Anixa Biosciences' CAR-T Therapy Delivers 28-Month Survival, Dose Up to 1×10^9 Cells/kg
In its Phase 1 lira-cel CAR-T trial for ovarian cancer, Anixa Biosciences treated twelve patients, seven of whom exceeded the expected three-to-four-month median survival, including one at 28 months and three beyond one year. No dose-limiting toxicities were observed, prompting IRB approval to escalate dosing from 1×10^5 to 1×10^9 cells/kg.
1. Phase 1 Trial Design and Patient Outcomes
The ongoing Phase 1 trial enrolls adult women with recurrent ovarian cancer who have failed two or more prior therapies. Lira-cel targets the follicle-stimulating hormone receptor on ovarian tumor cells, and twelve patients across four dose levels have been treated, with seven outliving the three-to-four-month median survival, including one at 28 months and three beyond one year.
2. Safety Profile and Protocol Amendment
No dose-limiting toxicities have been reported to date, supporting a favorable safety profile. This outcome secured IRB approval for a protocol amendment that raises dosing from 1×10^5 to 1×10^9 cells/kg, representing a 100-fold increase in CAR-T cell exposure.
3. Intra-Peritoneal Delivery Advantages
Lira-cel is administered directly into the peritoneal cavity to concentrate CAR-T activity at tumor sites while reducing systemic exposure. This approach is believed to lower off-tumor toxicity and improve localized cell expansion compared with conventional intravenous delivery.
4. Upcoming Dose Escalation and Milestones
The next patient cohort will receive 1×10^7 cells/kg following cyclophosphamide and fludarabine lymphodepletion to enhance CAR-T persistence and activity. If no toxicities emerge at this level, further dose escalations may proceed, with additional data expected later this year.