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Anixa Biosciences, Inc. (NASDAQ: ANIX) is a clinical-stage biotechnology company dedicated to the treatment and prevention of cancer. The company's core focus includes developing vaccines and therapies aimed at critical unmet needs in oncology. Anixa's innovative approach involves both diagnostics and therapeutics to detect and treat cancer at its most curable stages.
The company's therapeutic portfolio features a pioneering ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center. This program utilizes a novel CAR-T technology, known as chimeric endocrine receptor T-cell (CER-T), which targets the follicle-stimulating hormone receptor (FSHR) specifically expressed on ovarian cells. This technology represents a potential breakthrough in treating solid tumors, a challenge for traditional CAR-T therapies.
Anixa is also advancing a unique vaccine portfolio in collaboration with Cleveland Clinic, targeting the prevention of breast cancer, specifically triple-negative breast cancer (TNBC), the most aggressive form of the disease, as well as ovarian cancer. These vaccine technologies focus on immunizing against
Anixa Biosciences (NASDAQ: ANIX) has initiated dosing in the third cohort of its Phase 1 ovarian cancer CAR-T clinical trial, conducted in partnership with Moffitt Cancer Center. The new cohort receives one million CAR-positive cells, a tenfold increase from the initial dose. No dose-limiting toxicity was observed in the first two cohorts. The trial targets the follicle-stimulating hormone receptor (FSHR) in patients with recurrent ovarian cancer who have progressed on at least two prior therapies. Notably, one patient from the first cohort showed unusual stability and mild improvement for over a year post-infusion, with tumor biopsy revealing necrosis and T cell infiltration.
Anixa Biosciences and Cleveland Clinic presented updated positive data from their Phase 1 breast cancer vaccine trial at the SITC Annual Meeting. The vaccine, targeting α-lactalbumin protein, showed safety and tolerability across all three cohorts, with over 70% of patients exhibiting protocol-defined immune responses. The trial includes patients who completed triple-negative breast cancer treatment, high-risk individuals with genetic mutations, and patients receiving Keytruda. The primary side effect was injection site irritation. Based on these positive results, a Phase 2 study is planned for 2025, focusing on newly diagnosed breast cancer patients in the neoadjuvant setting.
Anixa Biosciences (NASDAQ: ANIX) announced that additional data from the Phase 1 clinical trial of its breast cancer vaccine will be made public on November 8, 2024, at 12:15pm CT. The presentation, titled 'Phase I Trial of alpha-lactalbumin vaccine in high risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC,' will be presented at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting. The data will be available on the company's website, accompanied by a press release analyzing the results.
Anixa Biosciences (NASDAQ: ANIX) announced its upcoming presentation at the Sidoti Micro-Cap Virtual Conference on November 14, 2024, at 1:00pm ET. Chairman and CEO Dr. Amit Kumar will present company updates and clinical program developments. The presentation follows the release of latest breast cancer clinical trial data scheduled for November 8, 2024.
Dr. Kumar will also provide updates on their CAR-T trial for recurrent and resistant ovarian cancer patients. Both trials are reportedly producing positive results that exceed expectations. The conference offers 1x1 meetings open to all registered investors.
Anixa Biosciences (NASDAQ: ANIX) announced that additional data from its Phase 1 breast cancer vaccine clinical trial will be presented at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting from November 6-10, 2024. The presentation, titled 'Phase I Trial of alpha-lactalbumin vaccine in high risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC,' will be delivered by Dr. Emily Rhoades from Cleveland Clinic. The trial is being conducted in collaboration with Cleveland Clinic and funded by the U.S. Department of Defense.
Anixa Biosciences (NASDAQ: ANIX) has administered a second dose of its CAR-T therapy to a patient in its ongoing Phase 1 clinical trial for ovarian cancer. This follows a positive response after the initial treatment, where the patient's tumor biopsy showed necrosis, inflammation, and T cell infiltration. The patient remained stable for nearly 18 months after the first infusion, maintaining a good quality of life.
The trial, conducted in collaboration with Moffitt Cancer Center, has treated six patients to date in two cohorts. The encouraging results have led to an amendment in the trial protocol to allow for second doses in patients who may benefit. Dr. Robert Wenham, the principal investigator, expressed optimism about the therapy's potential long-term benefits for ovarian cancer patients.
Anixa Biosciences (NASDAQ: ANIX) has appointed Suyasha Gupta as Senior Director of Clinical Development. Ms. Gupta will oversee the company's ongoing Phase 1 breast cancer vaccine and Phase 1 ovarian cancer CAR-T therapy clinical trials, as well as the upcoming Phase 2 breast cancer vaccine trial. She brings extensive experience in managing late-stage oncology and hematology clinical trials from her previous role at Genentech.
Dr. Pamela Garzone, Chief Development Officer, highlighted Ms. Gupta's expertise in oncology trial design and execution as important for Anixa's strategic goals. The company recently announced plans for their breast cancer vaccine Phase 2 trial, focusing on a therapeutic approach rather than prevention, aiming for a faster and more cost-effective path to approval.
Anixa Biosciences (NASDAQ: ANIX) and Moffitt Cancer Center have submitted an amendment to the protocol governing their ongoing CAR-T therapy clinical trial for ovarian cancer. The key change allows for a second dose of therapy to be administered to suitable patients without requiring individual INDs.
This amendment follows the approval of a single patient IND application for a second dose, where the patient showed signs of biologic activity after the initial treatment. Dr. Robert Wenham, principal investigator, noted that higher cell doses are expected to lead to efficacy, but a second dose may be necessary for some patients with solid tumors to improve response rates and durability.
Anixa's CEO, Dr. Amit Kumar, expressed enthusiasm about the trial's progress and anticipates regulatory approval for the amendment soon.
Anixa Biosciences (NASDAQ: ANIX) has announced its strategic plan for a Phase 2 study of its breast cancer vaccine. The trial will evaluate the vaccine's efficacy in combination with chemotherapy and Keytruda in a neoadjuvant setting. This approach allows for a broader patient range and a potentially faster path to approval. The therapeutic breast cancer market is projected to reach $89.67 billion by 2030, growing at a CAGR of 12.9%.
The trial, expected to start in 2025 and last 2-3 years, will assess immunological responses and compare clinical efficacy of standard care alone versus vaccine plus standard care. Initial Phase 1 data showed no safety concerns and immune responses in most patients. Additional Phase 1 data will be presented at the SITC Annual Meeting in November 2024.
Anixa Biosciences (NASDAQ: ANIX) has announced its participation in the Ovarian Cancer Research Alliance's International Gynecologic Cancer Conference, scheduled for September 25-27, 2024. Dr. Pamela Garzone, Anixa's Chief Development Officer, will present on the company's innovative CAR-T therapy for ovarian cancer on September 25 at 3:00 PM ET. The presentation, titled "Autologous T Cells Engineered to Target Follicle Stimulating Hormone (FSH) Receptor in Recurrent Ovarian Cancer, A Phase 1 Trial," will focus on the clinical development of this novel treatment approach. This conference, organized by OCRA, the world's leading organization in the fight against ovarian cancer, provides a platform for Anixa to showcase its advancements in cancer treatment and prevention.
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