Ganymed’s IMAB027 Enters Phase I/II Clinical Trial for Ovarian Cancer

Mainz, Germany, February 12, 2014 - Ganymed Pharmaceuticals AG announced today that the first patients are being enrolled and are starting treatment in a Phase I/II OVAR clinical trial to assess the safety, tolerability, and efficacy of IMAB027 as single agent for the treatment of advanced ovarian cancer. IMAB027 is a highly specific monoclonal antibody targeting the tight junction protein Claudin-6 (CLDN6). The trial is being conducted in Germany, Belgium, Russia, and Ukraine.

”IMAB027 is the second antibody from Ganymed to enter clinical development that is based on our Ideal Monoclonal Antibody platform,” said Dr. Özlem Türeci, Chief Executive Officer and Chief Medical Officer of Ganymed. “Women with recurrent ovarian cancer have few therapeutic options. We believe that the unmatched cancer-cell selectivity of IMAB027 holds great promises of improving treatment options for these patients.”

About IMAB027

IMAB027 is a first-in-class monoclonal antibody against CLDN6 which is absent from healthy adult tissues but is present in a wide range of non-hematological cancers such as ovarian, testicular, uterine, and lung cancers. The unparalleled specificity of CLDN6 to cancer cells potentially makes IMAB027 a high-precision therapeutic that efficiently kills cancer cells without harming healthy non-cancerous cells.

About the OVAR Clinical Trial

The OVAR trial will enroll 72 patients with advanced ovarian cancer who are resistant to or have relapsed following standard-of-care treatment with platinum-based chemotherapy agents. Patients will be selected according to the expression level of CLDN6 in their tumor biopsies. In the Phase I portion of the trial, patients will receive escalating doses of IMAB027 to assess safety, tolerability and determine the recommended Phase II dose. Upon full review and approval by an independent Data Safety Monitoring Board, the Phase II portion of the trial will be initiated to investigate the anticancer activity of IMAB027.

The company anticipates completing the trial in 2016. Additional information can be found at www.clinicaltrial.gov/show/NCT02054351

About 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% of gastroesophagealadenocarcinomas, 60% of pancreatic tumors as well as in other various solid tumors.

Ganymed is also developing IMAB027, a monoclonal antibody targeting Claudin-6 which is absent in healthy adult organs, but is expressed in a wide range of solid cancers, including testicular, ovarian, uterine, and lung cancers.

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, FCPB Gany GmbH, and private individuals.

Source: Ganymed Pharmaceutical AG

Posted: February 2014

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