HDP-101 (pamlectabart tismanitin) is based on Heidelberg Pharma’s proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology. The drug consists of highly specific antibodies against BCMA coupled to amanitin, an extremely potent toxin found in the death cap mushroom, among other sources. These antibody–drug conjugates combine the precision of antibodies with the cell-killing effect of amanitin and are designed to help overcome tumour resistance mechanisms. In the USA, the candidate holds orphan drug and fast track designations from the Food and Drug Administration (FDA).
The BCMA antibodies used in HDP-101 were developed at the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC). Heidelberg Pharma licensed them with support from Ascenion, the MDC’s technology transfer partner.
In March this year, Heidelberg Pharma announced that the first patient had been dosed in a Phase I bridging trial of HDP-101 in China. This triggered a contractually agreed milestone payment to the company from its Chinese partner, Huadong Medicine. The trial assessed and confirmed the safety, tolerability, pharmacokinetics and efficacy of pamlectabart tismanitin in Chinese patients with plasma cell disorders, including multiple myeloma. It also complemented the ongoing clinical development programme in Europe and the USA.
Another milestone has now followed: China’s National Medical Products Administration (NMPA) has approved a Phase Ib/II clinical trial in which HDP-101 will be investigated as a combination therapy for the first time. The drug will be given alongside established treatment regimens to patients with relapsed or refractory multiple myeloma. Huadong Medicine will conduct the trial in China and also bear the development costs.
Further information: Heidelberg Pharma press release
