Welcome to our dedicated page for Anixa Biosciences news (Ticker: ANIX), a resource for investors and traders seeking the latest updates and insights on Anixa Biosciences stock.
Anixa Biosciences, Inc. reports biotechnology developments tied to the treatment and prevention of cancer. The company's recurring news centers on its investigational breast cancer vaccine, developed with Cleveland Clinic and based on an α-lactalbumin immune-targeting approach, and liraltagene autoleucel, or lira-cel, an FSHR-targeted CAR-T therapy for recurrent ovarian cancer.
Company updates also cover clinical-trial observations, scientific conference presentations, intellectual-property protection for vaccine technology, manufacturing arrangements for clinical materials, and management presentations describing Anixa's oncology pipeline and business model.
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.
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.