What’s Being Lost in Translation?

Expected the unexpected: if it can snow in Florida, there’s hope for GI cancers yet!
The surge in ADC licensing deals from China has created a crowded development landscape where careful phase 1 evaluation risks being sacrificed for speed.
While the temptation to treat ADC development like traditional chemotherapy trials is strong, this approach overlooks crucial differences in therapeutic window optimisation, target expression validation, and resistance mechanisms. The recent flurry of ADCs (plain vanilla or Frankenstein versions) particularly highlights this challenge with multiple candidates racing through development, some with limited understanding of optimal dosing, target expression cutoffs, or sequencing strategies.
The following analysis examines five emerging new agents across ADCs, antibodies, and cell therapies where success may depend less on deal timing and more on thoughtful early phase development, particularly around patient selection and therapeutic index characterisation.
The historical pattern of failures in late stage oncology trials often traces back to inadequate phase 1/2 groundwork rather than target biology per se, making this distinction crucial for the field.
In this article it’s time to frame some specific examples, while highlighting the broader industry context and common development pitfalls…
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