ECEESPE2025 Poster Presentations Thyroid (141 abstracts)
Biological activity and therapeutic potential of SAFA-based long-acting rhTSH
Daham Kim 1 , Min Jeong Kang 1 , So Jeong Lee 1 , Yoon Hee Cho 2 , Gunuk Zi 3 , Jeongsuk An 3 , Jinjoo Park 3 , Jaekyu Han 3 , Susan Chi 3 , Sang-hoon Cha 3 & Eun Jig Lee 1
1Yonsei University College of Medicine, Department of Internal Medicine, Institute of Endocrine Research, Seoul, South Korea; 2Yonsei University College of Medicine, Department of Tropical Medicine, Seoul, South Korea; 3Kangwon National University, Aprilbio Co., Ltd., Rm 602, Biomedical Science Building, Chuncheon, South Korea
JOINT268
Thyrogen, a recombinant human thyroid-stimulating hormone (rhTSH), has a short half-life in the bloodstream, which necessitates multiple doses during treatment. Therefore, we developed a new long-acting rhTSH using anti-serum albumin Fab-associated (SAFA) technology to validate its biological activity through in vitro assays, pharmacokinetic (PK) studies in healthy mice, and pharmacodynamics (PD) studies in a TSH-suppressed mouse model. SAFA-TSH was produced using a Chinese hamster ovary expression system. To verify its biological activity, we generated Nthy-ori 3-1 cells stably overexpressing TSHR and measured the production of cyclic adenosine monophosphate (cAMP). In a rat study, slow-release triiodothyronine (T3) pellets were implanted 3 days before administering Thyrogen or SAFA-TSH, to measure the amount of thyroxine (T4) release alone resulting from exogenous administration. SAFA-TSH increased cAMP production dose-dependently, but less effectively than Thyrogen at similar concentrations. SAFA-TSH required six times the dose of Thyrogen to achieve similar cAMP levels, likely due to differences in molecular weight and relative bioactivity. In a rat study, SAFA-TSH produced elevated thyroid hormone levels well after the decline in the response to Thyrogen. SAFA-TSH had significantly higher cumulative effects on T4 and free T4 levels compared with Thyrogen, as observed by a more than two-fold higher average area under the effect curve of 262.56 vs 118.89 μg×h/dl and 127.47 vs 60.75 μg×h/dl, respectively. SAFA technology created successful long-acting TSH that demonstrated bioactivity. These findings endorse the continued development of SAFA-TSH for clinical use, highlighting its potential as a significant advancement treating thyroid cancer patients.
Volume 110
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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