stocktowatch
3 weeks ago
$BCTX News Out - BriaCell Reports Robust Overall Survival and Clinical Benefit Data at ASCO 2025
Three BriaCell posters and one publish-only abstract highlight robust clinical data from Bria-IMT™ and Bria-OTS™ studies in metastatic breast cancer (MBC)
Median Overall Survival of 17.3 months in Phase 2 study patients treated with Phase 3 formulation (since 2022) is superior to outcomes reported for comparable patients in the literature
Meaningful Clinical Benefit observed in all MBC subtypes, including HER2+, HR+/HER2-, and triple-negative breast cancer (TNBC)
Overall survival and clinical benefit data reported meets or exceeds that of FDA-approved therapies in comparable patients
No treatment-related discontinuations
PHILADELPHIA and VANCOUVER, British Columbia, June 02, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today presents clinical data in three clinical poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. BriaCell has featured robust survival and clinical benefit data from its Bria-IMT Phase 2 clinical study, clinical progress data from its ongoing pivotal Bria-IMT Phase 3 study (ClinicalTrials.gov identifier: NCT06072612), and Phase 1/2 study of Bria-OTS (ClinicalTrials.gov identifier: NCT06471673) in metastatic breast cancer.
“Prolonging survival and providing meaningful clinical benefit for patients whose disease has demonstrated resistance to multiple treatment options remains a critical unmet need in breast cancer. These Bria-IMT regimen results are promising for individuals with metastatic breast cancer,” said Sara A. Hurvitz, MD, FACP, Senior Vice President, Director of the Clinical Research Division, and Smith Family Endowed Chair in Women’s Health at Fred Hutch Cancer Center, as well as Professor and Head of the Division of Hematology and Oncology at the University of Washington, Seattle, WA, and co-author of one of the clinical posters. “The low incidence of all grade and grade 3/4 adverse events is particularly notable.”
“We are thrilled with our Phase 2 overall survival and clinical benefit data which meets and exceeds those of FDA approved drugs — even in very heavily pre-treated patients in our study,” noted Dr. William V. Williams, BriaCell’s President & CEO. “We look forward to further confirming these impressive results in our ongoing pivotal Phase 3 study with the ultimate goal of bringing novel treatments to cancer patients in need.”
The details of the poster presentation sessions and publish-only abstract are listed below.
Poster Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic
“Trial in Progress” poster presents early enrollment data and the overall design of the Phase 3 pivotal trial along with updated clinical outcomes from the Phase 2 Bria-IMT study.
Poster Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic
In the Phase 2 study of Bria-IMT combined with an immune checkpoint inhibitor (CPI) in 54 heavily pre-treated metastatic breast cancer (MBC) patients (median of six prior systemic therapies; range 2–13), Bria-IMT demonstrated promising efficacy and safety. Notably, 44% of patients had failed a prior antibody-drug conjugate, and 20% had failed a prior CPI. Among these patients, the overall clinical benefit rate (CBR; defined as CR, PR, or SD) was 55%, with CBRs of 100% in HER2+, 55% in HR+/HER2-, and 45% in triple-negative breast cancer (TNBC) subgroups, indicating antitumor activity across MBC subtypes. Additionally, patients treated with the selected Phase 3 formulation (without IFN?; N=37) experienced significantly improved overall survival (13.9 vs. 6.93 months; P=0.01) compared to those receiving the alternate formulation, highlighting the potential of Bria-IMT for advancing in clinical development.
Read more here : https://www.globenewswire.com/news-release/2025/06/02/3091756/0/en/BriaCell-Reports-Robust-Overall-Survival-and-Clinical-Benefit-Data-at-ASCO-2025.html
Frankestin
1 month ago
from 9.9% to 4.9%, holding 190,006 common shares.
holds 98,311 warrants to purchase common shares. However, the exercise of these warrants is subject to a 4.99% ownership limitation ("blocker"), preventing the holder from exceeding this threshold without prior adjustment.
https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=319163389&type=HTML&symbol=BCTX&cdn=4fd3b05ac8453fea46587e9835855dd1&companyName=BriaCell+Therapeutics+Corp.&formType=SCHEDULE+13G%2FA&formDescription=%5BAmend%5D+Statement+of+acquisition+of+beneficial+ownership+by+individuals&dateFiled=2025-05-13
CVI Investments, Inc., managed by Heights Capital Management, Inc., filed a Schedule 13G disclosing a passive ownership of 489,200 common shares of BriaCell Therapeutics Corp., representing approximately 8.6% of the company’s outstanding shares as of April 24, 2025.
