Instil Bio announced FDA clearance of its Investigational New Drug (IND) application for AXN-2510 (’2510), a PD-L1xVEGF bispecific antibody. The company plans to initiate a Phase 1 trial of ’2510 as a monotherapy for relapsed/refractory solid tumors by the end of 2025, focusing on safety, efficacy, pharmacokinetics, and pharmacodynamics. Concurrently, Instil anticipates initial safety and efficacy results from an ongoing Phase 2 trial of ’2510 combined with chemotherapy in first-line non-small cell lung cancer (NSCLC) in China during the second half of 2025.
This IND clearance is a crucial step for Instil Bio, allowing the company to expand clinical investigation of ’2510 into the United States. This broadens the patient population for clinical trials, offering a more diverse dataset for evaluating the drug’s potential across various demographics and genetic profiles. Furthermore, positive results from the U.S. trial could accelerate the drug’s development and potential approval within a key market. The concurrent progress of the Phase 2 trial in China provides another potential catalyst for the drug’s advancement, offering insight into its effectiveness in combination with existing chemotherapy treatments.
The Phase 1 trial will assess ’2510 as a monotherapy for several solid tumor types, providing foundational data on its safety and efficacy as a standalone treatment. Meanwhile, the Phase 2 trial in China explores the potential synergistic effects of ’2510 when used in conjunction with standard chemotherapy regimens for first-line NSCLC. This dual-pronged approach allows for a comprehensive evaluation of ’2510 across different treatment settings and disease stages.
The FDA’s IND clearance for ’2510 signifies a significant advancement in Instil Bio’s clinical development program. Positive data from both the Phase 1 and Phase 2 trials could position ’2510 as a promising new therapeutic option for patients with various solid tumors, potentially altering the treatment landscape and offering renewed hope for those with limited treatment options. This development also strengthens Instil Bio’s position in the oncology field, potentially attracting further investment and collaborative opportunities.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
