BriaCell Patient Achieves Sustained Complete Resolution of Lung Metastasis in Bria-OTS鈩� Metastatic Breast Cancer Study
BriaCell Therapeutics (NASDAQ: BCTX) reported sustained complete resolution of lung metastasis in the first patient treated with Bria-OTS, their personalized off-the-shelf immunotherapy for metastatic breast cancer. The 78-year-old patient with hormone receptor-positive, HER2-negative metastatic breast cancer showed 100% resolution of lung metastasis, maintained at 2, 4, and 6 months after treatment.
The patient, who had multiple prior treatment failures, has received 12 cycles of Bria-OTS monotherapy with no treatment-limiting toxicities. This milestone was achieved at the lowest dose level, demonstrating strong single-agent activity in a challenging patient population.
BriaCell Therapeutics (NASDAQ: BCTX) ha riportato una completa risoluzione duratura delle metastasi polmonari nel primo paziente trattato con Bria-OTS, la loro immunoterapia personalizzata pronta all'uso per il carcinoma mammario metastatico. Il paziente di 78 anni con carcinoma mammario metastatico positivo ai recettori ormonali e HER2-negativo ha mostrato una risoluzione del 100% delle metastasi polmonari, mantenuta a 2, 4 e 6 mesi dal trattamento.
Il paziente, che aveva subito diversi fallimenti terapeutici precedenti, ha ricevuto 12 cicli di monoterapia con Bria-OTS senza tossicit脿 che limitassero il trattamento. Questo traguardo 猫 stato raggiunto al livello di dose pi霉 basso, dimostrando una forte attivit脿 del singolo agente in una popolazione di pazienti difficile.
BriaCell Therapeutics (NASDAQ: BCTX) inform贸 una resoluci贸n completa y sostenida de las met谩stasis pulmonares en el primer paciente tratado con Bria-OTS, su inmunoterapia personalizada lista para usar para c谩ncer de mama metast谩sico. El paciente de 78 a帽os con c谩ncer de mama metast谩sico positivo a receptores hormonales y HER2-negativo mostr贸 una resoluci贸n del 100% de las met谩stasis pulmonares, mantenida a los 2, 4 y 6 meses despu茅s del tratamiento.
El paciente, que hab铆a tenido m煤ltiples fracasos en tratamientos previos, recibi贸 12 ciclos de monoterapia con Bria-OTS sin toxicidades que limitaran el tratamiento. Este logro se consigui贸 con la dosis m谩s baja, demostrando una fuerte actividad del agente 煤nico en una poblaci贸n de pacientes dif铆cil.
BriaCell Therapeutics (NASDAQ: BCTX)電� 鞝勳澊靹� 鞙犽癌鞎旍潉 鞙勴暅 臧滌澑 毵烄钉順� 歃夓嫓 靷毄 臧�電ロ暅 氅挫棴旃橂鞝� Bria-OTS搿� 旃橂氚涭潃 觳� 氩堨Ц 頇橃瀽鞐愳劀 韽� 鞝勳澊鞚� 鞕勳爠頃� 歆�靻嶌爜 靻岇嫟鞚� 氤搓碃頄堨姷雼堧嫟. 78靹� 頇橃瀽電� 順鸽ゴ氇� 靾橃毄觳� 鞏戩劚, HER2 鞚岇劚 鞝勳澊靹� 鞙犽癌鞎旍潉 鞎撽碃 鞛堨棃鞙茧┌, 旃橂 頉� 2, 4, 6臧滌洈鞐� 瓯胳硱 韽� 鞝勳澊臧� 100% 靻岇嫟霅� 靸來儨毳� 鞙犾頄堨姷雼堧嫟.
鞐煬 彀鞚� 鞚挫爠 旃橂 鞁ろ尐毳� 瓴潃 鞚� 頇橃瀽電� 12欤缄赴鞚� Bria-OTS 雼弲鞖旊矔鞚� 氚涭晿鞙茧┌ 旃橂毳� 鞝滍暅頃橂姅 霃呾劚鞚� 鞐嗢棃鞀惦媹雼�. 鞚� 鞚挫爼響滊姅 臧�鞛� 雮潃 鞖╇焿 靾橃鞐愳劀 雼劚霅橃柎, 鞏措牑鞖� 頇橃瀽甑办棎靹� 雼澕 鞎届牅鞚� 臧曤牓頃� 須姤鞚� 鞛呾頄堨姷雼堧嫟.
BriaCell Therapeutics (NASDAQ : BCTX) a rapport茅 une r茅solution compl猫te et durable des m茅tastases pulmonaires chez le premier patient trait茅 avec Bria-OTS, leur immunoth茅rapie personnalis茅e pr锚te 脿 l'emploi pour le cancer du sein m茅tastatique. Le patient de 78 ans atteint d'un cancer du sein m茅tastatique hormonosensible et HER2-n茅gatif a montr茅 une r茅solution 脿 100 % des m茅tastases pulmonaires, maintenue 脿 2, 4 et 6 mois apr猫s le traitement.
Le patient, qui avait connu plusieurs 茅checs de traitements ant茅rieurs, a re莽u 12 cycles de monoth茅rapie Bria-OTS sans toxicit茅s limitant le traitement. Cette 茅tape a 茅t茅 atteinte avec la dose la plus faible, d茅montrant une forte activit茅 du traitement en monoth茅rapie dans une population de patients difficile.
BriaCell Therapeutics (NASDAQ: BCTX) berichtete 眉ber eine anhaltende vollst盲ndige R眉ckbildung der Lungenmetastasen beim ersten Patienten, der mit Bria-OTS, ihrer personalisierten, sofort einsatzbereiten Immuntherapie f眉r metastasierten Brustkrebs, behandelt wurde. Der 78-j盲hrige Patient mit hormonrezeptor-positivem, HER2-negativem metastasiertem Brustkrebs zeigte eine 100%ige R眉ckbildung der Lungenmetastasen, die 2, 4 und 6 Monate nach der Behandlung anhielt.
