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J&J exits $1.6bn blood cancer drug licensing deal with argenx

J&J and argenx signed a deal in 2018 to develop cusatuzumab to treat haematological cancers

Johnson & Johnson (J&J) has pulled out of a $1.6bn licensing deal with Dutch biotech company argenx for the CD70-targeting antibody cusatuzumab.

In December 2018, J&J and argenx signed a deal centred on cusatuzumab, to develop the drug for the treatment of acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS) and other haematological cancers.

J&J paid £300m upfront as part of the deal, plus a $200m equity investment and milestone payments that could have taken the total funds funnelled into the programme to $1.6bn.

In a statement released yesterday, J&J subsidiary Cilag announced that it would not continue the collaboration for cusatuzumab.

“The decision is based upon Janssen's review of all available cusatuzumab data and in consideration of the evolving standard of care for the treatment of acute myeloid leukaemia (AML). Final results from Janssen's clinical studies of cusatuzumab will be presented in the future,” the statement said.

In its own statement, argenx said that interim data from the phase 1b ELEVATE trial supports the continued development of the antibody in AML, where the biotech company is planning to progress the drug.

The ongoing, early-stage trial is evaluating cusatuzumab in combination with AbbVie/Roche’s Venclexta (venetoclax) and chemotherapy Vidaza (azacitidine) in newly-diagnosed, elderly patients with AML.

According to early efficacy analyses in 42 evaluable patients, complete remission (CR) was observed in 48%, while composite complete remission – including CRs with incomplete haematologic recovery – was observed in 81% of the population.

In addition, the antibody achieved overall response rate (ORR) in 93% of the evaluable population.

“We have valued the productive collaboration with Janssen that has advanced our understanding of cusatuzumab and its role in AML biology. Together we have generated clinical and translational data that have optimised the dose of cusatuzumab and further characterised its effect on cells in the bone marrow,” said Tim Van Hauwermeiren, chief executive officer of argenx.

"We set our target high with the ELEVATE trial, recognising that cusatuzumab would have to add benefit to an already-established combination regimen. We believe this interim data shows that cusatuzumab could be meaningful to AML patients. We plan to evaluate all alternatives to advance cusatuzumab on behalf of the AML community, while maintaining our focus on our priorities – the launch of efgartigimod and the development of our autoimmune pipeline,” he added.

Article by
Lucy Parsons

8th June 2021

From: Research, Sales

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