Drug Development

A second wave of checkpoint inhibitors is swelling fast, with speedy BeiGene leaping into a pivotal trial

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.

Today, you can add Beijing-based Beigene $BGNE to that list.

The biotech dosed their first patient with refractory classical Hodgkin lymphoma — or cHL — with their anti-PD-1 drug BGB-A317 in a pivotal study.

Beigene’s goal here is to use a Phase II trial to push through the first PD-1 checkpoint approval in China, which has seen a groundswell of R&D at a growing slate of biotech upstarts. Their primary goal is the overall response rate, with secondaries on progression-free survival, duration of response, complete response rate, time to response, safety, and tolerability under the guidance of lead investigator Professor Jun Zhu of the Peking University Cancer Hospital.

BeiGene, which is also developing a PARP and a BTK inhibitor, is all about speed. Their Phase I PD-1 checkpoint trial started less then four months ago, and will be reviewed at ASCO in early June.

“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.

And BeiGene isn’t limiting its focus on China. They plan to broaden approvals beyond China’s boundaries as they expand their geographic focus.

Up to now, the initial target of the checkpoint crowd has been the US. 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.

The second wave of checkpoints includes programs at Incyte $INCY, which has a lead IDO1 drug in unexclusive late-stage partnerships with Bristol-Myers and Merck. 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 has another.

And so on.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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