On June 17, 2025 NAYA Therapeutics, a clinical-stage biopharmaceutical company dedicated to pioneering the next generation of cancer immunotherapies, reported that it is expanding its comprehensive hepatocellular carcinoma (HCC) pipeline with the addition of NY-700, a first-in-class GPC3-targeted Astatine-211 (211At) alpha radioimmunotherapy aiming to address residual disease, micro-metastasis, and post-immunotherapy failures (Press release, NAYA Therapeutics, JUN 17, 2025, View Source [SID1234656502]). NAYA’s HCC franchise also includes NY-303, a GPC3/NKp46/CD16-targeting NK engager bifunctional antibody entering Phase I/II as monotherapy in patients not responding to immunotherapy, and NY-500, a PD-1/VEGF bifunctional antibody positioned as a first-line immunotherapy.

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"We are excited to enter the rapidly growing field of radiopharmaceuticals with a first-in-class targeted alpha therapy with potential key advantages over existing alternatives," commented NAYA CEO Dr. Daniel Teper. "We believe that our GPC3-targeted Astatine-211 alpha radioimmunotherapeutic has the potential to transform HCC patient outcomes as a monotherapy in metastatic patients and in combination with immunotherapy at earlier stages of the disease. NAYA is committed to leveraging rapidly-scaling Astatine-211 global supply networks to ensure worldwide patient access. With its three novel and complementary HCC candidates addressing different stages of the disease, NAYA is positioned for leadership in one of the largest, fastest-growing solid tumor indications in which a majority of patients still fail to respond to standard-of-care."

NY-700 consists of an Astatine-211 isotope conjugated to our GPC3-internalizing antibody through a proprietary linker. Astatine-211, an alpha emitter radionuclide with a short half-life, high tumor specificity, and short-range cytotoxicity, shows promise to address the limitations of existing alpha emitters such as Actinium 225, which include bone marrow toxicity and decay management. GPC3 is expressed on up to 90% of HCC cells but not on healthy adult cells, enhancing precision targeting. HCC models have demonstrated that internalization of the GPC3 ligand allows intracellular delivery of the payload, inducing localized DNA damage and increasing cytotoxicity. Initial clinical data with GPC3-targeting Actinium 225 radioconjugates has shown promising efficacy in HCC.