On August 4, 2026 SHY Therapeutics ("SHY" or "the Company"), a clinical-stage biotechnology company developing small molecules that non-covalently target ATPases and GTPases and modulate their activity, reported that the first patient has been dosed in Luca-1, the Company’s first-in-human Phase 1 clinical trial evaluating SHY-ONC6, an investigational, novel and potentially first-in-class oral proteasome inhibitor for patients with advanced solid tumors. The Company expects initial Phase 1 data in 2027.
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"SHY-ONC6 targets the ubiquitin-proteasome system, which governs the degradation of damaged or unneeded proteins. Unlike current FDA-approved proteasome inhibitors that target the 20S Core Particle, SHY-ONC6 inhibits the ATPases within the 19S Regulatory Particle of the proteasome, introducing a novel and differentiated mechanism of proteasome inhibition," said Yaron Hadari, Ph.D., SHY’s Chief Executive Officer and Co-Founder.
While treatment with the current FDA approved proteasome inhibitors is limited to hematologic malignancies, SHY-ONC6 is being developed to expand this clinically validated therapeutic approach to solid tumors. Preclinical studies of SHY-ONC6 have demonstrated robust anti-tumor activity and favorable tolerability in multiple in vivo models of solid tumors, with similarly strong activity observed in hematologic malignancy models, supporting potential future development in additional cancer types.
"Dosing the first patient represents an important milestone as SHY advances its first clinical program and validates our strategy of developing differentiated small molecules against high-value ATPase and GTPase targets," said Michael Schmertzler, Executive Chairman and Co-Founder of SHY Therapeutics. "We believe SHY-ONC6 has the potential to expand the clinical utility of proteasome inhibition beyond hematologic cancers, addressing a much broader population of patients with solid tumors, and look forward to generating the first clinical data from the program next year," added Mr. Schmertzler.
The Luca-1 trial is a first-in-human, open-label, multicenter Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SHY-ONC6 in patients with advanced solid tumors. Additional information about the trial is available at ClinicalTrials.gov.
(Press release, SHY Therapeutics, AUG 4, 2026, View Source [SID1234669688])