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BriaCell’s cancer vaccine platform offers strong synergy with checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 therapies.
$BCTX shares major progress in its shareholder letter:
✅Repeated DSMB praise for Phase 3 Bria-IMT study
✅Fast Track status + accelerated enrollment
✅Phase 2 survival data outperforming standard of care
https://globenewswire.com/news-release/2025/05/20/3084743/0/en/BriaCell-CEO-Letter-to-Shareholders.html
MC 12,5 Mil
You see a flower? I see a future blockbuster that just needs the right value to grow on its own – it can buy its own flowers!
BriaCell hits the Fast Track!
The CEO’s letter is full of good news, but one shines above the rest:
Bria-IMT has received FDA Fast Track designation!
Canadian or not… when a tumor vanishes, science wins!
Plus:
• Phase 3 trial is enrolling well, with repeated green lights from the DSMB
• Phase 2 data: outperforming TRODELVY in HR+ patients
• Bria-OTS platform made a metastasis disappear – seriously impressive!
With $13.8 million raised and ASCO coming up…
BCTX, new 52 week low
Briacell is scheduled to present tomorrow and Wednesday.$BCTX
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,
BCTX: Roger that, Capt.!!
BCTX: I.e., where their 'Investigational Drug Group' consisted of 400-PATIENTS --- vs. merely just ONE, as in their bogus PR today!!!
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!!!"
/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////
BCTX: At least I can recognized a HOAX, when I see one!! (And they even PR'd a cute 'X-RAY' too, of a TINY SPOT of purported metastasized CANCER that had suddenly disappeared behind their disruptive new ELIXIR!!!)
BCTX: Straight-up HOAX!!! (Such a PR is never, never, never DONE behind one patient!!!)
BCTX: Their purported NEWS is a "Statistical Artifact" --- significant of NOTHING!!! No legitimate Pharma firm would ever PR such (One Patient) crap!!!
BCTX, new 52 week low
BCTX: It's actually GREEN now in price!!! (Heck, maybe there IS a "God" --- of WOMEN, hopefully!!!! And NOT some clown nailed to a cross in Naples, Italy, 2K years ago!!!!)
BCTX: I sincerely HOPE that this BCTX stock --- with GREAT news for Women's BREAST Cancer concerns --- gets monster short-SQUEEZED, like below!!! Metaphorically speaking, that is.)
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Dedicated to enhance the lives of cancer patients who are facing limited therapeutic options, BriaCell Therapeutics Corp. (OTCQB: BCTXF; TSX: BCT.V)’s mission has been to develop novel immunotherapies, as the most cutting edge technology to fight cancer. Immunotherapies have become the forefront of the cancer treatments because they use the body’s immune system to destroy the cancer cells, offering higher levels of safety and efficacy than chemotherapy, with less likeliness of recurrence.
Designed by our team of scientists and clinicians, BriaCell’s proprietary whole-cell based vaccine technology platform continues to show its impressive potential to establish a new model for treating cancer patients. Our lead product candidate, Bria-IMT™ (SV-BR-1-GM), is a genetically engineered whole-cell vaccine derived from a human breast cancer cell line. Bria-IMT™ is used in combination with multiple immune-modulators to powerfully trigger the immune system to recognize and eliminate cancerous cells.
In a preliminary Phase I clinical study in metastatic (i.e., Stage IV) breast cancer patients who had failed multiple treatments, Bria-IMT™ treatment significantly reduced the tumor size, without serious side effects. Importantly, the tumor regression was observed in other sites including the lung and even the brain -a difficult site. Impressively, the median lifespan of the patients was substantially longer than that of the comparable trials.
At our laboratory facility in Berkeley, CA, we are planning to expand our pipeline of oncology immunotherapy candidates using our proprietary technology platform.
Using the clinical data from the patients from the clinical studies, we are working to identify the molecular fingerprint of the patients for which the vaccine would be highly effective, and are planning to develop diagnostic testing products to identify this group. By directing the drug to the top-responders, we expect this approach to increase the likelihood of clinical trial success of Bria-IMT™ -to bring hope to thousands of cancer patients with few-to-no treatment options.
The company is currently recruiting its Phase I/IIa trial to further test Bria-IMT™ safety and activity in metastatic breast cancer patients. BriaCell maintains global rights for Bria-IMT™.
BriaCell is currently recruiting patients to evaluate the safety and activity of Bria-IMT™ in an additional Phase I/IIa study in 25-40 metastatic breast cancer patients who have failed at least one course of treatment.
For the details of the trial, please visit For the details of the trial, please visit https://www.clinicaltrials.gov/ct2/show/NCT03066947
FDA has approved the roll-over combination study of Bria-IMT™ with pembrolizumab (Keytruda; manufactured by Merck & Co., Inc.) or ipilimumab (Yervoy; manufactured by Bristol-Myers Squibb Company) for patients previously treated with BriaVax™ from the ongoing Phase I/IIa Clinical Trial in Advanced Breast Cancer. The study is available for patents on the SV-BR-1-GM Phase I/IIa study who develop progressive disease. These patients will be eligible to roll-over into combination therapy with Keytruda or Yervoy, depending on the type of breast cancer they have.
More information on the roll-over combination study of Bria-IMT™ with either ipilimumab or pembrolizumab will be available on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03328026)
Manufactured by Merck & Co., Inc., KEYTRUDA® (pembrolizumab) is a prescription medicine that may treat certain cancers by working with the immune system. It has been approved for the treatment of a number of cancer indications excluding breast cancer.
For more information on pembrolizumab, please see:
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
Manufactured by Bristol-Myers Squibb Company, YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable). It is a monoclonal antibody that works to activate the immune system and enabling them to recognize and destroy cancer cells.
For more informations on Ipilimumab, please see:
https://packageinserts.bms.com/pi/pi_yervoy.pdf
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