This section highlights FDA-related milestones and regulatory updates for drugs developed by Instil Bio (TIL).
Over the past two years, Instil Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AXN-2510, IMM2510/AXN-2510, IMM2510/SYN-2510, and PD-L1xVEGF. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AXN-2510 FDA Regulatory Timeline and Events
AXN-2510 is a drug developed by Instil Bio for the following indication: In Relapsed/Refractory Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AXN-2510
- Announced Date:
- January 6, 2026
- Indication:
- In Relapsed/Refractory Solid Tumors
Announcement
Instil Bio, Inc. announced that Axion Bio, Inc. ("Axion"), a wholly-owned subsidiary of Instil, has decided to discontinue clinical development of AXN-2510 and that Axion and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX: 1541.HK) ("ImmuneOnco") have entered into an agreement terminating their license and collaboration agreement for AXN-2510 and AXN-27M ("Termination Agreement").
AI Summary
Instil Bio announced that its wholly owned subsidiary Axion Bio has decided to discontinue clinical development of AXN-2510. Axion and collaborator ImmuneOnco Biopharmaceuticals (Shanghai) have signed a Termination Agreement ending their license and collaboration for both AXN-2510 and AXN-27M.
Under the agreement, all rights previously licensed to Axion have reverted to ImmuneOnco. This includes global development and commercial rights outside Greater China. ImmuneOnco now controls those programs again.
The Termination Agreement does grant Axion a limited license to wind down its remaining clinical activities related to AXN-2510. Instil framed the move as a shift in Axion’s program status and noted the change in ownership of development and commercial rights back to ImmuneOnco.Read Announcement
- Drug:
- AXN-2510
- Announced Date:
- September 10, 2025
- Indication:
- In Relapsed/Refractory Solid Tumors
Announcement
Instil Bio, Inc. announced that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 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.
AI Summary
Instil Bio, Inc. announced that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. presented early data for its bispecific antibody ‘2510 (IMM2510/AXN-2510) at the 2025 World Conference on Lung Cancer in Barcelona on September 9, 2025. The Phase 1 study involved 23 patients in China with squamous non-small cell lung cancer (sq-NSCLC) who had failed prior PD-(L)1 inhibitors and chemotherapy.
Of the 17 patients evaluable for response, the objective response rate (ORR) was 35.3%, with tumor shrinkage seen across low and negative PD-L1 scores. Doses ranged from 3 to 20 mg/kg every two weeks, with most patients on the highest dose. Many patients remain on treatment, and additional tumor assessments are planned.
‘2510 was well tolerated, featuring mostly low-grade infusion reactions in cycle one. Two Grade 3 VEGF-related events (proteinuria and bleeding) were reported. Enrollment at the 20 mg/kg dose continues.
Designed with a VEGF trap and ADCC enhancement, ‘2510 shows promise as a potential best‐in‐class PD-(L)1xVEGF bispecific therapy in second-line and beyond NSCLC.
Read Announcement- Drug:
- AXN-2510
- Announced Date:
- July 2, 2025
- Indication:
- In Relapsed/Refractory Solid Tumors
Announcement
Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND) application for AXN-2510 ("'2510") by the U.S. Food and Drug Administration.
AI Summary
Instil Bio recently announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for AXN-2510. This clearance marks a major step forward for the company as it prepares to evaluate the new PD-L1xVEGF bispecific antibody, designed to treat solid tumors. Instil Bio plans to start a phase 1 trial by the end of 2025, where the treatment will be tested as a monotherapy in patients with relapsed or refractory solid tumors. The trial will investigate the safety, effectiveness, how the drug is processed in the body, and its overall impact. This FDA clearance is an important milestone, allowing Instil Bio to further explore AXN-2510’s potential in a global patient population and move closer to offering a new option for cancer treatment.
