Company: ANIX
Filing Date: 2025-01-10
Form Type: S-8
Source: 0001493152-25-001798
Chunk: 26

Company: Anixa Biosciences Inc
Filing Date: 2025-01-10
Form: S-8
Chunk 26
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 to react quickly if an individual is exposed to the disease agent months or years later. Most vaccines attack pathogens, such as viruses and bacteria. The immune system is better able to assail these agents because they come from outside the body. Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for our immune system to find the diseased cells, especially as advancing age weakens our immune system. Once these aberrant cells gain critical mass, they become cancer.

CAR-T cell therapies are novel and present significant challenges.

CAR-T product candidates represent a relatively new field of cellular immunotherapy. Advancing this novel and personalized therapy creates significant challenges for us, or a partner, including:

| ● | obtaining                                                                                                                                
 regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of T cell therapies 
 for cancer;                                                                                                                              |
| ● | sourcing                                                                                                                                 
 clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;                 |
| ● | developing                                                                                                                               
 a consistent and reliable process, while limiting contamination risks, for engineering and manufacturing T cells ex vivo and             
 infusing the engineered T cells into the patient;                                                                                        |
| ● | educating                                                                                                                                
 medical personnel regarding the potential benefits, as well as the challenges, of incorporating our product candidates into their        
 treatment regimens;                                                                                                                      |
| ● | establishing                                                                                                                             
 sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and                |
| ● | the                                                                                                                                      
 availability of coverage and adequate reimbursement from third-party payors for our novel and personalized therapy.                      |

Our inability to successfully develop CAR-T cell therapies or develop processes related to the manufacture, sales and marketing of these therapies would adversely affect our business, results of operations and prospects.

While CAR-T technology has shown positive results in B cell cancers by others, its safety and efficacy has not been seen in solid tumors and we cannot guarantee our CAR-T technology will be safe or effective in ovarian or other cancers.

CAR-T therapies function through the binding of a genetically engineered killer T cell to a cancer cell. However, these engineered T cells destroy the cell they are bound to whether it is a cancer cell or a healthy cell. Therefore, the engineered T cells must be designed to only bind to either cancer cells or other target cells to minimize toxicity. Our CAR-T technology relies on the natural affinity of FSH to FSH-Receptor. Research by others has shown that in women the FSH