Anixa Biosciences Inc. (NASDAQ: ANIX) stock declined by 2.65% at the last close whereas the ANIX stock price rises by 5.45% in the pre-market trading session. Anixa is a biotechnology firm that is working on a variety of cancer and infectious disease projects. Anixa’s therapeutics pipeline comprises a cancer immunotherapy program based on chimeric endocrine receptor T-cell (CER-T) technology and a Covid-19 therapeutics program aimed at blocking the action of specific viral proteins.
On May 20, 2021, ANIX reported that the US Food and Drug Administration (US FDA) has given specifics of the additional information it is seeking in relation to its Chimeric Antigen Receptor-T cell therapy (CAR-T), which is being developed in collaboration with Moffitt Cancer Center.
This study’s Investigational New Drug (IND) proposal was submitted in March, and the US Food and Drug Administration (FDA) needed more detail before authorizing the experiment. The FDA has now given the specifics of the information request. Anixa and Moffitt believe that the requested information can be gathered and sent to the FDA in about 30 days, after which the FDA will respond within another 30 days.
This is an autologous cell therapy that usually requires the development of a one-of-a-kind drug product for each patient. Engineered T-cells that activate the follicle stimulating hormone receptor make up the medicinal product (FSHR). FSHR is only present on the granulosa cells of the ovaries at immunological grounds. This method is also known as CER-T (Chimeric Endocrine Receptor T-cell) treatment, a new version of CAR-T, since the target is a hormone receptor.
Dr. Amit Kumar, President and CEO of Anixa Biosciences, commented:
This letter, along with the extensive details order, has been received with pleasure by ANIX. Though they expect to complete the request within 30 days, certain assays can need additional time for confirmation before being submitted. ANIX will make every effort to submit their application as soon as possible, and they hope to begin this clinical trial before the end of the year.