AXL receptor tyrosine kinase

BerGenBio (BGBIO): FDA grants fast track designation

Retrieved on: 
Wednesday, June 16, 2021

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

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.

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

Retrieved on: 
Friday, June 11, 2021

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.

BerGenBio Receives FDA Fast Track Designation For Bemcentinib / Anti-PD-(L)1 Combination In NSCLC

Retrieved on: 
Tuesday, June 8, 2021

Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.

Key Points: 
  • Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.
  • It will enable BerGenBio to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market faster.
  • BerGenBio has developed proprietary biomarkers and companion diagnostic assays for selection of AXL positive patients, the cAXL assay is validated for clinical trial use.
  • Richard Godfrey, Chief Executive Officer of BerGenBio, commented:"Building on our encouraging clinical and translational data, we are excited to receive Fast Track designation from the FDA for the promising combination of bemcentinib in combination with a checkpoint inhibitor.

BeiGene Presents Clinical Data on Sitravatinib in Combination with Tislelizumab at the AACR Annual Meeting 2021

Retrieved on: 
Sunday, April 11, 2021

At the time of data cutoff, 16 patients (64%) remained on study treatment.

Key Points: 
  • At the time of data cutoff, 16 patients (64%) remained on study treatment.
  • The combination of sitravatinib and tislelizumab was generally well tolerated and showed promising antitumor activity among patients with advanced PROC, including those who were heavily pretreated.
  • Sitravatinib targets the VEGFR and TAM (TYRO3, AXL, MERTK) receptor families, which are implicated in orchestrating an immunosuppressive tumor microenvironment (TME).
  • We currently market two internally discovered oncology medicines: BTK inhibitor BRUKINSA\xc2\xae (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China.

Aravive to Present Phase 1b Data Evaluating AVB-500 in Platinum Resistant Ovarian Cancer at 2021 Society of Gynecologic Oncology Annual Meeting

Retrieved on: 
Friday, March 12, 2021

We remain focused on advancing the ongoing pivotal Phase 3 trial of AVB-500 to address the unmet needs of patients with ovarian cancer.

Key Points: 
  • We remain focused on advancing the ongoing pivotal Phase 3 trial of AVB-500 to address the unmet needs of patients with ovarian cancer.
  • For additional information, please visit the Society of Gynecologic Oncology Annual Meeting on Womens Cancer website: www.sgo.org .
  • In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer and clear cell renal cancer.
  • Aravive successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and has initiated a registrational Phase 3 trial of AVB-500 at a dose of 15 mg/kg.

BerGenBio (BGBIO): AXLeration of data catalysts in 2021

Retrieved on: 
Saturday, February 27, 2021

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.

BioAtla Conditionally Active Biologic Antibody Design And Functionality For Cancer Treatment Described In Leading Scientific Journal Peer-Reviewed Paper

Retrieved on: 
Monday, February 22, 2021

"CAB antibodies utilize a newly discovered switch mechanism that allows them to be active only in the tumor microenvironment and not active under normal physiological conditions.

Key Points: 
  • "CAB antibodies utilize a newly discovered switch mechanism that allows them to be active only in the tumor microenvironment and not active under normal physiological conditions.
  • The CAB technology capitalizes on the well-established Warburg Effect that through a glycolytic process leads to an acidic external tumor microenvironment.
  • Glycolytic metabolism is also the basis of the established PET scanning technology for cancer detection for tumor types.
  • BioAtla has two CAB programs currently in Phase 2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).

Global AXL Kinase inhibitor Pipeline Insights 2021: Emerging Drugs Include Sitravatinib (Mirati Therapeutics) and Bemcentinib (BerGenBio / Rigel Pharmaceuticals) - ResearchAndMarkets.com

Retrieved on: 
Friday, February 19, 2021

This "AXL Kinase inhibitor - Pipeline Insight, 2021," 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, 2021," report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in AXL Kinase inhibitor pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence AXL Kinase inhibitor R&D.
  • The therapies under development are focused on novel approaches for AXL Kinase inhibitor.
  • AXL Kinase inhibitor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

BioAtla to Present at 39th Annual J.P. Morgan Virtual Healthcare Conference

Retrieved on: 
Friday, January 8, 2021

SAN DIEGO, Jan. 8, 2021 /PRNewswire/ --BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that Jay M. Short, Ph.D., Chief Executive Officer, and Scott Smith, President, with participation by other BioAtla executives, will present at the 39th Annual J.P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021, at 2:50 PM Eastern Time.

Key Points: 
  • SAN DIEGO, Jan. 8, 2021 /PRNewswire/ --BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that Jay M. Short, Ph.D., Chief Executive Officer, and Scott Smith, President, with participation by other BioAtla executives, will present at the 39th Annual J.P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021, at 2:50 PM Eastern Time.
  • BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China.
  • BioAtla has two programs currently in Phase 1/2 clinical testing in the United States, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC).
  • BioAtla's investigational CAB CTLA-4 antibody, BA3071, is subject of a global co-development and collaboration agreement with BeiGene Ltd. for its development, manufacturing and commercialization.