Anixa Biosciences (NASDAQ: ANIX) and Moffitt Cancer Center have secured approval for a significant protocol amendment in their ongoing CAR-T therapy clinical trial for ovarian cancer, marking a crucial advancement in their innovative treatment approach.
The protocol modification introduces two key changes to the existing trial (NCT05316129). First, it permits eligible patients to receive a second dose of CAR-T therapy when potential benefit is indicated. Second, it broadens the trial's scope to include patients with sex cord-stromal tumors (SCSTs) and Sertoli Leydig cell tumors (SLCTs), expanding treatment options for these rare ovarian cancer variants.
Enhanced Treatment Flexibility
The amendment eliminates the previous requirement for individual Investigational New Drug (IND) applications for second doses. This streamlining follows a successful single-patient IND approval where biopsy results showed promising cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy.
Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the trial's principal investigator, emphasized the amendment's significance: "This amendment is a crucial development in our ongoing efforts to advance the treatment of ovarian cancer with CAR-T therapy. The ability to administer a second dose to patients who show potential for additional benefit provides us with more flexibility and an opportunity to further evaluate the effectiveness of this innovative therapy."
Innovative Therapeutic Approach
The trial utilizes a novel type of CAR-T technology, known as chimeric endocrine receptor-T cell (CER-T) technology. This approach represents part of Anixa's broader therapeutic portfolio, which includes collaborative efforts in developing vaccines for breast and ovarian cancers.
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, expressed optimism about the amendment's impact: "This is a significant step in optimizing the treatment for ovarian cancer. The ability to provide second doses and treat additional rare types of ovarian cancer enhances our potential to improve outcomes for patients facing this difficult disease."
Clinical Trial Implications
The protocol amendment addresses two critical aspects of clinical research in oncology:
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Treatment Optimization: The ability to administer second doses allows for more flexible treatment strategies based on individual patient responses.
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Expanded Patient Access: Including additional ovarian cancer histologies broadens the potential patient population who might benefit from this innovative therapy.
The ongoing trial continues to evaluate the safety and efficacy of this CAR-T approach, with the new protocol modifications potentially accelerating the development of more effective treatments for various forms of ovarian cancer.
