BriaCell Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer

On July 15, 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 a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612 ) in metastatic breast cancer (Press release, BriaCell Therapeutics, JUL 15, 2025, View Source [SID1234654405]).

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BriaCell’s Phase 3 study now has 69 active clinical sites across 15 states, including Mayo Clinic, DHR Health Oncology Institute, Hematology Oncology Associates of Fredericksburg, Los Angeles Cancer Network, Manhattan Hematology/Oncology Associates, New York Cancer & Blood Specialists, Northwestern University, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Texas Oncology-Baylor Charles A. Sammons Cancer Center, and University of Arizona.

"We are very excited to be working with renowned clinical experts at a leading cancer center like Mayo Clinic, who also participated in BriaCell’s Phase 2 study," stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We strongly believe that our novel immunotherapy has the potential to transform cancer care for patients and their families."

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor (CPI) versus physician’s choice in advanced metastatic breast cancer (Bria-ABC).

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. BriaCell recently (ASCO 2025) announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

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.

Tvardi Therapeutics to Participate in the BTIG Virtual Biotechnology Conference

On July 15, 2025 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, reported that the Company’s Management will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Wednesday, July 30, 2025 at 4:40 PM ET and participate in one-on-one investor meetings (Press release, Tvardi Therapeutics, JUL 15, 2025, View Source [SID1234654398]).

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The webcast of the fireside chat will be accessible on the Tvardi Investors’ website. A replay of the webcast will be available for approximately 60 days following the conference.

Oncomatryx Biopharma Awarded €12.5 Million EIC Accelerator Funding to Advance Groundbreaking ADCs

On July 15, 2025 Oncomatryx Biopharma, a biotechnology company pioneering next-generation Antibody-Drug Conjugates (ADCs) for oncology, reported that it has been awarded funding from the European Innovation Council (EIC) Accelerator under the EU’s Horizon Europe 2021-2027 Research and Innovation Program (Press release, Oncomatryx, JUL 15, 2025, View Source [SID1234654397]).

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As part of this highly competitive program, Oncomatryx will receive €2.5 million in grant funding, along with a €10 million equity investment in its upcoming financing round. The EIC Accelerator call attracted 959 applications, with only 40 companies selected across 16 countries. Oncomatryx is proud to be the only oncology company among this distinguished group.

"Securing EIC Accelerator funding is a major milestone for Oncomatryx and a strong validation of our innovative approach to oncology drug development," said Laureano Simón, CEO of Oncomatryx. "This funding will enable us to advance the expansion cohorts of our ongoing Phase I clinical trial in pancreatic, colorectal, and lung cancer, following highly promising results in the dose-escalation phase. We are honored to be recognized as Europe’s leading ADC platform and contribute to advancing new treatment options for patients with hard-to-treat solid tumors."

Oncomatryx’s unique ADC platform integrates proprietary novel payloads and advanced conjugation formats. With fully integrated R&D, chemistry, and conjugation facilities, Oncomatryx stands out as Europe’s most advanced ADC development platform, from discovery through to clinical-stage development. The company’s novel approach combines a deep understanding of the tumor microenvironment biology with proprietary payloads and linker technologies, positioning Oncomatryx as a strategic leader in oncology innovation.

Oncomatryx is currently advancing its lead ADC candidate, OMTX705, in clinical trials targeting Fibroblast Activation Protein in aggressive tumors with high unmet medical need. Encouraging clinical data have been presented at ASCO (Free ASCO Whitepaper) 2025 meeting. Ninety five patients were treated in the dose escalation and 3 backfilling cohorts of metastatic immune-cold solid tumors. An outstanding safety profile, with no dose limiting toxicity was shown, as well as long responses in patients expressing FAP. Randomized clinical trials are ongoing in immune-cold metastatic pancreatic, MSS colorectal and non-small cell lung cancer.

In addition to this recognition from the European Union, Oncomatryx has been designated a strategic company by both the Government of Spain and the Basque Regional Government. The Spanish government R&D funding body, CDTI through Innvierte co-investment initiative for strategic companies and the Basque Regional Government have both invested directly in Oncomatryx, acknowledging its pivotal role in advancing oncology innovation. Together with the EIC Accelerator award, these endorsements firmly position Oncomatryx as a european leading player in Oncology and the ADC field."

