Wednesday, April 09, 2014 11:24:17 AM
RSV unbeaten for decades. But, NVAX RSV vaccine is practically guaranteed.
by wily.coyote
Although RSV vaccine has been elusive for several decades, the difficulty is not in the virus itself. The RSV is closely related to the flu virus, and should be easily beaten. The problem was in the old approaches used, not the virus itself. The day a company called NVAX came up with a new method, RSV was beaten.
Briefly, the traditional methods of making vaccines consist of "farming" the virus, killing the resulting viruses, and then injecting the dead or weakened viruses in people. Then, the immune system learns how to produce antibodies against the virus. Since the viruses injected were inactivated or attenuated, the immune system can take its time to learn how to fight it. Later on, when the person contracts the real virus, the immune system is already "educated" in how to fight it. It will fight it and kill it before the person gets sick.
What made the RSV unbeatable was because the parts that the immune system needs to fight were simply not targeted by the immune system. Then, the only solution would be to force the immune system to target those parts. You could not do this with traditional technologies because all they could do is to create offsprings of the parent viruses with little difference from the parent virus.
How did NVAX solve the problem? NVAX realized that Synagis worked well against RSV, except that Synagis is incredibly expensive and has too many disadvantages to be used for cases other than very serious cases of newborns. What made Synagis work was the fact that it targets Site II of the fusion protein RSV-F. So, NVAX created a (nanoparticle) protein that mimics RSV-F, except for Site II, which NVAX made it more pronounced. NVAX could do this because their VLP/nanoparticle technology is capable of pruning/grafting RNA/DNA gene sequences in ways unbeatable by none.
To this date, only NVAX figured out how to do this. It was extremely difficult, but NVAX did it. Even if competitors succeeded in doing what NVAX did, they would remain a few years behind NVAX, especially since they cannot use the patented discoveries made by NVAX.
As you can see, the difficulty was in creating a "proper" protein to present to the immune system. Now that NVAX has done that, the RSV virus becomes just as easy/difficult to beat as flu viruses. Remember that in all past RSV clinical studies NVAX RSV vaccine induced the immune system to generate 5-10 times more Synagis-like antibodies than Synagis (5 for unadjuvanted, 10 for adjuvanted).
If you think about the above, you'll realize why the case with the (previously) unbeatable RSV is completely different from the cases of yet unbeatable diseases such as cancer. The risks to NVAX investors pale in comparison to the risks with any other company working on yet-unbeatable diseases.
The results of the upcoming RSV phase IIb and later H7N9 phase I/II are practically guaranteed to be just as OUTSTANDING as the results of previous clinical results.
Disclosure: More loaded with NVAX than any other investor, bar none (relative to net worth).
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