GV20 Therapeutics Presents Updated Phase 1 Monotherapy Data on GV20-0251 at the ASCO Annual Meeting 2025

On June 2, 2025 GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, reported that Dr. Kristopher Wentzel from the Angeles Clinic and Research Institute presented updated clinical and translational data of GV20-0251 monotherapy from the ongoing Phase 1/2 clinical trial evaluating GV20-0251 in patients with advanced solid tumors resistant to anti-PD(L)1 and other standard therapies (NCT05669430) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting (Press release, GV20 Therapeutics, JUN 2, 2025, View Source [SID1234653641]). GV20-251 is the first clinical stage, AI-designed antibody therapeutic against an AI-predicted target in the clinic.

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The presentation highlights favorable safety profile, promising monotherapy efficacy, substantial immune activation, and desirable pharmacokinetic properties in patients with advanced solid tumors.

Key highlights from the presentation:

Favorable safety profile
No dose-limiting toxicity up to 20mg/kg, highest dose tested
All treatment-related adverse events (TRAEs) are grade 1 or 2, except 1 grade 3 TRAE
Monotherapy efficacy
3 confirmed partial responses and 3 more with tumor shrinkage (ORR 33.3%, DCR 66.7%) observed in 9 patients with cutaneous melanoma with primary resistance to anti-PD1
2 of the 3 partial responders have liver metastasis with 1 on treatment > 14 months
Additional tumor shrinkage in non-small cell lung cancer and cervical cancer
Translational insights
Linear PK with T1/2 of 26 days and full target occupancy observed with top two dose levels
Substantial immune activation with increased T and NK cell infiltration observed with treatment, consistent with the mechanism of action and preclinical findings

Detail of the presentation can be found on gv20tx.com.