Heidelberg Pharma Advances ADC Candidate HDP-101 to Phase II Trial

Heidelberg Pharma AG has announced a key development in its clinical trial for the ADC candidate HDP-101, determining the recommended Phase II dose (RP2D). The Phase I trial with pamlectabart tismanitin showed promising safety and tolerability, leading to this decision. The study's Safety Review Committee, after reviewing safety and pharmacokinetic data, endorsed the progression to Phase IIa.

The upcoming Phase IIa trial aims to assess further the anti-tumor activity of pamlectabart tismanitin in patients with relapsed or refractory multiple myeloma. Patient enrollment is scheduled to begin in the following weeks across existing study centers with an intended cohort of 30 patients. Details on safety and efficacy will be announced at a forthcoming scientific conference.

Heidelberg Pharma’s innovative approach involves using Amanitin-based ADC technology, positioning HDP-101 as a significant candidate in tackling multiple myeloma. This candidate has already received Fast Track and Orphan Drug Designations, underscoring its importance.