Another endorsement for PI3K delta, this time in oncology

The direction in which MEI Pharma and Kyowa Kikrin, as of yesterday its global partner, take ME-401 will be interesting to watch. The PI3K delta inhibitor is in mid-stage studies for haematological cancers, which is also the focus of many competitor projects with the same mechanism, including Zydelig, umbralisib and parsaclisib. Zydelig has been constrained by toxicities in its approved use of CLL, though of course each agent’s specificity for PI3K subunits is not the same. But several companies are looking beyond oncology for PI3K delta inhibition, including in inflammation, respiratory disease and a rare condition called activated PI3K delta syndrome. It was a focus on the last that saw Pharming pay $20m to license Novartis’s leniolisib last August. Either way, Kyowa had been MEI’s Japan partner since November 2018, so it must have seen something impressive to hand across $100m for global rights, comprising a US profit share and royalty-based arrangement in the rest of the world, yesterday. The windfall saw MEI climb 50%, and for now the partners’ aim is to continue developing ME-401 for B-cell malignancies, including in combinations.

Clinical-stage PI3K inhibitors with delta subtype specificity
Project Company Indication highlight
Zydelig Gilead Approved for CLL
TG-1202/umbralisib TG Therapeutics Marginal zone & follicular lymphomas
Phase III
CDZ173/leniolisib Pharming/Novartis Activated PI3K delta syndrome
Phase II
Nemiralisib Glaxosmithkline Activated PI3K delta syndrome
ME-401 MEI Pharma/Kyowa Kirin B-cell malignancies
INCB50465/parsaclisib Incyte/Innovent Haematoligical oncology
HMPL-689 Hutchison China Meditech B-cell malignancies
ACP-319 Acerta Pharma B-cell malignancies
AZD8154 Astrazeneca Asthma
Phase I
IOA-244 Ionctura Solid tumours
Source: EvaluatePharma.

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