Heidelberg Pharma receives a financing commitment of up to € 36 m and is thus fully financed until mid-2023. In addition, the first patient was treated with the company’s novel ADC technology.

Heidelberg Pharma announced that it has received a financing commitment of up to € 36 m from its main shareholder dievini Hopp BioTech holding GmbH & Co KG (dievini).  This financing will "enable Heidelberg Pharma to advance its business activities, in particular to completely conduct the clinical Phase I/IIa with HDP-101 [...]" – a feat which would otherwise likely have been difficult to pull off. According to the company, the earlier financing commitment from Hopp and Co. had had a range until mid-2022. Since no other financially strong partner has come forward so far, the coffers had to be opened again.

A few days ago, the company was able to report positive results at the beginning of the clinical trials. The first patient received a dose of HDP-101 in a phase I/IIa trial at the Winship Cancer Institute of Emory University, Atlanta, GA, USA, and other centres such as the MD Anderson Cancer Center will follow shortly. The open-label, multicentre Phase I/IIa trial will evaluate HDP-101, a BCMA antibody-amanitin conjugate, for the treatment of relapsed or refractory multiple myeloma, a cancer of the bone marrow with high unmet medical need. This marks the first clinical investigation of Heidelberg Pharma's ADC conjugate with Amanitin.

Amanitin belongs to a group of naturally occurring toxins, the amatoxins, which are found in the green button mushroom (Amanita phalloides), among others. This group of toxins has a unique biological mode of action in the inhibition of RNA polymerase II, which leads to so-called programmed cell death (apoptosis) in cells. According to Heidelberg Pharma, all other chemotherapeutic agents or other ADCs used so far are either so-called spindle poisons (tubulin inhibitors) or act via the DNA, which makes them dependent on cell division. The inhibition of RNA polymerase II is a new active principle for cancer therapy and holds the chance of breaking through therapy resistances or even destroying dormant tumour cells, which could lead to considerable clinical progress.

The recruitment of study participants for the clinical investigation of the active substance has also begun in Germany.