Initiation of the first German study center planned within the next few months
Ladenburg, Germany, 19 July 2021 – Heidelberg Pharma AG (FSE: HPHA) today
announced that the German authority Paul Ehrlich Institute, Langen, Germany, (PEI) has
approved the study design of the planned Phase I/IIa clinical trial with the ATAC candidate
HDP-101. HDP-101 is a BCMA antibody-Amanitin conjugate that will be tested in the
indication multiple myeloma, a blood cancer with high unmet medical need.
Dr. András Strassz, Chief Medical Officer of Heidelberg Pharma AG, commented: "We are
very pleased that following the approval of the study by the FDA, the German regulatory
authority, the Paul Ehrlich Institute, has now also approved the initiation of a study with
our ATAC candidate HDP-101 in Germany. After approval byt he ethics committee and
signing the contracts, we will soon start with the initiation of the German study centers. In
the US, preparations are already underway and we expect to enroll the first patient in the
next few weeks."
About the Phase I/IIa study with HDP-101
The first part of the trial is a Phase I dose escalation study to determine the maximum tolerated dose of HDP-101. The findings from Phase I will be used to establish the dose for the Phase IIa portion of the trial, the primary objective of which is to assess the preliminary anti-tumor activity of HDP-101.
The two parts of the open-label, multicenter Phase I/IIa study will enroll up to 36 and 30
patients, respectively. Patients in the Phase IIa part will be stratified based on their 17p
deletion status. Preclinical data show that Amanitin has the potential to be especially
effective against tumors that have changed due to so-called 17p deletion mutations to bypass a special mechanism of cell protection. Patients with such a deletion usually show
a poorer response to standard therapies and have a significantly worse prognosis. The
Phase IIa part of the trial is intended to evaluate not only the efficacy of HDP-101 in
multiple myeloma patients, but also the clinical relevance of the 17p deletion.