This section highlights FDA-related milestones and regulatory updates for drugs developed by Anixa Biosciences (ANIX).
Over the past two years, Anixa Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Lira-cel and alpha-lactalbumin. 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.
Lira-cel FDA Regulatory Events
Lira-cel is a drug developed by Anixa Biosciences for the following indication: in recurrent ovarian cancer.
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:
- Lira-cel
- Announced Date:
- May 11, 2026
- Indication:
- in recurrent ovarian cancer
Announcement
Anixa Biosciences Announces Its Data From Phase 1 Clinical Study Of Liraltagene Autoleucel Demonstrates No Dose-Limiting Toxicities To Treat Recurrent Ovarian Cancer
AI Summary
Anixa Biosciences reported Phase 1 results for liraltagene autoleucel (lira-cel) in recurrent ovarian cancer showing no dose-limiting toxicities. The company presented preliminary safety observations at the ISCT 2026 Annual Meeting. Several patients lived much longer than expected, including one who survived 28 months, and others remain alive with ongoing follow-up.
The next trial cohort will test a dose roughly three times higher and add lymphodepletion with cyclophosphamide and fludarabine. Anixa expects this preparative regimen to create a better environment for CAR‑T cells to expand, persist, and work more effectively.
The Phase 1 study is designed to assess safety and tolerability, determine the maximum tolerated dose, and look for early signs of clinical activity for lira‑cel in recurrent ovarian cancer. The company plans to continue enrolling patients and report additional data as the trial progresses.
Read Announcement- Drug:
- Lira-cel
- Announced Date:
- April 22, 2026
- Indication:
- in recurrent ovarian cancer
Announcement
Anixa Biosciences, Inc announced that Cheryl Cox, MHA, Operations Director of the Cell Therapies and Gene Expression Engineering Facility at Moffitt Cancer Center, will be presenting at the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting, being held May 6 – 9, 2026, in Dublin, Ireland.
AI Summary
Anixa Biosciences announced that Cheryl Cox, MHA, Operations Director of the Cell Therapies and Gene Expression Engineering Facility at Moffitt Cancer Center, will present at the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting in Dublin, Ireland, May 6–9, 2026. Her session will highlight Anixa’s lira-cel program for recurrent ovarian cancer.
Her presentation, titled "Phase 1 clinical trial of autologous T cells genetically engineered with a chimeric receptor to target the follicle‑stimulating hormone receptor (FSHR) in recurrent ovarian cancer," will describe the trial’s design and objectives, patient selection and dosing plan, safety monitoring, and early measures of effectiveness.
Anixa reports that lira‑cel continues to exhibit positive survival data in the ongoing Phase 1 study. Cox will review the current trial status and next steps, offering clinicians and scientists an update on this targeted, autologous T‑cell therapy approach for ovarian cancer.
Read Announcement
Alpha-lactalbumin FDA Regulatory Events
Alpha-lactalbumin is a drug developed by Anixa Biosciences for the following indication: In high risk operable triple negative breast cancer.
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:
- alpha-lactalbumin
- Announced Date:
- September 22, 2025
- Indication:
- In high risk operable triple negative breast cancer
Announcement
Anixa Biosciences, Inc announced that final results from the Phase 1 clinical trial of its breast cancer vaccine will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025.
AI Summary
Anixa Biosciences will present final Phase 1 breast cancer vaccine results on Thursday, December 11, 2025, at the San Antonio Breast Cancer Symposium (SABCS). This presentation marks the most detailed data release of this first-in-class vaccine.
The trial, funded by the U.S. Department of Defense and conducted at Cleveland Clinic, tested an alpha-lactalbumin (aLA) vaccine to evaluate its safety and ability to trigger an immune response in healthy volunteers at risk for breast cancer.
Justin Johnson, Ph.D., co-inventor of the vaccine technology, will deliver the poster titled “Final Results of a Phase I Trial of Alpha-lactalbumin (aLA) Vaccine for Breast Cancer” at SABCS on December 11 from 5:00–6:30 PM CST.
Anixa plans to share full findings with the Department of Defense and the FDA to inform Phase 2 development. The data could pave the way for new prevention and treatment options in breast cancer.
Read Announcement
