Clarification on Coya Therapeutics IL-2 and CTLA4 Trial

Earlier this week, you may have seen the news from Coya Therapeutics on the publication of data from their phase I study testing a combination of CTLA4-Ig Fusion Protein (CTLA4) and low dose Interleukin-2 (IL-2).

We want to clear up any confusion that this data is linked to the study of IL-2 in the MIROCALS trial, for which we are still awaiting publication of the data.

The Coya Therapeutics trial is not linked to the MIROCALS trial. It is an independent trial led by a US-based biotechnology company. Earlier this week, Coya Therapeutics released data from a phase I study which included four people living with motor neuron disease (MND). The four people received a combination of CTLA4 and IL-2 for 48 weeks.

What does the treatment combination do?

IL-2 and CTLA4 are both naturally occurring proteins involved in our immune system.

• IL-2 is a protein that is released by certain white blood cells and functions by increasing the expansion and activity of a number of immune cells, thereby enhancing the immune system.
• CTLA-4 is a protein found on the outside of some immune cells and when activated, it suppresses their function and therefore suppresses the immune system.

In this study, Coya Therapeutics is harnessing IL-2 to increase immune activity and inhibiting (or stopping) CTLA-4 from suppressing immune activity. They hope that this two-pronged approach will boost activation of the immune system to treat MND.

What were the findings?

The trial did show promising results, with an improvement in the patient’s ALSFRS-R scores (a questionnaire-based scale that measures and tracks changes in a person's physical function over time, it is widely used in MND clinical trials). The treatment was also well tolerated.

On analysis of immune cells within the four patients, Coya Therapeutics found that the treatment had enhanced the function of Regulatory T cells. This is in line with previous findings from the IMODAL trial (a trial that led onto the MIROCALS trial), which showed that IL-2 increased the number of regulatory T cells in a small number of people with MND. You can read more about this from an article we published last year about some research we are funding with Professor Tim Tree at King’s College London here.

What’s our take on the data?

We need to be aware that this is a very small phase I trial of only four people. There was no control group in the study - neither healthy individuals nor a placebo treatment. So we cannot read too much into the data.

It is promising, however, that Coya Therapeutics also found an enhanced function of T-regulatory cells, which could add weight to the MIROCALS strategy of harnessing our immune system to treat MND.

We hope these early-stage positive results will help Coya Therapeutics to test the combination treatment in further larger-scale studies.

Update on MIROCALS data

Last month at our Scientific Advisory Meeting, we heard that the data from the MIROCALS trial was due to be submitted for publication by the end of June. We’ve now heard that this deadline has been pushed back by a further month until the end of July. We share your frustration on this constantly moving deadline, but hope we are reaching the end of this process now.