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BriaCell Therapeutics Corp is an immuno-oncology-focused biotechnology company based in Los Angeles. They specialize in developing targeted and safe immunotherapy approaches for cancer management, with a current focus on breast cancer. The company has seen success with their patented 'BriaVax' vaccine in FDA Phase I studies, showing promising results. BriaCell is gearing up for a Phase I/II study to broaden the application of their vaccine technology. They are also working on Bria-OTS, personalized immunotherapy for advanced-stage breast cancer.
BriaCell Therapeutics (NASDAQ: BCTX) has initiated dosing in its Phase 1/2 study of Bria-OTS™, a personalized next-generation immunotherapy for metastatic breast cancer. The study will evaluate Bria-OTS™ both as a standalone treatment and in combination with BeiGene's tislelizumab®. This therapy is an enhanced version of Bria-IMT™, which is currently in Phase 3 trials. The clinical trial targets patients with metastatic or locally recurrent breast cancer who have failed at least two prior systemic therapies. The company also plans to evaluate Bria-OTS+™, an advanced version, for prostate and other cancers.
BriaCell Therapeutics presented preclinical data showing strong anti-cancer activity of its next-generation immunotherapies, Bria-BRES+™ and Bria-PROS+™, at the 2024 SITC Conference. Both candidates effectively activated key components of the innate immune system and demonstrated ability to destroy breast and prostate cancer cells in preclinical models. The therapies are part of the Bria-OTS+™ platform, which represents an advancement in personalized, off-the-shelf cell-based immunotherapy. The company is currently conducting a Phase 1/2 study of first-generation Bria-OTS™ in metastatic breast cancer, with next-generation products expected to enter clinical trials in 1H2025.
BriaCell Therapeutics (Nasdaq: BCTX) announces five poster presentations, including a Spotlight poster, at the 2024 San Antonio Breast Cancer Symposium®. The presentations will showcase updated survival data and key biomarker findings from their Phase 2 trial of Bria-IMT™ plus immune checkpoint inhibitor in metastatic breast cancer. The presentations will also detail their planned Phase 3 study design for expanding Bria-IMT™ + CPI treatment to cancer patients with central nervous system metastases. The symposium will be held December 10-13, 2024, in San Antonio, Texas.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) reports positive survival data from its Phase 2 metastatic breast cancer (MBC) study. 55% of patients treated with Bria-IMT™ remained alive one year after enrollment, surpassing the survival rate of current standard care. The study included heavily pre-treated patients who had failed previous therapies, including checkpoint inhibitors and antibody-drug conjugates.
Notable outcomes include:
- Patient with 25 months overall survival (OS) after failing 6 prior treatments
- Patient with 24 months OS and stable disease
- Patient with 15 months OS after 7 prior therapy lines
- Patient with 14 months OS and 100% resolution of brain metastasis
BriaCell Therapeutics Corp. (NASDAQ: BCTX, TSX: BCT) has provided an update on its pivotal Phase 3 study of Bria-IMT™ in combination with an immune checkpoint inhibitor for metastatic breast cancer (MBC). Key points include:
- 35 clinical sites are actively enrolling patients
- The study will enroll up to 354 patients
- Primary endpoint is overall survival (OS)
- Interim data analysis planned at 144 events (deaths)
- Patient enrollment completion expected by mid-2025
- No serious adverse events related to Bria-IMT™ reported to date
Positive results could lead to full approval and marketing authorization for Bria-IMT™ in MBC patients. The Bria-IMT™ combination regimen has received FDA Fast Track designation.
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) has closed its previously announced best-efforts offering of 5,128,500 common shares and warrants. The offering was priced at $0.975 per share and associated warrant, at-the-market under Nasdaq rules. The warrants have an exercise price of $0.85 per share and are immediately exercisable for five years. The offering raised approximately $5 million in gross proceeds.
The company plans to use the net proceeds for working capital requirements, general corporate purposes, and advancing business objectives. ThinkEquity acted as the sole placement agent for the offering. The securities were offered under 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 a $5 million offering of 5,128,500 common shares and warrants. The offering is priced at $0.975 per share and associated warrant, at-the-market under Nasdaq rules. The warrants have an exercise price of $0.85 per share and will be immediately exercisable for five years upon issuance.
The offering is expected to close on October 2, 2024, subject to customary closing conditions. 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 Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) reports remarkable results from its Phase 2 study of Bria-IMT™ plus an immune checkpoint inhibitor regimen in metastatic breast cancer. A heavily pre-treated patient, who had failed 8 prior regimens including ADC therapy, showed complete resolution of right temporal lobe brain metastasis and significant reduction of an 'Eye-Bulging' orbital tumor.
Key highlights:
- 100% resolution of brain metastasis after 8 and 11 months of treatment
- Sustained drop in tumor markers
- Patient has completed 17 treatment cycles over 12 months
- Near-complete resolution of breast cancer tumor in the right orbit
Dr. William V. Williams, BriaCell's CEO, stated that these findings could transform treatment for metastatic breast cancer patients with brain metastasis. The company is now evaluating this patient subgroup in their ongoing pivotal Phase 3 study.
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.
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