W0180 / Pierre Fabre - LARVOL DELTA

First-in-human phase 1 dose-escalation study of W0180, an anti-VISTA monoclonal antibody, with and without pembrolizumab in patients with locally advanced or metastatic solid tumours. (PubMed, BMJ Oncol) - P1 | "W0180 demonstrated manageable safety, preliminary signs of clinical activity with prolonged SD and dose-dependent pharmacodynamics consistent with preclinical data (even though MTD was not reached) in patients with locally advanced/metastatic tumours, both as monotherapy and in combination with anti-programmed cell death protein-1 therapy. NCT04564417."

First-in-human • IO biomarker • Journal • P1 data • CNS Disorders • Fatigue • Oncology • Solid Tumor • VSIR

First-in-human phase I of anti-VISTA monoclonal antibody W0180 with and without anti-PD-1 pembrolizumab in patients with locally advanced or metastatic solid tumors (AACR 2024) - P1 | "Analysis is ongoing to assess the RDE of W0180 + pembro and collect additional evidence of proof of mechanism in pts with solid tumors. NCT04564417"

Clinical • IO biomarker • Metastases • P1 data • Appendix Cancer • Head and Neck Cancer • Oncology • Solid Tumor • CD8 • PD-L1 • VSIR

First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=33 | Terminated | Sponsor: Pierre Fabre Medicament | N=69 ➔ 33 | Trial completion date: May 2024 ➔ Dec 2023 | Recruiting ➔ Terminated

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial termination • Oncology • Solid Tumor

First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: Pierre Fabre Medicament | Active, not recruiting ➔ Recruiting | Trial primary completion date: Oct 2022 ➔ Sep 2023

Combination therapy • Enrollment open • Metastases • Trial primary completion date • Lung Cancer • Oncology • Solid Tumor

First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=69 | Active, not recruiting | Sponsor: Pierre Fabre Medicament | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2022 ➔ Oct 2022

Combination therapy • Enrollment closed • Trial primary completion date • Lung Cancer • Oncology • Solid Tumor

"#PierreFabre and #Lonza Enter Manufacturing Agreement for #W0180 #Antibody Drug Product https://t.co/gQJntPE0VX" (@1stOncology)

Pierre Fabre and Lonza Enter Manufacturing Agreement for W0180 Antibody Drug Product (PRNewswire) - "Lonza...announced today that the companies have entered into a manufacturing agreement. This collaboration is aimed at manufacturing W0180, an innovative monoclonal antibody discovered by Pierre Fabre targeting the VISTA checkpoint, currently being investigated as a single agent and in combination with pembrolizumab in a Phase I clinical trial (NCT04564417) in various solid tumors. Lonza will provide cGMP drug product (DP) manufacturing services for clinical supply from its fill and finish facility at Stein, Switzerland."

Licensing / partnership • Oncology • Solid Tumor

[VIRTUAL] W0180 novel anti-VISTA antibody: Rationale for target patient population and first-in-human trial design in monotherapy and in combination with anti-PD1 antibody (SITC 2020) - "In the dose escalation phase, 2 cohorts of patients will be assessed in parallel: the first cohort will be given W0180 as a single agent and the second cohort will receive W0180 in combination with pembrolizumab. Following completion of the dose escalation phase, the expansion phase will enroll cohorts of patients with homogeneous tumors to validate the dose/schedule, assess preliminary activity and to explore the potential relationship with VISTA and PSGL1 expression. Results N/A Conclusions N/A"

Clinical • Combination therapy • IO Biomarker • Monotherapy • P1 data • Oncology • Solid Tumor

[VIRTUAL] W0180 novel anti-VISTA antibody: Rationale for target patient population and first-in-human trial design in monotherapy and in combination with anti-PD1 antibody (SITC 2020) - "In the dose escalation phase, 2 cohorts of patients will be assessed in parallel: the first cohort will be given W0180 as a single agent and the second cohort will receive W0180 in combination with pembrolizumab. Following completion of the dose escalation phase, the expansion phase will enroll cohorts of patients with homogeneous tumors to validate the dose/schedule, assess preliminary activity and to explore the potential relationship with VISTA and PSGL1 expression. Results N/A Conclusions N/A"

Clinical • Combination therapy • IO Biomarker • Monotherapy • P1 data • Oncology • Solid Tumor

Pierre Fabre initiates a "First in Human" clinical trial for an innovative monoclonal antibody (W0180) targeting the VISTA checkpoint in patients with solid tumors (PRNewswire.co.uk) - "Pierre Fabre announced today the initiation of an international Phase I clinical study in patients with relapsed or refractory solid tumors for its investigational product W0180, an innovative monoclonal antibody targeting VISTA, developed by Pierre Fabre Medical Care R&D teams....is preparing an upcoming communication to the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting to be held virtually on November 9-14, 2020. The SITC communication is entitled 'W0180 novel anti-VISTA antibody: rationale for target patient population and first-in-human trial design in monotherapy and in combination with anti-PD1 antibody.'"

Clinical • Trial status • Oncology • Solid Tumor

First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=69; Recruiting; Sponsor: Pierre Fabre Medicament

Clinical • Combination therapy • New P1 trial • Lung Cancer • Oncology • Solid Tumor