A significant medical breakthrough is needed in the fight against metastatic breast cancer. According to the American Cancer Society, more than 3.1 million women in the United States have a history of invasive breast cancer. However, there’s hope for treatment, with companies like BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) seeing positive clinical data from Bria-IMT, a targeted immunotherapy being developed for the treatment of advanced breast cancer. “Our data highlights the potential clinical value of the Bria-MT™ regimen in patients with advanced metastatic breast cancer after receiving multiple prior therapies.” Said Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, Principal Clinical Investigator, and co-author of the study of Bria-IMT™ in combination with PD-1 inhibitors pembrolizumab and retifanlimab. “These results are promising and the fact that patients have had a great quality of life thus far is remarkable. We are hopeful that this novel immunotherapy proves to be an effective therapy for our patients.”
Other top companies fighting for the treatment of metastatic breast cancer include:
Eli Lilly (NYSE: LLY), Puma Biotechnology (NASDAQ: PBYI), Gilead Sciences (NASDAQ: GILD), and ImmunoGen (NASDAQ: IMGN).
Look at BriaCell Therapeutics (NASDAQ: BCTX), BCTXW) (TSX: BCT), For Example
BriaCell Therapeutics Corp., a clinical-stage immunotherapy company driven to fight cancer and improve patients’ lives, announces that it has received approval from FDA on its pivotal registrational study design for Bria-IMT™ in combination with a checkpoint inhibitor in advanced metastatic breast cancer.
FDA has approved the study design, the primary and secondary endpoints, and patient population in BriaCell’s upcoming pivotal registration clinical study. The study will include advanced metastatic breast cancer patients who have exhausted all other treatment options.
The trial will be a randomized, open-label study comparing the Bria-IMT™ combination regimen with an immune check point inhibitor in one arm with treatment of physicians’ choice in another arm in advanced metastatic breast cancer. A third smaller arm with the Bria-IMT™ regimen alone will be included in the study to address FDA’s combination drug assessment requirements. Upon achieving statistically significant milestones, BriaCell may apply for full approval of the Bria-IMT™ combination regimen following the Biologics Licensing Application (BLA) filing process.
“FDA approval of our study design represents a major milestone towards our goal of making a huge impact in the lives of advanced metastatic breast cancer patients who have failed currently approved therapies,” stated Dr. William V. Williams, BriaCell’s President and CEO.
“We are extremely grateful that the FDA Office of Oncologic Diseases has approved our strategy and has provided us with a route to accelerate the development of our novel immunotherapy in this difficult-to-treat patient population. A successful study may significantly transform the approach to treat advanced breast cancer,” added Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. “We are working closely with FDA to further accelerate the development of our lead candidate and eventual market authorization.”
Patient recruitment and dosing will commence in summer 2023.
Other related developments from around the markets include:
Eli Lilly and DICE Therapeutics announced a definitive agreement for Lilly to acquire DICE. DICE is a biopharmaceutical company that leverages its proprietary DELSCAPE technology platform to develop novel oral therapeutic candidates, including oral IL-17 inhibitors currently in clinical development, to treat chronic diseases in immunology. "In combination with its novel technology and expertise in drug discovery, DICE's talented workforce and passion for innovation will enhance our efforts to make life better for people living with devastating autoimmune diseases," said Patrik Jonsson, executive vice president, president of Lilly Immunology and Lilly USA, chief customer officer. "We welcome DICE colleagues to Lillyand, together, we can tackle the challenges ahead in finding new treatments for patients with significant unmet medical needs."
Puma Biotechnology announced financial results for the first quarter ended March 31, 2023. Unless otherwise stated, all comparisons are for the first quarter of 2023 compared to the first quarter of 2022. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net in the first quarter of 2023 was $46.8 million, compared to product revenue, net of $40.7 million in the first quarter of 2022. Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $1.4 million, or $0.03 per basic and diluted share, for the first quarter of 2023, compared to net loss of $3.4 million, or $0.08 per share, for the first quarter of 2022.
Gilead Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Trodelvy® (sacituzumab govitecan) as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. The final European Commission decision on the additional indication for Trodelvy is anticipated later in 2023. "This positive opinion from the Committee confirms the clinical benefit and value of sacituzumab govitecan in pre-treated HR+/HER2- metastatic breast cancer and is a positive step toward bringing this treatment option to patients in Europe," said Dr. Javier Cortes, Head of the International Breast Cancer Center, in Madrid and Barcelona, Spain. "Too many people living with pre-treated HR+/HER2- metastatic breast cancer are without treatment options after their cancer progresses, and this positive opinion is a significant step forward for patients and their loved ones across Europe."
ImmunoGen announced detailed results from the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE® compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC). "I am thrilled to share these impressive results from the confirmatory MIRASOL trial at ASCO, which further demonstrate the potential of ELAHERE to become the new standard of care for patients with FRα-positive PROC," said Kathleen Moore, Associate Director of Clinical Research and Director of the Oklahoma TSET/Sarah Cannon Phase I Program, Professor of the Section of Gynecologic Oncology at The University of Oklahoma and MIRASOL Principal Investigator. "As we saw in the top-line data announced last month, ELAHERE demonstrated an improvement versus chemotherapy across all efficacy endpoints and, importantly, is the first treatment to show an overall survival benefit in this patient population. The 33% reduction in the risk of death, along with the differentiated and well-characterized safety profile seen in MIRASOL, reinforce the potential of ELAHERE to serve as a transformative option for ovarian cancer patients and change how this disease is treated."
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