12-07-2017

Initiation of the First in Human clinical trial in patients with solid tumours with an innovative antibody drug conjugate (ADC W0101) discovered by Pierre Fabre Pharmaceuticals R&D

Pierre Fabre Pharmaceuticals, announced today the initiation of an international Phase I/II clinical study in patients with relapsed or refractory solid tumours for its investigational product W0101, an innovative antibody drug conjugate (ADC) product candidate. This clinical research in solid tumours is led by Principal Investigator Dr. Christophe Massard, Head of the Therapeutic Innovation and early clinical trial Department at Gustave Roussy, Villejuif, France and involves other sites in France and Spain.

We are excited to be enrolling our first patients with W0101 and are hopeful that this new immunotherapeutic compound will provide an effective weapon against a wide range of cancer types, said Dr. Massard Head of the Therapeutic Innovation and early clinical trial Department at Gustave Roussy, Villejuif.

W0101 a first-in-class ADC composed of an antibody targeting Insulin-like Growth Factor 1 (IGF-1) receptor conjugated to proprietary auristatin derivative was discovered and developed at Institut de Recherche Pierre Fabre. IGF-1R has been recognised for its role in tumorigenesis and growth in a broad range of cancers including non-small cell lung cancer, breast cancer and head and neck cancer. Many clinical trials involving naked monoclonal antibodies have demonstrated that IGF-1R can be efficiently targeted and such targeting could induce antitumor activities in several tumour types. However, these trials failed to show clinical benefit in the overall patient population. W0101 is a novel approach leveraging the advantages of ADCs that relies on a highly specific monoclonal antibody to selectively deliver a highly potent cytotoxic drug to tumour cells via IGF-1R mediated internalisation. W0101 is designed for the treatment of patients with tumours overexpressing IGF-1R.

This study is an important step that will allow us to determine a safe dose for further development of W0101 in clinical indications for which a significant reduction of tumour growth has been shown in a broad panel of pre-clinical studies. It also marks an important milestone for Pierre Fabre that highlights our expertise and capabilities for moving ADC candidates into the clinic, and hopefully providing innovative therapies to cancer patients, stated Dr. Eric Chetaille Head of Pierre Fabre Oncology Innovation Unit at Pierre Fabre Pharmaceuticals.

Additional information on the clinical trial