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G1 Therapeutics
GTHX
IndustryPharmaceuticals
Founded2008; 16 years ago (2008)
FoundersNorman Sharpless
HeadquartersNorth Carolina, United States
Key people
Mark Velleca
CEO

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[edit]

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 17th, 2017 and trades on the NASDAQ under the ticker symbol GTHX.[5][6] 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.[7][8]

Pipeline[edit]

Trilaciclib – G1T28[edit]

Trilacilib, a CDK 4/6 inhibitor,[9] 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).[10] The company has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) date set for February 15, 2020.[11] The company has also launched an expanded access program providing SCLC patients with access to Trilaciclib while the drug is under FDA review.[12] Trilaciclib is also being tested in colorectal cancer[13] and breast cancer.[14]

Rintodestrant – G1T48[edit]

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.[15][16][17]

Lerociclib – G1T38[edit]

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).[18] Rights to develop Lerociclib in the Asia-Pacific region have been licensed to Genor Biopharma. [19]

Footnotes[edit]

  • AACR 2017 Proceedings: Abstracts 3063-5947. N.p.: CTI Meeting Technology, 2017.
  • Brown, Sarah R.., Brown, Julia M.., Gregory, Walter M.., Twelves, Christopher J.. A Practical Guide to Designing Phase II Trials in Oncology. Germany: Wiley, 2014.
  • Resistance to Aromatase Inhibitors in Breast Cancer. Germany: Springer International Publishing, 2015.
  • Resistance to Anti-Cancer Therapeutics Targeting Receptor Tyrosine Kinases and Downstream Pathways. United States: Springer International Publishing, 2019.
  • Rivera, M. Patricia., Matthay, Richard A.. Lung Cancer PART II, An Issue of Clinics in Chest Medicine, E-Book. Netherlands: Elsevier Health Sciences, 2020.
  • Cancer Diagnostics: Current and Future Trends. Ukraine: Humana Press, 2004.
  • Antimicrobial Drug Resistance: Clinical and Epidemiological Aspects, Volume 2. Netherlands: Humana Press, 2009.
  • Antimicrobial Drug Resistance: Mechanisms of Drug Resistance, Volume 1. Netherlands: Humana Press, 2009.

References[edit]

  1. ^ Kaplan, Sheila (12 March 2019). "National Cancer Chief, Ned Sharpless, Named F.D.A.'s Acting Commissioner (Published 2019)". The New York Times. ISSN 0362-4331. Retrieved 11 December 2020.
  2. ^ McGinley, Laurie; Goldstein, Amy. "Nation's cancer chief appointed acting FDA commissioner". Washington Post. ISSN 0190-8286. Retrieved 11 December 2020.
  3. ^ "UNC spinout gets $33M for cancer treatment". www.bizjournals.com. Retrieved 11 December 2020.{{cite web}}: CS1 maint: url-status (link)
  4. ^ "SEC Filing - G1 Therapeutics, Inc". investor.g1therapeutics.com. Retrieved 11 December 2020.
  5. ^ Wiesmann, U. N.; DiDonato, S.; Herschkowitz, N. N. (27 October 1975). "Effect of chloroquine on cultured fibroblasts: release of lysosomal hydrolases and inhibition of their uptake". Biochemical and Biophysical Research Communications. 66 (4): 1338–1343. doi:10.1016/0006-291x(75)90506-9. ISSN 1090-2104. PMID 4.
  6. ^ "Xconomy: Cancer Drugmaker G1 Therapeutics Makes IPO Pitch To Wall Street". Xconomy. 17 April 2017. Retrieved 11 December 2020.
  7. ^ "Alabama company uses Zumbathon to promote Stepping Up initiative". Mental Health Weekly. 30 (21): 7–8. 22 May 2020. doi:10.1002/mhw.32378. ISSN 1058-1103.
  8. ^ Chow, Y. W.; Pietranico, R.; Mukerji, A. (27 October 1975). "Studies of oxygen binding energy to hemoglobin molecule". Biochemical and Biophysical Research Communications. 66 (4): 1424–1431. doi:10.1016/0006-291x(75)90518-5. ISSN 0006-291X. PMID 6.
  9. ^ Weiss, J. M.; Csoszi, T.; Maglakelidze, M.; Hoyer, R. J.; Beck, J. T.; Gomez, M. Domine; Lowczak, A.; Aljumaily, R.; Lima, C. M. Rocha; Boccia, R. V.; Hanna, W. (1 October 2019). "Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial". Annals of Oncology. 30 (10): 1613–1621. doi:10.1093/annonc/mdz278. ISSN 0923-7534. PMID 31504118.
  10. ^ "FDA Grants Trilaciclib Priority Review for Small Cell Lung Cancer". OncLive. Retrieved 11 December 2020.
  11. ^ "FDA Grants Priority Review to Trilaciclib to Treat Patients with SCLC". Cancer Network. Retrieved 11 December 2020.
  12. ^ "FDA Grants Priority Review to Trilaciclib in Small Cell Lung Cancer". Targeted Oncology. Retrieved 11 December 2020.
  13. ^ G1 Therapeutics, Inc. (10 December 2020). "PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer". {{cite journal}}: Cite journal requires |journal= (help)CS1 maint: numeric names: authors list (link)
  14. ^ G1 Therapeutics, Inc. (24 July 2020). "Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy". {{cite journal}}: Cite journal requires |journal= (help)CS1 maint: numeric names: authors list (link)
  15. ^ G1 Therapeutics, Inc. (16 September 2020). "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". {{cite journal}}: Cite journal requires |journal= (help)CS1 maint: numeric names: authors list (link)
  16. ^ "Rintodestrant - G1 Therapeutics - AdisInsight". adisinsight.springer.com. Retrieved 11 December 2020.
  17. ^ Andreano, Kaitlyn J.; Wardell, Suzanne E.; Baker, Jennifer G.; Desautels, Taylor K.; Baldi, Robert; Chao, Christina A.; Heetderks, Kendall A.; Bae, Yeeun; Xiong, Rui; Tonetti, Debra A.; Gutgesell, Lauren M. (1 April 2020). "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. doi:10.1007/s10549-020-05575-9. ISSN 1573-7217. PMC 7103015. PMID 32130619.{{cite journal}}: CS1 maint: PMC format (link)
  18. ^ "G1 Therapeutics nabs $310 million licensing deal for lerociclib". www.thepharmaletter.com. Retrieved 11 December 2020.
  19. ^ "G1 Therapeutics and Genor Biopharma sign agreement for Lerociclib". Express Pharma. 23 June 2020. Retrieved 11 December 2020.
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