New radiopharmaceutical asset 'WT-7695' introduced at U.S. WARF
[by Yu, Suin] SK Biopharmaceuticals reported on November 27 the signing of a license-in agreement with the Wisconsin Alumni Research Foundation (WARF), the technology transfer arm of the University of Wisconsin-Madison, securing global development and commercialization rights for the radiopharmaceutical candidate ‘WT-7695 (development code).’
The agreement is valued at up to KRW 842.5 billion (approximately USD 575.3 million), comprising an upfront payment of KRW 21.9 billion and KRW 820.7 billion allocated to development, regulatory approval, and commercialization milestones. Post-launch royalties are also included, payable upon product release.
The agreement grants SK Biopharmaceuticals global rights for the research, development, production, and commercialization of ‘WT-7695 (development code),’ a CA9-targeting radiopharmaceutical candidate under development by WARF. WT-7695 is a small-molecule-based radiopharmaceutical technology engineered to selectively bind to carbonic anhydrase IX (CA9), a membrane protein highly expressed in various solid cancers, such as renal, pancreatic, and colon cancers, and to enable targeted delivery of radioisotopes to cancer cells.
The agreement term extends for 10 years from product launch until expiration of the material patent or until lapse of regulatory approval exclusivity, whichever occurs first.
Since introducing its first RPT 라이트닝 바카라 사이트, SKL35501 (development code) in 2024, SK Biopharmaceuticals has secured supply agreements for actinium-225 (225Ac) with major global radioisotope developers, including TerraPower in the U.S. and PanTera in Belgium. In parallel, the company has expanded its RPT development ecosystem through sustained collaborations with key research institutions and industry partners, such as the Korea Institute of Radiological & Medical Sciences, reinforcing its foundational capabilities in the radiopharmaceutical sector. SKL35501 is currently in the final stages of preclinical development, preparing for Investigational New Drug (IND) submission for Phase 1 clinical trials.
WT-7695 is a small molecule, preclinical RPT 라이트닝 바카라 사이트 targeting CA9, a cell-surface protein expressed in cancer cells, and is regarded as a potential best-in-class novel therapy in its category. CA9 expression increases under hypoxic (oxygen-deficient) conditions, playing a key role in tumor cell proliferation and metastasis. Importantly, CA9 is a validated target, found to be overexpressed in more than 95% of patients with clear cell renal cell carcinoma (CRCC), making it a highly promising target for RPT, which uses radioactive isotopes to selectively deliver radioactive materials to cancer cells.
Furthermore, in the preclinical phase, WT-7695 showed single-dose efficacy and safety using both lutetium-177 (177Lu) and actinium-225Ac (225Ac). On this basis, 라이트닝 바카라 사이트 Biopharmaceuticals intends to prioritize initial clinical development of a 177Lu-based therapeutic while exploring the feasibility of later expanding 225Ac-based treatment options.
In addition, the company plans to develop a gallium-68 (68Ga)-based diagnostic for the same target molecule, creating a theranostic pair with a 177Lu therapeutic. 68Ga, a radioisotope widely used in oncology imaging, can bind to target molecules to enable rapid and precise identification of patients eligible for 라이트닝 바카라 사이트 through imaging techniques such as PET/CT.
"This candidate license agreement is a significant milestone reflecting the therapeutic potential of the CA9 target in our journey to transforming treatment for patients worldwide. The partnership is grounded in the research capacity and shared vision of both parties, and we will continue working closely to accelerate patient access to novel treatment options," said Erik Iverson, CEO of WARF.
“Following the introduction of our first RPT candidate, SKL35501, last year, the addition of WT-7695 further strengthens our RPT portfolio. SKL35501’s IND filing and global clinical studies are progressing as planned,” stated Lee Dong-hoon, CEO of SK Biopharmaceuticals. “We are concurrently accelerating the acquisition of new candidates through internal discovery efforts, and we intend to internalize a more complete RPT value chain, reinforcing our commitment to becoming a leading global player,” he added.