On May 23, 2025 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, reported the presentation of positive survival and clinical benefit data in three clinical poster presentations and one publish-only abstract at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL (Press release, BriaCell Therapeutics, MAY 23, 2025, View Source [SID1234653598]).

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"We are highly encouraged by the survival and clinical benefit data from our Phase 2 Bria-IMT study which meets and outperforms outcomes seen with FDA approved therapies – despite our patients being more heavily pre-treated," stated Dr. William V. Williams, BriaCell’s President & CEO. "These results reinforce our belief in Bria-IMT’s potential to address the urgent, unmet needs of patients with metastatic breast cancer and we look forward to confirming results in our ongoing pivotal Phase 3 study."

"These data provide additional validation of the mechanism of action and support the clinical efficacy of Bria-IMT," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "Importantly, the regimen has been well-tolerated and its favorable safety and efficacy profile positions it as a promising, less toxic therapeutic option for patients battling metastatic breast cancer."

The details of the poster presentation sessions and publish-only abstract are listed below.

Abstract 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

Preliminary selected clinical and biomarker data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612 ).

Abstract 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

Phase 2 study of Bria-IMT in combination immunotherapy with an immune checkpoint inhibitor (CPI) consisted of 54 patients; 11 received pembrolizumab, 44 retifanlimab (1crossover).

Table 1: Median overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR) were evaluated against two pivotal Phase 3 studies of FDA approved drugs, ASCENT (Trodelvy (SG) or Treatment of Physicians Choice (TPC) in triple-negative breast cancer (TNBC)) and TROPiCS-02 (SG or TPC in Hormone Receptor +/HER2- MBC)
Trial (Cohort) Age (median, range) Prior Therapies (median, range) OS (months) PFS (months) ORR
(%) CBR
(%)
Bria-IMT (Overall Cohort) 61 (38-81) 6 (2-13) 9.9 (1.8-30.3) 3.6 10% 55%
Bria-IMT (Phase 3 regimen) 62 (44-80) 6 (2-13) 13.43 (1.8-30.3) 3.6 (1.8-16.5) 14 % 61 %
ASCENT (SG) 54 (27-82) 4 (2-17) 11.8 4.8 31% 40%
ASCENT (TPC) 53 (27-81) 4 (2-14) 6.9 1.7 4% 8%
TROPiCS-02 (SG) 57 (49-65) 3 14.4 5.5 21% 34%
TROPiCS-02 (TPC) 55 (48-63) 3 11.2 4 14% 22%
Bria-IMT was well-tolerated with no treatment-related discontinuations. 22% of patients are still in active survival follow up.

This analysis does not stratify Bria-IMT patients by hormone receptor or HER2 status, and the dataset reflects the information available at the time of abstract submission. Updated data will be shared during the company’s presentation at ASCO (Free ASCO Whitepaper) 2025.

PFS (median) and OS (median): Patients treated with Bria-IMT’s selected Phase 3 formulation (without IFNγ; N = 37) demonstrated significantly improved progression-free survival (3.6 vs. 2.6 months; P = 0.01) and overall survival (13.4 vs. 6.9 months; P = 0.01) compared to those who received the alternate formulation not advanced to Phase 3.

The overall survival observed in the Phase 3 formulation cohort (13.4 months) was comparable to that reported in the ASCENT (11.8 months) and TROPiCS-02 (14.4 months) studies and exceeded survival outcomes in their respective treatment of physician’s choice (TPC) arms (6.9 and 11.2 months).

BriaCell’s Phase 2 study also achieved a Clinical Benefit Rate (CBR) of 61%, outperforming ASCENT (40%) and TROPiCS-02 (34%), and an Objective Response Rate (ORR) of 14%, which matched or exceeded the TPC arms in both studies (4% and 14%).

Importantly, these outcomes were achieved in a more heavily pretreated patient population than those in the comparator trials—highlighting Bria-IMT’s strong anti-cancer activity. The favorable efficacy profile of the Phase 3 formulation supports its continued evaluation in BriaCell’s ongoing pivotal Phase 3 trial comparing Bria-IMT to treatment of physician’s choice ( NCT06072612 ).

