DGAP-Adhoc

Heidelberg Pharma AG: FDA Allows Heidelberg Pharma to Start a Phase I/IIa Clinical Trial with ATAC Candidate HDP-101 - Seite 2

Contracts requiring approval from the clinical ethics committee are expected to be signed with the planned study sites in the US in the next weeks. Heidelberg Pharma expects the first patient to be enrolled and the first dose to be administered in the second quarter of 2021.

The next step is to submit the study protocol to the Paul-Ehrlich-Institut in Germany.

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Information and Explanation of the Issuer to this News:

Prof. Andreas Pahl, CSO of Heidelberg Pharma AG, commented: 'We have been working towards this goal for many months and are delighted that the FDA has allowed us to proceed with the Phase I/IIa trial with HDP-101. Developing a completely novel drug candidate to the point of first-in-human testing is a complex process. Therefore, the start of clinical development of the first candidate from our ATAC platform is an important milestone for us.'

About Heidelberg Pharma
Heidelberg Pharma is an oncology company 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 has entered into partnerships to further develop and commercialize its clinical assets upamostat (formerly MESUPRON^(R)) andTLX250-CDx (formerly REDECTANE^(R)). Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

Contact Heidelberg Pharma AG Sylvia Wimmer Tel.: [phone] Email: investors[at]hdpharma.com Gregor-Mendel-Str. 22, 68526 Ladenburg

IR/PR support MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: [phone] Email: katja.arnold[at]mc-services.eu

 

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