Shorla Oncology Announces FDA Orphan Drug Designation for SH-110 to Treat Rare Brain Cancer Using Oral Liquid

On July 15, 2025 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for SH-110, a palatable oral suspension to treat Glioma – a rare brain cancer – by providing a liquid form of treatment for patients who have difficulty swallowing (Press release, Shorla Oncology, JUL 15, 2025, View Source [SID1234654396]).

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While SH-110 will increase coverage and compliance by allowing more flexibility in dose preparation and site of care, its biggest impact will be for patients with Glioma who develop dysphagia, or have difficulty swallowing. These patients often rely on obtaining compounded treatments from a specialized pharmacy or self-compound capsules to fight their disease.

"For too long, many patients with Glioma and their pharmacists and caregivers had no other choice but to break open capsules and expose themselves to unnecessary hazards," said Sharon Cunningham, chief executive officer of Shorla. "SH-110 is a proprietary product that offers them a safer and more convenient formulation to treat this rare brain cancer."

SH-110 will join a growing portfolio of patient-friendly cancer medications developed by Shorla that have recently been approved by regulators.

"This is a difference maker in the lives of those who suffer from Glioma," said Orlaith Ryan, chief technical officer and co-founder of Shorla. "SH-110 complements our other Shorla treatments that are designed to be easier for patients to use, and for caregivers and providers to administer."

According to the National Brain Tumor Society, about 13,000 adults and 2,000 children are diagnosed each year in the U.S. with Glioma, an orphan disease.

About SH-110

SH-110 is a palatable oral suspension to treat Glioma addressing the unmet medical need for patients with difficulty swallowing. This proprietary product will benefit patients by reducing treatment burden and providing a palatable age-appropriate treatment. SH-110 represents the third oral liquid in Shorla’s growing portfolio of products.

Spear Bio Announces Strategic Partnership with Bio-Techne to Accelerate the Deployment of Its Next-Generation Immunoassay Technology

On July 15, 2025 Spear Bio, a biotechnology company pioneering homogeneous ultrasensitive immunoassay technology, reported a strategic distribution partnership with Bio-Techne Corporation (NASDAQ: TECH), a global leading provider of innovative reagents, instruments, and solutions for life-science research and clinical diagnostics (Press release, Bio-Techne, JUL 15, 2025, View Source [SID1234654395]). The partnership significantly expands global access to Spear Bio’s groundbreaking SPEAR UltraDetect immunoassays, focusing initially on the neurology research market. The introductory SPEAR UltraDetect offering targets biomarkers pivotal to neurodegenerative diseases, such as phosphorylated tau 231 (pTau 231), phosphorylated tau 217 (pTau 217), glial fibrillary acidic protein (GFAP), and neurofilament light (Nf‑L). This partnership follows Bio-Techne’s participation in Spear Bio’s $45 million Series A funding round in 2024.

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Early detection of protein biomarkers is essential for understanding historically challenging disease mechanisms, developing early interventions, and advancing clinical trials. Spear Bio’s Successive Proximity Extension Amplification Reaction (SPEAR) platform, based on breakthrough technology licensed from Harvard University, and amplified using conventional qPCR instrumentation, offers sensitivity two to three orders of magnitude higher than current immunoassay platforms.

"Partnering with Spear Bio marks an exciting step in our mission to advance biomarker detection in neurodegenerative disease research," said Will Geist, President of Bio-Techne’s Protein Sciences Segment. "By leveraging Bio-Techne’s global reach and immunoassay expertise with Spear Bio’s ultrasensitive technology, we are equipping researchers with innovative tools to detect and study critical biomarkers with unmatched precision and sensitivity."

With Bio-Techne’s global reach, Spear Bio is well-positioned to accelerate the deployment of its next-generation assay technology, enabling researchers to detect biomarkers in historically challenging conditions. Spear Bio’s initial focus is neurodegenerative diseases, with the technology relevant for inflammation, oncology and additional fields. In addition, Spear Bio’s advanced detection technology expands applications in high-growth markets, including early neurodegenerative disease diagnosis, enhancing patient access to critical interventions.

"Our strategic partnership with Bio-Techne represents a transformative opportunity for neurodegenerative disease research," said Feng Xuan, PhD, Founder and CEO of Spear Bio. "By combining Bio-Techne’s global distribution network and market leadership with Spear Bio’s next-generation immunoassay technology, we are empowering researchers worldwide to investigate earlier disease mechanisms, improve patient stratification in clinical trials, and accelerate the development of new treatments for neurological disorders."

This partnership underscores the promise of Spear Bio’s SPEAR technology and reinforces Bio-Techne’s commitment to advancing biomarker detection.