Heidelberg Pharma Secures Financing Commitment from its Main Shareholder, Doses First Patient in Study

Heidelberg Pharma said it has secured a commitment of $40.9 million (€36 million) in financing from its main shareholder dievini Hopp BioTech.

It replaces the not yet fully used financing commitment from March 2021, the company said.

The company said the financing commitment will enable Heidelberg Pharma to advance its business activities, in particular to completely conduct the clinical phase 1/2a study of HDP-101 and to further develop the candidates HDP-102 und HDP-103. Based on the current planning, the company’s cash reach is secured until mid-2023.

HDP-101, the company’s lead candidate, is a BCMA antibody-Amanitin conjugate (ATAC) for the treatment of multiple myeloma and is in clinical development. Earlier this week the company announced it had dosed the first patient with HDP-101 in the open label, multi-center phase 1/2a study to evaluate HDP-101.

Multiple myeloma is rare but belongs to the most common type of bone and bone marrow cancer. Approximately six to eight new cases per 100,000 people are recorded annually in Western industrialized countries. The median age at diagnosis is 70 years and patients often suffer from bone pain and spontaneous fractures along with other complications. The five-year survival rate is about 55 percent. Current treatment options are chemotherapy, immunomodulatory drugs, proteasome inhibitors, and autologous stem cell transplantation with a high impact on quality of life or significant side effects.

The payload Amanitin is a novel agent in cancer therapy with a unique mode of action that differentiates it from other therapies and promises significant advantages for the treatment of malignancies. For many patients with multiple myeloma, currently available therapies lead to relapses despite initial success, necessitating further treatment options.

The first part of the trial is a phase I dose escalation study to determine either the maximum tolerated dose (MTD) or recommend a biologically active dose of HDP-101 for the phase 2 part of the study. It is planned to treat up to 36 patients who will receive HDP-101 intravenously once every 3 weeks until disease progression, discontinuation at Investigator’s discretion, or patient withdrawal. During this part of the trial, tolerability of different dose levels will be evaluated.

During the phase 2a dose expansion part, the recommended dose of HDP-101 will then be administered to 30 patients. The primary objective of the phase 2a part of the trial is to assess the preliminary anti-tumor activity of HDP-101 along with further evaluation of the safety of the drug. Patients in this part will be stratified based on their 17p deletion status. Preclinical data show that Amanitin has the potential to be especially effective against tumor cells that harbor the 17p deletion, which allows them to bypass a cellular anti-tumor mechanism. Patients who have cancer with a 17p deletion usually show limited response to established therapies and have a poor prognosis. The phase 2a 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 Amanitin-based therapies on tumors with a 17p deletion.

“It is an important step for Heidelberg Pharma to have the first patient dosed in our study. This phase 1/2a study will test a new mode of action in oncology and is the first trial to evaluate an antibody drug conjugate carrying Amanitin as active component in patients,” said András Strassz, chief medical officer of Heidelberg Pharma. “Our goal is to demonstrate the safety and efficacy of our Amanitin-based ADC technology and we hope that our patients will benefit from this treatment.”

Photo: András Strassz, chief medical officer of Heidelberg Pharma

Author: Rare Daily Staff