MedPath

BriaCell Therapeutics Reports Progress in Phase 3 Metastatic Breast Cancer Trial

• BriaCell Therapeutics reported an operating loss of $(5.15) million, alongside a net loss of $(5.83) million, influenced by fair value changes in warrant liability. • The company's pivotal Phase 3 study of Bria-IMT™ in metastatic breast cancer is actively enrolling patients across 35 clinical sites. • BriaCell is also advancing its Bria-OTS™ personalized immunotherapy, with the first patient dosed in a Phase 1/2 study, marking a key milestone. • The company aims for full approval and marketing authorization for Bria-IMT™ pending positive Phase 3 results, focusing on clinical program advancement.

BriaCell Therapeutics Corp., a biotechnology company focused on developing immunotherapies for cancer, has released its Form 10-Q report for the third quarter of 2024, highlighting progress in its Bria-IMT™ and Bria-OTS™ immunotherapy programs. The company is currently prioritizing its pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer. As of October 15, 2024, 35 clinical sites are actively enrolling patients for the Phase 3 study. The company has also dosed the first patient in a Phase 1/2 study of Bria-OTS™ personalized immunotherapy.

Financial Overview

The report indicates an operating loss of $(5.15) million, reflecting a decrease in operating expenses compared to the previous year. The net loss for the period was $(5.83) million, compared to a gain of $5.96 million in the same period of 2023, primarily due to changes in the fair value of the warrant liability. The net loss per share attributable to BriaCell was $(0.22), compared to a gain of $0.38 in the same period of 2023.

Bria-IMT™ Phase 3 Trial

The pivotal Phase 3 study of Bria-IMT™ in advanced breast cancer is a key focus for BriaCell. The trial is designed to evaluate the efficacy and safety of Bria-IMT™ in combination with an immune checkpoint inhibitor. Enrollment is ongoing across 35 active clinical sites. BriaCell aims to achieve full approval and marketing authorization for Bria-IMT™ in metastatic breast cancer patients, contingent on positive results from this pivotal study.

Bria-OTS™ Phase 1/2 Study

BriaCell is also progressing with its Bria-OTS™ personalized immunotherapy. The first patient has been dosed in a Phase 1/2 study. This study will evaluate the safety and preliminary efficacy of Bria-OTS™ in patients with advanced cancer. The completion of the Phase 1/2a trial has allowed for a reallocation of resources to the ongoing Phase 1/2 study.

Operational Adjustments

BriaCell has optimized its expenditures for the pivotal Phase 3 trial, resulting in a decrease in research and development costs. The company has also adjusted its resource allocation, leading to a slight decrease in wages and salaries. These adjustments are aimed at maximizing efficiency and focusing resources on the most promising clinical programs.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

BriaCell's Phase 3 Breast Cancer Trial Receives Green Light from DSMB

The Data Safety Monitoring Board (DSMB) found no safety concerns in BriaCell's Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor.
The DSMB recommended the continuation of the Phase 3 trial in metastatic breast cancer patients without any modifications to the protocol.

Cellectar Biosciences Advances Iopofosine I 131 in Multiple Myeloma and Waldenstrom’s Macroglobulinemia Trials

Cellectar Biosciences is progressing its lead therapeutic, iopofosine I 131, through clinical trials targeting relapsed/refractory Waldenstrom’s macroglobulinemia (WM) and multiple myeloma (MM).
The CLOVER-WaM Phase 2 pivotal study for WM has completed enrollment, with Phase 2b studies in MM and central nervous system lymphoma (CNSL) ongoing.

Aura Biosciences Advances Bel-Sar in Multiple Clinical Trials for Ocular and Bladder Cancers

Aura Biosciences reports progress in Phase 3 trial for choroidal melanoma with bel-sar, showing an 80% tumor control rate in Phase 2 among Phase 3-eligible patients.
The company is expanding bel-sar's development into bladder cancer, with a Phase 1 trial underway for non-muscle invasive and muscle invasive bladder cancer.

Protara Therapeutics Announces Progress in TARA-002 and IV Choline Chloride Programs

Protara Therapeutics' TARA-002 shows promise in NMIBC treatment, with ADVANCED-2 trial results expected in Q4 2024, and positive interim data in Lymphatic Malformations.
The FDA granted Fast Track designation for IV Choline Chloride, planned for Phase 3 trial (THRIVE-3) initiation in Q1 2025 for parenteral support patients.

Kiromic BioPharma's Deltacel-01 Shows Promise in Solid Tumors, Faces Financial Hurdles

Kiromic BioPharma's Deltacel-01 demonstrates a 6-month median Progression Free Survival (PFS) in early clinical trials, with the longest PFS observed at 10 months.
The FDA granted Fast-Track Designation to Deltacel, potentially accelerating its approval process through benefits like Rolling Review and Priority Review.

89bio's Pegozafermin Advances Through Phase 3 Trials for MASH and SHTG

89bio is progressing pegozafermin, a FGF21 analog, through Phase 3 trials for metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).
Pegozafermin received Breakthrough Therapy Designation from the FDA for MASH and PRIME designation from the EMA, based on positive Phase 2b ENLIVEN trial data.

BioAtla Highlights Promising Clinical Data and Financial Results in Q3 2024

BioAtla's ozuriftamab vedotin Phase 2 trial shows a 9-month median overall survival in heavily pretreated head and neck cancer patients, indicating potential efficacy.
Evalstotug combined with PD-1 demonstrates tumor reduction in all first-line melanoma patients, including one complete response, with favorable tolerability.

PMV Pharmaceuticals Provides Update on PC14586 (Rezatapopt) Clinical Trials and Financial Status

PMV Pharmaceuticals is advancing PC14586 (rezatapopt) in a Phase 2 monotherapy trial (PYNNACLE) for solid tumors with p53 Y220C mutations, with interim data expected by mid-2025.
The company discontinued the Phase 1b combination arm of the PYNNACLE trial, which evaluated rezatapopt with pembrolizumab (KEYTRUDA®).

BriaCell's Bria-IMT™ Shows Promise in Metastatic Breast Cancer Phase 2 Trial

BriaCell's Bria-IMT™, combined with an immune checkpoint inhibitor, demonstrates promising results in a Phase 2 study for metastatic breast cancer, showing a median overall survival of 13.4 months.
The FDA has granted Fast Track Designation to Bria-IMT™, potentially accelerating the review process for this novel treatment addressing unmet needs in breast cancer.

BriaCell's Phase 3 Trial of Bria-IMT™ for Metastatic Breast Cancer Progresses

BriaCell's Phase 3 study evaluating Bria-IMT™ with immune checkpoint inhibitors in metastatic breast cancer has 35 active enrollment sites.
The primary endpoint is overall survival (OS) comparing the Bria-IMT™ regimen plus checkpoint inhibitor to physician's choice of treatment.

Reference News

[1]
BriaCell Therapeutics Corp. SEC 10-Q Report - TradingView
tradingview.com · Dec 16, 2024

BriaCell Therapeutics Corp. released its Q3 2024 Form 10-Q, reporting an operating loss of $(5.15) million and net loss ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy