Anixa Biosciences Commences Treatment of Fifth Patient in Ovarian Cancer CAR-T Clinical Trial
Anixa Biosciences has commenced treatment of the fifth patient in its Phase 1 clinical trial for CAR-T therapy targeting ovarian cancer. This trial, conducted in partnership with Moffitt Cancer Center, enrolls female patients with recurrent ovarian cancer unresponsive to at least two prior therapies. The trial aims to identify the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR), which is uniquely expressed on ovarian cells. Safety was confirmed in the first cohort of three patients, and the second cohort, including the fifth patient, receives triple the dose of engineered T-cells. According to Dr. Amit Kumar, Anixa's Chairman and CEO, the trial continues to show that the therapy is safe and well-tolerated, offering hope for an effective CAR-T treatment for solid tumors.
- Commencement of treatment for the fifth patient in the Phase 1 trial indicates steady trial progression.
- The first cohort confirmed safety, an essential milestone in clinical trials.
- The second cohort, including the fifth patient, receives a higher dose, indicating dose escalation within safety parameters.
- Exclusive worldwide license to the FSHR-mediated CAR-T technology secures Anixa's proprietary position.
- Potential to be the first effective CAR-T therapy for solid tumors can attract significant investor interest.
- The trial is still in Phase 1, indicating it is in the early stages with many years of development ahead.
- Focus on patients unresponsive to at least two prior therapies suggests a challenging patient population with potentially lower success rates.
- Higher doses in the second cohort imply an ongoing need to determine the maximum tolerated dose, highlighting safety risks.
Insights
The commencement of treatment for the fifth patient in Anixa's Phase 1 clinical trial for ovarian cancer using CAR-T therapy holds significant implications. The trial's focus on targeting the follicle-stimulating hormone receptor (FSHR), which is exclusively found on ovarian cells, presents a novel approach in the realm of solid tumor treatments. Historically, CAR-T therapies have shown more success in hematologic cancers, but their application in solid tumors has faced substantial challenges due to the tumor microenvironment and immunosuppressive conditions. The safety confirmation in the first cohort and now the dosage escalation to the second cohort emphasizes a cautious yet promising progression.
The unique targeting mechanism of FSHR could potentially bypass the common pitfalls of CAR-T therapies in solid tumors, which often struggle with off-target effects and limited efficacy. If Anixa's therapy continues to prove safe and tolerable, it may pave the way for more effective CAR-T treatments for various solid tumors, broadening the therapeutic landscape for oncology.
The progression of Anixa's clinical trial for their CAR-T therapy is a noteworthy development in cancer treatment research. The trial's move to treating the fifth patient and increasing the dose delivered highlights a critical phase in determining the maximum tolerated dose and potential efficacy. This step is important as it informs later-stage trials and eventual regulatory submissions. The unique focus on FSHR, a receptor specific to ovarian cells, suggests a highly targeted approach that could mitigate the severe side effects seen in other CAR-T therapies that affect a broader range of cells.
For investors, the success of these early trial stages can be a strong indicator of the therapy's potential. However, investors should remain cautious until further data on efficacy and broader application become available. The trial's ongoing nature means that significant milestones are yet to be reached and these will be critical in assessing the overall viability of the treatment.
Novel and proprietary CAR-T approach holds potential to be first effective CAR-T therapy for solid tumors
Anixa's first-in-human trial (NCT05316129) is enrolling female adult patients with recurrent/progressing ovarian cancer who were unresponsive to at least two prior therapies. Safety was confirmed in the first three-patient cohort. The patients in the second cohort, including patient #5, receive triple the dose of engineered T-cells compared with the first cohort of three patients. The study will identify the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR), found only on ovarian cells
"With our fifth patient treated, our trial is progressing, and we continue to see that our therapy appears to be safe and well-tolerated," said Dr. Amit Kumar, Chairman and CEO of Anixa. "The technology behind our novel CAR-T therapy differs from traditional CAR-T therapies by targeting the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. We developed this approach to tackle preexisting difficulties with CAR-T cell therapies in solid ovarian tumors. In our trial, we will also explore several parameters for applying our CAR-T therapy to solid tumors in general."
Anixa's FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.
About Anixa's CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa's chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.
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.
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