Doing Well and Giving Back in December
On Being Human
Humans share 96-98% of our DNA with non-human primates. And yet, for many years, we have caged our “NHP” brothers and sisters and used them to validate our scientific hypotheses.
Finally, there is good news for NHPs. The FDA and the CDC in the US as well as the PMDA in Japan say that NHP (and other animal) studies are no longer strictly required for drug approval. Instead, “New Approach Methodologies“ (NAMs) should (and can) be used. This includes in vitro, in silico and other approaches (organs-on-a-chip) more relevant to human biology. Indeed, we can help you with your NAMs journey. EpiVax scientists have three decades of experience providing computational modeling and human immune system-relevant assays that will help you replace and reduce reliance on animals. Now that’s good news for us humans.
Since it’s the giving season, if you would like to support the retirement of NHPs used in research, you can make a donation here.
Join the Tregitope Fan Club
There’s a new Treg epitope (a.k.a Tregitope) in town. Our new study with FDA scientists (in proofs in Frontiers in Immunology) identified a T cell epitope in teriparatide (TPT) that is highly conserved with those in human tubulin (and hence potentially tolerated or tolerogenic). It appears to be a Tregitope, in studies to be published soon (click to sign up for the PDF). Modifications to this peptide (in generic peptide impurities) changes the phenotype of immune response (potentially driving ADA in subjects receiving the drug).
Ok, but why is it relevant to you? FDA guidance for synthetic peptide generics explicitly calls for methods to assess the immunogenicity risk in ANDAs. The JanusMatrix tool, which is included in our PANDA Approach, provides a comprehensive look at generic peptide impurities, including whether they are ‘tolerated’ or not.
Doing Well by Giving Back
Calling all philanthropists! This holiday season, EpiVax is in the mood to spread a little cheer. We’re supporting gifts for children at Clínica Esperanza/Hope Clinic and at AIDS Care Ocean State. Another holiday tradition at EpiVax is to triple your philanthropy! Send us your donation receipt and some other info, and EpiVax and Annie will match you (within reason!). Let us triple your impact this holiday season!
Yes, I write this newsletter (with some welcome assistance from Elena Iemma!).
Feel free to write me about Tregitopes, vaccinations, or anything else that crosses your mind! Right HERE!
Stay Safe! Wash Your Hands! Be Happy!
-Annie
