Bemcentinib

BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation

Retrieved on: 
Wednesday, March 20, 2024
AXL, Survival, NSCLC, STK11, Bemcentinib, Patient, Cancer, Safety, DSMB, Pharmaceutical industry

BERGEN, Norway, March 20, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).

Key Points: 
  • The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda®) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.
  • Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11.
  • There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.
  • Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized.

BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation

Retrieved on: 
Wednesday, March 20, 2024
AXL, Survival, NSCLC, STK11, Bemcentinib, Patient, Cancer, Safety, DSMB, Pharmaceutical industry

BERGEN, Norway, March 20, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).

Key Points: 
  • The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda®) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.
  • Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11.
  • There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.
  • Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized.

BerGenBio Announces Initiation of Phase 1b/2a Trial Evaluating Bemcentinib in 1st line Non-Small Cell Lung Cancer Patients Harboring STK11 Mutations

Retrieved on: 
Tuesday, October 11, 2022
Pembrolizumab, STK11, OSE, Patient, Standard of care, Bemcentinib, Inflammation, AXL, Safety, Hypoxia, Pharmaceutical industry, NSCLC

BERGEN, Norway, Oct. 11, 2022 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m).

Key Points: 
  • STK11 mutations are detected in approximately 20% of non-squamous NSCLC patients and are known to create a more immunosuppressive tumor microenvironment limiting the response to checkpoint inhibition.
  • Early clinical data also point to the activity of bemcentinib in NSCLC patients, including those harboring STK11m.
  • The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations.
  • The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.

BerGenBio Announces Initiation of Phase 1b/2a Trial Evaluating Bemcentinib in 1st line Non-Small Cell Lung Cancer Patients Harboring STK11 Mutations

Retrieved on: 
Tuesday, October 11, 2022
Pembrolizumab, STK11, OSE, Patient, Standard of care, Bemcentinib, Inflammation, AXL, Safety, Hypoxia, Pharmaceutical industry, NSCLC

BERGEN, Norway, Oct. 11, 2022 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m).

Key Points: 
  • STK11 mutations are detected in approximately 20% of non-squamous NSCLC patients and are known to create a more immunosuppressive tumor microenvironment limiting the response to checkpoint inhibition.
  • Early clinical data also point to the activity of bemcentinib in NSCLC patients, including those harboring STK11m.
  • The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations.
  • The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.

BERGENBIO ANNOUNCES LAUNCH OF BUSINESS STRATEGY FOCUSED ON NSCLC AND COVID-19

Retrieved on: 
Wednesday, May 4, 2022
COVID-19, Population, Mutation, Lung cancer, Phase, Treatment of lung cancer, Company, Safety, Research, ASA, Patient, Immunotherapy, FDA, Data, Urinary tract infection, Vaccine, AXL, Bemcentinib, Infection, STK11, Large-cell lung carcinoma, Pharmaceutical industry, NSCLC

BerGenBio has for many years pioneered research into AXL inhibition, with its lead development candidate bemcentinib showing clinical potential in oncology and infectious disease.

Key Points: 
  • BerGenBio has for many years pioneered research into AXL inhibition, with its lead development candidate bemcentinib showing clinical potential in oncology and infectious disease.
  • BerGenBio is targeting 1stLine STK11 mutated Non-Squamous NSCLC patients, an extremely large patient population with very limited response to the standard of care treatments.
  • STK11 is an important tumor suppressor gene reported to confer immunotherapy resistance in NSCLC and is present in up to 20% of NSCLC patients.
  • With a focused strategy and rightsized organization BerGenBio plans to unlock significant potential value related to the two indications selected and define the path to market.

BERGENBIO ANNOUNCES LAUNCH OF BUSINESS STRATEGY FOCUSED ON NSCLC AND COVID-19

Retrieved on: 
Wednesday, May 4, 2022
COVID-19, Population, Mutation, Lung cancer, Phase, Treatment of lung cancer, Company, Safety, Research, ASA, Patient, Immunotherapy, FDA, Data, Urinary tract infection, Vaccine, AXL, Bemcentinib, Infection, STK11, Large-cell lung carcinoma, Pharmaceutical industry, NSCLC

BerGenBio has for many years pioneered research into AXL inhibition, with its lead development candidate bemcentinib showing clinical potential in oncology and infectious disease.

