PartyOperatorOP•

PLYMOUTH MEETING, Pa., Dec. 7, 2020 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced it has dosed its first subject in a Phase 2 clinical trial evaluating DNA medicine INO-4800, its COVID-19 vaccine candidate, as part of its Phase 2/3 clinical trial, called INNOVATE (INovio INO-4800 Vaccine Trial for Efficacy). The Phase 2 segment of the trial will enroll approximately 400 participants who are 18 years or older at up to 17 U.S. sites to evaluate safety and immunogenicity in order to confirm the dose(s) for the subsequent efficacy evaluation as part of the Phase 3 segment of the trial. INOVIO plans to fully enroll the Phase 2 segment of the trial by the end of this month.

  • Funded by the US DOD
  • Stable at room temperature for over a year
  • Needs a special electroporation widget to administer
9
Banmealreadymods•

If this works they claim the body will not have any side effects like mRNA based vaccines. But does anyone know why? If the claim is true and has high efficiency then it's better tech. But might end up like like beta vs vhs wars.

2
the_stark_reality•

There's no evidence it would change the side effect profile from immune system response.

5
TruthfulDolphin•

MRNA vaccines' side effects are really just an issue for vaccinee compliance especially in the context of multi-dose vaccinations like the ones being rolled out for COVID. The side effects themselves are innocuouos and transient, linked only to an aspecific activation of the innate immune system which is quickly turned off once the the mRNA has been degraded, a matter of hours or very few days.

However, if a vaccinee is sufficiently sick after the first dose, chances are he or she won't come back for the booster.

All in all, I don't think DNA vaccines have a very bright future in front of them - mRNA vaccines are much more efficient and "theoretically" safe.

3
Epistaxis•

Well, one thing they mention is that it's thermostable, supposedly room temp for a year. In contrast to the -80 supply chain we're apparently going to use for (some) RNA vaccines. I suspect those RNA needs are exaggerated and they just didn't have time to test -20, but the stability advantage always goes to DNA. That would also make it easier to produce and QC.

1
einar77PhD - Molecular Medicine•

Does anyone know why FDA, back in September, halted the Phase 3 of INO-4800?

7
GallantIce•

The FDA wanted more information on the Cellectra device.

From Inovio: “INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using one of INOVIO’s proprietary hand-held CELLECTRA® smart devices. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA.”

And if you read the article the OP posted you’ll see that Inovio has not yet fully met the FDA inquiries, which they say they will during phase III.

5
TruthfulDolphin•

My bet is the Inovio vaccine won't make it very far. There are way better candidates in the race with both traditional and innovative (eh) platforms.

1