On July 15, 2025 Kairos Pharma, Ltd. (NYSE American:KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported positive safety results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Kairos Pharma, JUL 15, 2025, View Source [SID1234654382]). The interim safety analysis of the trial demonstrated that ENV-105, a first-in-class CD105 antagonist, was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first ten enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care. Notably, no Grade 3 or 4 toxicities were observed.

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"The favorable safety profile observed in this Phase 2 study is encouraging, as it validates our belief in ENV-105’s clinical potential and supports continued development in a patient population with limited effective treatment options," said John Yu, MD, Kairos Pharma CEO.

With one million men in the US being diagnosed with prostate cancer annually, and millions more worldwide, the development of resistance to current hormone therapies is a growing unmet need with an increasingly aging population. Castration-resistant prostate cancer refers to tumors that grow despite receiving hormone blocking agents. Treatment options remain limited after hormone therapies fail. Kairos Pharma seeks to provide a safe and effective alternative for these patients with ENV-105.

The randomized Phase 2 trial aims to enroll 100 patients in total and is presently accruing patients at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to evaluate the safety, tolerability, and early signs of efficacy of ENV-105, a CD105 antagonist, in men whose disease has progressed following standard hormone-based therapies. Interim efficacy data from the trial are expected to be reported in September 2025.

Kairos Pharma plans to engage with regulatory agencies to discuss the design of a potential pivotal Phase 3 study, based on emerging data.

On July 15, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported the appointment of Corleen Roche as Chief Financial Officer (CFO), effective August 6th, 2025 (Press release, Iovance Biotherapeutics, JUL 15, 2025, View Source [SID1234654381]).

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"I am pleased to welcome Corleen to Iovance at such an important stage in our first commercial launch," said Frederick G. Vogt, Ph.D., J.D., Interim Chief Executive Officer, President and General Counsel. "Corleen’s experience in executive financial leadership roles and multiple product launches will be invaluable as we focus on growing revenue, managing our balance sheet and advancing our mission of developing and delivering novel therapies to patients with solid tumors."

Ms. Roche has built an extensive track record throughout 30 years of experience in the biotech and life sciences industry, including executive financial leadership roles in publicly traded companies. Most recently she served as CFO of CG Oncology, a late-stage clinical biopharmaceutical company. Her previous roles included CFO of Immunome, U.S. CFO at Biogen, North America CFO of CSL Behring, and various CFO roles within Sandoz, Wyeth and Pfizer. During her career, Ms. Roche developed and executed on financial strategies to prepare for commercial launches including ZARXIO, the first U.S. approved biosimilar, GLATOPA, the world’s first complex generic for multiple sclerosis, and PREVNAR 13, a pneumococcal conjugate vaccine. She holds a B.A. in accountancy from Villanova University.

"I am excited to join Iovance to navigate our continued revenue growth and focus our pipeline investments on the highest value opportunities," stated Ms. Roche. "I am committed to the company’s patient-focused mission while achieving our financial goals to build a profitable biotechnology company."

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 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 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]).

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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.