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PHILADELPHIA and VANCOUVER, British Columbia – BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT), a biotechnology firm engaged in the development of novel immunotherapies with a current market capitalization of $2.5 million, has announced new survival data from its Phase 2 study of Bria-IMT in combination with checkpoint inhibitors (CPI) for treating metastatic breast cancer (MBC). According to InvestingPro data, the company’s financial health score stands at 1.24, indicating challenging conditions as it advances its clinical programs. The results suggest an improvement over the current antibody-drug conjugate (ADC) standard of care, TRODELVY®.
In the study, 25 out of 37 patients with hormone receptor-positive (HR+) MBC treated with Bria-IMT plus CPI experienced median overall survival of 17.3 months, which is notably higher than the 14.4 months observed with TRODELVY® in a comparable patient group. For triple-negative breast cancer (TNBC) patients, who lack three specific receptors and typically have fewer treatment options, the BriaCell regimen showed comparable survival data to TRODELVY®.
Dr. William V. Williams, President and CEO of BriaCell, expressed his optimism about the survival benefit data, which appears to exceed or meet the performance of TRODELVY® in HR+ and TNBC metastatic breast cancer patients. He also noted that Bria-IMT is well-tolerated, with no related discontinuations reported to date. InvestingPro analysis reveals the company is quickly burning through cash, with negative free cash flow of $3.4 million in the last twelve months, a critical factor for investors monitoring clinical-stage biotech companies.
The Phase 2 study enrolled 54 heavily pre-treated MBC patients, with a median of six prior treatments, who received the Bria-IMT regimen plus CPI. The ongoing Phase 3 study, which uses the same formulation as the Phase 2 study, will continue to evaluate overall survival as its primary endpoint.
Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer, highlighted the significant proportion of MBC patients with HR+ and TNBC, emphasizing the limited therapeutic options and short overall survival typically associated with these conditions. The clinical data supports the potential of the Bria-IMT regimen plus CPI to meet the unmet medical needs of these patients.
BriaCell’s announcement is based on a press release statement and the company’s efforts to confirm these findings in its pivotal Phase 3 study. The company continues to develop Bria-IMT as a promising and well-tolerated therapeutic option for HR+ and TNBC MBC patients.
In other recent news, BriaCell Therapeutics Corp. announced that its Phase 3 study of Bria-IMT™ for metastatic breast cancer will continue following a positive safety review by the Data Safety Monitoring Board. This development is significant as the trial has been granted Fast Track Designation by the FDA, underscoring the urgency of developing new treatments for this challenging form of cancer. The company’s leadership expressed satisfaction with the trial’s progress, highlighting the DSMB’s recommendation as a positive indication of the treatment’s potential. Additionally, BriaCell has announced a best-efforts public offering of common shares, with ThinkEquity serving as the sole placement agent. The offering’s completion and terms depend on market conditions, and the proceeds are intended for working capital and corporate purposes. The offering will adhere to the guidelines set by the TSX Company Manual and is supported by a previously filed shelf registration statement. BriaCell has clarified that this announcement does not constitute an offer to sell securities where such actions would be unlawful. These developments reflect BriaCell’s ongoing efforts to advance its business objectives and address unmet medical needs in cancer care.
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