Read Announcement
IMM2510/AXN-2510 FDA Regulatory Events
IMM2510/AXN-2510 is a drug developed by Instil Bio for the following indication: For front-line patients with advanced non-small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMM2510/AXN-2510
- Announced Date:
- July 31, 2025
- Indication:
- For front-line patients with advanced non-small cell lung cancer (NSCLC)
Announcement
Instil Bio, Inc. announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510/AXN-2510 (‘2510) in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco.
AI Summary
In a Phase 2 open-label study conducted in China by ImmuneOnco, Instil Bio reported preliminary safety and efficacy data for IMM2510/AXN-2510 combined with first-line chemotherapy in advanced non-small cell lung cancer patients.
As of July 1, 2025, 33 patients received a 10 mg/kg dose of IMM2510. Twenty-one patients were evaluable for tumor response, showing partial responses in 62% overall, including 80% of squamous and 46% of non-squamous cases.
The treatment was generally well tolerated with no dose-limiting toxicities among safety-evaluable patients. There were no treatment-related adverse events leading to dose reduction or death, and only one case of drug discontinuation due to adverse events.
ImmuneOnco plans to present updated safety and efficacy results from the ‘2510 and chemotherapy combination trial at an upcoming medical conference, supporting its move into Phase 3 clinical studies.
Read Announcement
IMM2510/SYN-2510 FDA Regulatory Timeline and Events
IMM2510/SYN-2510 is a drug developed by Instil Bio for the following indication: In patients with advanced NSCLC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMM2510/SYN-2510
- Announced Date:
- May 22, 2025
- Indication:
- In patients with advanced NSCLC
Announcement
Instil Bio, Inc. announced clinical trial updates of ‘2510 and NSCLC clinical development strategy.
AI Summary
Instil Bio, Inc. has provided new clinical trial updates for its lead asset, ‘2510, a PD-L1xVEGF bispecific antibody. The company and its collaborator ImmuneOnco are advancing the NSCLC clinical development strategy in China. A Phase 2 trial is underway where ‘2510 is combined with chemotherapy for first-line NSCLC patients, with around 30 patients already enrolled. More than 20 of these patients are receiving first-line treatment, and preliminary safety and efficacy data are expected to be shared later in 2025.
In parallel, Instil Bio is revising its U.S. clinical approach. Instead of a combination trial, the company will initiate a Phase 1b/2 monotherapy trial in relapsed or refractory solid tumors to optimize dosing and bridge to the doses used in China. This change paves the way for a potential global Phase 3 trial in first-line NSCLC, anticipated to begin in mid-2026 in China, subject to regulatory discussions.
Read Announcement- Drug:
- IMM2510/SYN-2510
- Announced Date:
- March 4, 2025
- Indication:
- In patients with advanced NSCLC
Announcement
Instil Bio, Inc provided a corporate update.
AI Summary
Instil Bio, Inc. recently provided a corporate update while reporting its fourth quarter and full year 2024 financial results. In the update, the company highlighted key plans regarding its lead asset, AXN-2510/IMM2510. ImmuneOnco, its collaborator, expects to deliver clinical data for AXN-2510/IMM2510 monotherapy in patients with relapsed or refractory non-small cell lung cancer (NSCLC) during the first half of 2025. Additionally, safety data from about 100 patients treated across various solid tumors will also be shared.
ImmuneOnco has further advanced clinical studies by initiating patient enrollment in a Phase 1b/2 trial in China, combining AXN-2510/IMM2510 with chemotherapy, and plans to enroll first-line NSCLC patients starting in Q2 2025. A U.S. study with the combination therapy is also anticipated to begin before the end of 2025, pending the required regulatory approvals. Instil Bio’s robust financials are expected to support operations through 2026.
