FDA clears IND application for hormone receptor-directed CAR-T to treat ovarian cancer
Click Here to Manage Email Alerts
The FDA cleared an investigational new drug application for a chimeric antigen receptor T-cell therapy designed to treat women with relapsed epithelial ovarian cancer.
The agent — developed by Anixa Biosciences in partnership with Moffitt Cancer Center — is a new form of CAR-T also known as a chimeric endocrine receptor T-cell (CER-T) therapy.
The autologous, gene edited T-cell therapy targets the follicle stimulating hormone receptor found on the granulose cells of the ovaries.
The therapy is based on preclinical research from a team José Conejo-Garcia, MD, PhD — chair of the department of immunology at Moffitt — led when he was at Wistar Institute.
The IND clearance will allow Anixa and Moffitt to start enrollment for a clinical trial that will evaluate the novel therapy for women with relapsed epithelial ovarian cancer who previously received two or more lines of chemotherapy.
Robert Wenham, MD, FACOG, FACS, chair of the department of gynecologic oncology at Moffitt, will lead the trial.
“This is a major milestone for our program,” Wenham said in an Anixa-issued press release. “CAR-T therapy has had major successes in B-cell malignancies but no clinical success in other types of tumors. We feel that our technology could be the first CAR-T approach that will demonstrate efficacy in a solid tumor indication, and we are looking forward to testing and verifying that assertion in human trials.”
The press release did not specify when trial enrollment will begin.
“We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting therapy,” Amit Kumar, PhD, president and CEO of Anixa, said in the release. “Outcomes for women with late-stage ovarian cancer are poor so, if this approach demonstrates efficacy, it would have a dramatic impact on patients for whom there are no other options.”
Click Here to Manage Email Alerts