Abstract Title: Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1136
Poster Board Number: 107a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

Heavily pre-treated MBC patients were treated in a dose escalation Phase 1/2 study of Bria-OTS monotherapy (single agent). The Phase 1 part of the study has enrolled and treated 3 patients. The first patient treated with single agent therapy has confirmed resolution of a breast cancer metastasis in the lung and remains on study.

Publish-Only Abstract Title : Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer

Following the presentations, copies of the presentations will be posted on View Source

On May 23, 2025 GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, reported that Dr. Kristopher Wentzel from the Angeles Clinic and Research Institute will present updated clinical and translational data of GV20-0251 monotherapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, taking place in Chicago, IL on May 30- June 3, 2025 (Press release, GV20 Therapeutics, MAY 23, 2025, View Source [SID1234653366]).

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This presentation at ASCO (Free ASCO Whitepaper) builds on previously presented clinical data of the novel immune checkpoint IGSF8 inhibitor GV20-0251 (Wentzel et al, ESMO (Free ESMO Whitepaper) 2024) and will report updated clinical and translational findings from the monotherapy dose escalation portion of the ongoing Phase 1/2 trial evaluating GV20-0251 in patients with advanced solid tumors resistant to anti-PD(L)1 and other standard therapies (NCT05669430).

GV20-251 is the first clinical stage, AI-designed antibody therapeutic against an AI-predicted target in the clinic.

Presentation details (Abstract 2531):

Title: Preliminary monotherapy efficacy of novel immune checkpoint blockade GV20-0251 (anti-IGSF8) in advanced melanoma patients with primary resistance to anti-PD1
Session Title: Developmental Therapeutics—Immunotherapy
Session Type: Poster session
Session Date/Time: Monday, June 2, 2025, 1:30 PM – 4:30 PM CDT
Location: Hall A – Posters and Exhibits
Board Number: 178

On May 23, 2025 Verismo Therapeutics, a clinical-stage CAR T company pioneering the KIR-CAR platform, reported additional details on the Trials in Progress poster presentation at the upcoming 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held from May 30 – June 3, 2025 in Chicago, IL (Press release, Verismo Therapeutics, MAY 23, 2025, View Source [SID1234653367]). The trial Principal Investigator, Janos L. Tanyi, MD, PhD, of the Perelman School of Medicine at the University of Pennsylvania, will present an overview of the ongoing STAR-101 Phase 1 clinical study (NCT05568680).

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The STAR-101 trial is a first-in-human, multicenter, open-label, Phase 1 dose-escalation study designed to evaluate the safety, feasibility, and preliminary efficacy of SynKIR-110 in patients with advanced mesothelin-expressing tumors, including ovarian cancer, mesothelioma, and cholangiocarcinoma who have received at least 1 prior line of systemic therapy. SynKIR-110 utilizes Verismo’s novel KIR-CAR platform, employing a multi-chain signaling approach derived from natural killer cells in T cells. Preclinically, this unique mechanism has shown the ability to reduce T cell exhaustion and improve anti-tumor activity and functional persistence, thereby potentially overcoming critical hurdles that limit traditional CAR T cell therapies in solid tumors.

"This study represents an important advancement for ovarian cancer, a disease with few available treatment options," Dr. Tanyi said. "This novel therapy could have the potential to impact solid tumors by overcoming key limitations of existing CAR T cell treatments."

Poster Details:

Poster Board Number: 522a

Location: Hall A – Posters and Exhibits

Abstract Number: TPS5630

Abstract Title: SynKIR-CAR T Cell Advanced Research (STAR)-101 Phase 1 clinical trial for patients with advanced mesothelin-expressing ovarian cancer, mesothelioma, or cholangiocarcinoma.

Presenting Author: Janos L. Tanyi, M.D., Ph.D., Perelman School of Medicine at the University of Pennsylvania

Session Title: Gynecologic Cancer

Session Date: June 1, 2025, 9:00 AM-12:00 PM CDT

The Poster will be made available on the company’s website following the presentation.

