Briacell Therapeutics Corp Stock Price, News & Analysis

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, BCTXW; TSX: BCT) has successfully closed its previously announced best-efforts offering, raising approximately $8.5 million in gross proceeds. The clinical-stage biotechnology company, focused on developing novel immunotherapies for cancer care, sold 12,325,000 common shares at $0.69 per share. ThinkEquity acted as the sole placement agent for this at-the-market offering under Nasdaq rules.

The company plans to use the net proceeds for working capital requirements, general corporate purposes, and advancing business objectives. The securities were offered through BriaCell's effective shelf registration statement on Form S-3, with a prospectus supplement and prospectus filed with the SEC.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) has announced the pricing of a $8.5 million offering of 12,325,000 common shares or pre-funded warrants at $0.69 per share. The offering, priced at-the-market under Nasdaq rules, is expected to close on September 12, 2024. ThinkEquity is acting as the sole placement agent. BriaCell intends to use the net proceeds for working capital requirements, general corporate purposes, and advancing business objectives. The offering is made pursuant to a shelf registration statement on Form S-3 filed with the SEC. BriaCell is a clinical-stage biotechnology company developing novel immunotherapies for cancer care.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) has reported positive overall survival data from its Phase 2 clinical study of Bria-IMT™ in combination with an immune checkpoint inhibitor for late-stage metastatic breast cancer. The study showed a median overall survival of 15.6 months in patients treated since 2022, compared to 6.7-9.3 months reported in literature for similar patients. This represents a significant improvement over the previously reported 13.4 months median overall survival in December 2023.

The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients, with an average of 6 prior treatments. The Bria-IMT™ regimen showed no drug-related discontinuations to date. BriaCell is currently conducting a Phase 3 pivotal study using the same Bria-IMT™ formulation in metastatic breast cancer patients.

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, BCTXW; TSX: BCT), a clinical-stage biotechnology company focused on novel immunotherapies for cancer care, has announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. The event will take place from November 6-10, 2024, in Houston, TX.

The presentation is scheduled for Friday, November 8, 2024, from 9:00 am to 7:00 pm CST at the George R. Brown Convention Center. BriaCell's Chief Scientific Officer, Dr. Miguel Lopez-Lago, expressed excitement about presenting their data at this prestigious conference. The company aims to continue investigating novel targeted immunotherapy candidates for breast and prostate cancer patients. After the presentation, the poster will be available on BriaCell's website.

BriaCell Therapeutics Corp. (Nasdaq: BCTX) reports significant progress in its Phase 2 study of the Bria-IMT™ regimen for metastatic breast cancer. A patient with ADC-resistant cancer showed a 9.1-month progression-free survival (PFS), quadrupling the PFS of similar studies. This patient, who had failed 8 prior treatments, experienced a marked reduction in tumor size, including the disappearance of a temporal lobe lesion.

The company's President and CEO, Dr. William V. Williams, expressed optimism about replicating these results in their ongoing Phase 3 study. Dr. Giuseppe Del Priore, Chief Medical Officer, highlighted the treatment's favorable safety and tolerability profile. This development represents a potential breakthrough in treating metastatic breast cancer, an area with significant unmet medical needs.

BriaCell Therapeutics presented promising clinical efficacy data for its lead candidate, Bria-IMT™, at the ASCO 2024 meeting. The therapy showed a significant increase in Progression-Free Survival (PFS) and Clinical Benefit Rate (CBR) compared to historical treatments. The therapy was well-tolerated with no related discontinuations. The Phase 2 study included 54 heavily pretreated metastatic breast cancer patients, showing a median PFS of 4.1 months, nearly double the rate of similar studies. Dr. Saranya Chumsri and Dr. Carmen Calfa highlighted the potential for Bria-IMT™ to address unmet medical needs in advanced breast cancer. Further, BriaCell's pivotal Phase 3 study will compare Bria-IMT™ with Treatment of Physician's Choice (TPC).

BriaCell Therapeutics (NASDAQ: BCTX, BCTXW; TSX: BCT), a clinical-stage biotechnology company, has initiated a first-in-human Phase 1/2 study for its immunotherapy, Bria-OTS™, targeting advanced metastatic breast cancer. The study aims to evaluate the safety and efficacy of Bria-OTS™ both as a monotherapy and in combination with the PD-1 inhibitor tislelizumab. This milestone follows the successful completion of Institutional Review Board (IRB) and Clinical Trial Site Agreement (CTA) processes, along with FDA authorization for Investigational New Drug (IND) filings. BriaCell's leadership believes the personalized approach of Bria-OTS™ could lead to more potent and durable responses, potentially improving patients' quality of life and extending survival. The treatment's off-the-shelf nature is expected to provide rapid therapeutic intervention, important for patients with advanced metastatic breast cancer.