27.09.2016
WILEX AG DE000A11QVV0
DGAP-News: WILEX AG: Subsidiary Heidelberg Pharma contracts Suisse CDMO Celonic for antibody cell line development and antibody production
DGAP-News: WILEX AG / Key word(s): Alliance
WILEX AG: Subsidiary Heidelberg Pharma contracts Suisse CDMO Celonic for
antibody cell line development and antibody production
27.09.2016 / 07:24
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
WILEX AG: 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
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
http://www.wilex.com/.
About Celonic
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(TM) cell line technology to clients, drug developer
and service provider. Visit their website http://www.celonic.com/ to learn
more.
Contact IR/PRsupport WILEX AG MC Services AG Corporate Communications Katja Arnold (CIRO) Sylvia Wimmer Tel.: +49 (0)89-210 228-40 Tel.: +49 (0)89-41 31 38-29 Mobile: +49 (0)160 9360 3022 Email: investors[at]wilex.com Email: katja.arnold[at]mc-services.eu Grillparzerstr. 18, 81675 Munich, GermanyThis 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. --------------------------------------------------------------------------- 27.09.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de --------------------------------------------------------------------------- Language: English Company: WILEX AG Grillparzerstr. 18 81675 München Germany Phone: +49 (0)89 41 31 38 - 0 Fax: +49 (0)89 41 31 38 - 99 E-mail: [email protected] Internet: www.wilex.com ISIN: DE000A11QVV0 WKN: A11QVV Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange End of News DGAP News Service --------------------------------------------------------------------------- 505821 27.09.2016
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