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BriaCell Therapeutics Corp develops cellular immunotherapies for cancer treatment, with news coverage typically focusing on clinical trial results, regulatory milestones, and pipeline development updates. As a clinical-stage biotech company advancing therapies for metastatic breast cancer and other solid tumors, BriaCell generates news around patient enrollment progress, safety and efficacy data releases, and FDA interactions related to its investigational treatments.
Investors tracking BriaCell news can expect updates on several key development areas. Clinical trial announcements detail patient responses, survival data, and safety profiles from ongoing studies of the company's lead immunotherapy candidate and next-generation platform programs. Regulatory news includes FDA Fast Track designation updates, Investigational New Drug application filings for new indications, and interactions with health authorities regarding development pathways. Partnership announcements cover collaborations with academic medical centers, government research funding awards from institutions like the National Cancer Institute, and manufacturing agreements necessary for producing cellular therapy products.
Pipeline expansion news highlights BriaCell's progress in extending its platform technology beyond breast cancer into prostate, lung, and melanoma indications. The company also announces scientific presentations at major oncology conferences including the American Association for Cancer Research and Society for Immunotherapy of Cancer meetings, where clinical data and mechanistic findings are disclosed to the medical community. Manufacturing milestones represent another news category, as cellular immunotherapy development requires specialized Good Manufacturing Practice facilities and quality control achievements.
Financial news includes equity offerings, warrant exercises, and non-dilutive funding announcements that support ongoing clinical operations. Given the company's clinical-stage status, news flow tends to concentrate around data readouts from active trials and regulatory communications that impact development timelines. This news page aggregates these updates to help investors and stakeholders monitor BriaCell's progress advancing cellular immunotherapies through clinical development toward potential regulatory approval.
BriaCell Therapeutics Corp. (NASDAQ: BCTX) has presented positive Phase 2 data for its Bria-IMT™ immunotherapy in metastatic breast cancer at AACR 2025. Key highlights include:
- Clinical benefit observed in 83% of patients receiving Phase 3 formulation
- Overall survival reached 17.3 months for HR+ patients and 11.44 months for triple negative breast cancer
- 50% overall response rate for patients with intracranial metastases, with 75% clinical benefit rate
- Clinical benefit rates ranging from 45% to 100% based on subtype
The study included 54 metastatic breast cancer patients, with 37 receiving the current Phase 3 formulation. Patients were heavily pre-treated with a median of 6 prior treatments. The company also presented data on its enhanced Bria-OTS+ platform, which includes additional immune-activating factors for breast and prostate cancer programs.
BriaCell Therapeutics (Nasdaq: BCTX) has announced the pricing of a $13.8 million public offering consisting of 3,066,666 units, including 399,999 units from the full exercise of the underwriter's option. Each unit, priced at $4.50, includes one common share (or pre-funded warrant) and one warrant.
The warrants, trading under symbol 'BCTXZ' from April 25, 2025, are immediately exercisable at $5.25 per share with a five-year expiration. The offering is expected to close on April 28, 2025. ThinkEquity serves as the sole book-running manager.
The company plans to utilize the net proceeds for working capital requirements, general corporate purposes, and advancing business objectives.
BriaCell Therapeutics (Nasdaq: BCTX) has confirmed complete resolution of lung metastasis in their Phase 1/2a Bria-OTS study. The breakthrough was observed in a 78-year-old woman with hormone receptor positive (HR+) metastatic breast cancer who had previously failed multiple therapies.
The patient, enrolled on November 21, 2024, received Bria-OTS intradermal injections every 2 weeks for six weeks (4 doses), followed by dosing every 3 weeks. The treatment resulted in complete resolution of lung metastasis at 2 months, confirmed at 4 months follow-up, with stable disease maintained elsewhere.
The patient entered the study with extensive metastases in bone, lymph node, and lung. This response was achieved with the lowest dose level in the trial, demonstrating promising activity of the Bria-OTS platform as monotherapy. The Phase 1/2a dose escalation study (NCT06471673) will evaluate Bria-OTS both as monotherapy and in combination with an immune checkpoint inhibitor.
BriaCell Therapeutics (Nasdaq: BCTX) has announced four clinical data presentations at the upcoming 2025 ASCO Annual Meeting in Chicago. The presentations include three poster sessions and one publish-only abstract, all focusing on breast cancer treatments.
The presentations will showcase: 1) An update on the phase III pivotal trial of Bria-IMT combined with checkpoint inhibitor versus physician's choice in advanced metastatic breast cancer; 2) Phase I/II survival results of Bria-IMT with checkpoint inhibitor compared to benchmark trials; 3) A trial-in-progress study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer; and 4) A publish-only abstract on HLA Matching impact on clinical outcomes in Phase 2 trials.