Read Announcement- Drug:
- IMM2510/SYN-2510
- Announced Date:
- January 14, 2025
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- In patients with advanced NSCLC
Announcement
ImmuneOnco announced initial clinical data from the 1L advanced NSCLC trial in China is expected as early as 2H 2025
AI Summary
ImmuneOnco has started a Phase 1b/2 clinical trial in China for patients with advanced non-small cell lung cancer (NSCLC). The trial uses IMM2510/SYN-2510 combined with chemotherapy and has already dosed its first patient. Notably, the study is focused on first-line treatment patients, and ImmuneOnco expects to present its initial clinical data as early as the second half of 2025. This early data could play an important role in understanding the safety and effectiveness of this novel bispecific antibody, which targets both PD-L1 and VEGF pathways. Positive results might pave the way for further clinical studies and even support future global registrational trials for front-line NSCLC treatment. Overall, this trial represents a significant step forward in the search for more effective lung cancer therapies.
Read Announcement- Drug:
- IMM2510/SYN-2510
- Announced Date:
- January 14, 2025
- Indication:
- In patients with advanced NSCLC
Announcement
Instil Bio, Inc announced clinical progress of IMM2510/SYN-2510 in China by its collaborator, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, "ImmuneOnco").
AI Summary
Instil Bio, Inc. announced new clinical progress for its asset IMM2510/SYN-2510 in China through its collaborator, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ImmuneOnco has begun dosing the first patient in a Phase 1b/2 clinical trial, combining IMM2510/SYN-2510 with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). The trial targets first-line NSCLC patients, and the initial clinical data are expected to be presented as early as the second half of 2025. This step is important as the data could support further global development of the therapy and potentially lead to a future registrational study in front-line NSCLC. The development represents a key milestone for Instil Bio as the company and its collaborator work to advance cancer treatments with innovative combination approaches.
Read Announcement- Drug:
- IMM2510/SYN-2510
- Announced Date:
- January 14, 2025
- Indication:
- In patients with advanced NSCLC
Announcement
Instil Bio, Inc announced that Instil is targeting initiation of a potential first-line advanced NSCLC clinical trial of IMM2510/SYN-2510 combined with chemotherapy in 2H 2025, assuming necessary regulatory approvals
AI Summary
Instil Bio, Inc. announced plans to begin a potential first-line advanced NSCLC clinical trial using its combination treatment IMM2510/SYN-2510 with chemotherapy in the second half of 2025, pending the necessary regulatory approvals. The trial, which would focus on patients with advanced non-small cell lung cancer who have not received prior treatment, marks a significant step in advancing the company’s immunotherapy program.
In parallel, ImmuneOnco has already initiated a Phase 1b/2 clinical trial in China, where the first patient has been dosed, and initial clinical data are expected from first-line NSCLC patients as early as late 2025. If these early results are promising, Instil Bio aims to leverage the clinical progress to support a potential global registrational study for IMM2510/SYN-2510 in this patient population.
Read Announcement
PD-L1xVEGF FDA Regulatory Events
PD-L1xVEGF is a drug developed by Instil Bio for the following indication: In front-line triple-negative breast cancer (TNBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PD-L1xVEGF
- Announced Date:
- September 16, 2024
- Indication:
- In front-line triple-negative breast cancer (TNBC).
Announcement
Instil Bio, Inc. announced the global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510/IMM2510 in combination with chemotherapy in front-line non-small cell lung cancer (NSCLC) and in front-line triple-negative breast cancer (TNBC).
AI Summary
Instil Bio, Inc. recently announced its global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510/IMM2510, designed to work alongside chemotherapy for front-line non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). The plan focuses on initiating Phase 1b/2 trials in China. For NSCLC, the studies are set to start in late 2024 and will enroll patients with both non-squamous and squamous, driver gene mutation–negative tumors. Additionally, a similar Phase 1b/2 chemotherapy combination study for front-line TNBC is anticipated to begin in early 2025.
This strategic approach aims to address significant unmet medical needs in both NSCLC and TNBC. By establishing a clear pathway for regulatory approval in China and globally, Instil Bio and its partner ImmuneOnco are hopeful that SYN-2510 will offer a meaningful improvement over current treatment options in these challenging cancer indications.
Read Announcement
