BriaCell Announces FDA-Authorized Expanded Access Policy for Metastatic Breast Cancer Patients
BriaCell Therapeutics Corp. (NASDAQ: BCTX) has announced FDA authorization of an Expanded Access Policy (EAP) for metastatic breast cancer patients. This policy allows access to BriaCell's Bria-IMT™ regimen for patients beyond the scope of their pivotal Phase 3 trial. The EAP is a condition of BriaCell's Fast Track designation and aims to help patients in need of novel treatments.
Dr. William V. Williams, BriaCell's CEO, stated that the FDA authorization highlights the safety and efficacy profile of Bria-IMT™. The company expects their novel immunotherapy to bring hope to patients suffering from this deadly disease, which remains the second leading cause of cancer death in American women.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) ha annunciato l'autorizzazione della FDA per una Politica di Accesso Espanso (EAP) per pazienti con cancro mammario metastatico. Questa politica consente l'accesso al regime Bria-IMT™ di BriaCell per pazienti al di fuori del campo del loro studio clinico di fase 3. L'EAP è una condizione della designazione Fast Track di BriaCell e mira ad aiutare i pazienti in cerca di trattamenti innovativi.
Il Dr. William V. Williams, CEO di BriaCell, ha dichiarato che l'autorizzazione della FDA mette in evidenza il profilo di sicurezza ed efficacia di Bria-IMT™. L'azienda si aspetta che la loro innovativa immunoterapia porti speranza ai pazienti affetti da questa malattia mortale, che rimane la seconda causa principale di morte per cancro nelle donne americane.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) ha anunciado la autorización de la FDA para una Política de Acceso Ampliado (EAP) para pacientes con cáncer de mama metastásico. Esta política permite el acceso al régimen Bria-IMT™ de BriaCell para pacientes fuera del alcance de su ensayo pivotal de fase 3. La EAP es una condición de la designación de Vía Rápida de BriaCell y tiene como objetivo ayudar a los pacientes que necesitan tratamientos novedosos.
El Dr. William V. Williams, CEO de BriaCell, declaró que la autorización de la FDA resalta el perfil de seguridad y eficacia de Bria-IMT™. La empresa espera que su innovadora inmunoterapia brinde esperanza a los pacientes que sufren de esta enfermedad mortal, que sigue siendo la segunda causa principal de muerte por cáncer en mujeres estadounidenses.
브리아셀 테라퓨틱스 코퍼레이션(NASDAQ: BCTX)이 전이성 유방암 환자를 위한 확장 접근 정책(EAP)에 대한 FDA 승인을 발표했습니다. 이 정책은 환자들이 주요 3상 시험의 범위를 넘어 브리아셀의 브리아-IMT™ 요법에 접근할 수 있게 합니다. EAP는 브리아셀의 신속 심사 지정의 조건이며, 새로운 치료가 필요한 환자들을 돕는 것을 목적으로 합니다.
브리아셀의 CEO인 윌리엄 V. 윌리엄스 박사는 FDA 승인이 브리아-IMT™의 안전성 및 유효성 프로필을 강조한다고 밝혔습니다. 회사는 이 치명적인 질병으로 고통받는 환자들에게 희망을 줄 혁신적인 면역 요법을 기대하고 있으며, 이는 미국 여성의 암 사망 원인 중 두 번째로 남아 있습니다.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) a annoncé l'autorisation de la FDA pour une Politique d'Accès Élargi (EAP) destinée aux patients atteints de cancer du sein métastatique. Cette politique permet l'accès au régime Bria-IMT™ de BriaCell pour les patients au-delà du cadre de leur essai pivot de phase 3. L'EAP est une condition de la désignation Fast Track de BriaCell et vise à aider les patients qui ont besoin de nouveaux traitements.
Dr. William V. Williams, PDG de BriaCell, a déclaré que l'autorisation de la FDA met en lumière le profil de sécurité et d'efficacité de Bria-IMT™. L'entreprise s'attend à ce que son immunothérapie novatrice offre de l'espoir aux patients souffrant de cette maladie mortelle, qui reste la deuxième cause de décès par cancer chez les femmes américaines.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) hat die Genehmigung der FDA für eine Erweiterte Zugangsrichtlinie (EAP) für Patienten mit metastasierendem Brustkrebs angekündigt. Diese Richtlinie ermöglicht den Zugang zu BriaCells Bria-IMT™-Regime für Patienten außerhalb des Rahmens ihrer entscheidenden Phase-3-Studie. Die EAP ist eine Bedingung für BriaCells Fast-Track-Designierung und zielt darauf ab, Patienten in Notwendigkeit neuartiger Behandlungen zu helfen.
