Lisata and Kuva Labs Announce License for Solid Tumor Imaging

Lisata Therapeutics, a clinical-stage pharmaceutical company, has entered into a significant global collaboration and license agreement with Kuva Labs, a subsidiary of Mi2 Holdings, LLC. This partnership aims to advance non-invasive and precise cancer diagnostics. Under the agreement, Kuva will utilize Lisata's iRGD cyclic peptide product candidate, certepetide, within its NanoMark™ MR imaging platform technology. This combination is set to create a new class of advanced magnetic resonance (MR) imaging agents, facilitating the safe and definitive detection of solid tumors.

Kuva will take on the responsibility for the research, development, and commercialization of the NanoMark technology, while Lisata will provide certepetide. The collaboration includes an upfront license fee, potential substantial milestone payments, and royalties on future product sales, thereby adding significant value for both companies. Kristen K. Buck, M.D., Executive Vice President of Research and Development and Chief Medical Officer of Lisata, expressed enthusiasm for the partnership, highlighting the extension of certepetide's applications beyond solid tumor treatments to cancer diagnostics. This could enhance diagnostic accuracy, leading to earlier treatment and improved patient outcomes.

Andrew Hopkins, PhD, Chief Scientific Officer of Kuva Labs, underscored the importance of medical imaging in cancer detection and the limitations of current methods. He emphasized that the partnership with Lisata would leverage NanoMark's ability to selectively activate tumor cells, transforming cancer imaging and providing the first targeted, non-radioactive imaging option with unmatched contrast resolution. This advancement is expected to significantly improve the early detection and diagnosis of solid tumors.

Lisata Therapeutics is focused on discovering, developing, and commercializing innovative therapies for advanced solid tumors and other serious diseases. Certepetide, Lisata’s investigational drug, is designed to activate a novel uptake pathway, allowing co-administered or tethered anti-cancer drugs to selectively target and penetrate solid tumors more effectively. Lisata has established various commercial and research and development partnerships based on its CendR Platform® technology. The company anticipates announcing several milestones over the next 1.5 years and believes it has the capital to fund operations into early 2026, covering data milestones from ongoing and planned clinical trials.

Certepetide is an internalizing RGD (iRGD) cyclic peptide product designed to selectively activate the C-end rule active transport mechanism, resulting in more efficient tissue penetration by co-administered agents. It has shown favorable safety, tolerability, and clinical activity in oncology trials, enhancing the effectiveness of chemotherapy for pancreatic cancer and the combination of chemotherapy and immunotherapy in various solid tumors. Certepetide has potential applications beyond oncology, with its unique mechanism of action suggesting possibilities in non-oncology settings. It has received Fast Track designation and Orphan Drug Designation for pancreatic cancer in the U.S. and E.U., as well as designations for glioma, osteosarcoma, and cholangiocarcinoma in the U.S. Additionally, it has been recognized with Rare Pediatric Disease Designation for osteosarcoma.

Kuva Labs, founded in 2019, is a preclinical bioscience company developing the NanoMark direct MR imaging platform. Established after its founders experienced losses in cancer cases that could have been better managed with improved tools, Kuva aims to transform cancer diagnostics and treatment. The NanoMark platform enables selective imaging of solid tumors with high contrast and spatial resolution, without ionizing radiation, facilitating faster and more accurate diagnosis and treatment, leading to better patient outcomes. The platform's initial focus is on solid cancers, but it has the potential to target various tissues and introduce a new imaging modality.

This innovative collaboration between Lisata Therapeutics and Kuva Labs aims to revolutionize cancer diagnostics, potentially leading to significant advancements in early detection and treatment, thereby improving patient care and outcomes.