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BeiGene Receives Clinical Milestone Payment for Development of BGB-290

2014年09月15日 PM09:00
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BEIJING

BeiGene (Beijing), Co., Ltd., an innovative oncology company focused on developing targeted and immune-oncology therapeutics, today announced the achievement of a clinical milestone in the company’s collaboration with Merck Serono, the biopharmaceutical division of Merck, Darmstadt, Germany, for BGB-290, an investigational poly (ADP-ribose) polymerase (PARP) inhibitor candidate currently in Phase 1 development. The milestone triggers a US$ 9 million payment from Merck to BeiGene.

“We are very excited to reach this development milestone with Merck Serono, this time for BGB-290, a candidate that we believe has the potential to be a new PARP inhibitor option for cancer patients with high unmet medical need,” said John V. Oyler, CEO of BeiGene. “This candidate, one of three that we now have in clinical trials, demonstrates the potential of our unique translational research platform to consistently deliver targeted therapeutics with global best in class potential. We are pleased with the rapid development progress being made in all of these programs, and look forward to working with Merck Serono as BGB-290 continues to advance through clinical trials.”

BGB-290 is an investigational, oral, selective and potent inhibitor of poly (ADP-ribose) polymerase (PARP), an enzyme family which is involved in a number of cellular processes, including DNA repair and programmed cell death. In July 2014, BeiGene announced the enrollment of the first patient in a Phase 1 study of BGB-290 to assess safety, tolerability and pharmacokinetic properties of the candidate as a single agent. The enrollment of the fifth patient triggered this milestone payment.

BGB-290 is part of BeiGene’s two-asset strategic collaboration with Merck that was established in 2013. The first compound, BGB-283, an investigational second-generation B-RAF inhibitor, entered a Phase 1 study in November 2013 and BeiGene announced a $5 million clinical milestone payment from Merck for BGB-283 in May 2014.

About the Study

The Phase 1 multicenter, open-label, dose escalation clinical trial of BGB-290 is designed to assess the safety, tolerability and pharmacokinetic properties of BGB-290 as a single agent. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BGB-290. Disease-specific expansion cohorts will be enrolled at the maximally-tolerated or biologically-relevant dose.

About PARP Proteins and Inhibitors

PARP proteins are involved in DNA replication, transcriptional regulation and DNA damage repair. Inhibition of PARP converts common single-strand DNA breaks into double-strand breaks during DNA replication. Small-molecule inhibitors of PARP1/2 represent a class of anticancer agents that exert their cytotoxic effect by modulating the PARylation activity of PARP1/2 and trap PARP proteins on damaged DNA. A number of PARP inhibitors have demonstrated sustained antitumor responses as a single agent in patients with BRCA1- or BRCA2-mutant tumors with good safety profiles. (1)

About BeiGene (Beijing), Co., Ltd.

BeiGene is an innovative Chinese oncology R&D company focused on discovering, developing and commercializing targeted and immune-oncology therapeutics through a novel translational research platform that leverages our strong internal oncology biology expertise with unique access to large number of patient-derived tumor biopsies. With a team of 150 scientists and staff, its pipeline is comprised of novel oral small molecules and monoclonal antibodies for cancer. BeiGene Ltd. is a Cayman Islands exempted company that is an investor in and collaborator with BeiGene (Beijing), Co. Ltd. For more information, please visit our website at www.beigene.com.

1. Papeo, G., Casale, E., Montagnoli, A., and Cirla, A. (2013) PARP inhibitors in cancer therapy: an update, Expert opinion on therapeutic patents 23, 503-514.

CONTACT

Media/Investor:
Stern Investor Relations, Inc.
Jesse
Baumgartner, 212-362-1200
pr@beigene.com

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