WILEX AG: Subsidiary Heidelberg Pharma contracts Suisse CDMO Celonic for antibody cell line development and antibody production
| PDF Download
- Antibody for ATAC lead candidate HDP-101 to be produced under GMP conditions for later clinical development in multiple myeloma
Munich, Germany, 27 September 2016 – 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.”
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. More information is available at www.wilex.com
Celonic AG is a privately owned CDMO based in Basel, Switzerland, providing comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars worldwide. Applying empathy, efficiency and excellence, Celonic goes one step beyond expectations in all business aspects in order to help its clients attain their goals more efficiently and reliably.
Celonic’s services include the development of cell lines, production processes, as well as the non-GMP and GMP manufacturing of biopharmaceutical drug substances. In addition, Celonic licenses its proprietary CHOvolution™ cell line technology to clients, drug developer and service provider. Visit their website http://www.celonic.com/ to learn more.
Tel.: +49 (0)89-41 31 38-29
Grillparzerstr. 18, 81675 Munich, Germany
MC Services AG
Katja Arnold (CIRO)
Executive Director & Partner
Tel.: +49-89-210 228-40
Mobil: +49 160 9360 3022
This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”, “should”, “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial position, earnings, achievements, or industry results, to be materially different from any future results, earnings or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward- looking statements to reflect future events or developments.