Astellas Pharma Global Development, Inc. has terminated its Phase I clinical trial of ASP1012, an engineered oncolytic vaccinia virus, in adults with locally advanced or metastatic solid tumors. The ASP1012 clinical trial terminated with only 15 participants enrolled, the registry listing indicating that this reflected a "strategic decision made by the sponsor", with no other public records of studies under way for the molecule. Although Astellas has not officially commented, the decision appears consistent with a broader strategic rationalization of Astellas' early-stage oncology pipeline.
ASP1012 is a genetically modified vaccinia virus designed to selectively infect and lyse tumor cells while expressing a Leptin-IL2 fusion protein intended to render malignant cells visible to the immune system. The agent originated at KaliVir Immunotherapeutics, a private Pittsburgh-based biotech, which licensed worldwide rights to Astellas in 2020 for up to USD 56 million in upfront and research-support payments. Administered intravenously — an unusual delivery route for an oncolytic virus, most of which have been developed as intratumoral agents — ASP1012 represented KaliVir's lead clinical candidate from its Vaccinia Enhanced Template (VET) platform.
The Astellas Pharma ASP1012 program entered the clinic in May 2024 under NCT06171178, a first-in-human, open-label, non-randomized study spanning three sequential parts: dose escalation in previously treated solid tumor patients, followed by expansion cohorts in cutaneous melanoma (both refractory and treatment-naïve settings), and a third expansion arm targeting gastric cancer, colorectal cancer, and ovarian cancer. In Parts 2 and 3, ASP1012 was to be evaluated both as monotherapy and in combination with pembrolizumab (Keytruda), Merck's PD-1 inhibitor, for up to three cycles. The primary objectives were safety-focused, while secondary endpoints extended to viral shedding in multiple biological compartments, anti-drug antibodies, and standard oncology response metrics including objective response rate, progression-free survival, and overall survival.
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