28 September 2017
BGB324, BerGenBio’s Selective First-in-Class AXL Inhibitor, Featured in Three Clinical Presentations at the 18th World Conference on Lung Cancer
Bergen, Norway, Sep 28 2017 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors ( http://www.bergenbio.com ) for multiple cancer indications, is pleased to announce that the Company will present three ongoing lung cancer clinical trials with BGB324 at the 18th World Conference on Lung Cancer in Yokohama, Japan, October 15 – 18, 2017.
The three presentations will show clinical results to date and discuss the rationale of the clinical studies undertaken with BGB324, BerGenBio’s lead candidate, a first-in-class and highly selective small molecule Axl kinase inhibitor which is being developed to target tumour immune evasion and drug resistance.
Don L. Gibbons (MD, PhD) from the MD Anderson Cancer Center, Houston (US) will give an oral presentation entitled: A Ph I/II Study of BGB324, a Selective AXL Inhibitor as Monotherapy and in Combination with Erlotinib in Advanced NSCLC. The presentation will focus on the tolerability and efficacy combining BGB324 and erlotinib (TARCEVA®) in patients with advanced NSCLC driven by an EGFR mutation.
- Abstract 10388 – Monday, October 16, 2017, Oral and Mini Oral Abstract Sessions: 11:00-12:30 (JST)
- ClinicalTrials.gov identifier: NCT02424617
Murray Yule (MD, PhD), Clinical Development Officer at BerGenBio, will present a poster entitled: A Phase II Study of BGB324 in Combination with Pembrolizumab in Patients with Previously Treated Advanced Lung Adenocarcinoma. The trial-in-progress poster introduces the scientific rationale of combining BGB324 with pembrolizumab (KEYTRUDA®) in non-small cell lung cancer patients.
- Abstract 10315 – Tuesday, October 17, 2017, P2.07 Poster Session: 9:30 – 16:00 (JST)
- ClinicalTrials.gov identifier: NCT03184571
David E. Gerber (MD, PhD) from the Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center (US) will present a poster entitled: A Phase 1 trial of dose escalated BGB324 in combination with docetaxel for previously treated advanced NSCLC. The trial-in-progress poster introduces the scientific rationale of combining BGB324 with chemotherapeutic agents and will present available clinical data from the ongoing investigator initiated trial combining BGB324 with docetaxel.
- Abstract 10230 – Tuesday, October 17, 2017, P2.07 Poster Session: 9:00 – 16:00 (JST)
- ClinicalTrials.gov identifier: NCT02424617
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are pleased to have the opportunity to share our results and research at the 18th World Conference on Lung Cancer this year. The studies highlight our broad clinical development strategy, which is designed to demonstrate the potential of BGB324, a highly selective Axl inhibitor, to significantly improve the treatment of lung cancer.
About the 18th World Conference on Lung Cancer
The World Conference on Lung Cancer (WCLC) is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting over 6,000 researchers, physicians and specialists from more than 100 countries. The goal is to disseminate the latest scientific achievements; increase awareness, collaboration and understanding of lung cancer; and to help participants implement the latest developments across the globe. Organized under the theme of “Synergy to Conquer Lung Cancer,” the conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit http://wclc2017.iaslc.org/.
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class Axl kinase inhibitors to treat multiple cancer indications. The Company is a world leader in understanding the essential role of Axl kinase in mediating cancer spread, immune evasion and drug resistance in multiple aggressive haematological and solid cancers.
BerGenBio’s lead product, BGB324, is a selective, potent and orally bio-available small molecule Axl inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated in the second half of 2018. It is the only selective Axl inhibitor in clinical development.
The Company sponsored clinical trials are:
- BGB324 as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
- BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
- BGB324 with KEYTRUDA® (pembrolizumab) in advanced adenocarcinoma of the lung, and
- BGB324 with KEYTRUDA® in triple negative breast cancer (TNBC).
The clinical trials combining BGB324 with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co. Inc. (MSD), through a subsidiary.
In addition, a number of investigator-sponsored trials are underway, including a trial to investigate BGB324 with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining BGB324 with docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with BGB324. This will facilitate more efficient registration trials and support a precision medicine based commercialisation strategy.
The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.
-Ends-
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Media Relations
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedr.co.uk
+44 207 638 9571
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
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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).
