The company has completed an FDA pre-IND meeting and has gained agreement on the nonclinical package needed to file the IND and initiate the phase 1 monotherapy study in advanced, pre-treated, solid tumor patients. A world class CMO has been retained to develop the master cell line, the toxicology material, and the Phase 1 drug product. A CRO will conduct the toxicology studies required for IND filing.
If successful in phase 1, an extensive clinical development plan will be executed to test the antibody in multiple cancer types, potentially with combination therapy. The drug can be used in a substantially larger patient population than current therapies. A key differentiator for this asset is the fact that this human derived antibody was discovered in “exceptional outcomes” lung cancer patients, is human derived, recognizes a unique tumor epitope, and opens a new essential pathway in Immune-Oncology.
A second antibody against another key target is being developed as a follow on asset to the lead target. This antibody is in early preclinical development.