G1 Therapeutics Explained

G1 Therapeutics
Type:Public
Traded As:NASDAQ:
Industry:Pharmaceuticals
Founders:Norman Sharpless
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)

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]

G1 went public on May 17, 2017 and trades on the NASDAQ under the ticker symbol GTHX.[5] 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.[6]

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

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.[16]

In October 2020, G1 initiated a Phase 3 registrational study (NCT04607668 - PRESERVE 1)[17] evaluating the impact of trilaciclib on myelopreservation and antitumor efficacy in patients receiving chemotherapy for metastatic colorectal cancer.[18] 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.[19] 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.[20] 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.[21]

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.[22] [23] [24]

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.[25]

Products

Cosela

On February 12, 2021, the FDA approved trilaciclib (brand name Cosela) as a treatment to reduce the frequency of chemotherapy-induced myelosuppression for patients receiving certain types of chemotherapy for extensive-stage small-cell lung cancer.[26]

Collaborations

Footnotes

External Links

Notes and References

  1. News: Kaplan. Sheila . vanc . 2019-03-12. National Cancer Chief, Ned Sharpless, Named F.D.A.'s Acting Commissioner (Published 2019). en-US. The New York Times. 2020-12-11. 0362-4331.
  2. News: McGinley. Laurie. Goldstein. Amy . vanc . Nation's cancer chief appointed acting FDA commissioner. en-US. Washington Post. 2020-12-11. 0190-8286.
  3. Web site: UNC spinout gets $33M for cancer treatment. 2020-12-11. www.bizjournals.com.
  4. Web site: SEC Filing - G1 Therapeutics, Inc.. 2020-12-11. investor.g1therapeutics.com.
  5. Web site: 2017-04-17. Xconomy: Cancer Drugmaker G1 Therapeutics Makes IPO Pitch To Wall Street. 2020-12-11. Xconomy. en.
  6. Web site: G1 Therapeutics CEO Mark Vellecca to Step Down. 2021-01-07. Citybizlist.
  7. Web site: Trilaciclib intravenous CDK4/6 inhibitor G1 Therapeutics, Inc.. 2021-01-10. www.g1therapeutics.com.
  8. Web site: FDA Grants Priority Review to Trilaciclib in Small Cell Lung Cancer. 2021-01-05. Targeted Oncology.
  9. Epstein. Robert S.. Krenitsky. JoAnn. Weerasinghe. Roshanthi K.. Parrish. Amy S.. Sanborn. Rachel E.. Salimi. Tehseen. 2020-05-20. Real-world burden of myelosuppression in patients with small cell lung cancer (SCLC): Retrospective, longitudinal data analysis.. Journal of Clinical Oncology. 38. 15_suppl. e19300. 10.1200/JCO.2020.38.15_suppl.e19300. 219774668 . 0732-183X. subscription.
  10. Weiss. Jared. Goldschmidt. Jerome. Zoran. Andric. Dragnev. Konstantin H.. Pritchett. Yili. Morris. Shannon R.. Malik. Rajesh K.. Daniel. Davey B.. 2020-05-20. Myelopreservation and reduced use of supportive care with trilaciclib in patients with small cell lung cancer.. Journal of Clinical Oncology. 38. 15_suppl. 12096. 10.1200/JCO.2020.38.15_suppl.12096. 219780224 . 0732-183X.
  11. Web site: FDA Grants Trilaciclib Priority Review for Small Cell Lung Cancer. 2020-12-11. OncLive.
  12. Web site: FDA Grants Priority Review to Trilaciclib to Treat Patients with SCLC. 2020-12-11. Cancer Network.
  13. Web site: FDA Grants Priority Review to Trilaciclib in Small Cell Lung Cancer. 2020-12-11. Targeted Oncology.
  14. Web site: FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression. 2021-02-17. Drugs.com. en.
  15. Web site: NCCN Clinical Practice Guidelines in Oncology. 2021-03-25. www.nccn.org. en.
  16. Web site: The I-SPY Trials. 2021-02-18. www.ispytrials.org.
  17. G1 Therapeutics, Inc.. 2021-01-13. PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer.
  18. G1 Therapeutics, Inc.. 2020-12-10. PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer.
  19. G1 Therapeutics, Inc.. 2021-03-11. A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2).
  20. G1 Therapeutics, Inc.. 2021-04-23. A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib Versus Placebo in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4).
  21. G1 Therapeutics, Inc.. 2021-05-13. A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3).
  22. G1 Therapeutics, Inc.. 2020-09-16. A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination With Palbociclib in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer.
  23. Web site: Rintodestrant - G1 Therapeutics - AdisInsight. 2020-12-11. adisinsight.springer.com.
  24. Andreano KJ, Wardell SE, Baker JG, Desautels TK, Baldi R, Chao CA, Heetderks KA, Bae Y, Xiong R, Tonetti DA, Gutgesell LM, Zhao J, Sorrentino JA, Thompson DA, Bisi JE, Strum JC, Thatcher GR, Norris JD . 6 . G1T48, an oral selective estrogen receptor degrader, and the CDK4/6 inhibitor lerociclib inhibit tumor growth in animal models of endocrine-resistant breast cancer . Breast Cancer Research and Treatment . 180 . 3 . 635–646 . April 2020 . 32130619 . 7103015 . 10.1007/s10549-020-05575-9 .
  25. Berz. D.. Spira. A.. Gadgeel. S. M.. Anderson. I. C.. Goldman. J. W.. Thompson. J.. Foster. T.. Pritchett. Y. L.. Cisneros. C. G.. Li. C.. Sorrentino. J. A.. 2019-10-01. 1537P - Lerociclib (G1T38), an oral CDK4/6 inhibitor, dosed continuously in combination with osimertinib for EGFRmut non-small cell lung cancer: Initial phase Ib results. Annals of Oncology. Abstract Book of the 44th ESMO Congress (ESMO 2019) 27 September – 1 October 2019, Barcelona, Spain. en. 30. v631. 10.1093/annonc/mdz260.059. 0923-7534. free.
  26. Web site: Commissioner. Office of the. 2021-02-12. FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy. 2021-02-13. FDA. en.
  27. Web site: Therapeutics. G1. 2020-06-30. G1 Therapeutics and Boehringer Ingelheim Announce Co-Promotion Agreement for Trilaciclib in Small Cell Lung Cancer in the United States and Puerto Rico. 2020-12-27. GlobeNewswire News Room.
  28. Web site: Simcere licenses CDK4/6 inhibitor from G1 Therapeutics in $170M deal. 2021-01-05. www.bioworld.com. en.
  29. G1 Therapeutics, Inc.. 2020-09-16. A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Ascending Doses of G1T48 Alone and in Combination With Palbociclib in Women With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer.
  30. Web site: G1 Therapeutics nabs $310 million licensing deal for lerociclib. 2020-12-11. www.thepharmaletter.com.
  31. Web site: 2020-06-23. G1 Therapeutics and Genor Biopharma sign agreement for Lerociclib. 2020-12-11. Express Pharma. en-US.
  32. Web site: Latest News & Updates. 2021-01-10. Arc Therapeutics. en-US.

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