First signals of ‘Kick and Kill’ potential
Interim data from the Phase II REDUC trial of Vacc-4x for Bionor Pharma (OSLO:BIONOR) with romidepsin provide initial hints at the potential for this combination to reactivate and destroy latent HIV reservoirs. Although early stage and from only a few patients, we believe these signals are encouraging for Vacc-4x’s future, in particular as a functional cure for HIV. Full data by YE15 will be needed to confirm these trends and will be critical in determining the future development for Vacc-4x. Our valuation is largely unchanged at NOK993m.
‘Kicking’ by romidepsin reconfirmed
Interim data from nine patients in Part B of the ongoing REDUC trial have shown that romidepsin administration led to a spike in HIV viral production. Patients in this trial were well controlled on conventional ART with low viral loads. Hence, this finding is consistent with the virus being reactivated from HIV reservoirs and reconfirms prior Part A data where romidepsin was first shown to reactivate these reservoirs.
Hints at Vacc-4x mediated killing of HIV reservoirs
REDUC Part B is the first time that Vacc-4x has been administrated prior to romidepsin, with the combination safe and well-tolerated. Total HIV DNA, an indicative measure of HIV reservoir size, demonstrated a mean 21% decrease compared to baseline with Vacc-4x treatment. This is suggestive that the addition of Vacc-4x led to killing of reactivated HIV reservoirs. Furthermore, viral load, which is measured regularly throughout the study, remained low (below the levels of detection in seven of nine patients), implying that even with viral reservoir reactivation, the addition of Vacc-4x appears to keep the virus under control.
Further data expected by end 2015
These early results will need to be confirmed with further trial data, which are expected towards the end of 2015. This will include data from 20 patients already recruited into the trial post a 16-week interruption of current ART, in addition to a more robust measure of the reservoir size (via the gold standard outgrowth assay). Nevertheless, in our view these initial data point in the right direction and support the ‘Kick and Kill’ hypothesis, which is crucial for any HIV cure strategy.
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