Anixa Biosciences said that it has filed an investigational new drug (IND) application for its ovarian cancer CAR-T therapy with the US Food and Drug Administration (FDA).

The ovarian cancer CAR-T therapy was invented by a team headed by Dr. Jose Conejo-Garcia, who is presently Chair of the Department of Immunology at Moffitt Cancer Center (MCC).

The IND enabling studies of the chimeric antigen receptor T-cell therapy were carried out at Moffitt Cancer Center. The clinical trial will also be held there under the leadership of Dr. Robert Wenham, who is Moffitt Cancer Center’s Chair of Gynecological Oncology.

Dr. Robert Wenham said: “We are pleased to file this IND application, since women who have recurrent ovarian cancer have very few options. We hope the work of our scientific and clinical team at Anixa and MCC yields results that will address a critical unmet medical need.”

Anixa Biosciences has a worldwide, exclusive commercial license to the ovarian cancer CAR-T therapy.

According to the California-based biotech company, the technology targets the follicle stimulating hormone receptor (FSHR) with modified T-cells that use it as a homing mechanism.

FSHR is exclusively found at immunological levels on the granulosa cells of the ovaries. As the target is a hormone receptor, the technology is also called CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T, said Anixa Biosciences.

Dr. Amit Kumar – President and CEO of Anixa Biosciences said: “This IND application is a major milestone for Anixa and our partners at MCC.

“This is our second IND application filed within the last few months. Upon clearance from the FDA and commencement of the trial, we expect to have two programs in the clinic.”

  Anixa Biosciences, Dr. Amit Kumar, Dr. Jose Conejo-Garcia, Dr. Robert Wenham, Moffitt Cancer Center, Oncology, Ovarian Cancer, US Food and Drug Administration, USA