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Hybrigenics: First Patients Enrolled In AML Phase II Trial

Published 12/06/2016, 04:06 AM
Updated 07/09/2023, 06:31 AM

Hybrigenics (PA:ALHYG) has started dosing the first patients in France and the US in a double-blind, placebo-controlled Phase II study in elderly or frail acute myeloid leukaemia (AML) patients. Data are expected in Q418 or H119. Additionally, an open-label Phase II study in patients with chronic myeloid leukaemia (CML) in combination with imatinib continues; an update will be provided by Q117. Hybrigenics has an R&D collaboration with Servier focused on oncology, from which it received a €1.5m milestone payment in H216. Our updated valuation is €146.1m or €4.1/share.

Hybrigenics

Phase II trial in AML starts, CML study continues

During H216 Hybrigenics commenced dosing of the first patients in France and the US in its Phase II trial in AML patients unfit for chemotherapy. The company will test inecalcitol vs placebo in 110 patients and present overall survival data in Q418 or H119. Furthermore, a Phase II study in patients with CML in combination with imatinib continues; an update is expected by Q117. The collaboration with Servier has been renegotiated and is now focused on oncology. Hybrigenics received a €1.5m milestone payment from Servier. An additional €12m is due on completion of undisclosed development and regulatory targets. In vitro data showing the increase of CD38 expression were presented at the annual meeting of the American Society of Hematology (ASH).

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