Der Patient, der zuvor mehrere Therapieversagen erlitten hatte, erhielt 12 Zyklen Bria-OTS-Monotherapie ohne behandlungsbegrenzende Toxizit盲ten. Dieser Meilenstein wurde bei der niedrigsten Dosisstufe erreicht und zeigt eine starke Einzelwirkstoffaktivit盲t in einer herausfordernden Patientengruppe.
- Complete (100%) resolution of lung metastasis maintained for 6 months
- No treatment-limiting toxicities observed in the patient
- Strong single agent activity achieved at lowest dose level
- Patient remains on study with stable disease
- Results limited to only one patient so far
- Study still in early Phase 1/2a stage
Insights
BriaCell's Bria-OTS therapy shows remarkable durability with complete resolution of lung metastasis maintained at 6 months in first patient.
The clinical data presented in this announcement represents a potentially significant development in immunotherapy for metastatic breast cancer. A 78-year-old patient with hormone receptor-positive, HER2-negative metastatic breast cancer who had experienced multiple prior treatment failures has shown a complete response in lung metastasis following only four doses of Bria-OTS monotherapy. Most importantly, this response has been maintained for 6 months, suggesting meaningful durability.
From a clinical perspective, several elements make this result particularly noteworthy. First, this response was achieved with monotherapy rather than a combination approach, which is uncommon in advanced metastatic disease. Second, the patient population 鈥� elderly with multiple treatment failures 鈥� represents a challenging cohort with typically poor prognosis. Third, the response occurred at the lowest dose level of the Phase 1/2a study, suggesting potential for even greater efficacy at higher doses.
The lack of treatment-limiting toxicities is equally important in this elderly patient population, where tolerability often determines whether a therapy can be continued. The patient has now received 12 treatment cycles, indicating acceptable long-term tolerability.
While this represents data from just a single patient and broader efficacy patterns remain to be established, complete responses with durability beyond 6 months in heavily pretreated metastatic breast cancer patients are relatively rare. The company's plans to evaluate Bria-OTS in combination with checkpoint inhibitors represents a logical next step, as such combinations often show synergistic effects in immunotherapy approaches.
- [IMAGES BELOW] Complete resolution maintained at 6 months in first patient treated with BriaCell鈥檚 Bria-OTS in Phase 1/2a study
- No treatment limited toxicities observed
- Patient remains on study with stable disease elsewhere
PHILADELPHIA and VANCOUVER, British Columbia, July 09, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (鈥淏riaCell鈥� or the 鈥淐ompany鈥�), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, today announced the sustained complete resolution of lung metastasis in a patient with hormone receptor-positive (HR+), HER2-negative, metastatic breast cancer (MBC) treated with Bria-OTS, the Company鈥檚 personalized off the shelf immunotherapy.
BriaCell鈥檚 first Bria-OTS study patient, a 78-year-old woman with advanced disease and multiple prior treatment failures, achieved
Figure 1: Treatment with Bria-OTS monotherapy resulted in
鈥淭hese results represent an exciting clinical milestone in the Bria-OTS program,鈥� stated Neal S. Chawla MD, Director at the Sarcoma Oncology Center, Santa Monica, CA, and Principal Investigator for the Bria-OTS study. 鈥淲e are seeing strong single agent activity in a very challenging population and are eager to explore this approach across more patient subtypes and tumors.鈥�
鈥淲e are highly encouraged by this remarkable and durable clinical response, especially at the lowest dose level,鈥� added Dr. William V. Williams, BriaCell鈥檚 President and CEO. 鈥淭his data underscores the therapeutic potential of our Bria-OTS platform, and we look forward to further evaluating it in combination with a checkpoint inhibitor to improve outcomes in patients with advanced breast cancer.鈥�
About Bria-OTS
Bria-OTS is a next generation, off-the-shelf personalized immunotherapy based on BriaCell鈥檚 lead candidate Bria-IMT currently being evaluated in a Phase 1/2a study (ClinicalTrials.gov identifier: ) in patients with metastatic recurrent breast cancer. The trial includes both monotherapy dose escalation and check point inhibition combination dose expansion cohorts. The Company recently progressed into the dose expansion phase.
About BriaCell Therapeutics Corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at .
Safe Harbor
This press release contains 鈥渇orward-looking statements鈥� that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release include statements regarding: BriaCell continuing the Phase 1/2a Bria-OTS study and reproducing similar results in patients with MBC and other cancers; the use of the Bria-OTS platform as monotherapy; and Bria-OTS鈥檚 validation as a personalized immunotherapy approach. Forward-looking statements may be identified by the use of words such as 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ontemplate,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntend,鈥� 鈥渟eek,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減roject,鈥� 鈥渢arget,鈥� 鈥渁im,鈥� 鈥渟hould,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading 鈥淩isks and Uncertainties鈥� in the Company鈥檚 most recent Management鈥檚 Discussion and Analysis, under the heading 鈥淩isk Factors鈥� in the Company鈥檚 most recent Annual Information Form, and under 鈥淩isks and Uncertainties鈥� in the Company鈥檚 other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company鈥檚 profiles on SEDAR+ at听听and on EDGAR at听. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
听
Investor Relations Contact:
1 Note that the other white dots in the lungs are blood vessels.
A photo accompanying this announcement is available at .
FAQ
What are the latest clinical results for BriaCell's (BCTX) Bria-OTS cancer treatment?
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What type of cancer patients are being treated in the BCTX Bria-OTS trial?
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