Anixa Biosciences Begins Patient Dosing in Phase 1 Trial of Novel CAR-T Therapy

Anixa Biosciences Begins Patient Dosing in Phase 1 Trial of Novel CAR-T Therapy

By, Admin 21 November 2024

Anixa Biosciences begins patient dosing in third cohort in ongoing phase 1 trial of novel CAR-T therapy for recurrent ovarian cancer

Overview

Anixa Biosciences, Inc. (Anixa), a biotechnology company focused on the treatment and prevention of cancer, announced that it has dosed its first patient in the third cohort in the ongoing phase 1 clinical trial of its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer. The study is being conducted through a research partnership with Moffitt Cancer Center (Moffitt).

Regarding Toxicity

  • No dose limiting toxicity was observed in the initial three-patient cohort or in the second three-patient cohort, in which patients received a CAR-T cell dose triple that of the first cohort. 
  • After the required one-month waiting period to assess the occurrence of dose limiting toxicity and review of all safety data, the trial has now dosed its first patient in the third cohort at a tenfold increase over the initial dose.

FSHR-Mediated CAR-T Technology

  • Anixa's FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumour vasculature, and certain cancer cells. 
  • The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed on at least two prior therapies. 
  • The study is designed to evaluate safety and identify the maximum tolerated dose, while monitoring efficacy.

From the Principal Investigator of the Study

  • Dr. Robert Wenham, principal investigator of the study and Chair of the Department of Gynaecologic Oncology at Moffitt, stated, ""With no dose-limiting safety issues observed in the first and second patient cohorts, we have advanced to the next cohort to evaluate a 10x higher dose compared with the starting dose.
  • As the trial continues, our aim is to demonstrate the tolerability of our CAR-T but we are optimistic and hopeful about seeing efficacy in this solid tumour—a challenging area for traditional CAR-T therapies, which have shown efficacy mainly in hematologic tumours and lymphomas. We are very encouraged how the trial has progressed and our observation in one patient from the first cohort who had relative stability and even some mild improvement for well over a year after her infusion.
  • This is highly unusual for a platinum resistant multiply treated ovarian cancer. A tumour biopsy showed necrosis and T cell infiltration. Based on these findings, we recently submitted an amendment to the trial protocol to allow patients who may benefit from an additional dose. Generally, we expect higher cell doses to increase efficacy, although we also anticipate a second dose may further improve response rates and durability. We are proud of the progress to date and look forward to treating additional patients in the third cohort.

About the Company: Anix

  • Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. 
  • Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy programme being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology.

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