This stake likely originates from participation in BriaCell’s public offering announced on April 24, 2025, which involved 3,066,666 units (each consisting of a common share or prefunded warrant and one warrant with a $5.25 exercise price).
https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=319127530&type=HTML&symbol=BCTX&cdn=69d3e85b7de2a0c92a3ec26bb9949c5d&companyName=BriaCell+Therapeutics+Corp.&formType=SCHEDULE+13G&formDescription=Statement+of+acquisition+of+beneficial+ownership+by+individuals&dateFiled=2025-05-01
subslover
2 months ago
BriaCell Confirms 100% Resolution of Lung Metastasis with Bria-OTS™
(IMAGES BELOW) Complete resolution of lung metastasis confirmed at 4 month follow-up in hormone receptor positive (HR+) breast cancer patient
Treatment well-tolerated and patient remains on study with stable disease elsewhere
Sustained clinical response supports Bria-OTS personalized, off-the-shelf immunotherapy approach in Phase 1/2a metastatic breast cancer study
PHILADELPHIA and VANCOUVER, British Columbia, April 24, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, confirms the sustained complete resolution of the lung metastasis, first reported in February 2025, two months after initial treatment in the ongoing Phase 1/2 Bria-OTS study. The latest data at four months also demonstrates stable disease elsewhere.
Figure 1: Treatment with Bria-OTS monotherapy resulted in 100% resolution of tumor in the lung of the metastatic breast cancer (MBC) patient following 2 months of therapy and confirmed at 4 months of therapy1 (axial and coronal views)
https://ml.globenewswire.com/Resource/Download/19a24c7d-e793-4f57-b0df-c1605b7395dc/briacell-figure-1.png
As shown, the lesion in the patient’s right lung is undetectable after two months and confirmed resolved at 4 months. The updated images supersede those previously reported.
The patient, a 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative), had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS study. At enrollment on November 21, 2024, she had extensive metastases including bone, lymph node and lung involvement. Following Bria-OTS intradermal injections every 2 weeks for six weeks (4 total doses), and subsequent dosing every 3 weeks, the lung metastasis completely resolved with stable disease elsewhere. This response is now confirmed and shows the potentially promising activity of the Bria-OTS platform as monotherapy.
“Despite recent advancements with Antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), many patients, including those with HR+ disease, like BriaCell’s first OTS patient, have very few options,” stated Neal S. Chawla MD, Director at the Sarcoma Oncology Center, Santa Monica, Ca., and Principal Investigator for the Bria-OTS study. “We are thrilled with our initial data with single agent Bria-OTS showing rapid and strong anti-tumor activity in an HR+ patient and look forward to continuing this novel approach in patients with MBC, and other cancers.”
“This unprecedented anti-cancer response in the first patient dosed with Bria-OTS is an important milestone for us and provides early validation of BriaCell’s personalized immunotherapy approach,” stated Dr. William V. Williams, BriaCell’s President and CEO.
Bria-OTS is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673) in metastatic recurrent breast cancer. Bria-OTS represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT™ which is currently in a pivotal Phase 3 study for metastatic breast cancer. The Phase 1/2a clinical trial in metastatic breast cancer is a dose escalation study initially evaluating the safety and efficacy of Bria-OTS as monotherapy and will be followed by Bria-OTS in combination with an immune checkpoint inhibitor.
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/.
Safe Harbor
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements,
Invest-in-America
5 months ago
BCTX: Could you imagine where the PRICE of this stock would be right now, if this Firm had PR'd legitimate STATISTICS to the effect that 75% of the 'Investigational Drug Group' enjoyed 100% remission of their metastasized LUNG CANCERS --- when compared to the 'Placebo Group", & all other 'Control Groups' & 'Standard of Care Groups'??? (And moreover, this HOAX Company did NOT even entertain ANY 'Control Groups', nor 'Standard of Care Groups', AT ALL!!! Their only experimental 'competition', as it were, was a useless 'PLACEBO GROUP'!!! I myself KNOW this stuff, Peeps!!! Anyone who got suckered by the conspicuous NONSENSE within BCTX's PR today, is patently-STUPID --- even when compared to all universal, 'Standards of Stupidity!!!)
"Tell-it-like-it-is, Oh Great Invest-in-America, Dude!!! You're doing GOD's work, Homeboy!!!"
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axelvento
5 months ago
huge news-Treatment with Bria-OTS™ monotherapy resulted in 100% resolution of tumor in the lung of the MBC patient following 4 injection cycles
This 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative) had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS™ study. At enrollment on Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS™ every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere.
https://feeds.issuerdirect.com/news-release.html?newsid=7417246418288908
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