FDA clears Instil Bio’s IND for AXN-2510 cancer therapy

Published 02/07/2025, 11:08
FDA clears Instil Bio’s IND for AXN-2510 cancer therapy

DALLAS - Instil Bio, Inc. (NASDAQ:TIL) announced Wednesday that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for AXN-2510, a PD-L1xVEGF bispecific antibody being developed for solid tumors. The company’s shares, currently trading at $21.93, have shown remarkable strength with a 118% return over the past year, according to InvestingPro data.

The clinical-stage biopharmaceutical company plans to initiate a phase 1 trial evaluating AXN-2510 as monotherapy for patients with relapsed or refractory solid tumors before the end of 2025. The study will assess safety, efficacy, pharmacokinetics and pharmacodynamics.

"Evaluating AXN-2510 in a global population will be a critical milestone in the clinical development of AXN-2510," said Jamie Freedman, Chief Medical Officer of Instil Bio, in a press release statement.

Separately, Instil expects its partner ImmuneOnco to share initial safety and efficacy results from an ongoing phase 2 study of AXN-2510 in combination with chemotherapy for first-line non-small cell lung cancer in China during the second half of 2025.

AXN-2510 is described as a novel PD-L1xVEGF bispecific antibody being developed to treat multiple solid tumor types.

The company’s stock trades on the Nasdaq under the ticker TIL. While Instil Bio focuses on developing novel therapies for various indications, InvestingPro analysis indicates the stock is currently trading near its Fair Value, with strong liquidity as current assets exceed short-term obligations.

In other recent news, Instil Bio has been in the spotlight due to several significant developments. H.C. Wainwright analysts have increased their price target for Instil Bio shares to $125, citing the promising Phase 1/2 dose escalation data for AXN-2510, a treatment for non-small cell lung cancer. The clinical trial showed a 23% overall response rate among patients, which the analysts found competitive compared to other treatments. Meanwhile, JMP analysts have reiterated a Market Perform rating for Instil Bio, reflecting their assessment of the company’s current market position and the insights shared at the ASCO meeting.

In executive news, Instil Bio announced the appointment of Dr. Jamie Freedman as the new Chief Medical Officer, bringing extensive experience in oncology drug development. This appointment is expected to aid in advancing the company’s lead asset, AXN-2510, for treating solid tumors. Additionally, the company has been highlighted in the context of a strategic partnership between BioNTech and Bristol-Myers Squibb, which underscores the growing interest in PD-1/L1 x VEGF bispecifics.

These recent developments have maintained investor interest in Instil Bio, as evidenced by the reaffirmed Buy rating from H.C. Wainwright. The analysts have also noted the competitive clinical data of Instil Bio’s PD-L1 x VEGF agent in China. The company’s progress in drug development and strategic positioning continues to be closely watched by investors and analysts alike.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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