China's BeiGene reports positive initial PhI data on BGB-283

BeiGene CEO John Oyler

Beijing-based BeiGene said initial data from an ongoing Phase I trial of oncology candidate BGB-283 was positive, as it updated this week at the American Association for Cancer Research (AACR) annual meeting.

BGB-283 is a novel RAF dimer inhibitor for the treatment of solid tumors harboring B-RAF mutations and other aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway.

According to a press release, there were 31 patients in the clinical leg with various types of cancer in a trial conducted at 5 centers in Australia and New Zealand designed to assess the safety, tolerability, pharmacokinetic properties and antitumor activity of BGB-283 as monotherapy.


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“We believe BGB-283 works differently than the currently approved BRAF V600E inhibitors, inhibiting the activity of all RAF family proteins as well as the BRAF V600E mutant protein,” Jayesh Desai, a medical oncologist at The Royal Melbourne Hospital and Peter MacCallum Cancer Centre in Melbourne, Australia, and coordinating principal investigator of the study, said in the release.

“The responses observed in this preliminary analysis in some patients with RAS-mutated tumors, in addition to those with the BRAF V600E mutation, appear to validate the hypothesis that inhibiting the dimeric form of RAF may demonstrate activity in both RAF and potentially some RAS-mutated tumors.”

The patients covered colorectal, cholangiocarcinoma, lung, melanoma, thyroid, endometrial and ovarian cancers.

”The initial dose-escalation clinical data on BGB-283 in a range of different solid tumors are encouraging so far. We look forward to further validation from the ongoing dose-expansion phase of this study,” Eric Hedrick, interim chief medical officer for BeiGene, said in the release.

In October of last year, the company dosed the first patient in the China Phase I for BGB-283, where it holds exclusive development and commercial rights. Merck KGaA has a license to develop and commercialize the candidate outside of China.

BeiGene, which raised a bit more than $158 million on the Nasdaq earlier this year, is currently handling all development on the candidate.

- here's the release from BeiGene


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