Key Points: 
  • BerGenBio has for many years pioneered research into AXL inhibition, with its lead development candidate bemcentinib showing clinical potential in oncology and infectious disease.
  • BerGenBio is targeting 1stLine STK11 mutated Non-Squamous NSCLC patients, an extremely large patient population with very limited response to the standard of care treatments.
  • STK11 is an important tumor suppressor gene reported to confer immunotherapy resistance in NSCLC and is present in up to 20% of NSCLC patients.
  • With a focused strategy and rightsized organization BerGenBio plans to unlock significant potential value related to the two indications selected and define the path to market.

iOnctura to Present Preclinical Data on its Clinical Stage Autotaxin Inhibitor, IOA-289, at AACR

Retrieved on: 
Wednesday, March 9, 2022
Safety, Trial of the century, Pancreatic cancer, Cancer Research UK, Bemcentinib, Patient, Neoplasm, PDAC, Diagnosis, Pharmaceutical industry

iOnctura SA is clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface.

Key Points: 
  • iOnctura SA is clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface.
  • iOncturas best-in-class drug development programs combine immune-mediated and direct anti-tumor activity to deliver molecules with superior clinical efficacy and safety in oncology.
  • iOnctura has undertaken extensive validation of the autotaxin inhibition mechanism in multiple solid tumor preclinical models.
  • There are over 50,000 diagnoses of pancreatic cancer each year in the United States and over 65,000 in the EU5.

AXL Kinase Inhibitor Pipeline Market Report 2022: Insights on 15+ Companies and 15+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Monday, January 31, 2022
Health, Pharmaceutical, RTK, III, BGB324, Haematopoiesis, HER2, Clinical trial, VEGF, Discovery, PARP, MER, Tyrosine kinase inhibitor, Cell proliferation, TAM, II, KIT, Cancer, TYRO3, PI3K, Tumor microenvironment, Fibrosis, Neoplasm, Drug resistance, AXL, News, Receptor tyrosine kinase, Bemcentinib, VEGFR2, Apoptosis, Therapy, Degenerative disease, EGFR, Pharmaceutical industry

This "AXL Kinase Inhibitor - Pipeline Insight, 2022" report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in AXL Kinase Inhibitor pipeline landscape.

Key Points: 
  • This "AXL Kinase Inhibitor - Pipeline Insight, 2022" report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in AXL Kinase Inhibitor pipeline landscape.
  • AXL receptor tyrosine Kinase is a member of the tyrosine-protein Kinase receptor Tyro3, Axl and proto-oncogene tyrosine-protein Kinase Mer family of receptor tyrosine Kinases.
  • This segment of the report provides insights about the different AXL Kinase Inhibitor drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.
  • The companies which have their AXL Kinase Inhibitor drug candidates in the most advanced stage, i.e.

BerGenBio (BGBIO): FDA grants fast track designation

Retrieved on: 
Wednesday, June 16, 2021
Drugs, Cancer treatments, Clinical medicine, Orphan drugs, Breakthrough therapy, Lung cancer, Tyrosine kinase receptors, AXL receptor tyrosine kinase, Non-small-cell lung carcinoma, Bemcentinib, Treatment of lung cancer

FDA has granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment.

Key Points: 
  • FDA has granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment.
  • Notably durable responses were observed in the relapsed AML setting (ORR of 31%; 5/16) and median overall survival of 13.3 months (data still immature).
  • About Edison: Edison is a leading research and investor relations consultancy, connecting listed companies to the widest pool of global investors.
  • Having been the first in-market 17 years ago, Edison now has more than 100 analysts covering every economic sector.

Bergenbio Presents Encouraging Updated Preliminary Data From Phase Ii Study In Relapsed Aml Patients At Eha Virtual Meeting

Retrieved on: 
Friday, June 11, 2021
Chemical compounds, Tyrosine kinase receptors, Protein kinase inhibitors, Organic compounds, AXL receptor tyrosine kinase, Heterocyclic compounds, Bemcentinib, Orphan drugs, CD135, Midostaurin

An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.

Key Points: 
  • An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.
  • The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population.
  • Ongoing dialogue continues with the FDA and EMA regulatory agenciesto align on a pathway for apivotalregistration trial for the combination ofbemcentinibandLDAC in relapsed elderly AML patients unfit for intensive chemotherapy.
  • Data from a Phase II in human clinical trial has shown that treatment with AXL inhibitor bemcentinib increased the rate ventilator free survival in hospitalised COVID-19 patients.