Celgene endorsement sees Beigene come of age

Beigene, a group that has had a consistent if low-key presence at recent oncology conferences, looks finally to have come of age. In licensing its anti-PD-1 MAb BGB-A317 to Celgene it has struck by far the most lucrative asset deal in up-front terms for any Chinese biotech (see table).

Celgene clearly realises that it needs to be in the checkpoint inhibitor game, though investors might well wonder whether it has come to the party too late. At least the deal’s solid tumour focus reflects the lack of promise PD-1 inhibition has in haematology – as Merck & Co neatly demonstrated yesterday.

Celgene has specifically picked up Western rights to BGB-A317 in solid tumours, with local rights, plus global use in haematological malignancies, remaining with Beigene. The deal, struck after market close yesterday, has seen the US group hand across a $263m cash signing fee, in addition to buying a $150m equity stake.

It has one clear precedent: Incyte, another US biotech that saw the need for a presence in the immune checkpoint space, two years ago picked up rights to Jiangsu Hengrui Medicine’s anti-PD-1 MAb SHR-1210, though that tie-up was worth just $25m up front.

A separate part of this deal will see Beigene licensing China rights to Celgene’s Abraxane, Revlimid and Vidaza. This makes for an interesting parallel with Lilly’s deal with Innovent Biologics, which served both as the latter’s entry to the West and as the basis for Lilly’s presence in China. 

It cannot be denied that Beigene has moved quickly through development. A recent EP Vantage report into anti-PD-(L)1 combinations noted BGB-A317 as a new entrant into this analysis, but now the company says the project has already been dosed in over 500 subjects.

However, the huge number of ongoing trials, and the fact that five PD-(L)1-blocking MAbs are already marketed – two with blockbuster sales – makes this is a very crowded space. For its part Beigene says BGB-A317 has an engineered binding region that might minimise undesirable immune cell interactions and thus differentiate itself from the rest of the pack.

Beigene executives struck a notably conservative tone on a conference call this morning, saying the clinical data were still too early to determine whether BGB-A317 was looking like a best-in-class molecule.  

Celgene has taken one previous step into PD-(L)1 inhibition, licensing Astrazeneca’s Imfinzi in 2015, though that deal focused specifically on Celgene’s core expertise in haematology.

Multiple myeloma setback

This space took a knock yesterday, when Merck & Co revealed that three multiple myeloma trials of Keytruda combined with Celgene’s Revlimid or Pomalyst had been put on hold after interim analyses revealed more deaths in Keytruda than in control cohorts.

Merck was off 1% on the after-market news, though multiple myeloma represents a mere $193m of forecast $9.4bn 2022 sales, according to EvaluatePharma sellside consensus. The only promise PD-(L)1 blockade has shown in haematology has been in classical Hodgkin’s lymphoma, a setting where Keytruda and Bristol-Myers Squibb’s Opdivo are both approved.

For obvious reasons this is where Beigene’s blood cancer focus lies too; classical Hodgkin’s is one setting in which a pivotal BGB-A317 study is ongoing in China (the other is bladder cancer), and the company says global pivotal trials, essential to make headway in the US, are to begin next year.

Shares in the Chinese group, which listed on Nasdaq last year, climbed 24% in early trade today to value it at $2.5bn. Interestingly, BGB-A317 is not Beigene’s lead asset; that honour belongs to the BTK inhibitor BGB-311, which featured at last year’s Ash meeting.

Meanwhile, early BGB-A317 monotherapy data in liver cancer were reported at the Esmo World Congress on Gastrointestinal Cancer. The anti-PD-1 MAb is separately in combo studies with BGB-311 and the Parp inhibitor BGB-290, which had been licensed to Merck KGaA before the German group pulled out.

Given how far Celgene is behind the likes of Keytruda and Opdivo it is combination use that likely holds the most promise for BGB-A317.

To contact the writers of this story email Jacob Plieth, Amy Brown, Edwin Elmhirst in London at [email protected] or follow @JacobPlieth, @ByAmyBrownor @EdwinElmhirst on Twitter