Genmab has been promising a deal on its lead R&D project, epcoritamab, for some time now and today unveiled Abbvie as its new partner. The CD20-targeting bispecific sits in a field where Roche and Regeneron are ahead with similar agents, so the Danish biotech was always going to need help competing.
With its big presence in haematological cancers thanks to Imbruvica and Venclexta, partnering with Abbvie certainly makes sense. The deal terms point to the promise seen with bispecifics in this area: $750m up front and up to $3.2bn in milestones for Genmab, which also gets to keep a healthy portion of the profits should help epcoritamab make it to market.
The broad development and commercialisation deal also involves two other clinical-stage bispecifics and potentially four other projects down the road, so some of the fees will relate to progress elsewhere. A big proportion will be linked to epcoritamab, however, which Genmab will jointly market with Abbvie in the US and Japan.
Profits will be shared equally in these countries; elsewhere Genmab will receive 22-26% royalties. The terms are broadly similar for the other two projects: CD3 bispecifics targeting CD37, GEN3009, which is in a phase I trial; and 5T4, a target expressed on a wide variety of solid tumours. This is much earlier in development, with an IND having only just been filed.
On a call with investors this afternoon the deal was repeatedly described as a “50:50 partnership” and “transformational” by Genmab executives, although Abbvie’s management team are also probably hoping for pretty big things. The company has fired several blanks in oncology – think Rova-T and velaparib – and shares in the company opened up almost 2% today.
With an $18bn market cap Genmab can hardly be described as a small biotech anymore, though this valuation is largely thanks to a substantial rally over the past few months. The stock touched a record high in late May and has surged 64% so far this year, which probably explains a relatively muted response to the deal: shares were trading 5% higher on the news.
The bispecific promise
Highly encouraging response rates with Regeneron’s REGN1979 and Roche’s mosunetuzumab across various lymphomas have raised hopes that using a bispecific to hit CD20 might boost the effectiveness of this well established mechanism. The nearest term hope is that these agents might offer a more tolerable and convenient option than Car-T in later-stage settings.
While there are several CD20 bispecific projects in development, Roche and Regeneron are considered out in front. Both presented substantial data sets at Ash last year, which seems to show what REGN1979 gained in efficacy over mosunetuzumab, it lost in safety (Ash 2019 – Regeneron takes the bispecific baton and runs, December 10, 2019).
As a huge player in the CD20 space with Rituxan and Gazyva Roche should not be ruled out here, of course, but this is a race that is far from over.
Genmab presented the latest cut from an ongoing trial of epcoritamab at Asco this year, which appeared to show competitive efficacy. And on safety, which is more easily stacked up at this stage, epcoritamab certainly holds it own, with a much lower rate of more severe cytokine release seen, albeit in fewer patients to date.
| CD20 bispecific safety comparison | |||
|---|---|---|---|
| REGN1979 (Regeneron) | Mosunetuzumab (Roche) | Epcoritamab (Genmab/Abbvie) | |
| N | 110 | 270 | 58 |
| CRS | 59% | 29% | 57% |
| CRS grade 3-4 | 6.40% | 1.10% | 0% |
| CRS=cytokine release syndrome. Source: Ash 2019, Asco 2020. | |||
A “Darzalex type development programme” should be expected, they revealed, involving multiple thousands of patients; combinations with Imbruvica and Venclexta are also likely. Considering that epcoritamab data in only 58 patients has been published to date, some might find this talk premature.
And of course if this comes to pass much of Genmab’s new-found wealth will be earmarked for such studies. However it is clear that in Abbvie a motivated and ambitious partner has been found.
https://www.evaluate.com/vantage/articles/news/deals/genmab-brings-abbvie-bispecific-boost
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