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.

First Patient Enrolled in National Cancer Institute’s Vanguard Study Evaluating Guardant Health’s Shield Multi-Cancer Detection Test

On July 15, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that patient enrollment has begun in the National Cancer Institute (NCI)’s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology (Press release, Guardant Health, JUL 15, 2025, View Source [SID1234654394]). Guardant’s Shield MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—in future randomized controlled trials.

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Guardant’s Shield MCD test was chosen for the study based on the overall performance of its Shield platform in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The Vanguard study was initiated following review and approval by the U.S. Food and Drug Administration (FDA) as part of the NCI’s submission for an investigational device exemption (IDE).

"New screening technology like the Shield MCD test has the potential to detect multiple cancers earlier through a simple blood draw," said Craig Eagle, MD, Guardant Health Global Chief Medical Officer. "The earlier we can screen and diagnose cancers, the more options we can bring to patients and ultimately the more lives we can save. The Vanguard Study is a critical step in research to evaluate the role of this breakthrough technology in helping reduce cancer deaths."

The Vanguard Study, conducted by the Cancer Screening Research, a new NCI-sponsored clinical trials network, is enrolling individuals ages 45-75 who do not currently have cancer and who have not received a cancer diagnosis in the past five years. All participants will be offered standard cancer screenings as part of their care. Results from the study will inform the design of a much larger randomized controlled trial to evaluate the use of MCD tests for cancer screening.

"Initiation of the Vanguard Study is an exciting milestone, as we look to evaluate a new way to screen for cancer," said Scott Ramsey, M.D., Ph.D., director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center and principal investigator for the Vanguard Study. "The study will help us learn more about multi-cancer detection tests and assess whether they can help people from all backgrounds find cancer early, when it may be easier to treat."

The Shield MCD test recently received Breakthrough Device Designation from the FDA for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review.

Repare Therapeutics Enters Exclusive Worldwide Licensing Agreement with Debiopharm for Lunresertib

On July 15, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported it has entered into an exclusive worldwide licensing agreement with Debiopharm International S.A. ("Debiopharm"), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor (Press release, Repare Therapeutics, JUL 15, 2025, View Source [SID1234654393]).

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"The exclusive worldwide licensing agreement with Debiopharm allows for the continued development of lunresertib, a novel PKMYT1 inhibitor, that has demonstrated encouraging results across multiple clinical trials in difficult-to-treat solid tumors. This agreement builds upon the success of Repare and Debiopharm’s existing collaboration studying the combination of lunresertib and Debio 0123," said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "Our recent business development efforts have continued to enable Repare to focus on the advancement of our clinical priorities and sustained value creation. We remain focused on two ongoing Phase 1 clinical trials with readouts expected in the second half of 2025: the LIONS trial evaluating our RP-1664 PLK4 inhibitor and the POLAR trial evaluating our RP-3467 Polθ ATPase inhibitor."

Under the terms of the agreement, Repare will receive a $10 million upfront payment, and is eligible to receive up to $257 million in potential clinical, regulatory, commercial and sales milestones, including up to $5 million in potential near-term payments, and single-digit royalties on global net sales. Repare and Debiopharm entered into a clinical study and collaboration agreement in January 2024 to explore the synergy between lunresertib and Debio 0123, a potential best-in-class, brain penetrant and highly selective WEE1 inhibitor. Debiopharm will assume sponsorship of the MYTHIC study and take over existing and future development activities related to lunresertib.

"We are excited to enter into this worldwide license agreement with Repare for lunresertib. Based on very promising Phase 1/1b clinical data, we believe the combination of lunresertib and Debio 0123 is highly synergistic and could potentially drive rapid and deep tumor regressions," said Bertrand Ducrey, CEO of Debiopharm. "We believe the synthetic lethality approach of lunresertib in combination with Debio 0123 will allow us to bring this innovative precision therapy to patients with difficult to treat cancers."

Continued Prioritization of RP-3467 and RP-1664

Moving forward, Repare will remain focused on the advancement of its two ongoing Phase 1 clinical trials, POLAR and LIONS. The POLAR clinical trial is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467, a small molecule inhibitor of polymerase theta (Polθ) that is a synthetic lethality target associated with BRCA mutations and other genomic alterations, alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. Topline safety, tolerability and early efficacy data from the Phase 1 POLAR clinical trial of RP-3467 alone and in combination with olaparib is expected in the third quarter of 2025. The LIONS clinical trial is a first-in-human, multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664, a first-in-class, highly selective, oral inhibitor of Polo-like kinase 4 (PLK4) that is a synthetic lethality target associated with TRIM37 overexpression. Initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS clinical trial of RP-1664 is expected in the fourth quarter of 2025.