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

China flag

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.

Infographic

[Infographic] Machine Learning, Statistics and Optimizing Outcomes

In our infographic, we outline the potential of fusing machine learning and statistics algorithms together to more efficiently analyze clinical trial data output and ultimately revolutionize clinical research.

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

Related Articles:
China's BeiGene reports positive initial PhI data on BGB-283
BeiGene comes in at top end of range in Nasdaq IPO, raising $158.4M
BeiGene approved to start China leg of global BTK inhibitor trial
China's BeiGene gets U.S. FDA IND nod on oncology candidate BGB-3111

Read more on

Suggested Articles

Takeda sells €1.5 billion European drugs; top Indian drugmakers expand in China; Eisai moves closer to a quick Alzheimer’s blood test.

A buyer could emerge from private equity funds, European pharma players and Indian or Asian drugmakers looking to expand in Europe.

Leading Indian drugmakers Sun Pharma, Cipla, Aurobindo and Dr. Reddy's are all trying to expand their presences in China.