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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 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.
Anixa Biosciences (NASDAQ: ANIX) announced that Dr. Jose R. Conejo-Garcia, inventor of their ovarian cancer CAR-T technology, will deliver the opening keynote at the Rivkin Center-AACR 15th Biennial Ovarian Cancer Research Symposium on September 20, 2024. Dr. Conejo-Garcia will discuss Anixa's chimeric endocrine receptor-T cell (CER-T) therapy, which targets the follicle stimulating hormone receptor (FSHR) found exclusively on ovarian granulosa cells.
The presentation will cover the ongoing Phase 1 clinical trial of this technology, which has shown promising results with the treatment appearing safe and well-tolerated, and some patients exhibiting tumor necrosis. Anixa holds an exclusive worldwide license for this technology from The Wistar Institute and is developing it in partnership with Moffitt Cancer Center.
Anixa Biosciences (NASDAQ: ANIX), a biotechnology company focused on cancer treatment and prevention, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 at the Lotte New York Palace Hotel in New York City.
Key points:
- Anixa's presentation will be available on-demand to registered attendees starting September 9, 2024, at 7:00 AM Eastern Time
- A webcast of the presentation can be accessed via a provided link and on Anixa's investor relations website
- Management will participate in one-on-one meetings with investors throughout the conference
Investors interested in scheduling a meeting with Anixa's management can contact anix@crescendo-ir.com.
Anixa Biosciences (NASDAQ: ANIX) has announced a presentation on its ovarian cancer CAR-T therapy clinical trial at the International Gynecologic Cancer Society (IGCS) 2024 Annual Global Meeting in Dublin, Ireland. The presentation, titled 'Phase I Clinical Trial of Autologous T-cells Genetically Engineered with a Chimeric Receptor to Target the Follicle Stimulating Hormone Receptor (FSHR) in Recurrent Ovarian Cancer (OVCA)', will be delivered by Dr. Robert Wenham, Chair of Gynecologic Oncology at Moffitt Cancer Center, Anixa's collaboration partner. This presentation highlights Anixa's ongoing efforts in developing innovative cancer treatments, specifically focusing on their CAR-T therapy for recurrent ovarian cancer.
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.
Anixa Biosciences (NASDAQ: ANIX) announced that its collaborator, Cleveland Clinic, has received a 'Decision to Grant' notice from the Japan Patent Office for a patent application on breast cancer vaccine technology. This extends the patent protection to Japan, in addition to existing U.S. and European patents. Anixa is the exclusive worldwide licensee of this technology.
The vaccine, currently in phase one clinical trials at Cleveland Clinic, targets α-lactalbumin, a breast-specific lactation protein present in certain breast cancers but not in normal aging tissues post-lactation. By activating the immune system against this 'retired' protein, the vaccine aims to provide preemptive protection against emerging breast tumors expressing α-lactalbumin.
Anixa Biosciences (NASDAQ: ANIX), a biotechnology company focused on cancer treatment and prevention, has announced a $5 million share repurchase program. The program, authorized by the Board of Directors, allows for the repurchase of outstanding common stock over a 12-month period. Dr. Amit Kumar, Chairman and CEO, stated that this decision reflects confidence in the company's future outlook, balance sheet strength, and clinical development pipeline. He also expressed the belief that Anixa's stock is currently undervalued.
The repurchases will be made through open-market transactions in compliance with securities laws. The program can be suspended or discontinued at any time, and no shares have been repurchased to date. This initiative aims to enhance long-term shareholder value.
Anixa Biosciences has treated the sixth and final patient in the second dosage cohort of its Phase 1 clinical trial for an ovarian cancer CAR-T therapy, partnered with Moffitt Cancer Center. If no adverse effects are observed, the third dosage cohort, with a tenfold increase in dose, may commence next month. The trial focuses on evaluating the safety and efficacy of Anixa's FSHR-targeting CAR-T technology. The first cohort showed no dose-limiting toxicities, and a notable response from one patient was observed despite the subtherapeutic dose. The second cohort, receiving triple the initial dose, also reported no dose-limiting toxicities. The therapy involves intraperitoneal delivery, which potentially minimizes side effects and enhances targeting efficacy.
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.
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