IMM-201 Trials

IMM‑201 is at a very early stage of development and currently is only under investigation in a clinical trial in the prevention of tuberculosis (TB). Moreover, its therapeutic use in conditions associated with mental health disorders such as PTSD, and conditions associated with ongoing chronic inflammation is being studied in a pre-clinical research programme.

Researchers at the University of Colorado Boulder in the USA led by Dr Chris Lowry, have entered an agreement with Immodulon to perform pre-clinical research with Mycobacterium vaccae NCTC11659 in a variety of laboratory models of mental health disorders. As part of this programme of work, the University of Colorado Boulder in conjunction with a consortium of Universities in the USA, has been awarded a grant totalling $7.5m from the Department of Defence to study the microbiome and responsiveness to stress to identify strategies for improving resilience to stressors like sleep deprivation and circadian clock issues.

Dr Chris Lowry of the University of Colorado, Boulder, USA published a study in PNAS in May 2016 which found that mice injected with M. vaccae were more resilient to stress, showing less fear and anxiety in stressful situations. Treatment also changed serotonin activity in the brain, with similar beneficial effects to antidepressants or long-term exercise. Additionally, immunised mice were protected against colon inflammation which was caused or worsened by stress in unimmunised mice.

In addition, the Dartmouth College’s Geisel School of Medicine in New Hampshire, USA, has licenced M. vaccae NCTC11659 from Immodulon for the prevention of TB. Researchers led by Professor Ford von Reyn in collaboration with AERAS (a non for profit biotech primarily funded by The Bill & Melinda Gates Foundation and European donor governments) have completed a Phase I clinical trial and have now initiated a Phase II randomised study in Tanzania.

As part of this project, the Geisel School of Medicine, Muhimbili University of Health and Allied Sciences in Tanzania, and Tokyo Medical and Dental University received $1.4 million from Japan's Global Health Innovative Technology Fund to conduct this joint randomised clinical trial in Tanzania aimed at reducing the transmission of TB. The trial will evaluate the safety and efficacy of M. vaccae NCTC11659, as a booster TB vaccine, in adolescents.

In IMM‑201's previous form, as SRL 172, it has been administered by intradermal injection (the same route as IMM‑101) to approximately 550 patients in published oncology clinical trials and over 2,000 patients in other clinical trials.

History & Science behind IMM-201