Courtesy CIDRAP, We Learn That Soligenix (NJ) Won FDA "Orphan Drug" Designation, For Its Novel Ebola Vaccine Candidate SuVax®, Active Against Sudan Variant...

To be certain, the war is being won, month by month, in terms of efforts to mitigate additional Ebola virus outbreaks in Sub-Saharan Africa. The education of the public, coupled to rigorous safe burial practices, when a case is suspected, have done wonders. That, and using ring vaccine strategies -- as to all contacts of contacts, in an affected community. The outbreaks now rarely exceed 20 cases, and often with fewer than five fatalities. [Today's good news comes courtesy of the arm of the University of Minnesota's Med School's CIDRAP website.]

But all of that vaccine strategy only works for outbreaks of the older, Zaire variant. One of the most recent outbreaks (in September of 2022) was of the Sudan variant, and was thus cause for grave concern -- even when the careful public health efforts are able to arrest the spread. [In fact, the Sudan variant vaccine candidate has not been widely tested in the field yet, due to the rapid shutdown of transmission through public health outreach efforts.] Here is just one of our prior backgrounders, on the Sudan variant -- but it remains an open and gaping hole, in the defense net, for ring vaccinations, should another outbreak occur (and it is a near biological certainty there will be another).

So, it is wise that FDA will provide the New Jersey pharmaco with the streamlining review of an orphan drug designation. Orphan drug status also allows for greater overhead absorbing pricing, but is not designed for sponsors to recuperate all the costs of drug development. Rather, it confers a seven year exclusivity period (regardless of patent status), as a cost reduction and regulatory streamlining mechanism.

The FDA can, and occasionally does revoke orphan drug designation, if the side effect profile becomes too daunting, in aftermarket monitoring, or if initial estimates for efficacy turn out to be materially incorrect. But in this case, that would seem unlikely. So here's the latest:

. . .Soligenix, a biopharmaceutical company based in New Jersey, recently announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax^®, its subunit protein recombinant vaccine as prevention and postexposure prophylaxis against Ebola Sudan, for which no vaccines or treatments currently exist.

Ebola Sudan is the second most common cause of human Ebola infections. In 2022, Uganda experienced an Ebola Sudan outbreak that resulted in 164 cases, 55 of them fatal. Earlier this year, the company reported that a bivalent (two-strain) version of the vaccine in a nonhuman primate trial provided complete protection against Ebola Sudan and Marburg viruses. . . .

Now you know -- and this development caused Soligenix's stock to pop (more than double) on the NASDAQ, from $0.38 a share on Friday, to $0.83 per share by 10:00 am Eastern this morning -- though it has since retrenched a bit, this afternoon.

Onward, to a sunny Tuesday -- with Tangerine falling asleep at his own felony hush money trial in Manhattan. Charming. But grinning -- just the same.

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