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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 17th, 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.

Trilaciclib – G1T28
Trilacilib, a CDK 4/6 inhibitor, is an FDA-designated Breakthrough Therapy designed to protect patients from chemotherapy-induced toxicities. The drug’s first targeted indication is small cell lung cancer (SCLC). G1 filed a New Drug Application (NDA) for Trilaciclib in this indication with the Food and Drug Administration (FDA). The company has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date set for February 15, 2020. The company has also launched an expanded access program providing SCLC patients with access to Trilaciclib while the drug is under FDA review. Trilaciclib is also being tested in colorectal cancer and breast cancer.

Rintodestrant – G1T48
Rintodestrant, an oral selective estrogen receptor degrader (SERD), is being developed as a treatment for ER-Positive, HER2-Negative advanced breast cancer, both as a monotherapy and in combination with Palbociclib, a CDK 4/6 inhibitor marketed by Pfizer as Ibrance.

Lerociclib – G1T38
Lerociclib, an oral CDK 4/6 inhibitor, has been licensed by G1 to biopharmaceutical company EQRx. The license provides exclusive rights to develop Lerociclib for the USA, Europe, Japan, and other global markets, excluding the Asia-Pacific region (except Japan). Rights to develop Lerociclib in the Asia-Pacific region have been licensed to Genor Biopharma.