Hybrigenics’ (PA:ALHYG) main value driver is inecalcitol. A Phase II study in chronic myeloid leukaemia (CML) is on track to complete in H218. Interim analysis showed 33% of patients had a response after one year of treatment. A Phase II trial in acute myeloid leukaemia (AML) is ongoing with data expected in mid-2019. In another Phase II trial in chronic lymphocytic leukaemia (CLL), inecalcitol slowed progression in half of patients. In the field of inhibitors of ubiquitin-specific proteases (USP) the company has its own drug discovery programme and an R&D partnership with Servier focused on oncology worth up to €12m. Our valuation is broadly unchanged at €121m or €2.6/share.
Approaching key data in CML and AML
Inecalcitol continues its ongoing Phase II trial in CML with oral imatinib; the study is expected to be completed in H218. Interim data published in February 2017 showed that 33% of patients had a deep molecular response after one year of treatment, which we believe is encouraging. The Phase II study in AML in combination with decitabine has enrolled more than half of patients and will report results in mid-2019. In vitro data presented at the American Society of Haematology (ASH) meeting in December 2017 showed inecalcitol can induce the expression of CD38 in multiple myeloma cell lines, even more than other CD38 inducers, such as all-trans retinoic acid (ATRA), suggesting it could improve the efficacy of anti-CD38 products. We continue to forecast peak sales of $118.9m in AML and $257m in CML, in the US and the EU.
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