Pierre Fabre announced the initiation of an international Phase I clinical study in patients with relapsed or refractory solid tumors for its investigational product W0180, a monoclonal antibody targeting VISTA, developed by Pierre Fabre Medical Care R&D teams. The study started at the University Clinic of Navarra, Spain, under the supervision of Pr. Ignacio Melero, Immunologist and Senior Investigator at Centro de Investigación Médica Aplicada (CIMA).

This clinical research is led by Principal Investigator Pr. Aurelien Marabelle of the Gustave Roussy Cancer Institute (Villejuif, France). Pr. Marabelle is the Clinical Director of the Cancer Immunotherapy Program at Gustave Roussy and Senior Medical Oncologist within its Drug Development Department (DITEP). The study will involve other sites in France and Spain, including at the Toulouse University Hospital (IUCT) located at the Toulouse-Oncopole Campus.

"VISTA is a new immune-checkpoint molecule highly expressed in the tumor microenvironment. There are great expectations within the medico-scientific community for this new target and its biology. With this clinical study and its extensive translational medicine plan, we are delighted to contribute to improve the knowledge on VISTA for the benefit of cancer patients," Marabelle said.

"At Pierre Fabre, innovation in oncology is at the top of our strategic priorities and we are all very keen to bring this new molecule to clinical evaluation. Immunotherapy has already been a revolution for cancer patients in many indications, but the medical need is still incredibly huge. Our oncology R&D teams are fully committed to identify and develop innovative therapies for patients who are refractory or resistant to current treatments," Jean-Luc Lowinski, Pierre Fabre Medical Care CEO, said.

W0180 is a first-in-class antibody targeting VISTA (V-domain Ig suppressor of T cell Activation). VISTA is a negative checkpoint regulator of T cell response. VISTA is expressed within the tumor microenvironment, where its inhibition can enhance antitumor immune responses. An increase in VISTA expression has been reported after treatment by anti-PD1/L1 and anti-CTLA4. This confirms that VISTA may play a key role as a mechanism of resistance to the currently used immunotherapies. W0180 given to patients as a single agent or in combination with anti-PD1/L1 therapy has a potential in multiple cancer indications, including those with myeloid immunosuppressive infiltrates where VISTA pathway is expressed.