BriaCell showcases clinical data on Bria-IMT at AACR 2024

BriaCell Therapeutics is presenting clinical data from its lead product candidate, Bria-IMT, in two posters of its three poster sessions during the 2024 American Association for Cancer Research Annual Meeting held from April 5-10 at San Diego Convention Center, San Diego, CA. Poster 1 – Title: Efficacy of Bria-IMT regimen in inducing CNS metastasis regression: Superior clinical benefit of Bria-IMT regimen – alone or combined with an immune check point inhibitor in advanced breast cancer patients with CNS metastatic disease: Clinical efficacy: 71% intracranial objective response rate, defined as the percentage of patients who achieve a complete response or partial response in intracranial tumors, achieved in patients with central nervous system metastases treated with the Bria-IMT regimen, either alone or in combination with an immune checkpoint inhibitor. These patients failed multiple prior treatments including 2 antibody-drug conjugates in one case. Clinical benefit is observed across all subsets of breast cancer. Safety profile: Absence of both interstitial lung disease, a common serious adverse event with ADCs, and no Bria-IMT-related treatment discontinuations underscore Bria-IMT’s excellent tolerability and favorable safety profile. In summary, Bria-IMT’s tumor reductions observed in all breast cancer subtypes in patients with intracranial disease underlines its potential clinical effectiveness in managing CNS metastatic disease in advanced breast cancer. BriaCell will continue to monitor the data in this subgroup of patients including a pre-planned subgroup analysis in the current pivotal Phase 3 study in advanced metastatic breast cancer. Treatment of patients with CNS metastatic disease represents a potential additional indication for market approval of Bria-IMT. Poster 2 – Title: Efficacy and safety of SV-BR-1-GM after progression on ADC in metastatic breast cancer patients: Notable progression-free survival benefit of Bria-IMT in ADC resistant advanced metastatic breast cancer: Phase 2 clinical data of the Bria-IMT regimen in 23 advanced metastatic breast cancer patients who failed multiple prior treatments including ADCs and CPIs are presented. Progression-free Survival Benefit: Median progression free survival, defined as the length of time during which a patient’s cancer does not get worse, in heavily pre-treated patients of 3.5 months is comparable to that seen in similar studies in patients with a history of fewer prior treatments. Similarly, median PFS of 4.2 months in patients receiving the Bria-IMT pivotal phase 3 formulation is approximately twice the PFS figures reported for treatment of physician’s choice in other similar studies. These PFS results suggest superior clinical efficacy considering the larger number of prior treatments in Bria-IMT patients vs those of the other studies. Clinical efficacy: PFS is similar or better than that of the last regimen in 48% of the patients suggesting Bria-IMT effectiveness in delivering clinical and survival benefits in these patients. Additionally, a clinical benefit rate, defined as percentage of patients whose disease shrinks or remains stable over a certain time, of 56% is observed in evaluable patients further highlighting clinical benefit. Subset specific clinical benefits: Study data to date suggests clinical benefit for multiple breast cancer subtypes including HR+/HER2- with a CBR following treatment, of 63%; HER2+ subtype with a 100% CBR and HR-/HER2 low subtype showing a CBR of 66%. Safety profile: There are no incidents of interstitial lung disease – a well-documented serious adverse event associated with ADCs, – in either ADC naive or ADC treated patients, and no treatment-related discontinuations of Bria-IMT. In summary, the data to date shows that Bria-IMT(TM) provides prolonged progression-free survival and clinical benefits in heavily pre-treated, ADC resistant breast cancer patients compared with those in other similar studies. BriaCell will be monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT and CPI in advanced metastatic breast cancer.