All poster presentations are scheduled for June 2, 2025, from 9:00 AM to 12:00 PM CDT. The abstracts will be released on May 22, 2025, at 5:00 PM ET, with presentations later available on BriaCell's website.
BriaCell Therapeutics (Nasdaq: BCTX) reports accelerating enrollment in its pivotal Phase 3 clinical study for advanced metastatic breast cancer treatment. The study has enrolled over 75 patients across 54 clinical sites in 15 states, evaluating Bria-IMT plus immune checkpoint inhibitor versus physician's choice.
The company expects to complete patient enrollment by late 2025 or early 2026, with potential top-line data release in H1-2026. The study's primary endpoint compares overall survival between treatment groups, with interim analysis planned after 144 patient events. The Bria-IMT combination regimen has received FDA Fast Track designation, and positive Phase 3 results could lead to full approval and marketing authorization for metastatic breast cancer treatment.
BriaCell Therapeutics (Nasdaq: BCTX) has announced promising Phase 2 survival data for its Bria-IMT™ treatment in metastatic breast cancer patients. The study showed a median overall survival of 17.3 months in hormone receptor positive (HR+) patients, surpassing TRODELVY®'s 14.4 months in similar heavily pre-treated cases.
The Phase 2 trial included 54 patients with a median of 6 prior treatments. Of these, 37 received the current Phase 3 formulation, with 25 identified as HR+ breast cancer patients. In triple negative breast cancer (TNBC) patients, Bria-IMT showed comparable results to TRODELVY® with 11.4 months versus 11.8 months survival, both significantly higher than chemotherapy's 6.9 months.
Notably, no Bria-IMT related discontinuations have been reported in the ongoing pivotal Phase 3 study (NCT06072612), suggesting good tolerability.
BriaCell Therapeutics Corp (Nasdaq: BCTX, BCTXW) and its subsidiary BriaPro have announced the development of novel antibodies targeting B7-H3, a significant cancer antigen and immune checkpoint molecule. The technology, for which US patent applications have been filed, aims to create antibody-drug conjugates, T cell engagers, and targeted immune checkpoint inhibitors.
B7-H3 is highly expressed on both tumor and immune cells, making it an ideal target for cancer treatment. The protein is overexpressed in various solid tumors, including prostate, lung, breast, pancreatic, and ovarian cancers, while showing expression in normal tissues. BriaPro plans to incorporate these antibodies into its Bria-TILsRx™ platform, designed to redirect and activate T cells within the tumor microenvironment.
BriaCell Therapeutics (Nasdaq: BCTX) has announced its upcoming presentation of three posters at the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago from April 25-30.
The presentations include: 1) Results from Bria-ABC1 versus physician choice in late-stage MBC with biomarker correlates from the randomized registration trial; 2) Survival outcomes from a randomized phase 2 trial of Bria-IMT, an allogeneic whole cell cancer vaccine; and 3) Findings on Bria-OTS+, described as a versatile therapeutic platform for inducing anti-cancer immunity.
The posters will be presented across different sessions focusing on clinical research, Phase II/III trials, and immunology. Following the presentations, the posters will be made available on BriaCell's website.
BriaCell Therapeutics (Nasdaq: BCTX) received a positive recommendation from the Data Safety Monitoring Board (DSMB) for its pivotal Phase 3 study of Bria-IMT™ plus immune checkpoint inhibitor in metastatic breast cancer. The DSMB, an independent expert group, completed its second safety data review and found no safety concerns, recommending the continuation of the ongoing study without modifications.
The study is being conducted under Fast Track Designation from the FDA. The company's management expressed satisfaction with the safety and tolerability profile of the Bria-IMT plus immune checkpoint inhibitor combination therapy, viewing the DSMB's recommendation as an encouraging sign for their novel immunotherapy approach to treating metastatic breast cancer.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) held its annual general meeting on February 5, 2025, for the fiscal year ended July 31, 2024. The meeting saw a 36.26% participation rate of issued and outstanding common shares. Shareholders strongly supported all proposed resolutions, including the re-appointment of MNP LLP as auditors and the election of board directors.
The elected board members, all receiving over 86% approval, include Dr. William V. Williams (88.42%), Mr. Jamieson Bondarenko (86.57%), Dr. Jane A. Gross (88.37%), Dr. Rebecca Taub (88.44%), Mr. Vaughn C. Embro-Pantalony (88.05%), and Mr. Martin E. Schmieg (87.99%).