Dr. William Williams reports

BRIACELL ACCEPTS LETTER OF INTENT FROM WEILL CORNELL MEDICINE OUTLINING PLANS TO INITIATE A CLINICAL TRIAL OF BRIA-IMT IN HIGH-RISK EARLY-STAGE TRIPLE NEGATIVE BREAST CANCER

Briacell Therapeutics Corp. 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 checkpoint 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. William Williams, Briacell's president and chief executive officer. "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 favourable safety and efficacy profile in heavily pretreated 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 chief medical officer. "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 checkpoint 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 end point of event-free survival (EFS) will be compared with the EFS of 55 per cent in the historical control from Keynote 522 (Schmid et al., NEJM 2022; 386: 556 to 567).

About TNBC

TNBC accounts for 10 per cent to 15 per cent of all breast cancers and refers to the most invasive, fastest-growing and fastest-spreading breast cancer at which the cancer cells do not express estrogen, progesterone or a protein called HER2 (testing negative on all three 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.

We seek Safe Harbor.