Pierre Fabre initiates a "First in Human" clinical trial for an innovative monoclonal antibody (W0180) targeting the VISTA checkpoint in patients with solid tumors

TOULOUSE, France, Nov. 9, 2020 /PRNewswire/ -- Pierre Fabre announced today the initiation of an international Phase I clinical study in patients with relapsed or refractory solid tumors for its investigational product W0180, an innovative 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.

Aurelien Marabelle said: "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."

Jean-Luc Lowinski, Pierre Fabre Medical Care CEO, added: "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."

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. Furthermore, 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.

Pierre Fabre has presented 3 communications about W0180 to the Annual Meetings of the American Association of Cancer Research (AACR 2019 and AACR 2020) and is preparing an upcoming communication to the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting to be held virtually on November 9-14, 2020. The SITC communication is entitled "W0180 novel anti-VISTA antibody: rationale for target patient population and first-in-human trial design in monotherapy and in combination with anti-PD1 antibody."

About Pierre Fabre

Pierre Fabre is a French health and beauty care company with 35-year experience in innovation, development, manufacturing and commercialization in oncology. The company has recently reaffirmed oncology as one of its main R&D and commercial priorities, focusing on targeted therapies, biotherapies and immuno-oncology. Its therapeutic areas cover high unmet medical needs, including colorectal, breast, lung cancers, melanoma and pre-cancerous conditions like actinic keratosis.

In 2019, Pierre Fabre generated 2.4 billion euros in revenues, of which two-thirds originated from its international business. Pierre Fabre, which has always been headquartered in the South-West of France, employs approximately 10,400 people worldwide, owns subsidiaries and offices in 45 countries and enjoys distribution agreements in over 130 countries. Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognised public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.

In 2019, Ecocert Environment assessed the Group's corporate social and environmental responsibility approach according to the ISO 26000 standard on sustainable development and awarded it the ECOCERT 26000 "Excellence" level.

www.pierre-fabre.com ^[1]@PierreFabre

PRESS CONTACTAnne KERVEILLANT anne.kerveillant@pierre-fabre.com ^[2]