The Time is Now! for Tregs

I spoke at a conference on Treg-directed therapies this week and wow! Things are happening in Tregitopia! There were lots of fancy companies (e.g. Jeff Bluestone’s Sonoma featuring products named after grapes) aiming to use CAR-T-like approaches to address autoimmune disease. Sonoma, Trex Bio, GentiBioQuell, Abata Tx, and Tr1x are all raising funds by the bucketful. Meanwhile, innovator companies like PolTreg have been paving the way, generating more than 5 years of data! in T1D. Yes, Tregitopes are still our favorite immunomodulation power tool, and we’re working on translation to the clinic whenever we have a minute

Mastering Models? 

What in the world is a Model Master File? We had to go find out at the Center for Research on Complex Generics meeting a few weeks ago. VERY EXCITING! it may soon be possible to file “computational tools” that can be referred to, just as you would for a ‘drug master file‘, at the FDA. As you can well imagine, that may simplify the process of immunogenicity risk assessment for everyone involved. Watch this space! 

Epi-Paper Double Threat!

I say that (we’re busy) because this month you’ll see not one, but two long-awaited Epi-papers get published! Check out Individual and Population-Level Variability in HLA-DR Associated Immunogenicity Risk of Biologics Used for RAThat’s a look at regional immunogenicity risk (different populations have different HLA distributions!), published in a wonderful collaboration with our colleagues in Tokyo. Here’s the kick-off meeting with Sugiyama-san and team in 2019!

And then, with FDA colleagues, we developed methods for Assessing the Immunogenicity Risk of Salmon Calcitonin Peptide Impurities, coming out soon (you can sign up to get a notification). This publication describes in silico and in vitro methods to evaluate impurities that may occur in generic salmon calcitonin drug products. We’re thrilled to find ways to help make drugs safer for the world! 

Register Now to Attend AI/HI

Join the party in Providence for the Artificial Intelligence / Human Intelligence & Immunoinformatics Workshop

Our invited speakers will describe tools used for the exploration of immune responses and provide case studies related to biologic drugs and vaccines. Day one will cover the impact of AI and Human Intelligence (HI) on vaccine developmentDay two explores AI/HI’s role in biologic therapeutics, addressing biologics failures, high-throughput screening, and personalized medicine.

To conclude both days, we’re holding receptions at some of Providence’s most exciting dining locations.

Luminaries in academia (Brown, BU, UMinn, UGA & URI to name a few) and industry (Amgen, BMS, Alexion & more!) who are working at the AI/HI interface will be there. Join us! (No cost but the number of seats is limited-  and going fast!). Get all the info here.

👉 Save your spot –  Sign up here

You’re Invited!

Are you attending BIO International in June? Will you be in the San Diego area? Join us at our BIO reception, Tuesday, June 4th from 6:00-9:00pm at the Malibu Farm Pond Room in beautiful Seaport!

Put your name down here to reserve your spot, this one might fill up quickly. We hope you can make it! 🥳

(And, find us at BIO! Myself, Sarah Moniz, and the new CEO of EpiVax, Rich-Henry Schabowsky, PhD, JD will be there, shoot us a request through the partnering ap!)