China's BeiGene doses first patient in BGB-3111, BGB-A317 PhI

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Beijing-based oncology biotech BeiGene said it has dosed the first patient in a Phase I clinical trial for a combination of candidates--BGB-3111 and BGB-A317--aimed at B-cell malignancies as the firm ramps up pipeline work following a successful IPO at the start of the year.

BGB-3111, a Bruton’s tyrosine kinase (BTK) inhibitor, and BGB-A317, a PD-1 antibody, are internal candidates developed by BeiGene. BGB-3111 is the first BTK inhibitor to enter the clinic under China FDA guidelines and after the U.S. FDA approved an IND application for the candidate in June last year--a first for any of the company's early-stage candidates.

The combination trial is a multi-center dose escalation and expansion effort among 25 patients in Australia to assess safety, tolerability, pharmacokinetics, and anti-tumor activities, the company said in a release.


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The biotech is also studying another combination of BGB-A317 with PARP inhibitor BGB-290.

“We have presented initial clinical data on both of these candidates as single agents," Eric Hedrick, interim chief medical officer at BeiGene said.

“We believe the combination of BGB-3111 and BGB-A317 in clinical trials has been well-supported by compelling preclinical data. Additionally, we believe ownership of both components in the combination regimen puts us in an advantageous position to develop the regimen to its full potential.”

- here's the release

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