Anixa Biosciences Announces FDA Approval of Individual Patient IND for its Ovarian Cancer CAR-T Therapy
Rhea-AI Summary
Anixa Biosciences (NASDAQ: ANIX) announced FDA approval of an individual patient IND for a second dose of its ovarian cancer CAR-T therapy. This follows encouraging findings in a patient from the lowest dose cohort, including tumor necrosis, inflammation, and T cell infiltration. The patient has remained off new therapy for months with no new disease, and her tumor marker began to fall after initial elevation.
The Phase I clinical trial at Moffitt Cancer Center is treating recurrent ovarian cancer patients who have failed standard therapies. Six patients have been treated so far in two cohorts. Dr. Robert Wenham, principal investigator, expressed optimism about the potential for increased response with successive dosing. Anixa's CEO, Dr. Amit Kumar, noted surprise and encouragement at seeing a notable response at such a low initial dose.
Positive
- FDA approval for second dose of CAR-T therapy in individual patient
- Encouraging tumor response in lowest dose cohort patient
- Patient remained off new therapy for months with no new disease
- Tumor marker began to fall after initial elevation
- Potential for increased response with successive dosing
Negative
- Initial increase in tumor size meeting criteria for progression
- Only one patient showing notable response so far
- Trial still in early Phase I stage
Insights
The FDA's approval of an individual patient IND for Anixa Biosciences represents a critical milestone in the development of their ovarian cancer CAR-T therapy. This approval is particularly significant given the early signs of efficacy observed even at the lowest dose cohort. The findings of necrosis, inflammation and T cell infiltration in the tumor biopsy indicate a positive immune response, suggesting that the therapy is actively engaging the patient's immune system to target cancer cells. Such early positive results can often accelerate the clinical development process, potentially leading to earlier availability for other patients in need. However, it is important to manage expectations, as this is still in the early phases of clinical trials and broader efficacy and safety will need to be established.
As an oncology expert, I see the FDA approval for a second dose in this patient as a promising step forward in ovarian cancer treatment. The patient's prolonged period without new disease and the reduction in tumor markers are encouraging signs. These types of responses, especially in patients who have no other treatment options, can pave the way for more individualized and effective cancer therapies. However, these results are preliminary and pertain to a single patient. Comprehensive data from a larger cohort will be necessary to confirm the efficacy and safety of this CAR-T therapy for widespread use. Patients and investors alike should watch for further updates as the trial progresses to higher dose cohorts.
From a financial perspective, the FDA approval for Anixa's CAR-T therapy represents a significant value driver for the company. Early-stage biotech firms often experience volatility and notable clinical trial progress can lead to substantial stock price movements. This approval, along with the preliminary positive patient response, could attract investor interest and potentially lead to upward stock movement. However, it's important for investors to remain cautious. The therapy is still in Phase I trials and the ultimate success will depend on further clinical results and eventual market approval. Investors should keep an eye on upcoming clinical data releases and any strategic partnerships or funding activities that Anixa might pursue to support the continued development of their therapy.
IND follows encouraging findings of necrosis, inflammation and T cell infiltration in tumor biopsy of patient in lowest dose cohort
Dr. Robert Wenham, Chair, Department of Gynecologic Oncology at Moffitt, and the principal investigator of the trial, stated, "In the first cohort and at the lowest dose administered, despite an initial increase in tumor size that met criteria for progression, one patient has remained off new therapy for many months with no new disease. Even her tumor marker that was initially elevating later began to fall. A biopsy demonstrated tumor with necrosis, inflammation and T cell infiltration by Immunohistochemistry (IHC). Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response. Recently, we received that approval from the FDA."
"I am pleased with the very long duration absent of any further disease and the possible response that my patient has exhibited with this innovative therapy, as she had no other realistic options. I look forward to evaluating her progress with successive dosing, as well as future patients who have no other alternatives," stated Dr. Monica Avila, the patient's treating oncologist.
Dr. Amit Kumar, CEO of Anixa Biosciences commented, "We were somewhat surprised and quite encouraged to see such a notable response this early, given the low dose in the first cohort. We truly hope we can help this patient, as well as all other women fighting this terrible disease."
The Phase I clinical trial at Moffitt is treating recurrent ovarian cancer patients who have failed standard-of-care therapies. To date, six patients have been treated in the dose escalation trial, three in the first cohort and three in the second cohort. Dose escalation will continue after confirming the previous dosages are safe.
About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.
FAQ
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