The chief development officer of Anixa Biosciences discussed the company’s trial of a CAR-T in ovarian cancer that is looking at the effect of regional administration and lymphodepletion on efficacy.
This is the second part of an interview with Pamela Garzone, PhD. For the first part, click here.
“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.”
At the 8th Annual CAR-TCR Summit, held August 29-September 1, 2023, in Boston, Massachusetts, Pamela Garzone, PhD, the chief development officer of Anixa Biosciences, gave an update on the company’s phase 1 clinical trial (NCT05316129) evaluating an autologous chimeric endocrine receptor (CER) T-cell product that targets follicle-stimulating hormone receptor (FSHR) for the treatment of recurrent ovarian cancer. The study, which is currently recruiting, is also intended to explore several parameters of interest for the application of chimeric antigen receptor T-cell (CAR-T) therapy to solid tumors in general. Among these factors are delivery methods and the use of lymphodepletion. In particular, the trial is evaluating intravenous administration of the experimental product, dubbed FSHCER T-cells, against regional intraperitoneal administration; the effect of use or nonuse of lymphodepletion prior to administration is also being explored. Although intravenous administration and the use of lymphodepletion have become established standards when it comes to the application of CAR-T treatments in hematological malignancies, the necessity and utility of these methods for CAR-T therapies in the solid tumor space remains unclear.
In an interview with CGTLive™, Garzone discussed the design of the trial, which is being carried out in a collaboration with Moffit Cancer Center. In addition to discussing the aforementioned exploration of delivery and lymphodepletion parameters, Garzone noted that dosing of the patients in the trial’s first cohort has been completed and that to date, the treatment has been well-tolerated. She also pointed out that the vein-to-vein time for the FSHCER T-cells is a relatively short 14 days and emphasized the importance of evaluating novel treatment options for patients with recurrent ovarian cancer.