Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors

GEN2 is a non-replicating off-the-shelf gene therapy vector product being developed as a cancer immunotherapy to activate a patient's immune system against their personal cancer antigens (neoantigens). The vector payload encodes for a suicide gene, an enhanced viral thymidine kinase enzyme (HSV-eTK), which in the presence of a prodrug, valganciclovir, causes the tumor to release patient specific tumor antigens. These neoantigens in the presence of a human immune modulator cytokine, granulocyte-macrophage colony-stimulating factor (hGM-CSF), results in the generation of immune effector cells. These effector cells maintain continually amplifying therapeutic immune responses as more tumor cells are killed and release antigen and will potentially kill any new tumor metastases that arise.