On November 21, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that develops novel immunotherapies to transform cancer care, reported that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS, BriaCell’s personalized next generation immunotherapy (Press release, BriaCell Therapeutics, NOV 21, 2024, View Source [SID1234648542]). The study will investigate Bria-OTS alone and in combination with immune check point inhibitor tislelizumab (manufactured and supplied by BeiGene, Ltd. ) for the treatment of metastatic breast cancer. Bria-OTS is an enhanced form of Bria-IMT, currently in pivotal Phase 3 study for metastatic breast cancer.
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"Oncologists have been looking for treatments for our metastatic cancer patients who progress after treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs)," stated Sant P. Chawla, MD, FRACP, Head of the Sarcoma Oncology Center in Santa Monica, CA, and Principal Investigator for the Bria-OTS study. "We are very impressed by the survival and clinical benefit data we have seen with Bria-IMT and are looking forward to helping develop this novel platform with the goal of improving patient outcomes."
"Dosing the first patient with Bria-OTS is a significant milestone for both BriaCell and cancer patients," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "This represents a new chapter in cancer immunotherapy. This groundbreaking technology is a major advancement over prior approaches to cellular immunotherapy."
"Designed for superior efficacy and synergy with immune checkpoint inhibitors, Bria-OTS is a personalized and off-the-shelf cancer therapy," stated William V. Williams, MD, BriaCell’s President & CEO. "We are delighted that Dr. Chawla and his team of experts at the Sarcoma Oncology Center are supporting BriaCell as we bring our novel immunotherapy platform one step closer to delivering safe and effective treatment options for patients with melanoma, prostate and lung cancers."
The Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS as monotherapy and, later, in combination with tislelizumab in advanced breast cancer. Key inclusion criteria include metastatic or locally recurrent breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design will include a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with tislelizumab . Additionally, BriaCell plans to evaluate Bria-OTS+, a more advanced version of the immunotherapy platform, in prostate and other cancers.