Anixa Biosciences Unveils Phase 2 Study Plan for Breast Cancer Vaccine
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) ha annunciato il suo piano strategico per uno studio di Fase 2 del suo vaccino contro il cancro al seno. Il trial valuterà l'efficacia del vaccino in combinazione con la chemioterapia e Keytruda in un contesto neoadiuvante. Questo approccio permette di includere un ampio range di pazienti e una potenziale via più rapida verso l'approvazione. Si prevede che il mercato terapeutico del cancro al seno raggiunga i 89,67 miliardi di dollari entro il 2030, con una crescita del 12,9% CAGR.
Il trial, previsto per iniziare nel 2025 e durare 2-3 anni, valuterà le risposte immunologiche e confronterà l'efficacia clinica della terapia standard da sola rispetto al vaccino più la terapia standard. I dati iniziali della Fase 1 non hanno mostrato preoccupazioni di sicurezza e hanno evidenziato risposte immuni nella maggior parte dei pazienti. Ulteriori dati della Fase 1 verranno presentati al SITC Annual Meeting nel novembre 2024.
Anixa Biosciences (NASDAQ: ANIX) ha anunciado su plan estratégico para un estudio de Fase 2 de su vacuna contra el cáncer de mama. El ensayo evaluará la eficacia de la vacuna en combinación con quimioterapia y Keytruda en un entorno neoadyuvante. Este enfoque permite un rango más amplio de pacientes y un posible camino más rápido hacia la aprobación. Se proyecta que el mercado terapéutico del cáncer de mama alcance los 89,67 mil millones de dólares para 2030, creciendo a un CAGR del 12,9%.
El ensayo, que se espera inicie en 2025 y dure de 2 a 3 años, evaluará las respuestas inmunológicas y comparará la eficacia clínica del tratamiento estándar solo frente a vacuna más tratamiento estándar. Los datos iniciales de la Fase 1 no mostraron preocupaciones de seguridad y se observaron respuestas inmunológicas en la mayoría de los pacientes. Datos adicionales de la Fase 1 se presentarán en la Reunión Anual de SITC en noviembre de 2024.
아닉사 바이오사이언스( NASDAQ: ANIX)는 유방암 백신의 2상 임상시험에 대한 전략 계획을 발표했습니다. 이 시험은 네오아듀반 환경에서 화학요법 및 키트루다와 함께 백신의 효능을 평가할 것입니다. 이 접근 방식은 더 넓은 환자 범위를 허용하고 잠재적으로 승인까지의 더 빠른 경로를 제공합니다. 유방암 치료 시장은 2030년까지 896억 7천만 달러에 이를 것으로 예상되며, 연평균 성장률(CAGR)이 12.9%에 이를 것으로 보입니다.
2025년 시작될 예정인 이 시험은 2-3년 동안 지속되며 면역학적 반응을 평가하고 표준 치료 단독과 백신+표준 치료의 임상 효과를 비교합니다. 초기 1상 데이터는 안전성에 대한 우려가 없고 대부분의 환자에서 면역 반응이 나타났습니다. 추가 1상 데이터는 2024년 11월 SITC 연례 회의에서 발표될 예정입니다.
Anixa Biosciences (NASDAQ: ANIX) a annoncé son plan stratégique pour une étude de Phase 2 de son vaccin contre le cancer du sein. L'essai évaluera l'efficacité du vaccin en combinaison avec une chimiothérapie et Keytruda dans un cadre néoadjuvant. Cette approche permet d'élargir la gamme de patients et pourrait offrir un chemin plus rapide vers l'approbation. Le marché thérapeutique du cancer du sein devrait atteindre 89,67 milliards de dollars d'ici 2030, avec une croissance de 12,9 % CAGR.
L'essai, qui devrait commencer en 2025 et durer 2-3 ans, évaluera les réponses immunologiques et comparera l'efficacité clinique des soins standard seuls par rapport à ceux combinés avec le vaccin. Les données initiales de la Phase 1 n'ont montré aucun problème de sécurité et des réponses immunitaires ont été observées chez la plupart des patients. Des données supplémentaires de la Phase 1 seront présentées lors de la réunion annuelle de SITC en novembre 2024.
Anixa Biosciences (NASDAQ: ANIX) hat seinen strategischen Plan für eine Phase-2-Studie seines Impfstoffs gegen Brustkrebs angekündigt. Die Studie wird die Wirksamkeit des Impfstoffs in Kombination mit Chemotherapie und Keytruda in einem neoadjuvanten Setting bewerten. Dieser Ansatz ermöglicht eine breitere Patientenpopulation und einen potenziell schnelleren Weg zur Genehmigung. Der therapeutische Brustkrebsmarkt wird bis 2030 auf 89,67 Milliarden US-Dollar wachsen und mit einer CAGR von 12,9% wachsen.
