The history and science behind IMM-201

IMM‑201 consists of Mycobacterium vaccae, a bacterium isolated from soil collected from Lake Kyoga in Uganda in the early 1970s by Professor John Stanford and developed in collaboration with Professor Graham Rook. Professor John Stanford grew M. vaccae on a special medium and isolated a variant which he called M. vaccae NCTC11659. This bacterium has been shown to correct over-exuberant responses of the immune system and allow the body to deal with a wide range of pathological conditions associated with chronic inflammation, such as Tuberculosis (TB), allergic diseases and Post-Traumatic Stress Disorder (PTSD). Immodulon has the sole rights to M. vaccae NCTC11659.

Immune-modulators help the body to restore correct immune functions and, for example, control the damage caused by chronic inflammation, like that caused by cancer. As such, the effects of immune-modulators can also be highly relevant to several non-cancer diseases for which unregulated immune responses and persistent chronic inflammation is part of the problem. In particular these have been observed to drive allergic diseases, autoimmune diseases and inflammatory bowel disease as well as mood disorders.

IMM‑201 preferentially modulates the immune response towards control of over-exuberant immune responses (immune-regulation). It helps the body to control responses to harmless antigens present in its environment (e.g. pollen) and to control chronic inflammation that develop in conditions of stress which arise during infections (e.g. TB) or in life events (e.g. PTSD, sleep deprivation, anxiety).

IMM‑201 is a natural bacterium which would have been routinely consumed by our ancestors as part of their diet. Indeed, we have co-evolved with microbes present our environment including soil, water and our food for millions of years and have come to expect important clues in our immune system from them, providing a service essential to health. Only recently urban living conditions and modern living (e.g. inappropriate use of antibiotics, reduced animal interaction, processed food) have altered this balance. Immodulon is developing a strategy to “re-introduce” patients to beneficial bacteria to promote an optimal immune response to disease.

History of IMM‑201

SR Pharma, which rose out of Stanford Rook Ltd. and has since changed its name to Silence Therapeutics, is a biotechnology company which was developing treatments derived from heat-killed Mycobacterium vaccae (NCTC11659) and called SRL172 or SRP299 (depending on the manufacturing process used) in the 1990s. One of the founders of Stanford Rook, Professor John Stanford, helped Dr Charles Akle to set up Immodulon in 2007. Immodulon bought the rights to M. vaccae and is now continuing development under the name IMM‑201 using an improved manufacturing process and target indications which are more relevant to its known mode of action.

Original studies by SR Pharma into the impact of M. vaccae on tuberculosis and lung cancer had varying levels of success but clearly provided important information for the further development of M. vaccae as an immunotherapeutic agent, rather than a vaccine. Moreover, work on a murine model of pulmonary allergic inflammation provided strong evidence for the immunoregulatory properties of this bacterium and laid the foundation for the Old Friends Hypothesis proposed by Prof. Graham Rook in 2003, which explains the important link between exposure to environmental microorganisms and control of diseases of immunodysregulation.

Now that the role of immuno-modulators as treatments, as opposed to vaccines, is better understood, both pre-clinical investigations and clinical trials of IMM‑201 are being pursued by Immodulon, and positive pre-clinical results have generated great interest within the research community.

IMM-201 Trials