Ganymed Pharmaceuticals has started treatment of the first patient in a Phase I/II OVAR clinical trial, designed to assess IMAB027 as a single agent for the treatment of advanced ovarian cancer.
The trial is being carried out in Germany, Belgium, Russia and Ukraine. It will evaluate the safety, tolerability and efficacy of IMAB027, a first-in-class monoclonal antibody targeting the tight junction protein Claudin-6 (CLDN6).
A total of 72 patients with advanced ovarian cancer who are resistant to or have relapsed following standard-of-care treatment with platinum-based chemotherapy agents will be enrolled in the trial and they will be selected according to the expression level of CLDN6 in their tumour biopsies.
The company said that in the Phase I portion of the trial, patients will be given escalating doses of IMAB027 to assess safety, tolerability and determine the recommended Phase II dose.
Following full review and approval by an independent data safety monitoring board, the Phase II portion of the trial will be started to assess the anticancer activity of IMAB027.
The company intends to complete the Phase I/II OVAR clinical trial of IMAB027 in 2016.
Ganymed chief executive officer and chief medical officer Özlem Türeci said IMAB027 is the second antibody from the company to enter clinical development that is based on its ideal monoclonal antibody platform.
"Women with recurrent ovarian cancer have few therapeutic options," Türeci added.
"We believe that the unmatched cancer-cell selectivity of IMAB027 holds great promise of improving treatment options for these patients."
According to the company, IMAB027 is a highly specific monoclonal antibody against CLDN6, which is absent in healthy adult tissues and is present in a wide range of non-haematological cancers such as ovarian, testicular, uterine and lung cancers.
Based on the unparalleled specificity of CLDN6 to cancer cells, IMAB027 is claimed to be a high-precision therapy that kills cancer cells without harming healthy non-cancerous cells.
Image: Micrograph of a low malignant potential mucinous ovarian tumour. Photo: courtesy of Nephron.