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TIL News
TIL Events
Instil Bio Discontinues Clinical Development of AXN-2510
Instil Bio announced that Axion Bio, a wholly-owned subsidiary of Instil, has decided to discontinue clinical development of AXN-2510 and that Axion and ImmuneOnco Biopharmaceuticals have entered into an agreement terminating their license and collaboration agreement for AXN-2510 and AXN-27M. Under the terms of the Termination Agreement, all rights previously licensed to Axion, including global development and commercial rights outside Greater China, have reverted to ImmuneOnco, subject to a limited license to Axion to wind down its clinical development activities.
Instil Bio Announces Q3 EPS of $1.75 Compared to $2.55 Last Year
As of September 30, 2025, Instil had cash, cash equivalents, restricted cash, marketable securities and long-term investments of $83.4 million, which consisted of $5.8 million in cash and cash equivalents, $0.3 million in restricted cash, $73.9 million in marketable securities, and $3.4 million in long-term investments, compared to $115.1 million in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2024, consisting of $8.8 million in cash and cash equivalents, $1.8 million in restricted cash, and $104.5 million in marketable securities. Instil expects that its cash, cash equivalents, restricted cash, marketable securities and long-term investments as of September 30, 2025 will enable it to fund its operating plan beyond 2026.
Instil Bio Unveils ImmuneOnco Presentation Featuring '2510 Monotherapy Results
Instil Bio announced that ImmuneOnco Biopharmaceuticals presented preliminary efficacy and safety data of '2510 as monotherapy in a Phase 1 study of patients in China with previously treated squamous non-small cell lung cancer 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, with the majority of patients treated at the 20 mg/kg Q2W dose level. In the 17 efficacy evaluable patients, the objective response rate 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, CMO. "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."
Instil Bio: ImmuneOnco reports results from Phase 2 study of IMM2510/AXN-2510
Instil Bio noted that ImmuneOnco Biopharmaceuticals announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510/AXN-2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer conducted in China by ImmuneOnco. As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment. Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% of patients with squamous NSCLC and 46% of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the '2510 chemotherapy combination trial in front-line NSCLC at a future medical conference. The '2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.
Instil Bio announces FDA clearance of IND application for AXN-2510
Instil Bio announced the clearance of an Investigational New Drug application for AXN-2510 by the U.S. FDA. Instil expects to initiate a phase 1 trial of '2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of '2510 in patients with solid tumors. Additionally, Instil continues to anticipate that initial safety and efficacy results from the ongoing phase 2 study of '2510 in combination with chemotherapy in first-line NSCLC in China will be shared in the second half of 2025 by ImmuneOnco.
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