Anixa Biosciences Secures FDA Clearance to Redose Single Patient in Ovarian Cancer CER-T Trial
It was noted that the patient, who is 1 of 6 treated in the study so far, may be showing clinical activity in response to their first dose with the CER-T.
Anixa Biosciences, via its partner Moffitt Cancer Center, has received clearance of a individual patient investigational new drug (IND) application from the FDA, allowing Moffitt to administer a second dose of Anixa's novel follicle stimulating hormone receptor (FSHR)-targeting chimeric endocrine receptor (CER) T-cell therapy to a patient being treated in the company’s ongoing phase 1 clinical trial (NCT05316129).1
It was noted that the patient, who is 1 of 6 treated in the study so far, may be showing clinical activity in response to her first dose with the CER-T. The therapy is Anixa’s modified chimeric antigen receptor (CAR) T-cell therapy approach using an endocrine receptor (FSHR) as the target of the engineered T-cells.2 Notably, FSHR is exclusively expressed at immunologically relevant levels on the granulosa cells of the ovaries.3
"In the first cohort and at the lowest dose administered, despite an initial increase in tumor size that met criteria for progression, 1 patient has remained off new therapy for many months with no new disease,” Robert Wenham, the chair of the Department of Gynecologic Oncology at Moffitt and the principal investigator of the trial, said in a statement.1 “Even her tumor marker that was initially elevating later began to fall. A biopsy demonstrated tumor with necrosis, inflammation and T-cell infiltration by immunohistochemistry. Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response. Recently, we received that approval from the FDA."
So far, 3 patients have been treated in the trial at a dose of 1x105 CER T-cells (cohort 1) and 3 patients have been treated at a dose of 3x105 CER T-cells (cohort 2).3 According to a June 2024 update given by Anixa at the time of the dosing of the study’s sixth patient overall, no dose-limiting toxicities (DLT) had been observed among the treated patients in the trial.
"I am pleased with the very long duration absent of any further disease and the possible response that my patient has exhibited with this innovative therapy, as she had no other realistic options,” Monica Avila, MD, MPH, the treating oncologist of the patient cleared for redosing.1 “I look forward to evaluating her progress with successive dosing, as well as future patients who have no other alternatives."
Anixa noted in June 2024 that pending the continued nonoccurrence of a DLT or new adverse events among the treated patients by the sixth patient’s completion of a 1-month safety follow-up, enrollment for the trial’s third cohort would begin.3 The third cohort will treat patients at a dose 10 times higher (1x106) than the dose used for cohort 1.
"We are highly encouraged by the favorable safety profile observed thus far in both the first and second patient cohorts, and are eager to evaluate a higher dose in the next cohort,” Amit Kumar, PhD, the chairman and chief executive officer of Anixa Biosciences, said in a June 2024 statement.1 “We are particularly encouraged by a notable response in 1 of the patients in the first cohort, even though the dosage was considered a subtherapeutic level. Our aim is to maintain a positive safety profile as we escalate dosing, with the goal of demonstrating additional objective evidence of efficacy. Unlike conventional CAR-T cell therapies, which have achieved amazing results in various hematological cancers, they have not been effective in solid tumors. In contrast, we believe Anixa's novel technology has the potential to make CAR-T effective in ovarian cancer and perhaps across multiple solid tumor types. Our unique and highly targeted CER-T approach targets the FSHR, which is exclusively expressed on ovarian cells. A potential dual mechanism of action is operating with our therapy targeting tumor vasculature by starving or shrinking the tumor from the inside out, as well as direct targeting of ovarian cells."
