7 September 2021
BerGenBio ASA: BERGENBIO COMPLETES RECRUITMENT OF PHASE II AML STUDY (BGBC003)
Bergen, Norway, 7 September 2021 - BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, is pleased to announce the completion of patient recruitment into BGBC003 (ClinicalTrials.gov ID: NCT02488408), a Phase Ib/II multicenter open-label study of bemcentinib as a single agent and in combination with cytarabine or decitabine in patients with Acute Myeloid Leukemia (AML) or as a single agent in patients with myelodysplastic syndrome (MDS).
BerGenBio has recruited a total of 86 patients in cohort B, with between 14 and 18 patients in each of the cohorts B1-B4 and 20 patients in cohort B5, as per protocol.
In June 2021, the latest study data was published at the European Haematology Association (EHA) Meeting, which indicated that the combination of bemcentinib and low dose cytarabine (LDAC) is efficacious and well tolerated in relapsed elderly AML patients unfit for intensive chemotherapy, with an overall response rate of 31% (5/16) and median overall survival of 13.3 months. The encouraging preliminary survival data reported showed that the addition of bemcentinib more than doubled the historic survival rates seen with standard of care treatment in this patient population.
An in-depth translational research program to identify predictive molecular and biological factors associated with response is ongoing.
Dialogue continues with the regulatory agencies in the US and Europe to align on a pathway for a pivotal registration trial for the bemcentinib/LDAC combination in relapsed elderly AML patients unfit for intensive chemotherapy.
Rune Skeie, Interim Chief Executive Officer, said: “We are pleased to have completed enrolment of the BGBC003 study and now look forward to delivering our full analysis of the data from this important trial. There is a significant unmet need for an effective therapy for relapsed elderly AML patients unfit for intensive chemotherapy, for whom there are currently few treatment options available. With encouraging data shown so far, we will continue dialogue with the regulators towards progressing bemcentinib in this indication.”
Prof. Dr. Sonja Loges, Chief Investigator of the trial, commented: “We have been very encouraged by the positive responses observed so far in relapsed AML patients with many patients remaining on bemcentinib for extended durations. With the trial fully recruited, we hope that data gathered will prove useful in the continued exploration of bemcentinib’s potential efficacy in AML, as well as helping us identify predictive biomarkers that may help identify patients most likely to benefit from this approach.”
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About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.
In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters the host cell, and AXL expression is upregulated in infected organs with an activation of the signalling pathway leading to suppression of the Type 1 Interferon immune response by infected cells and neighbouring cells, in their environment. Pre-clinical research studies demonstrate that bemcentinib inhibits SARS-CoV-2 host cell entry and promotes anti-viral Type I interferon response.
In cancer, increase in AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumours and drives treatment failure across many cancers. High AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases including fibrosis.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for aggressive diseases, including immune-evasive, therapy resistant cancers. The company’s proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme focused on combination and single agent therapy in cancer, leukaemia and COVID-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is undergoing phase I clinical testing. In parallel, BerGenBio is developing a companion diagnostic test to identify patient populations most likely to benefit from AXL inhibition: this is expected to facilitate more efficient registration trials supporting a precision medicine -based commercialisation strategy.
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more information, visit www.bergenbio.com
Contacts
ir@bergenbio.com
Rune Skeie, Interim CEO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700
Forward looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties, and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements.
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
About Oncoinvent
Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.
This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.
Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).
