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News Tag: Regulatory
· First stage clinical efficacy endpoint met for the Phase II trial cohort evaluating selective AXL inhibitor bemcentinib in combination with Keytruda[®] in patients with advanced NSCLC who have failed checkpoint inhibitor therapy. Criteria were met for expansion of this cohort to a second stage. Bergen, Norway, 15 January 2019 – BerGenBio ASA (OSE: BGBIO) a … Read more
· Phase II trial evaluating bemcentinib in combination with low-dose cytarabine (LDAC) in elderly AML patients unfit for intensive therapy is well tolerated and shows promising efficacy Long duration of response (>9.9 mo, still maturing) with 50% CR/CRi in 6 evaluable newly diagnosed patients receiving the bemcentinib-LDAC combination. Clinical benefit demonstrated in >2L relapsed and … Read more
FDA granted Fast Track Designation for 2L Acute Myeloid Leukaemia (AML) High Impact oral presentation of 2L NSCLC clinical data at SITC Met primary and secondary endpoints in non-small cell lung cancer (NSCLC) Phase II clinical trial in patients previously treated with chemotherapy (cohort A) Proprietary composite AXL tumor immune score (cAXL) identified patients that … Read more
· BerGenBio’s proprietary Composite AXL Tumor-Immune Score predicts patients that have significantly prolonged clinical benefit Primary endpoint of ORR in cohort A met, in predominantly PD-L1 low/negative patients Combination is 5-fold more active in composite AXL positive patients (33% ORR) vs AXL negative patients (7% ORR) Secondary endpoint, median Progression Free Survival of 8.4 months in … Read more
Bergen, Norway, 7 November 2019 – BerGenBio ASA (OSE:BGBIO), will announce its results for the third quarter on Tuesday 19 November 2019. A presentation by BerGenBio’s senior management team will take place at 10am CET at: Arctic SecuritiesHaakon VIIs gate 5Oslo The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial … Read more
Primary endpoint, Overall Response Rate, has been met in predominantly PD-L1 negative/low patients Secondary endpoint, median Progression Free Survival, exceeds expectations in AXL positive patients Data to be presented at Society for Immunotherapy of Cancer 34th Annual Meeting on 8 November 2019 Bergen, Norway, 6 November 2019 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company … Read more
Bergen, Norway 22nd October 2019 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track Designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed. There … Read more
Bergen, Norway, 27 September 2019 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is to provide study updates in two poster presentations from its Phase II clinical development programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor, at the European Society for Medical … Read more
Bergen, Norway, September 10 2019 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces today that Richard Godfrey, BergenBio’s chief executive officer, will present at the H.C. Wainwright 21st Annual Global Life Sciences Conference today, September 10, 2019. Date: Tuesday, September 10, 2019Time: 5.15pm CESTLocation: Lotte New … Read more