Fibroblast growth factor

Eisai: MHLW Grants Orphan Drug Designation in Japan to Novel FGF Receptor Selective Tyrosine Kinase Inhibitor E7090

Monday, February 22, 2021 - 6:40am

In Japan, a Phase I clinical trial of E7090 was conducted, and E7090 has been designated as the target drug for the SAKIGAKE Designation System of the MHLW for the treatment of unresectable biliary tract cancer.

Key Points: 
  • In Japan, a Phase I clinical trial of E7090 was conducted, and E7090 has been designated as the target drug for the SAKIGAKE Designation System of the MHLW for the treatment of unresectable biliary tract cancer.
  • Discovered in-house by Eisai's Tsukuba Research Laboratories, E7090 is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2 and FGFR3.
  • et al., "Biliary tract cancer registry in Japan from 2008 to 2013", J Hepatobiliary Pancreat Sci., 2016, 23, 149-157.
  • (6) Arai Y. et al., "Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma", Hepatology, 2014, 59, 1427-1434.

Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement

Friday, January 29, 2021 - 6:36pm

The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

Key Points: 
  • The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.
  • If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement and would be commercialized under the brand name Pemazyre.
  • Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor1,2.
  • FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

Trefoil Therapeutics to Present Update on Regenerative Treatments for Corneal Diseases

Monday, November 2, 2020 - 1:00pm

Trefoil Therapeutics announced today it will provide an update on the company and its clinical program for TTHX1114 at the upcoming Eyecelerator virtual conference.

Key Points: 
  • Trefoil Therapeutics announced today it will provide an update on the company and its clinical program for TTHX1114 at the upcoming Eyecelerator virtual conference.
  • TTHX1114 is the companys first-in-class, engineered fibroblast growth factor 1 (FGF-1), for the regenerative treatment of corneal diseases.
  • Trefoil also has a topical product based on its engineered FGF-1 that is in preclinical development for the treatment of corneal epithelial disorders.
  • Trefoil Therapeutics is a private biotechnology company focused on leveraging its engineered fibroblast growth factor-1 protein technology platform to develop first-in-class pharmacologic treatments for serious corneal endothelial diseases and epithelial disorders.

Basilea reports data from poster presentations at ESMO Virtual Congress 2020

Tuesday, September 22, 2020 - 6:15am

Basilea Pharmaceutica Ltd. (SIX: BSLN) today reports on several e-posters with new preclinical and clinical data on its fibroblast growth factor receptor (FGFR) inhibitor derazantinib and its tumor checkpoint controller, lisavanbulin, presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which took place from 19-21 September, 2020.

Key Points: 
  • Basilea Pharmaceutica Ltd. (SIX: BSLN) today reports on several e-posters with new preclinical and clinical data on its fibroblast growth factor receptor (FGFR) inhibitor derazantinib and its tumor checkpoint controller, lisavanbulin, presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which took place from 19-21 September, 2020.
  • In addition, gastric and lung cancer models showed the strongest correlation of FGFR1-3 expression versus the anticancer activity of derazantinib.
  • The results support the planned clinical investigation of derazantinib in gastric cancer as its next indication.
  • Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN).

Everest Medicines Announces First Patient Dosed in a Phase 1b/2 Study of FGF401 in Combination with Pembrolizumab for the Treatment of Advanced Solid Tumors

Friday, August 7, 2020 - 4:00am

FGF401 is an ATP-competitive, reversible-covalent inhibitor of fibroblast growth factor receptor 4, or FGFR4, for which Everest Medicines obtained global development and commercial rights from Novartis AG, or Novartis.

Key Points: 
  • FGF401 is an ATP-competitive, reversible-covalent inhibitor of fibroblast growth factor receptor 4, or FGFR4, for which Everest Medicines obtained global development and commercial rights from Novartis AG, or Novartis.
  • Growing evidence demonstrates that the activation of the FGF19-FGFR4 pathway is associated with the formation of solid tumors.
  • FGF401 is an ATP-competitive, reversible-covalent inhibitor of FGFR4 for which Everest Medicines obtained exclusive global development and commercial rights from Novartis.
  • Everest is developing FGF401 as a potential new treatment for HCC and other solid tumors associated with activation of the FGF19-FGFR4 pathway.

