12 October 2017

Klinisk studie med BGB324, BerGenBio’s selektive First-in-Class AXL Inhibitor, presenteres på 9th World Congress of Melanoma

Bergen, Norge, 12 oktober 2017 – BerGenBio ASA (OSE:BGBIO), et onkologisk bioteknologiselskap i klinisk fase som utvikler ‘first-in-class’ legemidler mot nye medikamentmål (drug targets) som driver aggressiv kreft, meddeler at den kliniske studien av BGB324 i kombinasjon med enten MEKINIST (trametinib) pluss TAFINILAR (dabrafenib) eller KEYTRUDA i ikke-operabel føflekkreft eller føflekkreft med spredning vil presenteres på den 9ende verdenskongressen om føflekkreft i Brisbane, Australia, 18-21 oktober 2017.

Dr. Oddbjørn Straume, overlege på Haukeland universitetssykehus og professor ved Centre for Cancer Biomarkers (CCBIO) på Universitetet i Bergen, vil presentere sin studie kalt: A Phase Ib/II randomised study of BGB324 in combination with pembrolizumab or dabrafenib/trametinib in patients with advanced melanoma. Presentasjonen vil introdusere bakgrunnen for studien og dets design i tillegg til å vise data knyttet til hvorvidt den eksperimentelle medisinen tåles hos pasienter med føflekkreft som er behandlet til nå.

  • Poster nummer P12-10 – Brisbane Convention & Exhibition Centre, October 18 – 21 2017

For mer informasjon se: https://www.melanomacongress.com/

Om BerGenBio ASA 

BerGenBio er et onkologisk bioteknologiselskap i klinisk fase som utvikler ‘first-in-class’ legemidler mot nye medikamentmål (drug targets) som driver aggressiv kreft. Selskapet er verdensledende i forståelsen av den essensielle funksjonen og rollen til Axl, et medikamentmål av typen reseptor tyrosin kinase.

Selskapets mest avanserte legemiddelkandidat mot kreft er BGB324. Dette er en ‘first-in-class’ hemmer av Axl kinase, den inntas gjennom munnen (oralt), og er den eneste selektive Axl hemmeren som er i klinisk utprøving. BerGenBio er sponsor i fire pågående kliniske studier der BGB324 administreres både som monoterapi og i kombinasjon med standard legemidler hos pasienter med akutt myelogen leukemi (“AML”), myelodysplastisk syndrome (“MDS”), ikke-småcellet lungekreft (“NSCLC”) og trippel negativ brystkreft (“TNBC”).

De fire kliniske studiene BerGenBio sponser er:

1. BGB324 som monoterapi og kombinasjonsterapi i akutt myelogen leukemi (AML) / myelodysplastisk dysplastisk syndrome (MDS)
2. BGB324 med TARCEVA® (erlotinib) i fremskredet EGFR mutasjons-drevet ikke-småcellet lungekreft (NSCLC)
3. BGB324 med KEYTRUDA® (pembrolizumab) i fremskredet adenocarcinoma av lungen, og
4. BGB324 med KEYTRUDA® i trippel negativ brystkreft (TNBC).

De kliniske studiene som kombinerer BGB324 med KEYTRUDA i adenocarcinoma av lungen og TNBC er gjort i samarbeid med Merck & Co. Inc. (MSD).

I tillegg er det en rekke investigator-sponsede studier underveis, inkludert en studie som tester BGB324 med enten MEKINIST® (trametinib) pluss TAFINLAR® (dabrafenib) eller KEYTRUDA® i fremskredet føflekkreft, og en studie som kombinerer BGB324 med docetaxel i fremskredet NSCLC.

BerGenBio utvikler samtidig en companion diagnostic test som skal identifisere hvilke pasientgrupper som mest sannsynlig vil ha nytte av behandling med BGB324.

Selskapet utvikler også en diversifisert pre-klinisk pipeline av potensielle legemiddelkandidater, inkludert BGB149, et anti-AXL monoklonalt antistoff.

For mer informasjon, besøk hjemmesiden vår på: 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.

Kontakt 

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

Tom Henrik Sundby

Finance Director, BerGenBio ASA

+47 477 54 415

tom.sundby@bergenbio.com

-Slutt-

Denne meldingen er informasjonspliktig etter verdipapirhandelloven §5-12.

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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).

Øystein Soug

Chief Executive Officer

soug@oncoinvent.com

Oystein Soug has over 15 years of experience in biotechnology, holding several management positions. Most recently, Mr. Soug was CEO of Arxx Therapeutics, where he led the company to initiate the clinical programme and was responsible for the merger with Dutch pharma company Oxitope Pharma to create Calluna Pharma. Prior to Arxx, he served as CFO and then CEO of Targovax, an Oslo listed biotechnology company, which went public during Mr. Soug’s tenure. Mr. Soug started his career in biotech as CFO of Oslo-listed radiopharmaceutical company Algeta. During this period, the company conducted a successful phase 3 trial, launched its radium-223 based prostate cancer drug Xofigo® and out-licensed the drug. Mr. Soug co-led the sale of the company to Bayer in 2014.

Mr. Soug holds an MSc in Economics and
Financial Markets from Universität St. Gallen in Switzerland in 1997

Anders Månsson

Chief Executive Officer

mansson@oncoinvent.com

Anders Månsson is a business executive with over 25 years of experience from management roles in the pharmaceutical industry, focusing on commercialisation and M&A + licensing. Mr. Månsson has held leading roles in the industry both in his native Sweden and in other European countries, and he has worked extensively with the USA and Asia as focus markets in global roles.

Mr. Månsson holds a B.Sc. degree in Business & Economics from Lund’s University in Sweden as well as an MBA from Business School Lausanne in Switzerland. He has a broad-based industrial experience, featuring both large multinational companies such as Meda, Ferring & LEO Pharma, and including leading roles in start-ups and smaller biotech companies. On top of his executive role in Oncoinvent, Mr. Månsson holds two non-executive director positions serving on the board of EQL Pharma AB as well Immetric AB, the latter being an investment company focusing on life science.