Dupilumab biosimilar(BiosanaPharma)

Kymera Therapeutics saw its stock jump more than 44% on Monday after releasing encouraging early results for its oral STAT6 degrader KT-621, as it looks to take on Sanofi and Regeneron's injectable immunology blockbuster Dupixent (dupilumab)."Building from the compelling preclinical data demonstrating a dupilumab-like profile, this impressive dataset – the first reported clinical data for a STAT6-targeted medicine – is a powerful demonstration of what we believe is an impeccable translation into humans," said Kymera CEO Nello Mainolfi."KT-621's degradation potency, tolerability and initial Th2 biomarker profile in healthy volunteers demonstrates its potential for the treatment of IL-4/IL-13-driven allergic diseases," he added.The Phase I study enrolled 118 healthy volunteers across single and multiple ascending dose (MAD) cohorts, with doses ranging from 1.5 mg to 800 mg. At all doses above 1.5 mg, KT-621 achieved >90% mean STAT6 degradation in blood, with complete degradation – defined as 95% or greater reduction – occurring at MAD doses of 50 mg and higher in both blood and skin tissue.The impact on Th2 biomarkers was a secondary focus. After 14 days, KT-621 was associated with median reductions of 37% for TARC and 63% for Eotaxin-3, a highly specific downstream cytokine of the IL-4/IL-13 pathway. Speaking of the TARC reduction, Kymera said the results were on par with or better than what has been seen in healthy volunteers taking Dupixent. Further, similar to the Dupixent healthy volunteer study, Kymera said changes in IgE levels in its trial were "minimal…given the low levels of IgE at baseline and the short duration of treatment."The company also reported an encouraging safety picture. There were no serious or severe adverse events, and no treatment-related adverse events (TRAEs) affecting more than one subject and none leading to discontinuation. "We expect a clean safety readout in the [healthy volunteer] data set to serve as an important clearing event for investor perception on the commercial viability of KT-621," Morgan Stanley analysts said in a recent note.Kymera is advancing KT-621 through its ongoing Phase Ib BroADen trial in moderate-to-severe atopic dermatitis patients, with data expected in the fourth quarter. It also plans to initiate parallel Phase IIb studies in atopic dermatitis and asthma in the fourth quarter of 2025 and first quarter of 2026, respectively.The progress comes as Kymera doubles down on immunology – shifting away from a previous focus on cancer, and concentrating resources on KT-621 alongside its Sanofi-partnered IRAK4 degrader KT-474 (SAR444656) programme and its TYK2 asset, KT-295.Kymera isn't alone in chasing STAT6. Coinciding with its announcement Monday, Sanofi said it agreed to pay $15 million to advance a similar drug from Nurix Therapeutics. Gilead Sciences and Johnson & Johnson have also invested in STAT6 programmes over the last six months.