IMM‑101 Phase I
In 2010, IMM‑101 was evaluated in a Phase I trial (a trial which tests what a drug does to a patient’s body and how well it is tolerated), enrolling 18 patients with advanced melanoma where the disease had spread to the patient’s other organs. Sadly, historically only approximately 10% of patients survive 5 years with this condition. The unexpected result of an extension to Phase 1 trial, however, was that six patients receiving IMM‑101 are still alive more than five years later.
This is a 5-year survival rate of 33% and is exciting because it is comparable with leading approved immunotherapy treatments, but without adding to toxicity levels in the body and has the potential to be used in combination with other treatments, further enhancing their impact on patient outcomes.
The initial paper on the Phase I study was published in the Annals of Oncology (Oxford Journals) 2011: Stebbing J. et al. An intra-patient placebo-controlled phase I trial to evaluate the safety and tolerability of intradermal IMM‑101 in melanoma which describes the initial safety and tolerability data.
These long term follow up results were presented at the international European Society of Medical Oncology (ESMO) meeting in Lausanne in November 2015 and some patients are still in a follow up study.
IMM‑101 Phase II
In 2013, IMAGE-1, a Phase II proof-of-concept study of 110 patients with locally advanced or metastatic pancreatic cancer was initiated. Patients were given the chemotherapy drug gemcitabine with and without IMM‑101. The study was designed to provide indicative rather than definitive efficacy results, but exceeded expectations by providing promising overall survival results and durable responses in all prospectively defined populations as well as a favourable safety profile.
The graph shows the Kaplan Meier (KM) survival curves for the Intention-to-Treat (ITT) population with metastatic disease where an increase in median survival of 2.6 months corresponds to a 59% increase in survival for patients receiving IMM‑101 + gemcitabine compared to gemcitabine alone. Equally importantly, the continued separation of the KM curves to 24 months and the survival outcomes at 12, 18 and 24 months indicate a long lasting response for some patients with this devastating disease. Safety analysis indicated no apparently additional burden of side-effects in adding IMM‑101 to gemcitabine. IMM‑101 is gentle to the body and does not add a further burden on the patient’s health and quality of life. Side effects were limited to swelling and itching where the injection is administered, similar to a BCG injection.
For the full paper published in the British Journal of Cancer (Nature Journals) 2016: Dalgleish A. et al. Randomised, open-label, phase II study of Gemcitabine with and without IMM‑101 for advanced pancreatic cancer. The IMAGE-1 Trial (Immune Modulation and Gemcitabine Evaluation-1).