Tyrosine kinase receptors

Amunix Raises $117 Million Series B Financing to Fund its Oncology Pipeline

Thursday, March 4, 2021 - 1:00pm

Also participating in the round were existing investors Redmile Group, Venrock, Casdin Capital, Omega Funds, Frazier Healthcare Partners, Longitude Capital, and Polaris Partners.

Key Points: 
  • Also participating in the round were existing investors Redmile Group, Venrock, Casdin Capital, Omega Funds, Frazier Healthcare Partners, Longitude Capital, and Polaris Partners.
  • Proceeds from the financing will fund the advancement into the clinic of AMX-818, a masked, protease-activated T cell engager (XPAT) targeting HER2-expressing solid tumors, as well as support Amunixs robust pipeline of earlier stage XPATs and masked, protease-activated cytokines (XPACs).
  • We are building on the promise of these potent drugs to target and attack solid tumors, while potentially reducing their toxicity.
  • The companys pipeline includes AMX-818, an XPAT T cell engager targeting a variety of HER2-expressing solid tumors, which is currently in IND-enabling studies.

U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

Thursday, March 4, 2021 - 12:03am

LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Key Points: 
  • LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.
  • AEs leading to dose interruptions and dose reductions occurred in 49% and 21% of people treated with LORBRENA, respectively.
  • Based on the CROWN data, the FDA has also converted the accelerated approval to full approval.
  • LORBRENA is approved in the U.S. for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

BerGenBio (BGBIO): AXLeration of data catalysts in 2021

Saturday, February 27, 2021 - 8:01am

Lead asset bemcentinib (oral, once a day, highly selective AXL inhibitor) reported encouraging efficacy data from ongoing Phase II trials.

Key Points: 
  • Lead asset bemcentinib (oral, once a day, highly selective AXL inhibitor) reported encouraging efficacy data from ongoing Phase II trials.
  • Multiple catalysts expected in 2021 will define BGBIO's clinical trial strategy in AML/MDS and/or NSCLC.
  • The FY20 operating loss was significantly higher than in FY19 (NOK261.1m vs NOK204.4m) due to higher set-up costs and increased investment in programme expenses.
  • About Edison: Edison is a leading research and investor relations consultancy, connecting listed companies to the widest pool of global investors.

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.

Basilea reports positive topline results from phase 2 study FIDES-01 for derazantinib in FGFR2 gene fusion-positive patients with bile duct cancer (iCCA)

Wednesday, February 10, 2021 - 6:15am

Enrolment into cohort 2 of FIDES-01 is ongoing, assessing the activity of derazantinib in iCCA patients with FGFR2 gene mutations or amplifications.

Key Points: 
  • Enrolment into cohort 2 of FIDES-01 is ongoing, assessing the activity of derazantinib in iCCA patients with FGFR2 gene mutations or amplifications.
  • The disease control rate (DCR), reflecting the proportion of patients with a partial response or with stable disease, was 72.8%.
  • The results are not yet fully mature, as 12 patients are still ongoing, including 3 patients with a partial response.
  • The first study, FIDES-01, is a phase 2 study in patients with inoperable or advanced iCCA.

Apollomics, Inc. and Edison Oncology Announce Licensing Agreement for Novel Protein Tyrosine Kinase Inhibitor Targeting Solid Tumors

Wednesday, February 10, 2021 - 1:10am

EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.

Key Points: 
  • EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.
  • Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan.
  • EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.
  • Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer.

Apollomics, Inc. and Edison Oncology Announce Licensing Agreement for Novel Protein Tyrosine Kinase Inhibitor Targeting Solid Tumors

Tuesday, February 9, 2021 - 12:10pm

EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.

Key Points: 
  • EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.
  • Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan.
  • EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent.
  • Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer.

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.

Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18-Mutated, Metastatic Non-Small Cell Lung Cancer at WCLC 2020

Friday, January 29, 2021 - 1:00pm

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations.

Key Points: 
  • The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations.
  • 10 patients had been previously treated with an EGFR targeted tyrosine kinase inhibitor (gefitinib, erlotinib, osimertinib and/or afatinib).
  • Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.
  • Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.

Janssen: New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations

Friday, January 29, 2021 - 4:00am

8 Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.

Key Points: 
  • 8 Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
  • 9 Janssen Submits European Marketing Authorisation Application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
  • HSR19-082: Epidemiological Findings and Outcomes in Non-Small Cell Lung Cancer Patients with Exon 20 Insertion Mutations: A Meta-Analysis.
  • Comparative Clinical Outcomes for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutations and Common EGFR Mutations.