GV20-0251 / GV20 Therap - LARVOL DELTA

GV20 Therapeutics to Present Updated Phase 1 Monotherapy Data on GV20-0251 at the ASCO Annual Meeting 2025 (PRNewswire) - "GV20 Therapeutics (GV20)...today announced that Dr. Kristopher Wentzel from the Angeles Clinic and Research Institute will present updated clinical and translational data of GV20-0251 monotherapy at the American Society of Clinical Oncology 2025 Annual Meeting, taking place in Chicago, IL on May 30- June 3, 2025....This presentation at ASCO builds on previously presented clinical data of the novel immune checkpoint IGSF8 inhibitor GV20-0251 (Wentzel et al, ESMO 2024) and will report updated clinical and translational findings from the monotherapy dose escalation portion of the ongoing Phase 1/2 trial evaluating GV20-0251 in patients with advanced solid tumors resistant to anti-PD(L)1 and other standard therapies."

P1 data • Melanoma

Preliminary monotherapy efficacy of novel immune checkpoint blockade GV20-0251 (anti-IGSF8) in advanced melanoma patients with primary resistance to anti-PD1. (ASCO 2025) - P1/2 | "GV20-0251 demonstrated a favorable safety profile in heavily pretreated patients with advanced solid tumors and showed promising monotherapy efficacy in cutaneous melanoma patients with primary resistance to anti-PD1."

Checkpoint block • Checkpoint inhibition • Clinical • IO biomarker • Metastases • Monotherapy • Cervical Cancer • Cutaneous Melanoma • Fatigue • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

GV20-0251-100: A Study of GV20-0251 Monotherapy and GV20-0251 in Combination with Pembrolizumab in Participants with Solid Tumor Malignancies (clinicaltrials.gov) - P1/2 | N=365 | Recruiting | Sponsor: GV20 Therapeutics | Phase classification: P1 ➔ P1/2 | N=268 ➔ 365 | Trial completion date: Jun 2026 ➔ Sep 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Combination therapy • Enrollment change • Metastases • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A phase I/II, open-label study of the novel checkpoint IGSF8 inhibitor GV20-0251 in patients with advanced solid tumors (ESMO 2024) - P1 | "GV20-0251, a first-in-class antibody against a novel immune checkpoint IGSF8, is safe and well-tolerated up to 20 mg/kg in heavily treated patients with advanced solid tumors, and demonstrates preliminary clinical efficacy. Additional enrollment, safety, PK, PD and efficacy data will be presented."

Clinical • Metastases • P1/2 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

GV20 Therapeutics Presents Promising Phase 1 Monotherapy Data on Novel Checkpoint Inhibitor GV20-0251 at ESMO Congress 2024 (PRNewswire) - P1 | N=268 | NCT05669430 | Sponsor: GV20 Therapeutics | "GV20 Therapeutics...announced presentation of clinical results from its Phase 1/2 study of GV20-0251 at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain....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."

P1 data • Bladder Cancer • Cholangiocarcinoma • Cutaneous Melanoma • Endometrial Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology • Rectal Cancer • Solid Tumor • Urothelial Cancer

GV20 Therapeutics to Present Clinical Data on GV20-0251 at the ESMO Congress 2024 (PRNewswire) - "GV20 Therapeutics...announced today that Dr. Kristopher Wentzel from The Angeles Clinic and Research Institute will present the clinical data on GV20-0251 monotherapy dose escalation at the ESMO Congress 2024, taking place in Barcelona on Sept 13-17, 2024."

P1/2 data • Bladder Cancer • Cholangiocarcinoma • Cutaneous Melanoma • Endometrial Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Oncology • Rectal Cancer • Solid Tumor • Urothelial Cancer

GV20 Therapeutics Announces Publication in Cell Highlighting the Discovery of IGSF8 as an Innate Immune Checkpoint and Cancer Immunotherapy Target (PRNewswire) - "GV20 Therapeutics...announced the publication of a peer-reviewed article...in the journal Cell....In this study, the authors discovered that tumors with antigen presentation defects over express IGSF8 which interacts with NK receptors to suppress NK cell cytotoxicity. A monoclonal antibody against IGSF8 increases NK cell killing of cancer cells in vitro. In multiple syngenetic tumor models, anti-IGSF8 alone or in combination with anti-PD1 potently inhibit tumor growth in vivo. These results support IGSF8 as a novel innate immune checkpoint that could be exploited as a therapeutic target, and led to the nomination of GV20's lead program, GV20-0251....'We look forward to advancing GV20-0251 into monotherapy cohort expansion and combination studies later this year.'"

