Beigene Ltd (NASDAQ:BGNE) is launching a combination study of its drug candidate BGB-A317 and BGB-3111 for B-cell lymphoid malignancies. The company has announced dosing of the first patient in the trial that seeks to enroll 25 patients. Beigene didn’t reveal how many patients it has enrolled in the trial so far. However, it pointed out that it was seeking to get 25 patients to participate in the Phase I trial.
Primary endpoints
As Beigene rolls out the Phase I trial, it is focusing on primary endpoints surrounding pharmacokinetics, safety, tolerability and anti-tumor properties of the candidates in B-cell lymphoid malignancy patients.
Beigene said that the BGB-3111 component of the combination regimen will be administered orally. BGB-A317 will be dosed through injection every three weeks in addition. The trials of the combination Phase 1 study will be carried out from four centers in Australia.
Positive preclinical data
Beigene is hoping that the ongoing combination Phase 1 trial will turn up similarly compelling data as the two candidates did in their pre-clinical testing. A positive outcome from the Phase 1 study should pave the way for continued development of the candidates towards marketabiliy. Failure to hit the primary endpoint could throw Beigene’s program into disarray.
According to Beigene’s Interim Chief Medical Officer, Eric Hedrick, the fact that the company owns all the candidates in the combination study gives it significant room to work on them until it realizes their full potential.
Spike in R&D spending
But developing the pipeline candidates is costing Beigene a fortune. The company spent $17.88 million in R&D in 1Q2016 compared to $10.06 million in a similar quarter last year. Development of candidates BGB-3111, BGB-A317 and BGB-283 was largely responsible for the increase in R&D budget.
Beigene Ltd finished 1Q2016 with cash and equivalents of $247.2 million, significantly up from $100.5 million in the prior quarter, despite the cash burn, putting it in a relatively healthy financial situation for now.