G1 Therapeutics
G1 Therapeutics, Inc. is an American biopharmaceutical company headquartered in Research Triangle Park, North Carolina. The company specializes in developing and commercializing small molecule therapeutics for the treatment of patients with cancer. History G1 Therapeutics was co-founded in 2008 by Norman Sharpless, 15th Director of the National Cancer Institute, and Kwok-Kin Wong, to develop and commercialize drug candidates discovered at, and licensed from, Sharpless’ lab at the University of North Carolina at Chapel Hill. Early investors in G1 included Hatteras Venture Partners, and Fred Eshelman, founder of PPD, Inc. Other early investors included AstraZeneca’s venture capital fund MedImmune Ventures, and Cormorant Asset Management. G1 went public on May 17, 2017 and trades on the NASDAQ under the ticker symbol GTHX. On September 30, 2020, the company announced CEO, Mark Velleca, will be stepping down on January 1, 2021, and is to be replaced by Jack Bailey, former President of U.S. pharmaceuticals and vaccines for GlaxoSmithKline. Pipeline Trilaciclib – G1T28 Trilaciclib, a small molecule CDK4/6 inhibitor, is a first-in-class, FDA-designated Breakthrough therapy designed to improve outcomes for cancer patients being treated with chemotherapy. The drug's first targeted indication is small cell lung cancer (SCLC). Patients receiving chemotherapy as part of SCLC treatment frequently experience chemotherapy-induced myelosuppression. In three randomized, placebo-controlled SCLC trials, trilaciclib, when administered to patients before chemotherapy, significantly reduced the occurrence of chemotherapy-induced myelosuppression and the need for supportive care. In June 2020, G1 filed a New Drug Application (NDA) with the Food and Drug Administration (FDA). The application was granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date set for February 15, 2021. In September 2020, G1 launched an expanded access program providing SCLC patients access to trilaciclib while the drug is under FDA review. The FDA approved trilaciclib for use in SCLC on February 12, 2021. In March 2021, trilaciclib was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as an appropriate prophylactic option to decrease the incidence of chemotherapy-induced myelosuppression for patients undergoing chemotherapy for extensive-stage small-cell lung cancer. Trilaciclib is one of several novel agents under review for breast cancer treatment as part of the I-SPY series of clinical trials organized by Quantum Leap Healthcare Collaborative. In October 2020, G1 initiated a Phase 3 registrational study (NCT04607668 - PRESERVE 1) evaluating the impact of trilaciclib on myelopreservation and antitumor efficacy in patients receiving chemotherapy for metastatic colorectal cancer. In March 2021, the company initiated a Phase 3 registrational study (NCT04799249 - PRESERVE 2) evaluating trilaciclib in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for locally advanced, unresectable, or metastatic triple-negative breast cancer. In April 2021, G1 initiated a Phase 2 study (NCT04863248 – PRESERVE 4) evaluating trilaciclib in patients with metastatic non-small cell lung cancer who are receiving the chemotherapy agent docetaxel. In May 2021, G1 initiated a Phase 2 study (NCT04887831 – PRESERVE 3) evaluating trilaciclib in patients with metastatic bladder cancer who are receiving chemotherapy followed by avelumab. Rintodestrant – G1T48