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]).

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 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.

On July 15, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported it has received notification of allowance from the China National Intellectual Property Administration (CNIPA) for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry (Press release, BioAffinity Technologies, JUL 15, 2025, View Source [SID1234654378]).

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!

China represents a large prospective market for CyPath Lung with more than 300 million people who smoke, or nearly one-third of the world’s total smokers, according to the World Health Organization. The China cancer registry estimated 1.06 million new cases of lung cancer were diagnosed in 2022.

"This patent is another step forward in our strategy to safeguard and expand the reach of our proprietary diagnostic platform internationally," said Maria Zannes, President and CEO of bioAffinity Technologies. "With lung cancer representing a major health burden globally and particularly in China, we believe that securing this intellectual property positions us well for future opportunities in one of the world’s largest and most underserved healthcare markets. It reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives."

The newly allowed Chinese patent—titled "System and Method for Determining Lung Health"—protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.

CyPath Lung is the Company’s first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. In the study, CyPath Lung detected all forms of lung cancer and 80% of cancers that were Stage 1.

This newly allowed patent complements bioAffinity’s expanding global patent estate, which now includes multiple patents in the U.S, China, Japan, Australia, Mexico, Canada and the EU.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

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.

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!

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.

On July 15, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported that the United States Patent and Trademark Office ("USPTO") issued the Company a new composition of matter patent for certepetide through March 2040, with subsequent opportunity for patent term extension (Press release, Lisata Therapeutics, JUL 15, 2025, View Source [SID1234654379]).

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!

A composition of matter patent is the strongest form of intellectual property ("IP") protection, safeguarding the unique chemical structure of a substance. The U.S. Patent No. 12,351,653 includes claims to certepetide’s chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumor cancers. For Lisata, securing this patent is profoundly significant as it not only strengthens Lisata’s robust IP estate, but, more importantly, grants exclusive rights to the drug itself, preventing others from manufacturing or selling it.
"This new patent marks a key milestone, significantly boosting the value of both certepetide and the Company by delaying generic encroachment for essentially the next two decades," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "This extended patent protection aids our commercialization efforts by offering long-term market exclusivity and enhances the potential future development and commercialization of certepetide. It not only secures our IP but also greatly strengthens our negotiating position with potential partners, increasing the potential for sustained growth and value creation for our shareholders."

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

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.

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!

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.