Pharma BD Deal Intelligence
Janssen's $300M upfront bet on argenx's cusatuzumab looked like strong platform validation in 2018, but the collaboration collapsed in June 2021 when Janssen discontinued it as venetoclax+azacitidine reshaped the AML standard of care, sending rights back to argenx, which spun the asset into OncoVerity in 2022.
Outcome grade pending — assessed 5 years post-close.
Full analysis, sources & comparables →PharmaTimes covered Janssen's $300M upfront plus $200M JJDC equity stake at EUR 100.02/share, characterizing the structure as a strong validation of argenx's…
BioSpace noted argenx regained worldwide rights to cusatuzumab after Janssen termination, with argenx evaluating partnering or in-house development paths…
FierceBiotech reported J&J culled the $1.6B argenx collaboration in June 2021, citing the 'evolving standard of care' in AML—a tacit reference to…
Source summaries from our enrichment pipeline; follow links for originals.
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argenx and Janssen (Cilag) entered exclusive global collaboration and license for cusatuzumab (ARGX-110), an anti-CD70 antibody, in December 2018. Janssen paid $300M upfront, JJDC bought $200M in newly issued argenx shares (4.68% stake at EUR 100.02/share), with up to $1.3B in development, regulatory and sales milestones plus tiered double-digit royalties ex-US and 50/50 US co-promotion economics. Lead indication AML/MDS in elderly patients unfit for chemotherapy. The collaboration was terminated in June 2021 when Cilag/Janssen discontinued the agreement following review of all cusatuzumab data and the evolving AML standard of care (venetoclax+azacitidine), returning worldwide rights to argenx. Rather than developing cusatuzumab in-house, argenx co-created OncoVerity, Inc. in 2022 with the University of Colorado Anschutz Medical Campus and UCHealth as an asset-centric spin-off, then granted OncoVerity an exclusive license to cusatuzumab in 2023 and provided funding (with additional participation in a 2024 financing round). As of 2024-2025 OncoVerity is the program sponsor: the Phase 2 OV-AML-1231 trial (NCT06384261) of cusatuzumab plus venetoclax and azacitidine versus venetoclax+azacitidine in newly diagnosed AML unfit for intensive therapy began July 2024 (active, not recruiting; estimated primary completion January 2027).
22K US cases/yr
Acute myeloid leukemia is an aggressive hematologic malignancy of myeloid progenitor cells, with a median diagnosis age of 68 and rapidly fatal course if untreated. Older and unfit patients—the majority of incident cases—face dismal outcomes, with 5-year survival of just 5% in those over 70. Standard induction chemotherapy ('7+3') is intolerable for many elderly patients, leaving a major unmet need for effective, lower-intensity regimens.
At deal signing in December 2018, the unfit-AML standard of care was hypomethylating-agent monotherapy (azacitidine/Vidaza or decitabine), with median OS under 10 months. The competitive landscape was about to shift dramatically: AbbVie/Genentech's Venclexta (venetoclax, BCL-2 inhibitor) plus azacitidine received FDA accelerated approval November 2018 and full approval in October 2020 based on VIALE-A showing 14.7-month median OS, reshaping the unfit-AML market and effectively setting a new bar for any new entrant. Cusatuzumab (anti-CD70) was positioned as an add-on to azacitidine targeting leukemic stem cells, with Phase 1 data showing CR in 50% of evaluable patients. Other competitive assets included Astellas's Xospata (gilteritinib, FLT3) approved 2018, Daiichi Sankyo/Servier's Tibsovo (ivosidenib, IDH1) and Idhifa (enasidenib, IDH2), and BMS/Celgene's Onureg (oral azacitidine maintenance). The deal mattered because Janssen was making a $300M upfront bet on a novel mechanism (anti-CD70 leukemic stem-cell targeting) at the moment venetoclax was rewriting the unfit-AML treatment paradigm. Janssen terminated in June 2021 citing 'evolving standard of care'—a tacit admission venetoclax+aza had moved the goalposts.
Cilag/Janssen discontinued the cusatuzumab collaboration after reviewing all data and citing the evolving AML standard of care (venetoclax+azacitidine). argenx regained worldwide rights.
argenx co-created OncoVerity, Inc. with the University of Colorado Anschutz Medical Campus and UCHealth as an asset-centric spin-off to continue cusatuzumab development in AML.
In 2023 argenx granted OncoVerity an exclusive license to cusatuzumab plus funding support; argenx participated in an additional financing round in 2024.
Phase 2 randomized trial (NCT06384261) of cusatuzumab plus venetoclax and azacitidine vs venetoclax+azacitidine in newly diagnosed AML unfit for intensive therapy began 2024-07-22; active, not recruiting; estimated primary completion January 2027.
| Deal | Year | Value | Outcome |
|---|---|---|---|
| Janssen (Cilag GmbH International, J&J) / argenx SE (this deal) | 2018 | $1.8B | — |
| Amgen Inc. / Micromet Inc. | 2012 | $1.2B | 88 |
| Servier / Shire plc (Oncology Business) | 2018 | $2.4B | 88 |
| AstraZeneca PLC / Alexion Pharmaceuticals Inc. | 2020 | $39.0B | 86 |
| Swedish Orphan Biovitrum AB / Biovitrum | 2001 | $493M | 84 |
| Otsuka Pharmaceutical Co. Ltd. / Astex Pharmaceuticals | 2013 | $886M | 79 |
| AbbVie Inc. / Pharmacyclics Inc. | 2015 | $21.0B | 79 |
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