Alive and kicking
Encouraging data in the last few months are supportive of Bionor Pharma ASA's (OSLO:BIONOR) Vacc-4x strategy, with patient response variability highlighting the importance of developing predictive biomarkers. Although reboosting with Vacc-4x did not show a further reduction in viral load, the reboost data provide more evidence of Vacc-4x’s ability to induce an immune response to HIV. This could be enhanced by boosting the immune system and by releasing hidden HIV reservoirs; both are under investigation.
Response variability could be key
Bionor’s strategy to develop Vacc-4x as a potential functional cure for HIV remains intact. This strategy encompasses three key elements: Kick, Kill and Boost. Vacc-4x has already demonstrated viral load reduction (‘Kill’) with supportive data from the recent reboost study. ‘Boost & Kill’ and ‘Kick & Kill’ trials are ongoing, with data expected in Q414 and H215, respectively. Bionor has disclosed that some patients in the recent reboost trial did show a stronger response to Vacc-4x. While baseline characteristics of these patients are not yet known, differing response levels according to anti-C5 levels were recently reported in a subset analysis. Analysing and understanding why certain patients respond better to Vacc-4x and the development of predictive biomarkers could be key for maximising value.
Data support strategy
In the last few months encouraging data from Bionor’s two HIV vaccines have been released, in addition to first data confirming the ability to for an HDACi to ‘kick’ awake HIV reservoirs. In the latter, data from the first part of the HDACi combo study have demonstrated that romidepsin (‘Kick’) can successfully reactivate latent HIV reservoirs. Data from the Phase I Vacc-C5 trial confirmed it is safe and well tolerated and that it can increase anti-C5 antibody levels in patients with low baseline anti-C5. Finally, although Vacc-4x reboost data did not show any additional significant lowering of the 2010 viral load set point, this small trial did provide additional evidence of Vacc-4x’s ability to lower viral load (‘Kill’).
Valuation: Risk-adjusted NPV of NOK888m
Our underlying Vacc-4x assumptions are unchanged, with our rNPV now NOK888m (from NOK882m) owing to updated net cash and rolling our valuation forwards. Net cash of NOK89m at end March should be sufficient to fund operations into H215, which could allow for the complete HDACi combination data.
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