G1 Therapeutics, Inc., is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. Two of the company’s pipeline assets, trilaciclib and lerociclib, are CDK4/6 inhibitors, a validated and promising class of oncology therapeutics. Trilaciclib and lerociclib have broad therapeutic potential in many forms of cancer and may serve as backbone therapy of multiple combination regimens. Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. In April 2019, G1 announced plans to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation in small cell lung cancer (SCLC). The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2020, and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) subsequent to the NDA filing.
Lerociclib is a potential best-in-class oral CDK4/6 inhibitor for use in combination with other targeted therapies. G1 is also advancing G1T48, a potential best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer. G1 owns or holds an exclusive license for worldwide commercial rights to each of its product candidates.