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.[1]

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.[2] Early investors in G1 included Hatteras Venture Partners, and Fred Eshelman, founder of PPD, Inc.[3] Other early investors included AstraZeneca's venture capital fund MedImmune Ventures, and Cormorant Asset Management.[4]

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.[8] The drug's first targeted indication is small cell lung cancer (SCLC).[9] Patients receiving chemotherapy as part of SCLC treatment frequently experience chemotherapy-induced myelosuppression.[10] 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.[11] In June 2020, G1 filed a New Drug Application (NDA) with the Food and Drug Administration (FDA).[12] The application was granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date set for February 15, 2021.[13] In September 2020, G1 launched an expanded access program providing SCLC patients access to trilaciclib while the drug is under FDA review.[14] The FDA approved trilaciclib for use in SCLC on February 12, 2021.[15] 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.[16]

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.[17]

In October 2020, G1 initiated a Phase 3 registrational study (NCT04607668 - PRESERVE 1)[18] evaluating the impact of trilaciclib on myelopreservation and antitumor efficacy in patients receiving chemotherapy for metastatic colorectal cancer.[19] 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.[20] 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.[21] 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

Rintodestrant, an oral selective estrogen receptor degrader (SERD), is being developed as a treatment for ER-Positive, HER2-Negative advanced breast cancer, both as monotherapy and in combination with palbociclib, a CDK 4/6 inhibitor marketed by Pfizer as Ibrance.[23][24][25]

Lerociclib – G1T38

Lerociclib is a potent, selective oral CDK4/6 inhibitor. Preclinical and early clinical data have demonstrated that lerociclib is differentiated from other CDK4/6 inhibitors based on its favorable safety profile and ability to be dosed continuously with less dose-limiting neutropenia.[26]

traded as	(2017-24)
industry	Pharmaceuticals
foundation	2008
founders	Norman Sharpless Kwok-Kin Wong
location	North Carolina, United States
key people	Jack Bailey (CEO) Terry Murdock (COO) John Umstead V (CFO) Raj Malik, M.D. (CMO) Andrew Perry (CCO) Mark Avagliano (CBO)
products	Cosela
num employees	170 (Dec. 2022)
owner	Pharmacosmos (2024–present)
homepage	g1therapeutics.com

History

Pipeline

Trilaciclib – G1T28

Rintodestrant – G1T48

Lerociclib – G1T38

Products

Collaborations

External Links

References