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Subsidiary Heidelberg Pharma contracts Suisse CDMO Celonic

Munich, Germany, 27 September 2016 Subsidiary Heidelberg Pharma contracts Suisse CDMO Celonic for antibody cell line development and antibody production. Antibody for ATAC lead candidate HDP-101 to be produced under GMP conditions for later clinical development in multiple myeloma. WILEX AG (ISIN DE000A11QVV0 / WL6 / FSE), today announced that its subsidiary Heidelberg Pharma, has signed an agreement with Celonic AG, Basel, Switzerland, a specialist in the development and manufacturing of biologics (CDMO). This agreement includes cell line development and the production of non- GMP and GMP (Good Manufacturing Practice) batches of antibody material to be used in the manufacture of clinical material of Heidelberg Pharma’s first ATAC (Antibody Targeted Amanitin Conjugate) candidate HDP-101 to treat multiple myeloma. HDP-101, an antibody drug conjugate, combines a BCMA antibody that specifically recognizes a highly expressed target on malignant plasma cells with a linker and the chemically coupled toxic payload Amanitin for the potential treatment of multiple myeloma. BCMA antibodies were originally developed by the Max Delbrück Center in Berlin and then adapted for the proprietary ATAC technology of Heidelberg Pharma. Based on promising preclinical data, Heidelberg Pharma has decided to further advance HDP-101 into IND- enabling studies. Multiple myeloma is the third most common and often incurable hematologic malignancy with a significant unmet medical need for this patient population. Professor Andreas Pahl, Head of Research & Development and member of the Management Board of WILEX and Heidelberg Pharma, commented:
“With this contract, Heidelberg Pharma starts the cooperation with different partners involved in developing and manufacturing ATACs towards clinical application. We are pleased to work with Celonic, which offers cell lines that are proven to be particularly robust and efficient and are also suited to GMP processes.”
– Andreas Pahl, Head of Research & Development Vikalp Mohan, Vice President Global Commercial Operations at Celonic mentioned: “Celonic is excited to partner with Heidelberg Pharma as it prepares for the clinical development of its first ATAC candidate. The development and production of this antibody requires an excellent development platform, process efficiency and proven manufacturing expertise. This is exactly what Celonic stands for. We are committed to supporting Wilex AG in achieving its project objectives.” About Heidelberg Pharma’s proprietary ATAC technology Antibody-drug conjugates (ADCs) combine the high affinity and specificity of antibodies with the potency of cytotoxic small molecules for the treatment of cancer and inflammatory diseases. ATACs are ADCs that are bound to highly potent amatoxin molecules. Amatoxins are small bicyclic peptides naturally occurring in the Green Death Cap mushroom. They inhibit mRNA transcription by binding to RNA polymerase II, a mechanism that is crucial for the survival of eukaryotic cells. In preclinical testing, ATACs have been shown to be highly efficacious, overcoming frequently encountered resistance mechanisms and combatting even quiescent tumor cells. About WILEX and Heidelberg Pharma WILEX AG is a biopharmaceutical company based in Munich, Germany, that serves as a parent and holding company. The Company’s research and development work is conducted by its subsidiary Heidelberg Pharma GmbH in Ladenburg. Heidelberg Pharma is focused on developing an innovative ADC technology platform based on the compound Amanitin (ATAC technology) and also provides preclinical drug research and development services. WILEX has diagnostic and therapeutic Phase III drug candidates, which are available for out- licensing. WILEX AG is listed at the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6.