Preclinical • Oncology • Solid Tumor

GV20 Therapeutics Announces Clinical Trial Collaboration to Evaluate GV20-0251, a First-in-Class Antagonist Antibody Against the Novel Immune Checkpoint IGSF8, in Combination with KEYTRUDA (pembrolizumab) (PRNewswire) - "GV20 Therapeutics...today announced that it has entered into a clinical collaboration and supply agreement with Merck (known as MSD outside the US and Canada). Under the terms of the agreement, GV20 will evaluate its lead investigational program GV20-0251, a first-in-class antibody targeting the novel immune checkpoint IGSF8, in combination with Merck's anti-PD-1 therapy, KEYTRUDA®(pembrolizumab), in patients with advanced solid tumors in an ongoing Phase I study."

Licensing / partnership • Oncology • Solid Tumor

IGSF8 is a novel innate immune checkpoint and cancer immunotherapy target (AACR 2024) - P1 | "IGSF8 is a novel innate immune checkpoint and cancer immunotherapy target. A phase 1 study is ongoing to explore the IGSF8 inhibitor GV20-0251 in patients with advanced or metastatic solid tumors (NCT05669430)."

IO biomarker • Melanoma • Oncology • Solid Tumor • PTPRC

GV20 Therapeutics Presents Preclinical Data on GV20-0251 for Solid Tumors Targeting IGSF8 at AACR Annual Meeting 2024 (PRNewswire) - "GV20 Therapeutics...presented preclinical data on it GV20-0251 program during an oral presentation at the American Association of Cancer Research (AACR) Annual Meeting 2024....The oral presentation at AACR included an overview on the company's novel discovery and development process of its lead antibody, GV20-0251, which antagonizes a novel cancer immunotherapy target, IGSF8....Anti-IGSF8 enhances NK cell killing, antigen presentation, and turns immune-cold tumors hot. In addition, anti-IGSF8 alone or in combination with anti-PD1 inhibits tumor growth in multiple models, including some known to resist anti-PD1 therapy."

Preclinical • Solid Tumor

GV20-0251: A First-in-Class Antibody Drug Targeting the Immune Checkpoint IGSF8 for Cancer Immunotherapy (FOB-USA 2024) - P1 | "Furthermore, GV20-0251 augments antigen presentation and unleash NK cell-mediated cytotoxicity pathways in in vivo models.Our preclinical evaluations, conducted across multiple syngeneic tumor models, have revealed that GV20-0251 has single-agent efficacy and is synergistic with anti-PD1 in controlling tumor growth. Given the potential of anti-IGSF8 to activate innate immunity, we have initiated a Phase 1 clinical trial (NCT05669430) to investigate GV20-0251 in patients with advanced or metastatic solid tumors."

IO biomarker • Oncology • Solid Tumor

GV20 Therapeutics Announces Oral Presentation on GV20-0251 for Solid Tumors Targeting IGSF8 at AACR Annual Meeting 2024 (PRNewswire) - "GV20 Therapeutics...announced today that its abstract was selected for an oral presentation at the American Association of Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10, 2024, in San Diego, CA."

Clinical • Solid Tumor

A Study of GV20-0251 in Patients With Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=268 | Recruiting | Sponsor: GV20 Therapeutics | N=76 ➔ 268 | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Rectal Cancer • Solid Tumor • Urothelial Cancer

IGSF8 is a novel innate immune checkpoint and cancer immunotherapy target (SITC 2023) - P1 | "Conclusions IGSF8 is a novel innate immune checkpoint and cancer immunotherapy target. A phase 1 study is ongoing to explore the IGSF8 inhibitor GV20–0251 in patients with advanced or metastatic solid tumors (NCT05669430)."

IO biomarker • Melanoma • Oncology • Solid Tumor • PTPRC

IGSF8 is an innate immune checkpoint and cancer immunotherapy target (ESMO 2023) - P1 | "Conclusions IGSF8 is a novel innate immune checkpoint and cancer immunotherapy target. Given the ability for anti-IGSF8 to activate innate immunity, a phase 1 study has been initiated to explore the IGSF8 inhibitor GV20-0251 in patients with advanced or metastatic solid tumors (NCT05669430)."

IO biomarker • Melanoma • Oncology • Solid Tumor

A Study of GV20-0251 in Patients With Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: GV20 Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of GV20-0251 in Patients With Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: GV20 Therapeutics

Metastases • New P1 trial • Oncology • Solid Tumor