BriaCell(US:BCTX)2022-10-27 16:00Breast Cancer Statistics and Market Overview - In 2022, approximately 287,500 women in the U.S. were diagnosed with breast cancer, with over 43,000 projected deaths[15]. - About 12.9% of women will be diagnosed with breast cancer in their lifetime, with 81% of cases presenting as invasive breast cancer[17]. - The global market for cancer drugs is expected to reach nearly $269 billion by the end of 2025, growing at a CAGR of 10% from 2021 to 2025[16]. - The market for breast cancer drugs is a multibillion-dollar market, indicating a shortage of safe and effective treatments[26]. - The estimated 5-year survival rate for patients with metastatic breast cancer (MBC) at diagnosis is 27%[18]. - The company estimates that approximately 150,000 women in the U.S. are living with MBC, with 34,000 patients available for treatment based on HLA allele matching[27]. Treatment Efficacy and Clinical Trials - Current therapeutic options for breast cancer show response rates ranging from 6.9% to 59%, highlighting the opportunity for Bria-IMT™[29]. - The best response to Bria-IMT™ is observed in patients with 2+ HLA allele matches, which constitutes approximately 15-35% of cases[22]. - The median overall survival for patients with de novo stage IV MBC is 39.2 months, while for relapsed disease it is 27.2 months[18]. - The company proposes that Bria-IMT™ will target patients with MBC who have failed at least two lines of therapy[18]. - In a study, 241 out of 331 patients (72%) treated with trastuzumab progressed within 27 months, indicating a median survival of 13-14 months, highlighting the unmet need for effective therapies[34]. - The combination of PANVAC with docetaxel increased median progression-free survival (PFS) from 3.9 months to 7.9 months, supporting further clinical trials[35]. - The overall response rate (ORR) for docetaxel monotherapy at 100 mg/m2 was 36.0%, with a median overall survival (OS) of 12.3 months[30]. - The ORR for trastuzumab combined with paclitaxel was reported at 59%, with a median OS of 12.2 months[30]. - The ORR for ABI-007 (Nab paclitaxel) was 33%, with a median OS of 65 weeks[30]. - The median time to tumor progression was 144 days (range 64 – 223 days), with overall survival exceeding 33 months for most patients[48]. - The Bria-IMT™ regimen elicited cellular immune responses in 85% of evaluated patients and antibody responses in 58%[48]. - The median progression-free survival (PFS) was 5.7 months for monotherapy and 6.9 months for combination therapy[109]. - The median overall survival (OS) for the combined monotherapy and combination therapy was 12.5 months[110]. - Seventy percent of patients who developed an immune response showed disease control, particularly in those with moderately-well differentiated tumors[109]. Immunotherapy Developments - Bria-IMT™ has shown potential to induce long-term remission in metastatic breast cancer (MBC) patients, especially when combined with immunotherapies[30]. - Bria-IMT™ is currently undergoing a Phase I/IIa clinical trial in combination with immune checkpoint inhibitors, including pembrolizumab and retifanlimab[39]. - A new Phase I/IIa study (BRI-ROL-001) is evaluating the combination of Bria-IMT™ with KEYTRUDA®, with 11 patients treated and a median of 3 cycles administered[54]. - The combination of Bria-IMT™ with immune system activators aims to enhance the immune response against breast cancer cells[58]. - The collaboration with Incyte Corporation will explore the combination of Bria-IMT™ with INCMGA00012 and epacadostat, shifting from the previous KEYTRUDA® combination[56]. - BriaCell achieved proof of concept for Bria-IMT™ in advanced breast cancer patients, showing that patients with specific HLA molecules had a higher likelihood of tumor regression[40]. - The company is developing Bria-OTS™, a personalized off-the-shelf immunotherapy, to cover over 99% of the breast cancer patient population using genetically engineered cell lines[60]. - BriaDx™, a diagnostic test, is being developed to identify patients most likely to respond to Bria-IMT™, focusing on HLA typing and specific biomarkers[62]. Financial Overview and Research Costs - For the year ended July 31, 2022, research costs amounted to $8,021,489, an increase from $2,020,899 for the year ended July 31, 2021, attributed to the recommencement of clinical trials and increased lab activity[98]. - For the year ended July 31, 2022, the company incurred $7,585,926 in net research and development expenses, a significant increase from $1,315,496 in the previous year[131]. - BriaCell incurred net losses of $26,838,903 and $13,816,200 in the fiscal years ended 2022 and 2021, respectively[195]. Regulatory and Market Strategy - The FDA approved the combination study of Bria-IMT™ with immune checkpoint inhibitors in advanced breast cancer, marking a significant step in the company's clinical research efforts[95]. - The FDA has granted "Fast Track" status to Bria-IMT™ for the treatment of metastatic breast cancer, facilitating potential accelerated approval[112]. - The company must navigate extensive regulatory requirements, which require substantial time and financial resources for product approval[138]. - The FDA review process for a Biologics License Application (BLA) typically aims for a ten-month review period, or six months for serious unmet medical needs[149]. - Fast Track designation allows for rolling review of a BLA, potentially reducing the review period to six months if priority review is granted[153]. - Under the Accelerated Approval program, the FDA may approve a BLA based on surrogate endpoints, requiring post-marketing studies to verify clinical benefits[154]. - The company anticipates needing additional capital for ongoing research and development, which may dilute current shareholder holdings[212]. - The company is heavily reliant on third-party manufacturers for product development and marketing, with no in-house capabilities expected[201]. - The company lacks internal marketing capabilities and plans to establish strategic partnerships for marketing and distribution[203]. Clinical Trial Management and Partnerships - BriaCell has added multiple clinical trial sites, including Mayo Clinic and Hoag Memorial Hospital, to enhance patient enrollment for its studies[181][192]. - The partnership with Caris Life Sciences aims to accelerate patient enrollment in clinical trials through efficient patient identification[190][191]. - The company entered into a Cooperative Research and Development Agreement with the U.S. Department of Health and Human Services, providing funding of $433,400 over three years for preclinical studies[90]. - The company has entered into a License Agreement with Faller-Williams Technology, which includes milestone payments totaling up to $30 million upon FDA approvals[118]. - The company is developing multi-specific binding reagents designed to activate the immune system against cancer cells, with a focus on reducing toxicity compared to current therapies[89].