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.

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]).

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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.

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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.

On July 15, 2025 CNS Pharmaceuticals presented its corporate presentation (Presentation, CNS Pharmaceuticals, JUL 15, 2025, View Source [SID1234654380]).

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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.