Ganymed’s IMAB027 enters Phase I/II trial to treat ovarian cancer

The trial of IMAB027, which is a first-in-class monoclonal antibody targeting the tight junction protein Claudin-6 (CLDN6), is being carried out in Germany, Belgium, Russia and Ukraine.

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 said.

"We believe that the unmatched cancer-cell selectivity of IMAB027 holds great promises of improving treatment options for these patients."

The company said that IMAB027 is a highly specific 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, and it is a high-precision therapy that kills cancer cells without harming healthy non-cancerous cells.

Around 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 tumor biopsies.

In the Phase I portion of the trial, patients will be given escalating doses of IMAB027 to evaluate 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 trial in 2016.

Image: Ganymed intends to complete the Phase I/II OVAR clinical trial of IMAB027 in 2016. Photo: courtesy of Jscreationzs/ freedigitalphotos.net