BriaCell Announces Positive Pre-IND Meeting with FDA for Bria-PROS+™ for Prostate Cancer
BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) has received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with the FDA for Bria-PROS+™, its personalized off-the-shelf immunotherapy for advanced prostate cancer. The FDA has waived the requirement for animal toxicology and pharmacokinetic studies, simplifying the development pathway. This feedback provides a clear path towards filing an IND and conducting a Phase 1/2 study of Bria-PROS+™. The company views this as a major step in developing a potential novel approach for prostate cancer, which remains the second-leading cause of cancer death in American men. These interactions also inform the development of BriaCell's proprietary Bria-OTS+™ platform for other cancers.
BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) ha ricevuto feedback positivo dal suo incontro Pre-Investigational New Drug Application (Pre-IND) con la FDA riguardo a Bria-PROS+™, la sua immunoterapia personalizzata pronta all'uso per il cancro prostatico avanzato. La FDA ha esentato il requisito per studi di tossicologia animale e farmacocinetici, semplificando il percorso di sviluppo. Questo feedback offre una chiara via per presentare un IND e condurre uno studio Fase 1/2 di Bria-PROS+™. L'azienda considera questo un passo fondamentale nello sviluppo di un potenziale approccio innovativo per il cancro alla prostata, che rimane la seconda causa principale di morte per cancro negli uomini americani. Queste interazioni informano anche lo sviluppo della piattaforma proprietaria di BriaCell, Bria-OTS+™, per altri tumori.
BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) ha recibido comentarios positivos de su reunión Pre-Investigational New Drug Application (Pre-IND) con la FDA sobre Bria-PROS+™, su inmunoterapia personalizada lista para usar para el cáncer de próstata avanzado. La FDA ha eximido el requisito de estudios de toxicología animal y farmacocinéticos, simplificando así el proceso de desarrollo. Este feedback proporciona un camino claro para presentar un IND y llevar a cabo un estudio de Fase 1/2 de Bria-PROS+™. La compañía ve esto como un paso importante en el desarrollo de un enfoque potencialmente novedoso para el cáncer de próstata, que sigue siendo la segunda causa principal de muerte por cáncer en hombres estadounidenses. Estas interacciones también informan sobre el desarrollo de la plataforma propietaria BriaCell, Bria-OTS+™, para otros tipos de cáncer.
브리아셀 제약 회사 (NASDAQ: BCTX, TSX: BCT)는 Bria-PROS+™의 FDA와의 Pre-Investigational New Drug Application (Pre-IND) 회의에서 긍정적인 피드백을 받았습니다. Bria-PROS+™는 고급 전립선암을 위한 맞춤형 면역 요법입니다. FDA는 동물 독성 및 약물 동태 연구에 대한 요구 사항을 면제하여 개발 경로를 간소화했습니다. 이 피드백은 IND 제출 및 Bria-PROS+™의 1/2상 연구를 수행하는 명확한 경로를 제공합니다. 회사는 이를 남성 미국인에서 암 사망의 두 번째 주요 원인인 전립선암을 위한 잠재적인 새로운 접근 방식을 개발하는 데 있어 중요한 단계로 보고 있습니다. 이러한 상호작용은 브리아셀의 Proprietary Bria-OTS+™ 플랫폼의 다른 암에 대한 개발에도 정보를 제공합니다.
BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) a reçu des retours positifs lors de sa réunion Pre-Investigational New Drug Application (Pre-IND) avec la FDA concernant Bria-PROS+™, son immunothérapie personnalisée prête à l'emploi pour le cancer de la prostate avancé. La FDA a exempté de l'obligation d'études de toxicologie animale et de pharmacocinétique, simplifiant ainsi le parcours de développement. Ce retour offre un chemin clair pour déposer un IND et mener une étude de Phase 1/2 de Bria-PROS+™. L'entreprise considère cela comme une étape majeure dans le développement d'une approche potentiellement nouvelle pour le cancer de la prostate, qui reste la deuxième cause de décès par cancer chez les hommes américains. Ces interactions informent également le développement de la plateforme propre à BriaCell, Bria-OTS+™, pour d'autres cancers.
