Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) has received guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for VAXinia (CF33-hNIS), the company’s lead oncolytic virotherapy for the treatment of solid tumours.
The purpose of a pre-IND (Investigational New Drug) meeting with the FDA was to obtain regulatory guidance and agreement of the pre-clinical, chemistry, manufacturing and clinical development plan to be included in an IND for Imugene’s VAXinia oncolytic virotherapy.
“Clear roadmap for development”
The US FDA provided guidance on the development plan for VAXinia phase one study design including feedback on part two of the study in combination with immune checkpoint inhibitors, the proposed patient population, safety monitoring plan and strategy for evaluating drug exposure during the study.
Imugene managing director and chief executive officer Leslie Chong said, “The remote meeting was productive and provided Imugene with a clear roadmap for a successful IND submission and clinical development of VAXinia.”
In addition, the FDA provided further guidance on key aspects of non-clinical investigations and provided valuable feedback on studies required to support the Phase 1 development plan.
Australian regulatory pathway
Given the uncertainty in the COVID-19 era, Imugene remains flexible in identifying regulatory pathways.
In parallel with the US strategy, the company is also pursuing a regulatory pathway in Australia.
The first-in-human, adaptive phase one, multi-centre, dose-escalation study of VAXinia (CF33-hNIS) is investigating intratumoural and intravenous administration lines as monotherapy and in combination with immune checkpoint inhibitors in a patient population with advanced or metastatic melanoma, non-small cell lung, TNBC, bladder, head and neck, gastric, colorectal and renal cell cancers.
IMU shares have been as much as 8% higher to A$0.06 intra-day.