Basilea announces data presentations at ESMO Virtual Congress 2020

Tuesday, July 28, 2020 - 6:15am

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that three abstracts featuring preclinical and clinical data on its fibroblast growth factor receptor (FGFR) kinase inhibitor derazantinib and its tumor checkpoint controller lisavanbulin are going to be presented as e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which is taking place from 19-21 September, 2020.

Key Points: 
  • Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that three abstracts featuring preclinical and clinical data on its fibroblast growth factor receptor (FGFR) kinase inhibitor derazantinib and its tumor checkpoint controller lisavanbulin are going to be presented as e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which is taking place from 19-21 September, 2020.
  • Dr. Marc Engelhardt, Chief Medical Officer, said: The preclinical derazantinib data may provide an explanation for differences in reported adverse event profiles between various FGFR kinase inhibitors.
  • He continued: We are also pleased that the full data from the phase 1 study with oral lisavanbulin in patients with recurrent glioblastoma will be presented at ESMO.
  • Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN).

Basilea announces completion of patient enrolment into first cohort of phase 2 study FIDES-01 with derazantinib in bile duct cancer (iCCA)

Monday, July 20, 2020 - 6:15am

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today the completion of patient enrolment into the first cohort of the phase 2 registrational study, FIDES-01, assessing the activity of the FGFR kinase inhibitor derazantinib in patients with intrahepatic cholangiocarcinoma (iCCA), a form of bile duct cancer.

Key Points: 
  • Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today the completion of patient enrolment into the first cohort of the phase 2 registrational study, FIDES-01, assessing the activity of the FGFR kinase inhibitor derazantinib in patients with intrahepatic cholangiocarcinoma (iCCA), a form of bile duct cancer.
  • This first cohort enrolled patients with iCCA expressing fusions of the fibroblast growth factor receptor 2 (FGFR2) gene and reached its target enrolment of 100 patients.
  • This cohort is assessing the activity of derazantinib in patients with FGFR2 gene mutations or amplifications, thus broadening the range of investigated FGFR2-driven tumors.
  • The first study, FIDES-01, is a registrational phase 2 study in patients with inoperable or advanced iCCA.

RIBOMIC Announces Dosing of First Subject in RBM-007 Phase 1 Clinical Trial for Achondroplasia

Wednesday, July 15, 2020 - 2:30pm

Achondroplasia has no known cure, and is designated as an intractable disease by the Ministry of Health, Labour and Welfare in Japan.

Key Points: 
  • Achondroplasia has no known cure, and is designated as an intractable disease by the Ministry of Health, Labour and Welfare in Japan.
  • This disease results mainly from a genetic variant in FGFR3 (fibroblast growth factor type 3 receptor).
  • Achondroplasia occurs in a frequency of 1 in approximately 25,000 normal live births and is estimated to affect approximately 250,000 people worldwide.
  • "RIBOMIC," "RiboART system" and the RIBOMIC logo are registered trademarks or trademarks of RIBOMIC Inc. in various jurisdictions.

FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

Thursday, June 18, 2020 - 6:45pm

The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.

Key Points: 
  • The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
  • "Treatment for TIO focuses on identifying and removing the tumor that causes the disease.
  • FGF23 regulates levels of phosphate, an electrolyte that plays important roles in bone maintenance, energy production by cells and nerve function.
  • When there is not enough phosphate in the body, bones begin to soften and weaken, causing osteomalacia (marked softening of bones).

Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with Advanced Malignant Mesothelioma in China

Tuesday, March 31, 2020 - 7:46am

LONDON, March 31, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited ( Chi-Med ) (Nasdaq/AIM: HCM) has initiated a Phase II study of HMPL-453, its novel small molecule inhibitor targeting fibroblast growth factor receptors (FGFR), in patients with advanced malignant mesothelioma.

Key Points: 
  • LONDON, March 31, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited ( Chi-Med ) (Nasdaq/AIM: HCM) has initiated a Phase II study of HMPL-453, its novel small molecule inhibitor targeting fibroblast growth factor receptors (FGFR), in patients with advanced malignant mesothelioma.
  • The clinical study is a single-arm, multi-center, open-label study, evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in historically confirmed patients with advanced malignant mesothelioma that failed at least one line of systemic therapy.
  • Secondary outcome measures include preliminary efficacy such as disease control rate (DCR), time to response (TTR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
  • The lead investigator of the study is Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University.