Everybody wants their own checkpoint inhibitor, or so it may seem. Now that the biology is thoroughly understood, we’re seeing a second wave of late-stage programs taking shape — each with their own niche markets in mind for disruption – and today, you can add Beijing-based BeiGene (BGNE) to that list.

Written by John Carroll (ENDpts.com)

BeiGene’s goal here is to use a Phase II trial to push through the first PD-1 checkpoint approval in China (BeiGene isn’t limiting its focus on China; they plan to broaden approvals beyond China’s boundaries as they expand their geographic focus), which has seen a groundswell of R&D at a growing slate of companies. (Bristol-Myers, Merck, Roche/Genentech, Pfizer/Merck KGaA — and probably soon AstraZeneca — have all been piling in). 

The checkpoints, which take the brakes off an immune system attack on cancer cells, make ideal combo partners, so we’re seeing hundreds of clinical trials focused on new doubles and triples…[and] up to now, the initial target of the checkpoint crowd has been the U.S..

BGNE’s primary goal is:

with secondaries on:

Under the guidance of lead investigator Professor Jun Zhu of the Peking University Cancer Hospital…

“We are pursuing the approval of our PD-1 antibody for patients with relapsed or refractory Hodgkin lymphoma in China because of the urgent unmet medical need and significant activity observed with this class of agents in this setting,”

commented Jane E. Huang, Chief Medical Officer, Hematology.

The second wave of checkpoints includes programs at Incyte (INCY), which has a lead IDO1 drug in non exclusive late-stage partnerships with Bristol-Myers (BMY) and Merck (MRK). Agenus (AGEN) started a Phase I/II of their lead checkpoint — AGEN2034 — a few days ago, looking to double down on a PD-1/CTLA-4 strategy. TG Therapeutics (TGTX) has another – and so on.