IMM-101 and Cancer

Immodulon is dedicated to the development of novel, safe and effective combination treatments for cancer patients. Patients with diagnoses including Pancreatic, Sarcoma, Melanoma, Mesothelioma, Lung, Glioblastoma and Colorectal cancers, have been treated with our lead product, IMM-101, either in clinical studies or compassionate use programmes.

Immodulon sponsored clinical studies with repeated intradermal injections of IMM-101 to date have shown that IMM-101 is well tolerated and may potentially increase the overall survival of patients with metastatic Pancreatic cancer and advanced Melanoma with no incremental burden of side effects.

COMPANY SPONSORED STUDIES

PATIENTS

Immodulon’s vision is for IMM-101 to become a backbone immunotherapy across multiple cancer types in combination with any of the four major pillars of cancer therapy – immunotherapy (including innovative checkpoint inhibitors (CPIs)), chemotherapy, radio/ablation therapy, and surgery – and increase their efficacy without compromising on patient’s safety and quality of life. Our present and future clinical trials, including studies sponsored by our collaborators, are designed with this vision in mind.

Our key focus is on developing better therapies for the different areas in advanced Pancreatic cancer and to advance Immodulon’s pipeline in cancer indications where there has been hardly any progress in survival over the last decades.

Pancreatic

Melanoma

Colorectal

Pancreatic cancer (pancreatic ductal adenocarcinoma)

Despite all the progress made in the treatment of various other cancer types, the development of new effective therapies for Pancreatic cancer has been disappointing, and it remains one of the most challenging cancers to treat. It has a 5-year survival rate of only 5-10%, and accounting for 7% of all the cancer deaths and is expected to become the second leading cause of death from cancer in the US by 2030. Pancreatic cancer is observed in four different stages:

local and surgically resectable (10-20% incidence and a 5-year survival of about 20%)
local and borderline surgically resectable (5-15% and <5%)
locally advanced and surgically unresectable (20-30% and <3%)
metastatic (45-55% and <1%)

Eventually, the vast majority of the initially diagnosed local Pancreatic cancers become metastatic. IMM-101 was investigated in a randomized, Phase II study (IMM-101-002¹), comparing IMM-101 with and without Gemcitabine. A total of 110 patients were included in the study of whom 18 had locally advanced and 92 had metastatic disease. IMM-101 demonstrated a favourable safety profile for all patients with an increased overall survival in metastatic disease.

A long-term follow-up study (IMM-101-002A²), included 11 patients with metastatic disease at entry to the first study. The survival probability at 24, 30 and 36 months indicated long-term benefits for IMM-101 used in combination with other anti-cancer treatments and showed survival probabilities beyond 24 months comparable to the more toxic, standard of care combination of Abraxane plus Gemcitabine.

Based on the promising results from this study, the evaluation of IMM-101 is being expanded in various sub-areas of locally advanced and metastatic Pancreatic cancer treatments in combination with immune-based therapies (CPIs and others), chemotherapy, local radiation, ablation therapies, surgery, and potentially combinations of these treatments. These studies will be either company or investigator sponsored and conducted in major European, South Asian and North American centres of excellence.

¹Dalgleish et al., 2016

²Dalgleish and IMAGE 1 Trial Investigators, 2018

IMM-101 is being evaluated in an investigator sponsored open label, non-randomised study (“LAPC-2”) in Locally Advanced Pancreatic Cancer (LAPC) conducted at the Erasmus University Medical Centre in Rotterdam. The LAPC-2 study is designed to evaluate the safety and efficacy of IMM-101 administered in combination with stereotactic radiotherapy of the primary tumour in LAPC patients who initially responded to FOLFIRINOX.

Based on the initial observations in LAPC-2, a second open label, non-randomised investigator sponsored study commenced in Q1-2021 in patients with limited metastatic Pancreatic cancer (“MEPANC-1”). The trial is designed to evaluate the safety and efficacy of IMM-101 administered in combination with stereotactic radiotherapy on metastases in the liver and lung.

Further investigator sponsored studies with IMM-101 in advanced Pancreatic cancers are in different phases of preparation and recruitment is planned to commence in 2022. These studies include combinations with CPIs in metastatic (in collaboration with a Pharma partner), locally advanced disease and combinations with CPIs and other immunotherapies in metastatic disease.

Immodulon plans to commence recruitment in Q1-2022 for a company sponsored Phase III randomised global study in metastatic Pancreatic cancer patients who are not suitable candidates for FOLFIRINOX treatment. This study will recruit patients who are ECOG Performance Status 2 or are older than 70 years and will evaluate the effect of IMM-101 in combination with gemcitabine and nab-paclitaxel.

Advanced Melanoma

Melanoma is a serious form of skin cancer that begins in cells known as melanocytes. While it is less common than other skin cancers (basal cell carcinoma and squamous cell carcinoma), Melanoma is more dangerous because of its ability to spread to other organs more rapidly if it is not treated at an early stage.

Immodulon has completed two clinical trials of IMM-101 in Melanoma. A Phase I in 18 patients with advanced unresectable Melanoma to investigate safety and tolerability (IMM-101-001³) and an open label follow up study (IMM-101-008) with 10 of these patients, who were observed for nearly eight years. In these studies, IMM-101 demonstrated a favourable safety profile with highly encouraging long-term survival data⁴.

A Phase I/II study (IMM-101-015) in advanced unresectable Melanoma is currently in progress to evaluate the safety and efficacy of IMM-101 in combination with the CPI Nivolumab. Treatment will continue for up to 18 months with headline results expected in Q4 2021.

³Stebbing et al., 2012

⁴Fusi and Dalgleish, 2019

Colorectal Cancer

Colorectal cancer – also known as bowel cancer, colon cancer, or rectal cancer – is the second leading cause of cancer death in women, and the third for men. The cancer can grow through the gut wall (stage III) and spread to other parts of the body (Stage IV). IMM-101 will be investigated in a specific sub-set of patients with Colorectal cancer.

Following favourable safety results in a proof of concept, exploratory, company sponsored Phase II study combining IMM-101 with stereotactic radiotherapy in Colorectal cancer (IMM-101-007) and based on recent clinical progress, Immodulon has been approached to provide IMM-101 for an investigator sponsored Phase II open-label, prospective, multicentre study. This study which will be performed in collaboration with a Pharma partner and a centre of excellence in Germany, is in late stages of preparation and is expected to start recruiting in Q4-2021. The study will evaluate a CPI with or without IMM-101 in patients with Colorectal cancer.