BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study

On July 31, 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 addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 31, 2025, View Source [SID1234655022]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The randomized Phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe BriaCell’s Phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer," stated Kelly E. McCann, MD, PhD, Breast Medical Oncologist, and Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center. "We are excited to support this important study and anticipate strong patient enrollment through our large multi-center clinical site."

"The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrollment and execution," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We remain confident in our timeline for sharing top-line data in 2026."

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor against physician’s choice in patients with advanced metastatic breast cancer. This design builds upon maturing positive survival data from BriaCell’s Phase 2 study, most recently presented at ASCO (Free ASCO Whitepaper) 2025, which evaluated the same combination in a similar MBC patient population . Notably, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .

H1 2025 results

On July 31, 2025 Ipsen reported first half 2025 financial results (Presentation, Ipsen, JUL 31, 2025, View Source [SID1234654821]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Ipsen delivers strong results in the first half of 2025 and upgrades its full-year guidance

On July 31, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2025 (Press release, Ipsen, JUL 31, 2025, View Source [SID1234654820]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Revisions to patient enrollment

On July 31, 2025 Pyxis Oncology, Inc.’s (the "Company") reported revisions to patient enrollment participants related to Phase 1 monotherapy clinical trial to evaluate micvotabart pelidotin ("MICVO", formerly PYX-201) were made available on ClinicalTrials.gov (Press release, Pyxis Oncology, JUL 31, 2025, View Source [SID1234654730]). This clinical trial is a first-in-human, open-label, multicenter, Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Micvo in participants with advanced solid tumors and includes a part 1 dose escalation and part 2 dose expansion (NCT05720117).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Consistent with the industry practices, the revision in patient enrollment participants reflects the maximum number of patients that will be allowed to be enrolled as per protocol. The Company confirms its prior guidance related to estimated number of head and neck squamous cell carcinoma ("HNSCC") patients to be enrolled in the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study as disclosed in its quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2025.

Genvira and Labskin Receive £1.2 Million ($2.0 Million) UK–Canada Collaboration Award to Advance Immunotherapies for Malignant Melanoma

On July 31, 2025 Genvira Biosciences Inc. ("Genvira"), a Canadian innovator in next-generation viral vectors, Labskin Limited ("Labskin"), a leader in 3D in vitro human skin models, and the National Research Council of Canada (NRC) reported the launch of a collaborative project to develop novel immunotherapies for malignant melanoma (Press release, Genvira Biosciences, JUL 31, 2025, View Source [SID1234654697]). The collaboration is receiving advisory services and up to £1.2 million ($2.0 million) in funding through the Canada–UK Biomanufacturing of Biologics and Advanced Therapies program. UK participants are supported by Innovate UK, part of UK Research and Innovation (UKRI), while in Canada, support for the project is offered through the NRC Industrial Research Assistance Program (NRC IRAP) and the NRC Collaborative Science and Technology Innovation Program (NRC CSTIP).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Malignant melanoma continues to be a serious global health concern, with an estimated 330,000 new cases and 60,000 deaths each year. This international partnership aims to address the unmet need by developing cutting-edge cancer vaccines and optimizing targeted antigen delivery systems.

As part of the collaboration, Labskin will utilize its expertise in advanced disease modeling to develop a novel 3D human skin model of melanoma, enabling in vitro testing of vaccine candidates. Genvira will contribute its proprietary viral vector and gene delivery platforms, while the NRC will support the integration of mRNA technologies to engineer innovative, targeted immunotherapies tailored to melanoma.

Dr. Nicola Kingswell, Scientific Director at Labskin Limited, stated:

"We’re extremely grateful to Innovate UK for supporting this exciting project. It represents a step-change in the treatment of malignant melanoma, which will benefit many patients worldwide. This partnership will not only produce and validate new immunotherapies, but also establish a framework for developing future cancer therapeutics."

Dr. Jiahu Wang, President of Genvira Biosciences, added:

"We’d like to thank NRC IRAP for their support, and the NRC for their collaborative role. This partnership enables us to rapidly translate our viral vector technologies into clinical applications for melanoma and lays the groundwork for broader advances in cancer immunotherapy."

The project brings together unique and complementary strengths in 3D tissue engineering, gene and viral therapy, mRNA technology, and advanced biomanufacturing. In addition to therapeutic development, the consortium will focus on scalable production processes, quality control assays, and robust technologies to enable rapid response to future healthcare challenges.

This initiative highlights the importance of international collaboration in driving innovation and accelerating the development of advanced biologics and therapies.