Graviton BioScience Corporation Announces Publication of Positive Ph1b Trial Results for GV101 (TDI01) in Chronic Graft versus Host Disease in Signal Transduction and Targeted Therapy, by Beijing Tide Pharmaceutical
Graviton BioScience Corporation Announces Publication of Positive Ph1b Trial Results for GV101 (TDI01) in Chronic Graft versus Host Disease in Signal Transduction and Targeted Therapy, by Beijing Tide Pharmaceutical
* GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in chronic Graft versus Host Disease (cGvHD) patients who had failed at least two prior lines of therapy. * GV101's 24-week bORR exceeds published 6-month bORRs for all existing, approved steroid-refractory cGvHD therapies. * Failure-free survival (FFS) was 83.9% at 24 weeks and reached 89.4% at 400 mg (78.6% at 200 mg); this FFS also exceeds published 6-month FFS probabilities for all approved steroid-refractory cGvHD therapies. * Complete responses were observed in all but one organ system (only one participant had lower GI involvement). * Favorable safety profile with no evidence of hematopoietic toxicity and no increased incidence of infections. * The single Grade ≥3 adverse event occurring in ≥5% of participants was benign bilirubin elevation without transaminase elevation. This laboratory abnormality is related to reversible enzymatic (UGT1A1) and transporter (OATP1B3) inhibition by GV101. NEW YORK, Aug. 26, 2026 /PRNewswire/ -- Graviton BioScience Corporation, a privately held, clinical-stage biotechnology company, announced the publication of peer-reviewed data from a multicenter Phase Ib/II multi-dose, open-label clinical trial evaluating the safety, tolerability, and efficacy of GV101 in patients with moderate to severe chronic Graft versus Host Disease (cGvHD). The data, published in Signal Transduction and Targeted Therapy, a Springer Nature Portfolio journal, provide efficacy and findings from the 60 enrolled patients, 30 at 200 mg and 30 at 400 mg, who had previously received one to five prior systemic therapies for cGvHD.
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