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SAN JOSE - Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company with a market capitalization of approximately $109 million, has dosed the first patient in the fourth cohort of its Phase 1 clinical trial evaluating a chimeric antigen receptor T-cell (CAR-T) therapy for recurrent ovarian cancer, according to a company press release. While the stock has seen a 31% gain over the past six months, InvestingPro analysis suggests the shares are currently trading above their Fair Value.
The fourth cohort will receive three million CAR-positive cells per kilogram of body weight, which represents a thirtyfold increase from the first cohort dose. The company reported that no dose-limiting toxicities were observed in the third cohort, allowing progression to this higher dosage level.
The trial is being conducted in partnership with Moffitt Cancer Center under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt and principal investigator of the study.
Anixa’s therapy targets the follicle-stimulating hormone receptor (FSHR), which the company states is expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.
"Although the study is primarily focused on safety at these early, low-dose levels, we have seen promising signs of potential efficacy," said Dr. Amit Kumar, Chairman and CEO of Anixa, in the statement.
The trial is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy of the treatment. This dose escalation represents a planned step in the ongoing Phase 1 study to assess the therapy’s safety profile and potential therapeutic effect in ovarian cancer patients.
In other recent news, Anixa Biosciences has made notable advancements in its cancer vaccine portfolio. The company completed enrollment in a Phase 1 trial for its breast cancer vaccine, developed in collaboration with Cleveland Clinic, with funding from the U.S. Department of Defense. Preliminary results from this trial indicate that over 70% of participants demonstrated a protocol-defined immune response. Anixa has also been granted a Notice of Allowance by the United States Patent and Trademark Office for its breast cancer vaccine technology, which strengthens its intellectual property portfolio. In addition, Anixa received a Notice of Allowance for a patent application related to its ovarian cancer vaccine technology, developed with Cleveland Clinic and the National Cancer Institute. This patent covers methods to induce an immune response against the AMHR2 protein, a target for ovarian cancer prevention and treatment. H.C. Wainwright has maintained its Buy rating and a $7.00 price target for Anixa, citing these developments as key factors in their positive outlook. The firm’s continued progress in vaccine technology is expected to bolster its position in the biotechnology sector.
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