ASP1012 / KaliVir, Astellas - LARVOL DELTA

A Study of ASP1012 in Adults With Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: Astellas Pharma Global Development, Inc. | Trial completion date: Feb 2026 ➔ Sep 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2026 ➔ Sep 2025; Due to strategic decision made by the sponsor the study was terminated

Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Gastric Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor

Safety and tolerability of ASP1012, an oncolytic virus, in adults with locally advanced or metastatic solid tumors: Results from a first-in-human, Phase 1, open-label, dose-escalation study (SITC 2025) - P1 | "Among 11 response-evaluable patients, 4 had best overall response of confirmed stable disease per iRECIST and disease control rate (95% CI) was 36.4% (10.9%–69.2%).Conclusions ASP1012 demonstrated a tolerable and manageable safety profile up to and including 3×109 pfu/dose.Acknowledgements This study was funded by Astellas Pharma Inc. Medical writing support, conducted in accordance with Good Publication Practice (GPP 2022) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Dolly Alkoborssy, PhD, of Oxford PharmaGenesis Inc., Wilmington, DE, USA, and funded by Astellas Pharma Inc.Trial Registration clinicaltrials.gov - NCT06171178Ethics Approval This study received IRB approval from Western Institutional Review Board - Copernicus Group and Institutional Review Boards (Approval numbers: 1-1754242-1; STUDY00002345/P-3713323; 202310303; 1-1786751-1; 1-1758102-1; 1-1715602-1; 1-1732476-1; 1-1718237-1;..."

Clinical • First-in-human • Metastases • Oncolytic virus • P1 data • Oncology • Solid Tumor • IL2 • LEP

A Study of ASP1012 in Adults With Solid Tumors (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Recruiting ➔ Active, not recruiting | N=229 ➔ 15 | Trial completion date: Jun 2029 ➔ Feb 2026 | Trial primary completion date: Jun 2029 ➔ Feb 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor

Trial in progress: Phase 1 study of an oncolytic virus, ASP1012, in adults with advanced solid tumors (AACR 2025) - P1 | "ASP1012, a double-stranded DNA oncolytic and immunotherapeutic vaccinia virus encoding a leptin-interleukin 2 fusion protein that selectively replicates in cancer cells, is being developed for the treatment of patients with locally advanced or metastatic (la/m) solid tumors. This Phase 1, first-in-human, open-label, multicenter dose escalation (Part 1) and dose expansion (Parts 2/3) study (NCT06171178) of ASP1012 alone or + pembrolizumab will evaluate the safety, tolerability, maximum tolerated dose (MTD), and/or recommended Phase 2 dose (RP2D) in US adults...Safety follow-up will occur 30 days posttreatment, posttreatment follow-up every 6 weeks, and survival follow-up ≥ every 12 weeks ± 2 weeks. Study enrollment is currently ongoing in the US."

Clinical • IO biomarker • Metastases • Oncolytic virus • P1 data • Colorectal Cancer • Cutaneous Melanoma • Gastric Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • IL2 • LEP

A Study of ASP1012 in Adults With Solid Tumors (clinicaltrials.gov) - P1 | N=229 | Recruiting | Sponsor: Astellas Pharma Global Development, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncolytic virus • Gastric Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

A Study of ASP1012 in Adults With Solid Tumors (clinicaltrials.gov) - P1 | N=229 | Not yet recruiting | Sponsor: Astellas Pharma Global Development, Inc.

New P1 trial • Gastric Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

KaliVir Immunotherapeutics Announces FDA Clearance of Investigational New Drug (IND) for Systemic Oncolytic Virus ASP1012 for Phase I Clinical Trials for Locally Advanced or Metastatic Solid Tumors (Businesswire) - "KaliVir Immunotherapeutics, Inc...announced clearance of an Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to initiate a Phase 1 clinical study of ASP1012 in participants with locally advanced or metastatic solid tumors....The trial is expected to begin in Q1 2024."

IND • New P1 trial • Oncology • Solid Tumor

KaliVir Immunotherapeutics Enters into Global Exclusive Licensing Agreement with Roche for Novel Oncolytic Viruses (PRNewswire) - "KaliVir Immunotherapeutics...announced a collaboration and global exclusive licensing agreement with Roche for the discovery, development and commercialization of novel oncolytic vaccinia viruses derived from KaliVir's oncolytic immunotherapy VETTM platform....Under the terms of the agreement, KaliVir will generate oncolytic vaccinia virus product candidates derived from the company's VETTM platform expressing Roche proprietary therapeutic transgenes. Roche will have exclusive license to discover, develop and commercialize the products worldwide. KaliVir will receive an upfront payment, and may be eligible to receive research, development and commercial milestone payments..."

Licensing / partnership • Oncology