Immunome has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for IM-1340, an investigational antibody-drug conjugate (ADC) being developed for advanced solid tumours.

IM-1340 is designed to target a transport receptor with a tumour expression profile across several solid cancers, including neuroendocrine tumours, lung cancer and colorectal cancer. The ADC uses HC74, Immunome’s proprietary topoisomerase I (TOP1) inhibitor payload.

Preclinical studies showed anti-tumour activity for IM-1340 across multiple tumour models. The results included tumour regressions after a single dose in several in vivo models, supporting the move towards clinical development.

Immunome plans to begin a Phase 1 clinical trial in the fourth quarter of 2026. The open-label, multicentre study will assess the safety, tolerability and pharmacokinetics of IM-1340, as well as its preliminary anti-tumour activity in patients with advanced solid tumours.

The study will use dose-escalation and expansion phases to evaluate the investigational therapy across different patient groups.

The IND clearance marks the transition of IM-1340 from preclinical development into clinical testing and adds another programme to Immunome’s ADC pipeline based on its proprietary HC74 payload.

 

Source: businesswire.com

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