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PlentyParanoid

09/01/20 12:04 PM

#321734 RE: KMBJN #321722

Like who will be the Covid trial PI?

Helluva good question. None of the current crop of IPIX scientific advisors do fit. Even less so with board of directors. Additional confounding factor, I am afraid, is that there are so many covid trials running currently. Most of the prominent and slightly less prominent virologists are probably fully occupied.

MinnieM

09/01/20 1:08 PM

#321746 RE: KMBJN #321722

It's been my understanding that many teaching hospitals that host trials provide their own PI along with other trial services. That's one scenerio.






Message in reply to:

Thanks for the nice summary, and hope you don't mind expression of two minor points of disagreement. First, the antiviral MOAs are all theoretical at this point, until we see some studies showing how brilacidin was able to reduce viral replication in vitro. Second, Regeneron's antibodies as you described are neutralizing antibodies, which bind to virus and make sure the body disposes of it before infecting cells. They are not immune-suppressing antibodies like used for many other diseases (and some of which were tried and failed in Covid-19: the anti-IL6 ones, which are somewhat immunosuppressive). They would not be much different than neutralizing antibodies induced naturally or by vaccine in that sense. They have a good chance of working prophylactically and early in the virological stage of disease. They have government backing so will be given the green light all the way.

Similarly, with proven safety of B-IV in ABSSSI and strong preclinical in vitro results, brilacidin should get an IND for Covid-19 without too much trouble. Agree with you there for sure. Hopefully LE is using some good advisors/experts/CROs to help design and run the clinical trial, and for all the FDA regulatory work. It's good to have an expert advisor and advocate like deGrado on speed dial, although more will be needed. Like who will be the Covid trial PI?






farrell90

09/01/20 1:58 PM

#321754 RE: KMBJN #321722

I have noticed Regeneron does not like to describe their monoclonal antibody treatments as monoclonal antibodies any more , but the fact is they used the same Velocimmune mice to produce the Covid19 neutralizing antibodies as the older monoclonal antibody pharmaceticals.

Do you have a link that demonstrates the "equalizing antibodies" are safer or functionally different from what they used to call monoclonal antibodies?

It is an important point. All the monoclonal antibody drugs are unique and have different side effects ,but as a pharmaceutical class they share a list of life threatening complications.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668229/

Infection:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668229/

Immunologic complications:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2668229/


"Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19."

https://investor.regeneron.com/index.php/news-releases/news-release-details/regeneron-begins-first-clinical-trials-anti-viral-antibody

"VelocImmune provides perhaps the most powerful and efficient way of generating fully human monoclonal antibodies that are ready for clinical testing. Its invention has allowed Regeneron to become a leading antibody therapeutics company, with twelve clinical stage antibodies generated through our VelocImmune platform currently in clinical development,"

https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-granted-fundamental-patents-covering-mouse-antibody

GLTA Farrell

farrell90

09/01/20 2:07 PM

#321757 RE: KMBJN #321722

The MOA's outlined in IPIX's PRs were based on data from the RBLs.

Both the RBL and IPIX signed nondisclosure agreements. IPIX was allowed to PR the summary findings of the RBL in regards to Brilacidin's MOAs, but the rest of the data is to be released in the peer review publications.

The publication of the peer review journal articles should answer the questions as to how the Brilacidin MOAs was determined.

GLTA Farrell