Die BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) hat positive Rückmeldungen von ihrem Pre-Investigational New Drug Application (Pre-IND) Meeting mit der FDA zu Bria-PROS+™, ihrer personalisierten, gebrauchsfertigen Immuntherapie für fortgeschrittenen Prostatakrebs, erhalten. Die FDA hat die Anforderung für tierische Toxikologie- und Pharmakokinetikstudien aufgehoben, was den Entwicklungsweg vereinfacht. Dieses Feedback bietet einen klaren Weg zur Einreichung eines IND und zur Durchführung einer Phase 1/2-Studie von Bria-PROS+™. Das Unternehmen betrachtet dies als einen bedeutenden Schritt zur Entwicklung eines potenziell neuartigen Ansatzes für Prostatakrebs, der nach wie vor die zweitgrößte Todesursache durch Krebs bei amerikanischen Männern ist. Diese Interaktionen informieren auch über die Entwicklung von BriaCells proprietärer Plattform Bria-OTS+™ für andere Krebserkrankungen.
- FDA waived animal toxicology and pharmacokinetic studies requirement, simplifying development pathway
- Clear path towards filing an IND and conducting Phase 1/2 study for Bria-PROS+™
- Positive feedback from FDA indicates potential for novel personalized approach in advanced prostate cancer treatment
- None.
This Pre-IND meeting outcome is a significant milestone for BriaCell's Bria-PROS+™ immunotherapy. The FDA's waiver of animal studies requirements streamlines the path to clinical trials, potentially accelerating the development timeline. This is particularly noteworthy given prostate cancer's high mortality rate.
The positive feedback suggests that the FDA sees promise in BriaCell's personalized off-the-shelf approach. If successful, Bria-PROS+™ could address a critical need in advanced prostate cancer treatment, where current therapies often fall short. The potential impact extends beyond prostate cancer, as this platform technology could be applied to other hard-to-treat cancers like breast, lung and melanoma.
Investors should note that while this news is encouraging, it's still early in the development process. The true test will come with human clinical trials, which are yet to begin.
BriaCell's positive Pre-IND meeting outcome is a strategic win, potentially saving
The company's multi-cancer platform approach with Bria-OTS+™ is noteworthy. Success in prostate cancer could catalyze rapid expansion into other indications, significantly expanding BriaCell's market potential. However, investors should be cautious: while the FDA's feedback is positive, it doesn't guarantee clinical or commercial success.
Financial implications are twofold: reduced near-term R&D expenses due to streamlined development, but potential increased capital needs to fund accelerated clinical programs. BriaCell's ability to leverage this regulatory win into partnerships or funding could be key to realizing the full potential of their platform.
- BriaCell has received positive feedback from its Pre-Investigational New Drug Application (Pre-IND) meeting with FDA for Bria-PROS+™ in prostate cancer
- The meeting provides a clear path towards filing an IND and conducting a Phase 1/2 study of Bria-PROS+™
PHILADELPHIA and VANCOUVER, British Columbia, Sept. 10, 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 that it has received positive feedback from its Pre-IND meeting with the U.S. Food and Drug Administration (FDA), which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+™, in advanced prostate cancer.
“We were truly impressed by the FDA team of experts’ keen interest in Bria-PROS+™ as a potential novel personalized approach for advanced prostate cancer,” stated Dr. William V. Williams, BriaCell’s President and CEO. “Despite numerous approved drugs, prostate cancer remains the second-leading cause of cancer death in American men. We view the FDA’s positive feedback as a major step forward in the clinical development of our Bria-PROS+™ and in our efforts to bring hope to patients and families suffering from this deadly disease.”
As a result of the Pre-IND meeting, FDA waived the animal toxicology and animal pharmacokinetic (PK) studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+™. Other areas of discussion included BriaCell’s plan to initiate the Phase 1/2 study pending completion of standard manufacturing and testing requirements. These interactions also inform the further development of the proprietary Bria-OTS+™ platform as the company pursues the development of Bria-BRES+™, Bria-LUNG+™ and Bria-MEL+™, for breast cancer, lung cancer and melanoma, respectively.
BriaCell is currently evaluating its personalized immunotherapy Bria-BRES™ in a phase 1/2a study in metastatic breast cancer (ClinicalTrials.gov NCT06471673).
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. Forward-looking statements, including statements about the Company's belief of the therapeutic potential of Bria-PROS+™’s as a safe and effective treatment for prostate cancer patients, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements 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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