On September 16, 2024 GV20 Therapeutics, a clinical-stage AI-based next generation biotherapeutics company, reported presentation of clinical results from its Phase 1/2 study of GV20-0251 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain (Press release, GV20 Therapeutics, SEP 16, 2024, View Source [SID1234646674]).
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Dr. Kristopher Wentzel from The Angeles Clinic and Research Institute gave an oral presentation on the clinical data from the monotherapy dose escalation portion of the ongoing study of GV20-0251, a first-in-class antibody targeting the novel immune checkpoint IGSF8, in patients with advanced solid tumors (NCT05669430).
Key highlights from the presentation include:
Patient Population: The study enrolled 38 heavily pre-treated patients across six dose levels and two dosing schedules. The median age was 62 years, with a median of 4 prior lines of treatment.
Safety: GV20-0251 was well-tolerated across all dose levels (0.5 to 20 mg/kg) with no dose-limiting toxicities observed. Most of treatment-related adverse events were grade 1/2, with only one case of grade 3 pneumonitis reported.
Efficacy: Two confirmed partial responses were observed in 12 efficacy-evaluable metastatic cutaneous melanoma patients. Additionally, 14 of 29 efficacy-evaluable patients showed stable disease, including 4 with tumor shrinkage.
Pharmacokinetics: Dose-proportional pharmacokinetics with half-life around 25.6 days and full target occupancy on circulating T cells were observed at doses ≥ 3 mg/kg.
Click here to access the ESMO (Free ESMO Whitepaper) presentation.
"We are excited by these encouraging results for GV20-0251, which represent a significant milestone as the first clinical data for an AI-designed antibody against an AI-predicted target," said Dr. Shirley Liu, Co-founder and Chief Executive Officer of GV20 Therapeutics. "The favorable safety profile and preliminary efficacy signals, particularly in melanoma patients, support the potential of IGSF8 as a novel immune checkpoint target."
GV20-0251 is designed to enhance NK cell killing of malignant cells, upregulate dendritic cell antigen presentation, and increase T cell signaling. This mechanism of action may be particularly relevant for patients with antigen presentation-deficient tumors, which are often resistant to current immune checkpoint inhibitors.
The company is currently recruiting anti-PD1-relapsed and refractory cancer patients to be treated by GV20-0251 in combination with pembrolizumab to further evaluate the drug safety, pharmacokinetics, pharmacodynamics, and efficacy.