BriaCell Therapeutics Corp. announces that it has accepted a letter of intent from Dr. Massimo Cristofanilli, Director of Breast Medical Oncology and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties’ plans and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell’s novel immunotherapy, Bria-IMT™.
PHILADELPHIA and VANCOUVER, British Columbia, Aug. 31, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces that it has accepted a letter of intent from Dr. Massimo Cristofanilli, Director of Breast Medical Oncology and Associate Director of Precision Medicine in the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine, outlining the parties’ plans and commitment, upon regulatory approval, to initiate a Phase 2 investigator-initiated clinical study to evaluate BriaCell’s novel immunotherapy, Bria-IMT™, in combination with a check point inhibitor (CPI), in early stage, newly diagnosed, high-risk triple negative breast cancer (TNBC) patients in the neoadjuvant setting.
“We are beyond excited to work with a world class research team at Weill Cornell Medicine led by Dr. Cristofanilli,” stated Dr. Williams, BriaCell’s President & CEO. “We are grateful for this collaboration on Bria-IMT™ as a much-needed oncology treatment solution for early stage TNBC patients and will gladly support the Phase 2 clinical study by providing Bria-IMT™ and expertise.”
“Bria-IMT™ combination regimen’s recently reported clinical data shows a favorable safety and efficacy profile in heavily pre-treated advanced metastatic breast cancer patients,” Dr. Cristofanilli said. “We look forward to testing its potential impact in earlier stage high-risk TNBC patients in this setting.”
“Through this study, we anticipate furthering our understanding of the Bria-IMT™’s mechanism of action and its potential use in early stage TNBC patients,” stated Dr. Giuseppe Del Priore, BriaCell’s CMO. “Given the extremely poor survival outlook of TNBC patients, our goal remains to improve the survival and quality of life in this group of patients who are fighting this aggressive and extremely deadly disease.”
The clinical trial is designed to address the urgent and unmet need in high-risk TNBC patients who failed the current standard of care, a neoadjuvant regimen combination with check point inhibitors.
The clinical trial is designed to evaluate the safety, and efficacy of the Bria-IMT™ combination regimen with CPI in early TNBC patients who completed neoadjuvant therapy and did not achieve pathological complete remission (pCR). The primary endpoint of event-free survival (EFS) will be compared to the EFS of 55% in the historical control from Keynote 522 (Schmid et al, NEJM 2022; 386:556-567).
About TNBC
TNBC, accounts for 10-15% of all breast cancers, refers to the most invasive, fastest-growing, and fastest-spreading breast cancer at which the cancer cells don’t express estrogen, progesterone, or a protein called HER2 (i.e., test “negative” on all 3 and hence the name “triple negative”), the historical factors used in diagnosis and treatments of breast cancer. TNBC patients have fewer treatment options and tend to have a worse prognosis and survival outlook.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/.
About Weill Cornell Medicine
Since its inception on April 14, 1898, Weill Cornell Medicine has become one of the world’s leading medical institutions and clinical research centers. More information is available at https://weill.cornell.edu/.
About New York-Presbyterian Hospital
With over 200 locations of hospitals, primary and specialty care clinics and medical groups, New York-Presbyterian is one of the top United States medical institutions offering most comprehensive, integrated academic healthcare systems in Greater New York area. For more information, visit www.nyp.org.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements, including in relation to (i) the timing and completion of the Phase 2 investigator-initiated clinical study to evaluate Bria-IMT™; and (ii) the results of the Phase 2 clinical study including an understanding of the Bria-IMT™'s mechanism of action and its potential use in early stage TNBC patients, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com
Investor Relations Contact:
CORE IR
investors@briacell.com
