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Mersana's ADC Technology Faces A Setback With Partial Clinical Trial Hold

 
• By Jessica Merrill

A patient death in a Phase I dose-escalation study of XMT-1522 in patients with HER2-expressing tumors rattled investors, but CEO Protopapas said it is not clear what the cause of death was in the very sick patient and that Mersana is working closely with the FDA.

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Just one year after Mersana Therapeutics Inc. debuted on the public markets, the company's first clinical trial has been put on a partial clinical hold by the US FDA because of safety concerns. The company announced the partial hold July 19 after a cancer patient in the Phase I dose-escalation trial died.

The trial is testing XMT-1522, an antibody-drug conjugate targeting HER2-expressing tumors built using Mersana's Dolaflexin platform, which links a Fleximer polymer with a proprietary auristatin payload to deliver a drug load of approximately 12 molecules per antibody

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