I had the enormous privilege of providing an update on the Tregitope technology to a group of about 30 members of the FDA protein therapeutics group this past Friday, January 29th. The topic for discussion was “Tregitope”, a very recent discovery by EpiVax scientists that we can use a peptide (or set of peptides) to suppress immune response to a range of antigens – most notably to protein therapeutics. (See a short story about some special peptides for more information about the discovery).

I was able to present this update thanks to hard work by a group of investigators including the team lead by David Scott and Achsah Keegan at University of Maryland (effects of Tregitope in models of T1D, FVIII intolerance, and allergy), Mo Sayegh and Nader Najafian at the Brigham and Women’s Hospital (effects of Tregitope in transplantation), Katherine High and Federico Mingozzi at Children’s Hospital of Pennsylvania (gene therapy) and the team at EpiVax. My presentation highlighted progress made since the original publication about Tregitopes appeared in Blood. The visit to the FDA followed a visit to Helen Quill at NIAID, program project officer for my $13M U19 grant (See https://tinyurl.com/13M-Validation-Epi-Technology for more information). I’m really excited about the NIAID’s interest in potential funding for the Tregitope project as a program project – that would make it possible for our very strong team of investigators at this first rate institutions to fund the work that they are doing rather than paying out of pocket!

The presentation to the FDA went well, I’m happy to report. In attendance were all the key players on the FDA “immunogenicity” team – notably Daniela Verthelyi, Ph.D. and Amy Rosenberg. Ph.D. The highlights of the meeting were an animated discussion about the mechanism of action of Tregitopes, and the presentation of our data comparing Ofatumumab and Rituximab– which provided a follow up to our publication last May in Clinical Immunology about the effect of Tregitopes on the immunogenicity of monoclonal antibody therapeutics. I’ve provided a glimpse of the new information here.

Long story short? Tregitopes are a hot topic! Of course, much remains to be resolved about their mechanism of action, but members of the audience at the FDA agreed that they may explain the effects of IgG, and they were very intrigued by reports that Roche had selected EpiVax as a partner for further development of Tregitopes. And, as one member of the audience wrote after the presentation: “Splendid talk. Fascinating approach. We look forward to seeing clinical trials soon!!”.