Dr. William V. Williams, CEO von BriaCell, erklärte, dass die Genehmigung der FDA das Sicherheits- und Wirksamkeitsprofil von Bria-IMT™ hervorhebt. Das Unternehmen erwartet, dass ihre neuartige Immuntherapie Hoffnung für Patienten bringen wird, die an dieser tödlichen Krankheit leiden, die nach wie vor die zweithäufigste Todesursache durch Krebs bei amerikanischen Frauen ist.
- FDA authorization of Expanded Access Policy (EAP) for Bria-IMT™ regimen
- Potential to provide treatment option for metastatic breast cancer patients beyond Phase 3 trial
- FDA's Fast Track designation for Bria-IMT™
- Reported impressive survival and clinical benefit in patients who failed multiple prior treatments
- None.
Insights
The FDA's authorization of BriaCell's Expanded Access Policy (EAP) for Bria-IMT™ is a significant development for metastatic breast cancer patients. This move demonstrates the FDA's confidence in the safety and potential efficacy of Bria-IMT™. The EAP allows patients who don't qualify for the ongoing Phase 3 trial to access this novel immunotherapy, potentially expanding the patient pool and generating additional real-world data.
However, it's important to note that while the EAP is promising, it doesn't guarantee FDA approval. The pivotal Phase 3 trial (NCT06072612) remains important for establishing Bria-IMT™'s efficacy and safety profile. Investors should monitor the trial's progress and any interim results, as these will be key determinants of BriaCell's future success.
The authorization of the Expanded Access Policy for Bria-IMT™ is a positive development for metastatic breast cancer patients who have exhausted standard treatment options. As an immunotherapy, Bria-IMT™ represents a novel approach in breast cancer treatment, potentially offering hope to patients with alternatives.
The reported "impressive survival and clinical benefit" in heavily pretreated patients is intriguing, but we must await peer-reviewed data to fully assess its impact. If Bria-IMT™ proves effective in the Phase 3 trial, it could indeed become a new standard of care for metastatic breast cancer, addressing a significant unmet medical need in this patient population.
This FDA authorization for the Expanded Access Policy is a positive indicator for BriaCell (NASDAQ: BCTX, TSX: BCT). It potentially accelerates the path to commercialization by allowing broader patient access and data collection. The EAP could also generate additional revenue streams before full FDA approval, though this is likely to be
Investors should note that while this news is encouraging, the pivotal Phase 3 trial remains the key value driver. Positive results from this trial could significantly impact BriaCell's market valuation. However, the breast cancer treatment market is highly competitive and success is not guaranteed. Investors should closely monitor trial progress and any interim data releases for a more comprehensive assessment of BriaCell's potential.
- FDA has authorized the Expanded Access Policy (EAP) to help metastatic breast cancer patients in need for novel treatments
- Expanded access policy will provide potential lifesaving Bria-IMT™ to those cancer patients in need beyond the scope of BriaCell’s pivotal Phase 3 clinical trial.
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 18, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce U.S. FDA (FDA) authorization of an Expanded Access Policy (EAP) for metastatic breast cancer (MBC) patients.
FDA requires BriaCell to have an EAP policy, as a condition of granting BriaCell’s Fast Track designation, and to help MBC cancer patients in need of novel treatments. The EAP provides access to cancer patients beyond the scope of BriaCell’s pivotal Phase 3 trial (ClinicalTrials.gov as NCT06072612) to receive treatment with the Bria-IMT™ regimen.
“FDA authorization for the EAP highlights its awareness of the safety and efficacy profile of Bria-IMT™ and patients’ need to access such a novel treatment. While we are conducting our pivotal Phase 3 trial of Bria-IMT™ regimen with an immune checkpoint inhibitor, Bria-IMT™ may provide a treatment option for cancer patients in need,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Despite numerous approved drugs, breast cancer remains the second leading cause of cancer death in American women. With our novel immunotherapy, we expect to bring hope to patients and families suffering from this deadly disease.”
“Given the recently reported impressive survival and clinical benefit of Bria-IMT™ regimen in metastatic breast cancer patients who failed multiple prior treatments, more patients would be able to benefit from the EAP with BriaCell’s novel immunotherapy approach,” stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. “We hope that our novel immunotherapy will become a new standard of care for metastatic breast cancer patients.”
For additional information on BriaCell’s EAP program, please visit: https://briacell.com/eap/.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Further, certain forward-looking statements, including statements about the Company's belief of the therapeutic potential of Bria-IMT™ for metastatic breast cancer patients, are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Media Relations:
Jules Abraham
CORE IR
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
FAQ
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