On November 9, 2020 Pierre Fabre reported 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 (Press release, Pierre Fabre, NOV 9, 2020, View Source [SID1234570659]). 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).
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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 (Free AACR Whitepaper) 2020) and is preparing an upcoming communication to the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting to be held virtually on November 9-14, 2020. The SITC (Free SITC Whitepaper) 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."