Die Studie, die voraussichtlich 2025 beginnt und 2-3 Jahre dauert, wird immunologische Reaktionen bewerten und die klinische Wirksamkeit der Standardbehandlung allein mit der Kombination aus Impfstoff und Standardbehandlung vergleichen. Erste Daten aus der Phase 1 zeigten keine Sicherheitsbedenken und Immunreaktionen bei den meisten Patienten. Weitere Daten aus Phase 1 werden auf dem SITC Annual Meeting im November 2024 präsentiert.
- Phase 2 study plan unveiled for breast cancer vaccine
- Therapeutic approach allows for broader patient range and potentially faster approval path
- Breast cancer therapeutic market projected to reach $89.67 billion by 2030
- Initial Phase 1 data showed no safety concerns and immune responses in majority of patients
- Collaboration with Cleveland Clinic and funding from U.S. Department of Defense
- Phase 2 trial not expected to commence until 2025
- Trial projected to last approximately 2-3 years
Insights
This announcement marks a significant shift in Anixa's strategy for their breast cancer vaccine, focusing on a therapeutic approach rather than prevention. This is a smart move that could accelerate their path to market:
- The therapeutic market for breast cancer is substantial, projected to reach
$89.67 billion by 2030 with a12.9% CAGR. - Targeting treatment allows for a broader patient population, potentially expediting regulatory approval and partnerships.
- The neoadjuvant setting (pre-surgery) combined with standard therapies could demonstrate clear efficacy benefits.
The planned Phase 2 study, set to begin in 2025, will provide important data on immunological responses and clinical efficacy. If successful, this could position Anixa as a key player in the breast cancer treatment landscape. However, investors should note that the timeline to potential approval is still several years away and clinical trial outcomes remain uncertain.
The strategic shift to a therapeutic approach for Anixa's breast cancer vaccine is scientifically intriguing. Key points to consider:
- Combining the vaccine with chemotherapy and Keytruda in the neoadjuvant setting could potentially enhance tumor reduction and prevent recurrence.
- Evaluating breast cancer tissue and validating the vaccine's immunological mechanism of action will provide important insights into its efficacy.
- The broader patient inclusion criteria, covering multiple types of breast cancer, increases the potential impact of this therapy.
The positive safety profile and immune responses observed in the Phase 1 trial are encouraging. However, it's important to note that Phase 2 efficacy data will be critical in determining the vaccine's true potential. The upcoming SITC presentation in November 2024 may offer additional insights into the vaccine's performance.
Announces focus on therapeutic approach; resulting in a faster and more cost-effective path to approval
The proposed Phase 2 trial will evaluate the efficacy of the vaccine administered in the neoadjuvant (before surgery) setting, in combination with chemotherapy and Keytruda (pembrolizumab). The goal of neoadjuvant therapy is to reduce tumor burden and to prevent tumor recurrence with the intent to improve survival. This clinical trial approach allows Anixa to enroll a broader range of patients, encompassing multiple types of breast cancer. The therapeutic market for breast cancer is large due to the increase in prevalence of breast cancer and an increase in screening resulting in a demand for treatment. Compared with primary prevention, the development path for breast cancer treatment is expected to have a shorter path to approval. The therapeutic market covers all stages of breast cancer, from early to advanced and metastatic cases. In 2023, the market was valued at approximately
The key objectives of the trial include evaluating the immunological response to the vaccine and comparing clinical efficacy of standard of care therapy alone with the vaccine plus standard of care therapy. A key component of this trial will be the evaluation of breast cancer tissue and the validation of the immunological mechanism of action of the vaccine.
The trial is expected to commence in 2025 and is projected to last approximately two to three years. Immunological responses to the vaccine will be made available as the trial advances, providing a faster and more cost-effective path toward potential approval and/or partnerships with pharmaceutical companies.
"We are excited to unveil our Phase 2 study plan, bringing us one step closer to a potentially transformative therapy for breast cancer patients," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "By targeting treatment rather than prevention, we can reach a broader patient population and potentially expedite the process of regulatory approval and partnerships. This trial marks a key milestone in advancing our mission to fight cancer through innovative therapies. While our Phase 2 trial focuses on the therapeutic market, with the data obtained in this trial, we expect to conduct additional, more informed studies for both recurrence prevention and primary prevention with partners in the future."
Initial Phase 1 data was presented at the San Antonio Breast Cancer Symposium in December 2023. The data showed no safety concerns, with protocol defined immune responses observed in a majority of patients. Additional data from the Phase 1 trial will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in early November 2024.
The Phase 1 trial is conducted in collaboration with Cleveland Clinic and is funded by a grant from the
About Anixa Bioscience's Breast Cancer Vaccine
Anixa's breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in certain breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.
This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute. Cleveland Clinic exclusively licensed this technology to Anixa Biosciences. Dr. Tuohy was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.
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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