BerGenBio has entered an agreement with MSD and announces its intention to launch an Initial Public Offering (IPO) and to apply for a listing on Oslo Børs.
The agreement with MSD is a collaborative agreement, through a subsidiary, focused on the clinical evaluation of BGB324 with KEYTRUDA (pembrolizumab) in patients with advanced non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). BerGenBio’s lead candidate BGB324 is a selective, potent and orally available small molecule Axl kinase inhibitor in clinical development in a variety of cancer indications. The Axl tyrosine kinase is a key driver of cancer spread, immune evasion and drug resistance – the cause of the majority of cancer-related deaths. Increased understanding of the role of Axl in suppressing innate immunity supports the rationale for evaluating BGB324 in combination with KEYTRUDA.
Under the terms of the collaboration with MSD, BerGenBio will conduct two international Phase II studies to evaluate the potential clinical synergy of combining BGB324 with MSD’s anti-PD-1 therapy, KEYTRUDA. Biomarker studies will be conducted in parallel to the above studies with the goal of developing companion diagnostics to identify patients who would be most suitable for treatment with the BGB324/KEYTRUDA combination.
The clinical trials will be sponsored by BerGenBio while MSD will provide the trial with KEYTRUDA. The rights to the study results will be shared.
BerGenBio is investigating BGB324 in multiple cancer indications based on preclinical and early clinical findings. Phase II studies with BGB324 as a single agent in relapsed acute myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS); and in combination with erlotinib (TARCEVA) in advanced EGFR-positive NSCLC are in progress.
“We are delighted to enter this collaboration with MSD, a leader in developing novel cancer therapies. This new agreement gives us the opportunity to evaluate the clinical potential of BGB324 in combination with KEYTRUDA in advanced lung and breast cancer; two of the areas of significant unmet medical need. We believe that BGB324 is a unique drug candidate that addresses a critical cancer mechanism responsible for promoting immune evasion. We believe the clinical utility of BGB324 in combination with immunotherapies has enormous potential. BerGenBio is excited to advance BGB324 in combination with KEYTRUDA into Phase II trials and we anticipate results in mid-2018,” commented Richard Godfrey, Chief Executive Officer of BerGenBio.
Intend to launch an IPO
Completion of the IPO will be subject to receiving the relevant approvals from Oslo Børs as well as prevailing equity capital market conditions.
”BerGenBio is pioneering a new approach to treating aggressive cancers based on its deep understanding of Axl biology. Our lead compound, BGB324, the only highly selective Axl inhibitor in clinical development, has already delivered encouraging clinical data in patients with AML/MDS and NSCLC, indicating it could provide an important new improved treatment option for these indications. The clinical collaboration with MSD announced today will allow us to assess BGB324 in combination with its immune checkpoint inhibitor KEYTRUDA. Our planned IPO will provide BerGenBio with the funds needed to develop BGB324 through to regulatory trials and to generate significant value for shareholders. We will continue to evaluate the optimal strategy for further development and commercialisation of BGB324, either alone or in conjunction with partners,” said Richard Godfrey, CEO of BerGenBio.
“The IPO is a natural next step in the company’s development that will help it secure a broader, long-term shareholder base. In addition, the listing will enhance BerGenBio’s visibility among potential partners, ensure organised and regulated trading of the shares as well as provide access to the capital markets,” said Stein H. Annexstad, Chairman of the Board.
The IPO will comprise a public offering to institutional and retail investors in Norway and Sweden, and a private placement to certain institutional investors internationally. The largest existing shareholder has indicated that it will offer strong support through the IPO of the Company. ABG Sundal Collier, Arctic Securities and DNB Markets are acting as Joint Global Coordinators and Joint Bookrunners in the IPO.