The trial has dosed its third patient, and, safety validation pending, plans to dose a second cohort beginning at the end of 2023.
Anixa Biosciences has treated the third patient in its phase 1 clinical trial (NCT05316129) evaluating its novel follicle stimulating hormone receptor (FSHR)-targeting chimeric endocrine receptor (CER) T-cell therapy for patients with recurrent ovarian cancer. The trial is being conducted in partnership with Moffitt Cancer Center.
"We are pleased that the Phase 1 clinical trial evaluating this CAR-T therapy for ovarian cancer continues to progress. We are looking forward to analyzing the safety data from the first cohort, and look forward to escalating the dose in the following cohort,” principal investigator Robert Wenham, MD, chair, Gynecologic Oncology Program, Moffitt Cancer Center, said in a statement.
The dose-escalation, phase 1 trial is primarily evaluating the therapy's safety, determining the maximum tolerated dose of the therapy, and assessing preliminary clinical activity. The trial is enrolling female adult patients with recurrent ovarian cancer that is progressing and has failed to at least 2 prior therapies.
The third patient was treated at the same dose level as the first 2 patients, in which safety has previously been validated. Pending safety validation of the latest patient, Anixa expects to begin dosing the second cohort in the fourth quarter of 2023. This cohort will receive about 3 times the dose as the first cohort.
The CER-T therapy is Anixa’s modified chimeric antigen receptor (CAR) T-cell therapy approach using an endocrine receptor as the target of the engineered T-cells. Anixa developed this approach to tackle preexisting difficulties with CAR T-cell therapies in solid tumors. The company’s CER T-cell therapy targets FSHR, which is exclusively expressed at immunologically relevant levels on the granulosa cells of the ovaries.
"Though enrollment of patients in this trial has been slow, which is common for clinical studies of this type, we are pleased to have completed the first cohort," Amit Kumar, PhD, chairman and chief executive officer, Anixa Biosciences, added. "Assuming there are no safety issues with this third patient, we look forward to advancing to the next higher dose cohort."
Anixa Biosciences recently gave an update on the trial at the 8th Annual CAR-TCR Summit, held August 29-September 1, 2023, in Boston, Massachusetts. CGTLive spoke with Pamela Garzone, PhD, chief development officer, Anixa Biosciences, to learn more about the trial and the CER T-cell therapy.
“We are actually comparing at 1 dose level [the administration of the FSHCER T-cells] with and without lymphodepletion to see if [either approach shows] better expansion, better peak levels, and better persistence of the CARs over time. While there are several proposed mechanisms of why giving preconditioning for solid tumors is a good idea, we're testing that hypothesis within our own trial. So that, to me, is very exciting,” she told CGTLive.