MER3101 is vaccine-like formulation of Insulin Beta Chain (IBC) and MAS-1, an adjuvant. That makes more sense when you read it back to front, and go through it word by word:
The idea behind this trial is to expose the immune system to part of the insulin molecule in order to train the immune system not to attack beta cells which generate that insulin. This is vaguely similar to giving people with a peanut allergy peanut proteins in the hopes their body will learn to accept peanuts. But remember that is a crude analogy, and type-1 diabetes is not a classic allergy!
We know that type-1 diabetes involves at least five different autoantibodies: islet cells (ICA), insulin (IAA), GADA, IA2 (also called ICA512), and ZnT8A. Of these, the insulin autoantibody (IAA) often shows up first, so several researchers have tried to cure or prevent type-1 diabetes by teaching the immune system not to generate these autoantibodies. This clinical trial is another in this line of research.
This study can be thought of as a follow on to this previous work:
https://cureresearch4type1diabetes.blogspot.com/2011/05/orbans-phase-i-results.html
This Study
The study design is more complex than usual. It's clear they are trying to get as much out of this study as they can:
The primary results are safety and immune effect, which are important to running more studies in the future, and learning about the vaccine. The secondary results are measuring success for both a cure and a treatment: C-peptide, A1c, and insulin use.
People in this study must be between 18 and 45 years old, and within 2 years of diagnosis.
The study started recruiting in August 2018, they hope to finish in April 2022, and was funded by the Helmsley Charitable Trust.
They are recruiting in one place:
University of Colorado, Denver: Aurora, Colorado, United States, 80045
Contact: Mara Kinney 303-724-8272 mara....@ucdenver.edu
Contact: Hali Broncucia 303-724-7526 hali.br...@ucdenver.edu
Principal Investigator: Peter Gottlieb, MD
Clinical Trial Registry: https://clinicaltrials.gov/ct2/show/NCT03624062
The History
Dr. Tihamer Orban has been working on curing / preventing type-1 diabetes using vaccines based on the Insulin B-Chain for at least 10 years.
The earliest human trials that I know of were done at the Joslin center and reported in 2010, on an IBC based formulation called IBC-VS01. This is how I summarized the results back then:
In terms of safety, the results were fine: nothing bad happened, and this is a new treatment, so safety was an important question. But in terms of effectiveness, the results are mixed. The vaccine did result in a specific immune system change that looks promising. ... But no effectiveness was seen during the trial. Their was no improvement in C-peptide generation of the treated group compared to the non-treated group.
You can read more in my previous post:
https://cureresearch4type1diabetes.blogspot.com/2011/05/orbans-phase-i-results.html
After this trial, Dr. Orban created his own company Orban Biotech to pursue this research which was issued patents in the 2012 to 2014 time frame, but is not operating now.
On the adjuvant side, a company called Mercia licenced an adjuvant technology from another company called Aphton and developed it into MAS-1. They then started a group of research projects, collectively called MERIT, to combine MAS-1 with different vaccine parts (called "antigens") to create vaccine-like treatments for four different diseases (Type-1 Diabetes, Influenza, Alzheimer's, and Asthma).
The type-1 diabetes branch of this research was to work with Dr. Orban to combine his IBC-VS01 antigen with their MAS-1 adjuvant to create MER3101 which Mercia is now testing. In order to show the history of MER3101, the Mercia web page shows some of Dr. Orban's previous IBC-VS01 results, renaming it MER3001. In the world of fictional fandoms, this would be called retroactive continuity ("retconning" for short) to make it look like Mercia has been involved since before 2010.
Some Discussion
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.