To activate the Axl kinase and transmit its signal to the cell nucleus, the GAS6 ligand has to bind externally and the energy carrier ATP (green) internally. Inhibitors (orange) prevent transmission of the signal, © MPI for Biochemistry

BerGenBio plans IPO and partners with MSD

Norwegian BerGenBio ASA said it will go public at Oslo Børs and partnered with Merck & Co. for conducting Phase II combination studies of its oral Axl kinase blocker BGB324 with Merck's PD-1 inhibitor pembrolizumab in lung cancer patients.

The IPO, underwritten by ABG Sundal Collier, Arctic Securities and DNB Markets, includes a public offering to institutional and retail investors in Norway and Sweden, and a private placement to certain institutional investors internationally.

BerGenBio’s lead candidate BGB324 (formerly R-428), licensed from Rigel Pharmaceuticals in 2010, has passed Phase Ib testing in acute myeloid leukemia (AML), myeloid dysplastic syndrome (MDS), and non-small cell lung cancer (NSCLC, in combination with erlonitib) patients. On the day of the IPO announcement, BerGenBio additionally said it will start two collaborative Phase II combination studies of BGB324 with Merck & Co’s PD-1 checkpoint inhibitor pembrolizumab this year in patients with adenocarcinoma (NSCLC) and and triple-negative breast cancer (TNBC). The clinical trials will be sponsored by BerGenBio while Merck will provide the trial with Keytruda. The rights to the study results will be shared. Financial details were not disclosed. Preclinical data from 2015 indicate that BGB324 showed enhanced tumour clearance, survival and tumour infiltration of cytotoxic T lymphocytes compared with checkpoint inhibition (CTLA-4, PD1) alone.

Axl kinase promotes cancer cell migration, epithelial-mesenchymal transition (EMT) and tumour cell proliferation as well as therapy resistance. The protein is overexpressed in the membranes of 60% of lung cancers, highly invasive breast cancers, and pancreatic cancer as well as in AML, where it serves as independent prognostic marker. Additionally, several studies suggest that overexpression of AXL may result in resistance to both targeted therapies and conventional chemotherapy in different models, such as lung cancer, breast cancer resistant to EGFR inhibition, esophageal carcinoma, gastrointestinal stromal tumours, and AML.

Besides its selective Axl kinase inhibitor, the Norwegian company also has an anti-Axl kinase antibody and an antibody drug conjugate (ADC) under preclinical development. Treatment responders are set to be stratified prior to therapy by a companion diagnostics test that measures Axl kinase expression.

Thomas Gabrielczyk

9 March 2017