Marking what it says is the first BTK inhibitor to enter the clinic under China FDA guidelines, Beijing-based oncology focused biotech BeiGene ($BGNE) said it received approval of its Clinical Trial Application for the BGB-3111 candidate to treat B-cell malignancies.
Newly Nasdaq-listed BeiGene reported that the Phase I candidate showed single-agent activity in B cell malignancy subtypes and was well tolerated in a presentation to the American Society of Hematology in December.
That data came from monotherapy trial conducted in Australia and New Zealand with a dose expansion planned in 2016 and further clinical studies in combination with other agents.
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| BeiGene CEO John Oyler |
That update followed a June note that the U.S. FDA approved an IND application for BGB-3111, a first for any of its early-stage candidates.
The steps in Australia, New Zealand and the U,S. highlight the challenge BeiGene faces in its China push for a candidate the company hopes would compete or better Imbruvica (ibrutinib) from AbbVie ($ABBV) globally. The approval for trials came later in the game, though on a local pathway that will be closely watched as China has vowed to speed new oncology drugs through the regulatory process.
In October of last year, the company said it had dosed the first patient in a China Phase I for BGB-283, 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. The study is being conducted across multiple centers in China.
In addition, the company has BGB-290, a PARP inhibitor candidate.
"We believe that BGB-3111 is the first BTK inhibitor being developed in China under the domestic regulatory pathway to enter the clinic," CEO John V. Oyler said in a statement. "We are expanding our clinical trials globally, in Australia, New Zealand, Korea and the United States, This CTA approval is a key milestone for our company as we seek to bring this differentiated agent to patients globally."
In January, BeiGene said the U.S. FDA gave the nod for clinical development of oncology mAb BGB-A317, marking the company's first biologic candidate to undergo trials in the U.S.
- here's the release from BeiGene