CK-302 is a fully human agonistic monoclonal antibody that is designed to bind and trigger signaling in GITR expressing cells. GITR is a co-stimulatory molecule of the TNF receptor family and is expressed on activated T cells, B cells, natural killer (“NK”) and regulatory T cells (“Treg”). As a co-stimulatory molecule, GITR engagement increases proliferation, activation, and cytokine production of CD4+ and CD8+ T cells. We believe our anti-GITR monoclonal antibody abrogates immunosuppressive activity of natural Treg on expansion of T-effector cells. GITR-specific agonistic monoclonal antibodies under development by third parties have been shown to induce tumor regression in vivo through the activation of CD4+ T cells, CD8+ T cells and NK cells in a number of tumor models.
We are developing CK-302 for oncology indications where scientific literature supports the potential for an anti-GITR to be effective. In March 2015, we entered into a collaboration agreement to co-develop anti-GITR antibodies for hematological oncological indications with TGTX. We retain the right to develop and commercialize anti-GITR antibodies in solid tumors. We believe that an anti-GITR antibody has the potential to be effective in many oncological indications as a mono therapy or in combination with anti-PD-L1 or anti-CAIX as well as other anti-tumor immune response potentiating compounds and other targeted therapies.
We licensed the exclusive worldwide rights to anti-GITR antibodies from Dana-Farber in March 2015. Currently we are in preclinical development for this program.