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Heidelberg Pharma AG: US patent rights granted for diagnosis and treatment of patients with TP53/RNA polymerase II deletion

- Heidelberg Pharma's partner MD Anderson Cancer Center receives patent rights from the US patent office for diagnosis and treatment of select patient groups with RNA polymerase II deletion

- Heidelberg Pharma holds an exclusive license to these patent rights

- Applicable as a biomarker to select particularly relevant patient groups for the entire ATAC platform

Ladenburg, Germany, 4 March 2020 - Heidelberg Pharma AG (FSE: WL6) today announced that the partner University of Texas, MD Anderson Cancer Center, Houston, TX, USA, (MD Anderson), was granted patent rights related to the diagnosis and treatment of patients with RNA polymerase II deletion. The patent application is named "Methods Of Treating Cancer Harbouring Hemizygous Loss Of TP53" and was submitted at the US patent office by MD Anderson. Heidelberg Pharma holds an exclusive license to these patent rights.

The toxin Amanitin developed by Heidelberg Pharma has the potential to be particularly effective against aggressive tumors in connection with a 17p deletion. The name '17p' refers to the short arm of chromosome 17, whose DNA includes both the gene for the tumor suppressor protein TP53 and the largest subunit for RNA polymerase II. The loss-of-function of TP53 in tumor cells weakens the cells' natural defenses and leads to an aggressive tumor growth. Since RNA polymerase II is also routinely suppressed, this change makes the tumor cells particularly sensitive to Amanitin and Heidelberg Pharma's Antibody Targeted Amanitin Conjugates (ATACs). 17p deletion is frequently connected to aggressive tumors with poor prognosis or resistance to standard therapies.

The patent application is based on research that was co-published by MD Anderson and Heidelberg Pharma in the peer-reviewed journal, Nature, in April 2015. Heidelberg Pharma had the option to license the results of this research, which was exercised in March 2018. This research is serving as foundation to evaluate the potential of this drug candidate and advance the program into clinical testing.

Professor Andreas Pahl, Chief Scientific Officer of Heidelberg Pharma AG, said: "We are delighted about the grant of the patent by the US patent office, which further strengthen and protect our ATAC technology. The 17p deletion and TP53/RNA polymerase II deletion gene status as a biomarker could be used for the entire ATAC platform independent from tumor indications and targets. The biomarker allows a selection of patient groups with poor prognosis and that could benefit most from the therapy with ATACs. This personalized medicine approach could furthermore enable an accelerated marketing authorization of ATACs."

About Heidelberg Pharma
Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany. Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies using its proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. This proprietary technology platform is being applied to develop the Company's proprietary therapeutic ATACs as well as in third-party collaborations to create a variety of ATAC candidates. The proprietary lead candidate HDP-101 is a BCMA ATAC for multiple myeloma. Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at .

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