We know what Rich Purcell said in the May CC:
“The manufacturing run for our clinical supply will be filled on May 18th at the University of Iowa Pharmaceuticals, great specialty fill-finish provider, and they've done a great job for us too; and so, May 18th, we'll be filling our clinical supply. From there, we have to just wait for the stability, stability, and variants tests; it takes six to eight weeks--and this is what Joe has alluded to before with the FDA. We have to have a full CMC package to go to the FDA before we finally move for a Phase 1 IND. Other pharma companies--and I spoke with one of the developers from one of the major pharmaceutical companies, who told me that they were allowed to do a rolling IND and pass information to the FDA all along last year to accelerate the work.
But we didn't get that advantage and we didn't get the advantage of the Operation Warp Speed funding, but we've been able to come up with our vaccine anyway; and we're very excited about where we're at we hope to be able to initiate the clinical trials this summer to then get our data that will tell us whether we have a complete vaccine, and we believe strongly, based upon our work so far, as Joe alluded to before, we vaccinated transgenic animals to show that we produce IgG against the vaccine and that came out positive; and we're currently repeating that experiment to confirm those results and that result will be available in two weeks, just to confirm that we have the complete vaccine with an antibody and a T-cell response in a transgenic animal model.
And that will pave the way for us to move into the clinic to give us these answers; and I think the most exciting part about this is that this peptide-based vaccine--amino acid-based vaccine--doesn't have genetic material in it; it's stable; it's easily manufactured at scale because people have been making peptides for decades, we know how to make large quantity peptides very quickly, we can supplement the current supply of vaccine; especially in international markets, if they don't have access, we can provide access to a new brand of vaccine; and most importantly, from a commercial standpoint, we can be the universal booster. If everybody needs a booster shot with the current vaccines, our vaccine will direct the specific response from the immune system against only those sections of the virus that will neutralize it and give us long- term immune protection; we've eliminated regions of the virus that overlap with human sequences, that overlap with old Coronavirus viri like common cold coronavirus sequences, and we've only focused on those regions of the virus that are susceptible to our immune system so that we can direct the immune response specifically.
So, there we go. We're ready to move; we have the ability to manufacture at scale; we have a lyophilization process that is commercial-ready, not just Phase 1 ready like we thought we'd have, we have a full commercial CMC package and we're ready to go to the clinic as soon as we get the FDA go-ahead on our IND.”
Page 6 of the transcript you can find on their webpage.
“The manufacturing run for our clinical supply will be filled on May 18th at the University of Iowa Pharmaceuticals, great specialty fill-finish provider, and they've done a great job for us too; and so, May 18th, we'll be filling our clinical supply. From there, we have to just wait for the stability, stability, and variants tests; it takes six to eight weeks--and this is what Joe has alluded to before with the FDA. We have to have a full CMC package to go to the FDA before we finally move for a Phase 1 IND. Other pharma companies--and I spoke with one of the developers from one of the major pharmaceutical companies, who told me that they were allowed to do a rolling IND and pass information to the FDA all along last year to accelerate the work.
But we didn't get that advantage and we didn't get the advantage of the Operation Warp Speed funding, but we've been able to come up with our vaccine anyway; and we're very excited about where we're at we hope to be able to initiate the clinical trials this summer to then get our data that will tell us whether we have a complete vaccine, and we believe strongly, based upon our work so far, as Joe alluded to before, we vaccinated transgenic animals to show that we produce IgG against the vaccine and that came out positive; and we're currently repeating that experiment to confirm those results and that result will be available in two weeks, just to confirm that we have the complete vaccine with an antibody and a T-cell response in a transgenic animal model.
And that will pave the way for us to move into the clinic to give us these answers; and I think the most exciting part about this is that this peptide-based vaccine--amino acid-based vaccine--doesn't have genetic material in it; it's stable; it's easily manufactured at scale because people have been making peptides for decades, we know how to make large quantity peptides very quickly, we can supplement the current supply of vaccine; especially in international markets, if they don't have access, we can provide access to a new brand of vaccine; and most importantly, from a commercial standpoint, we can be the universal booster. If everybody needs a booster shot with the current vaccines, our vaccine will direct the specific response from the immune system against only those sections of the virus that will neutralize it and give us long- term immune protection; we've eliminated regions of the virus that overlap with human sequences, that overlap with old Coronavirus viri like common cold coronavirus sequences, and we've only focused on those regions of the virus that are susceptible to our immune system so that we can direct the immune response specifically.
So, there we go. We're ready to move; we have the ability to manufacture at scale; we have a lyophilization process that is commercial-ready, not just Phase 1 ready like we thought we'd have, we have a full commercial CMC package and we're ready to go to the clinic as soon as we get the FDA go-ahead on our IND.”
Page 6 of the transcript you can find on their webpage.
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