Yes and it was discussed in the recent CC- And
Post# of 36566
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Posted On: 02/24/2021 11:37:55 AM
Yes and it was discussed in the recent CC-
And we've also gone to GMP production--we've gone to GMP production at risk, it's a little later than what we would have done if we had the government funding that allowed all the other companies to go and manufacture complete GMP.
Lots of risk, but we had to wait till we had the science first and we've been letting the science drive our decisions all along; and by doing that, we've got a lot of information about the immunological regulation of our vaccine prior to even going to humans because we've been working with ex vivo human samples. We know we have human data, and therefore, our science has been able to direct us and now we've gotten to the point where we've selected these five Ii-Key epitopes and gone to GMP production; two of them are almost completed on the first round of GMP, the engineering run, and the others are currently in the engineering run for GMP.
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Lastly, we're working with our CRO, PPD, and they've finalized the protocol; we've been working diligently to get to a final protocol, I think we've got that now and the IND is in preparation; the folks are working in coordination with our GMP manufacture, our finish partner here, a major corporation doing full finish for us, and all of the T-cell results and antibody results are being incorporated right now into that IND.
And we've also gone to GMP production--we've gone to GMP production at risk, it's a little later than what we would have done if we had the government funding that allowed all the other companies to go and manufacture complete GMP.
Lots of risk, but we had to wait till we had the science first and we've been letting the science drive our decisions all along; and by doing that, we've got a lot of information about the immunological regulation of our vaccine prior to even going to humans because we've been working with ex vivo human samples. We know we have human data, and therefore, our science has been able to direct us and now we've gotten to the point where we've selected these five Ii-Key epitopes and gone to GMP production; two of them are almost completed on the first round of GMP, the engineering run, and the others are currently in the engineering run for GMP.
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Lastly, we're working with our CRO, PPD, and they've finalized the protocol; we've been working diligently to get to a final protocol, I think we've got that now and the IND is in preparation; the folks are working in coordination with our GMP manufacture, our finish partner here, a major corporation doing full finish for us, and all of the T-cell results and antibody results are being incorporated right now into that IND.
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