Anixa Biosciences Initiates Dosing in Second Cohort of Ovarian Cancer CAR-T Clinical Trial

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Anixa Biosciences, Inc. announces dose escalation for fourth patient in Phase 1 clinical trial of CAR-T therapy for ovarian cancer. The trial, in partnership with Moffitt Cancer Center, aims to demonstrate efficacy of FSHR-mediated CAR-T technology in solid tumors.
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The commencement of treatment for the fourth patient in Anixa Biosciences' Phase 1 clinical trial represents a critical step in the development of their novel CAR-T therapy for ovarian cancer. This trial's progression into higher dosing cohorts indicates initial safety and tolerability of the therapy. The implications for stakeholders, particularly investors in the biotechnology sector, revolve around the potential of this technology to address the substantial unmet need in the treatment of solid tumors, which have historically been challenging for CAR-T therapies.

It is important to note that the efficacy of this therapy in solid tumors like ovarian cancer could be a significant breakthrough, as CAR-T therapies have predominantly shown success in hematological malignancies. If Anixa's CAR-T therapy proves to be effective in later-stage trials, it could lead to a paradigm shift in oncological treatment options and potentially offer a competitive edge in the market. However, the inherent risks of clinical trials, especially in early phases, should temper expectations as many treatments fail to progress beyond Phase 1 due to safety concerns or lack of efficacy.

From an oncological perspective, the targeting of FSHR by Anixa's CAR-T therapy, known as CER-T, is a novel approach that could offer specificity in attacking ovarian cancer cells. FSHR expression is a promising target due to its presence on ovarian cancer cells and the vasculature of tumors, potentially allowing for more targeted therapy and reduced off-target effects. The direct intraperitoneal administration of the engineered T-cells is another strategic element of the trial, as it could lead to enhanced delivery to tumor sites and a reduction in systemic side effects such as cytokine release syndrome (CRS), which is a significant concern with CAR-T therapies.

Continued observation for any signs of CRS or other adverse events will be crucial as the trial progresses, especially with the increased dosing. The direct peritoneal delivery method may also present logistical challenges or variability in efficacy based on tumor location and patient-specific factors, which will need to be evaluated in subsequent trial phases.

In terms of market impact, Anixa Biosciences' progression in their clinical trial could signal to investors the company's potential for growth and innovation in the oncology space. The success of this trial could attract partnership opportunities, licensing deals, or even make the company a target for acquisition by larger pharmaceutical entities seeking to expand their oncology pipelines. The focus on ovarian cancer, a market with high unmet needs, may position Anixa favorably if their therapy proves to be efficacious and safe.

However, investors should consider the long development timelines and the significant investment required to bring a CAR-T therapy to market. The competitive landscape, including other companies developing similar therapies and the regulatory hurdles that Anixa must clear before commercialization, should also be factored into the analysis of the company's long-term prospects.

Dose escalation for fourth patient follows successful completion of first cohort

SAN JOSE, Calif., Feb. 12, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that treatment has commenced for the fourth patient in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. The study is being conducted through a research partnership with Moffitt Cancer Center. 

The first-in-human trial is enrolling patients with recurrent/resistant ovarian cancer who have progressed on at least two prior therapies. The CAR T was safe and tolerable in the first three patients treated. The fourth patient, the first patient enrolled in the second cohort, received triple the dose of CAR-T cells compared with the dose of the first cohort. Anixa's Follicle Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology, also known as chimeric endocrine receptor T-cell (CER-T), differs from traditional CAR-T therapy by targeting FSHR, which research indicates is expressed on ovarian cells, as well as in the vasculature of tumors.

Dr. Amit Kumar, Chairman and CEO of Anixa, commented, "With no safety issues observed in the first cohort of patients, we have successfully advanced to the next cohort to evaluate a 3x higher dose. As the trial progresses, we seek to demonstrate efficacy of our cell therapy in solid tumors—a difficult challenge for traditional CAR-T therapies that have been shown to be efficacious in hematological tumors and lymphoma."

Dr. Robert Wenham, the Principal Investigator of the trial and the Chair of Gynecologic Oncology at Moffitt, stated, "First, we have the advantage of a target that is much more specific to our tumor tissue, which should minimize any on-target, off-tumor effect. Additionally, we are administering the engineered T-cells directly into the peritoneum (IP), which is the location of most of the ovarian tumor lesions. We hope that this delivery approach will enable direct trafficking of the CER-T-cells to the tumor sites and minimize adverse events such as cytokine release syndrome (CRS)".

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 a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer. 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 clinical development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit 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.

Mike Catelani
President, COO & CFO

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SOURCE Anixa Biosciences, Inc.

The Phase 1 clinical trial aims to evaluate the safety and efficacy of Anixa's novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer.

Anixa Biosciences, Inc. is conducting the trial in partnership with Moffitt Cancer Center.

Anixa's CAR-T technology targets the Follicle Stimulating Hormone Receptor (FSHR), which is expressed on ovarian cells and in the vasculature of tumors, making it more specific to tumor tissue.

The fourth patient in the trial, the first in the second cohort, received a triple dose of CAR-T cells compared to the first cohort to evaluate efficacy.

Dr. Robert Wenham is the Principal Investigator, and the engineered T-cells are being administered directly into the peritoneum (IP) to target ovarian tumor lesions.
Anixa Biosciences Inc


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