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FDA approves Heidelberg Pharma’s IND for its antibody conjugate against cancer

Heidelberg Pharma AG is allowed to initiate a Phase I/IIa clinical study in the US to evaluate the dosing, safety and anti-tumour efficacy of its lead candidate HDP-101 in multiple myeloma.

HDP-101 is the most advanced candidate derived from the company’s unique ATAC (Antibody Targeted Amanitin Conjugates) platform. It consists of highly specific anti-BCMA antibodies coupled with amanitin, a highly effective toxin that is found in certain mushrooms including the death cap. The conjugates combine the antibodies’ specificity with the potency of amanitin and have strong potential to overcome tumour resistance mechanisms.

The anti-BCMA antibodies were discovered at the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) and licensed to Heidelberg Pharma with the support of Ascenion, the MDC’s technology transfer partner.

‘The start of clinical development of the first candidate from our ATAC platform is an important milestone,’ says Prof. Andreas Pahl, CSO of Heidelberg Pharma.

The study will enroll up to 66 patients in two parts at study sites in the US. The company also plans to submit the study protocol to the Paul Ehrlich Institute in Germany.

For further information see: Heidelberg Pharma’s press release