SK Biopharmaceuticals Acquires Second Radiopharmaceutical Therapy Candidate

Introduction of Radiopharmaceutical Candidate 'WT-7695'
through Technology Transfer from the University of Wisconsin's Research Foundation

On November 27, SK Biopharmaceuticals announced that it has signed a license-in agreement with the Wisconsin Alumni Research Foundation (WARF), the technology transfer office of the University of Wisconsin, to acquire the global development and commercialization rights for the radiopharmaceutical therapy (RPT) candidate 'WT-7695'.

Since introducing its first RPT candidate, 'SKL35501', last year, SK Biopharmaceuticals has entered into actinium-225 (225Ac) supply agreements with global radioisotope production companies such as TerraPower in the United States and PanTera in Belgium. The company has also strengthened its RPT business foundation through ongoing research collaborations with various institutions and companies, including the Korea Institute of Radiological & Medical Sciences. Currently, preparations for submitting an Investigational New Drug (IND) application for 'SKL35501' to enter Phase 1 clinical trials are progressing smoothly.

'WT-7695' is a preclinical-stage, small-molecule RPT candidate targeting carbonic anhydrase IX (CA9), a surface protein on cancer cells. It is considered to have best-in-class potential in its field. CA9 expression increases in hypoxic environments and plays a critical role in cancer cell growth and metastasis. Notably, CA9 is a validated target that is overexpressed in more than 95% of patients with clear cell renal cell carcinoma, making it a highly suitable target for RPT, which selectively delivers radioactive agents to cancer cells.

Additionally, in preclinical studies, 'WT-7695' demonstrated both efficacy and safety with a single administration using both lutetium-177 (177Lu) and 225Ac labels. Based on these results, SK Biopharmaceuticals will first begin development of a 177Lu-based therapeutic, while also considering the potential expansion to 225Ac-based treatment options in the future. The company also plans to develop a diagnostic agent using gallium-68 (68Ga) for the same target molecule, aiming to create a theranostics pair with the 177Lu therapeutic. 68Ga is a widely used radioisotope for cancer diagnostics and, when bound to the target molecule, enables rapid and accurate identification of RPT-eligible patients through imaging techniques such as PET/CT.

Eric Iverson, CEO of WARF, stated, "This candidate licensing agreement is a meaningful achievement that demonstrates the potential of the CA9 target in the journey toward therapeutic innovation for patients worldwide. This partnership is built on the research capabilities and vision of both organizations, and we will continue to work closely together to deliver new treatment options to patients more quickly."

Lee Donghoon, CEO of SK Biopharmaceuticals, said, "With the acquisition of WT-7695 following the introduction of our first RPT candidate, SKL35501, last year, our RPT portfolio has become even more robust. The IND and global clinical trials for SKL35501 are proceeding as planned, and we are also accelerating the discovery of additional candidates through our own research. Through these efforts, we aim to internalize a more complete RPT value chain and establish ourselves as a global leading player."

This content was produced with the assistance of AI translation services.