming the necessary regulatory approvals are obtained. The trial is expected to be a monotherapy dose optimization trial in relapsed/refractory solid tumors, which is intended to bridge the doses to the ongoing China trials and replaces the previously planned US IMM2510/AXN-2510 and chemotherapy combination trial in first-line NSCLC.
o Instil believes that this change may accelerate the path to initiating a potential global Phase 3 trial in first-line NSCLC.
● Preclinical assays demonstrate cooperative binding of IMM2510/AXN-2510 to PD-L1 in the presence of VEGF in vitro. Further preclinical datasets demonstrating the unique and potentially best-in-class mechanism of action of IMM2510/AXN-2510 are anticipated to be presented at future medical or scientific conferences.
About IMM2510/AXN-2510
IMM2510/AXN-2510 is a PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors. IMM2510/AXN-2510 is differentiated from other PD-(L)1xVEGF bispecific antibodies by its VEGF trap, which binds multiple VEGF receptor ligands beyond VEGF-A, a bispecific structure which leverages PD-L1 as an anchor in the tumor microenvironment (TME), and enhanced antibody-dependent cellular cytotoxicity (ADCC) to direct killing of PD-L1-positive tumor cells.
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.
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 .
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