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Ganymed Pharmaceuticals Announces CE Marking for Test to Assess Claudin-18.2 Expression in Solid Tumors

CLAUDETECT(TM) 18.2 is the first and only CE marked IVD test specific for the detection of Claudin-18.2 in gastroesophageal, pancreatic and other solid tumors

(PresseBox) (Mainz, ) Ganymed Pharmaceuticals announced today that it has fully developed and obtained CE marking for its in vitro diagnostic (IVD) test CLAUDETECT(TM) 18.2 which allows to assess the expression levels of Claudin-18.2 (CLDN18.2) in solid tumors. CLAUDETECT(TM) 18.2, which was developed in collaboration with Theracode GmbH, is now compliant with the requirements of European Community Directive 98/79/EC on in vitro diagnostic medical devices.

CLAUDETECT(TM) 18.2 is a semi-quantitative immunohistochemical assay that determines selectively CLDN18.2 protein expression in formalin fixed paraffin-embedded cancer tissue in particular from patients with adenocarcinoma of the stomach, esophagus and pancreas as well as bile duct and lung. CLDN18.2 is the target of the therapeutic antibody IMAB362, Ganymed's lead investigational drug product. IMAB362 is being developed for first-line treatment of gastroesophageal adenocarcinomas. CLAUDETECT(TM) 18.2 is being used in all ongoing clinical studies to determine the condition of use for IMAB362. This includes a randomized Phase IIb trial, which compares IMAB362 in combination with best standard treatment to best standard treatment alone.

"Ganymed is dedicated to develop predictive biomarkers that complement new therapeutic concepts in cancer treatment and hold promise for personalizing medicine" said Dr Özlem Türeci, CEO of Ganymed Pharmaceuticals. "With the CE marking of CLAUDETECT(TM) 18.2, we have achieved an important milestone in the concurrent development of our drug IMAB362 and the diagnostic tool intended to aid in the identification of patients for treatment with IMAB362."

Inquiries about CLAUDETECT(TM) 18.2 can be made at

About Theracode GmbH

Theracode GmbH is an in vitro diagnostics company that combines its in-house scientific and management expertise in immunology, molecular pathology and clinical medicine with its own integrated discovery and development platform to identify, validate, develop, manufacture, and market in-vitro diagnostic kits based upon new classes of highly sensitive and cancer specific molecular markers. The application of these biomarkers will dramatically improve today's management of cancer by individually guiding the therapy of cancer patients. Theracode develops and manufactures biomarker-based diagnostic tests (IVDDs) under ISO 9001/13485 and FDAs QSR. Theracode is a fully owned subsidiary of BioNTech AG.

GANYMED Pharmaceuticals AG

Ganymed Pharmaceuticals AG is a biopharmaceutical company with the mission of revolutionizing cancer treatment by developing a new class of therapeutic drugs called Ideal Monoclonal Antibodies (IMABs). IMABs are unique in that they are highly selective for proteins which are present on tumor cells, but do not bind to healthy cells. This unmatched tumor cell specificity makes IMABs cancer cell selective allowing them to efficiently kill tumor cells without harming normal healthy tissues. They can thus be administered at optimal dose and have a broad therapeutic window with reduced risks of side effects. Ganymed's lead program, IMAB362, is in advanced phase II testing for gastroesophageal cancer. IMAB362 binds to the tight junction protein Claudin-18.2 which is expressed in up to 80% gastroesophageal adenocarcinomas, 60% pancreatic tumors as well as in other various solid tumors. Ganymed is also developing IMAB027, a monoclonal antibody targeting GT512 which is absent in healthy adult organs, but is expressed in a wide range of solid cancers, including testicular, ovarian, uterine, and lung cancers. The company plans to initiate clinical studies with IMAB027 in the near future. Ganymed is a private company that was founded in 2001 as a spin-off from the Universities of Mainz and Zurich. Its majority shareholder is ATS Beteiligungsverwaltung GmbH. Other investors include Future Capital AG, MIG Fonds, First Capital Partner GmbH, and private individuals.