About the KIR-CAR Platform

The KIR-CAR platform is a multi-chain CAR T cell therapy that has shown highly effective prolonged solid tumor treatment in otherwise CAR-resistant preclinical animal models with challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel paired activation and co-stimulation separate from the usual T cell stimulation pathways. KIR-CAR also enables sustained chimeric receptor expression with improved long-term CAR T cell function and decreased T cell exhaustion. This results in CAR T cell resistance to tumor immunosuppression, prolonged functional persistence and improved tumor elimination. Together, this platform provides the potential for improving CAR T treatment in both solid and hematologic tumors.

On May 23, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported that two abstracts on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting taking place May 30 – June 3 in Chicago (Press release, SystImmune, MAY 23, 2025, View Source [SID1234653368]). Iza-bren is being jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement.

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Expanded results from clinical trials of iza-bren will include data from patients with advanced stages of Small Cell Lung Cancer and Non-Small Cell Lung Cancer with driver genomic alterations (GA) outside of classic EGFR mutations and having multiple lines of prior therapies. The data to be presented at ASCO (Free ASCO Whitepaper) highlights continued progress in iza-bren clinical development and builds upon the previously reported clinical data in lung and breast cancer patients at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), and SABCS in 2023 and 2024.

"Recent data have bolstered our confidence in iza-bren’s safety profile while highlighting its encouraging efficacy across tumors that have been difficult to treat," stated Jonathan Cheng, M.D., CMO of SystImmune. "Iza-bren emerges as a promising therapeutic option, potentially fulfilling the unmet need of patients with few treatment alternatives. Our commitment to advancing this therapy through a series of comprehensive clinical trials remains steadfast, as we explore its potential both as a standalone treatment and in combination with other agents to improve cancer patient outcomes globally."

Details on the presentations at ASCO (Free ASCO Whitepaper) are below:‍‍

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Driver Genomic Alterations (GA) outside of Classic EGFR Mutations
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract: 3001
Speaker: Yunpeng Yang (Guangzhou, China)
Session Date & Time: Friday, May 30th, 2025, 2:45 PM-5:45 PM CDT

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Small Cell Lung Cancer (SCLC)
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract: 3002
Speaker: Yan Huang (Guangzhou, China)
Session Date & Time: Friday, May 30th, 2025, 2:45 PM-5:45 PM CDT

About iza-bren
The company is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3. These proteins are highly expressed in most epithelial tumors. The tetravalent iza-bren has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Iza-bren blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, iza-bren is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induces genotoxic stress activating pathways leading to cancer cell death.

On May 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the presentation of biomarker data from its OPTIMIZE-1 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Alligator Bioscience, MAY 23, 2025, View Source [SID1234653353]).

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OPTIMIZE-1 is an ongoing Phase 1b/2 trial of mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The trial has demonstrated strong clinical outcomes to date, including a ~30% survival rate at 24-months follow up.

Mitazalimab-induced biomarkers were associated with clinical benefit supporting a significant contribution of mitazalimab to clinical efficacy, including the intratumoral immune activation in responding patients. In addition, a fibrosis-related gene signature was identified as potentially predictive of improved overall survival, while ctKRAS clearance and molecular response were significantly associated with longer survival and outcomes.

These translational data strengthen the rationale for mitazalimab’s mode of action, showing that mitazalimab-induced immune activation and suppression of tumor-promoting genes contribute to the clinical benefits observed in OPTMIZE-1. With an observed median overall survival of 14.9 months and objective response rate of 54.4%, the results support further development of mitazalimab in mPDAC, including the planned randomized confirmatory trial.

Alligator’s participation at ASCO (Free ASCO Whitepaper) reflects its commitment to scientific exchange and business development. The meeting provides an important platform to highlight mitazalimab’s potential and engage in strategic partnering discussions.

Abstract information:

Title: Biomarkers associated with outcomes from OPTIMIZE-1: CD40 agonist mitazalimab with mFOLFIRINOX in patients with untreated metastatic pancreatic cancer
First Author: Philippe Cassier
Date and time: 2nd June 2025, 1.30 p.m. – 4:30 p.m CDT.
Session Title: Developmental Therapeutics—Immunotherapy
Sub Track: Tissue-Based Biomarkers
Abstract Number: 2624
Poster Board Number: 271
Abstract link