E An Update On VBI Vaccines Inc: What's Happened And What It Means

The company has a pretty deep development pipeline that essentially takes the technology used to create the Sci-B-Vac vaccine (something I'll get to in a little more detail shortly) and applies it to various other indications – oncology, neurodegenerative disorders and viral infection to name three. While these are potentially valuable programs longer term, it's the hepatitis B asset I'm interested in for the purposes of this discussion.

So, as noted, it's called Sci-B-Vac, and it's built using a proprietary technology that allows VBI to create vaccines that look and act, from the perspective of a patient's immune system, almost exactly like the the virus against which they are trying to induce seroprotection. The improved likeness is rooted in the vaccine's expression of three separate antigens, each of which are expressed by the hepatitis B virus in its natural form – the S antigen, the Pre-S1 antigen and the Pre-S2 antigen. More antigens mean an increase in the immune system's response to the introduction of the vaccine, and in turn, an improved performance.

Current standard of care hepatitis vaccines generally use one of these antigens (the S antigen) and make use of an adjuvant to improve the performance (with performance defined as induced seroprotection) of the treatment. The incorporation of three antigens negates the necessity for an adjuvant of the type used by current SOC, and this helps VBI to avoid any of the potential side effects (or safety concerns) associated with their inclusion; for example, the autoimmune condition side effects that Dynavax Technologies Corporation (DVAX) is battling right now to prove to the FDA that its Heplisav-B development vaccine doesn’t induce.

So, let's get to the latest updates.

As mentioned, this program is all about getting approval in the US, Canada and Europe right now. Normally, to pick up said approval, a company would have to carry its asset through the standard development pathway – phase I, phase II, phase III, NDA submission, etc. That's what the just mentioned Dynavax is doing (struggling to do) with Heplisav-B. VBI is a bit of an outlier to this standard pathway, however.

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Bill Myers 1 year ago Member's comment

Thanks for the update.