China's BeiGene gets U.S. FDA IND nod on oncology candidate BGB-3111

BeiGene CEO John Oyler

China's BeiGene has received U.S. FDA approval on an IND application for clinical development of BGB-3111, a proprietary Bruton tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies, putting a fresh round of funds to use as it works on three main oncology candidates.

The candidate is a highly selective and potent oral inhibitor of BTK, a critical component of B-cell receptor signaling that plays an important role in B-cell malignancies, according to a press release.

"We are delighted to receive our first approval from the FDA to start clinical studies with BGB-3111 in the United States," said John Oyler, CEO of BeiGene, in a statement.

"BTK is a well validated target in B-cell malignancies and data from our pre-clinical studies indicates that BGB-3111 may demonstrate a superior efficacy and safety profile compared to the market leading BTK inhibitor. We look forward to expanding our clinical studies of BGB-3111 in B-cell malignancies into the United States over the next few months."

The company, based in Beijing, said that BGB-3111 has completed a dose-escalation trial in Australia.

In May, BeiGene said it has completed financing of more than CNY600 million ($97 million) from initial angel and strategic investors as well as new investors Hillhouse Capital and CITIC PE, joined by an unnamed "blue chip U.S. public investment fund" specializing in life sciences.

The oncology company is focused on developing targeted and immune-oncology therapeutics. The company has set its sights on three small molecules in Phase I, BGB-283, a second-generation BRAF and EGFR inhibitor; BGB-290, a PARP inhibitor; as well as BGB-3111 among other candidates, including PD-ligand 1, for which AstraZeneca ($AZN) is conducting trials for MED14736 and Roche's ($RHHBY) Genentech for MPD3280A.

Earlier this month, BeiGene dosed the first patient in a Phase I study of BGB-A317, a humanized anti-PD-1 monoclonal antibody, for the treatment of advanced cancer.

- here's the release