Poster presentation at CICON and oral and poster presentation at BSI demonstrated the immunomodulatory effects of IMM-101 in pre-clinical models

Oral and poster presentation at Pancreatic Cancer Symposium reported results from the IMAGE 1 open label Phase II study in advanced pancreatic cancer

Data presented supports ongoing Phase I/II study of IMM-101 in advanced melanoma in combination with checkpoint inhibitor

Uxbridge, UK, 16 December 2019 – Immodulon, the immuno-oncology company, today announces that pre-clinical and clinical data on its lead drug candidate, IMM-101, has been presented at the CRI CIMT EATI AACR International Cancer Immunotherapy Congress (CICON), 25-28 September 2019, in Paris; the Pancreatic Cancer Symposium, 23-24 October 2019, in Toulouse; and at the British Society for Immunology Congress (BSI), 2-5 December 2019, in Liverpool.

At CICON and BSI, data from an on-going collaboration with the laboratory of Professor Andrew MacDonald at the Manchester Collaborative Centre for Inflammation Research, University of Manchester demonstrating the immunomodulatory effects of IMM-101 was presented by Alicia Galdon. The data from in vitro and in vivo experiments in mice clearly showed that IMM-101 activates dendritic cells, and that such activated dendritic cells induce a typical Type I immune response with the generation of large numbers of different subsets of IFN-γ producing activated immune cells. These activated immune cells were not only present locally in the draining lymph nodes close to the site of the IMM-101 injection but were also present elsewhere in the body. This systemic multitargeted immunomodulating effect on the immune system by IMM-101 is believed to play a crucial role in its efficacy in the treatment of cancers. The oral presentation by Alicia Galdon of the results of these experiments was awarded a ‘Bright Sparks’ prize at the BSI.

At the Pancreatic Cancer Symposium, data from the Company’s open label Phase II study of IMM-101 in advanced pancreatic cancer (IMAGE 1) was orally presented and discussed by Professor Angus Dalgleish, the principal investigator of IMAGE 1, alongside the proposed mode of action of IMM-101 and potential future trials using IMM-101 in combination with checkpoint inhibitors. In addition, results from a pancreatic cancer patient, whose surgery and FOLFIRINOX chemotherapy was not successful, were presented. The patient, who is now free of disease for more than three years, was treated with nab-paclitaxel, gemcitabine and IMM-101 prior to further treatment with a checkpoint inhibitor. At the symposium, a poster of the IMAGE 1 study was also presented, reporting that metastatic pancreatic cancer patients receiving IMM-101 and gemcitabine benefitted from a 59 percent increase in median overall survival compared to those receiving gemcitabine alone. The combination therapy was well tolerated and the survival probabilities at 24 and 36 months were similar to those seen with the nab-paclitaxel and gemcitabine combination for which higher grade treatment-related side effects were much more frequent.

Jaap Kampinga, Chief Executive Officer of Immodulon, commented: “We are delighted that encouraging data on IMM-101 has been presented at such prestigious conferences. Pancreatic cancer is currently the third leading cause of cancer death, with a very small improvement seen in survival rates over the past four decades. We are therefore pleased that a new clinical study has commenced, using IMM-101 in combination with standard of care in locally advanced pancreatic cancer, and that other initiatives are in early stages of discussion. Immodulon is presently focused on our Phase I/II clinical study of IMM-101 in combination with checkpoint inhibitor therapy in advanced melanoma, which the data presented at these conferences provides support for. We congratulate Alicia with her ‘Bright Sparks’ prize and are very pleased with the ongoing collaboration with the Manchester Collaborative Centre for Inflammation Research and look forward to presenting further data about IMM-101’s mechanism of action in the future.”

About Immodulon’s current advanced melanoma trial

Immodulon’s current advanced melanoma trial, IMM-101-015 (NCT03711188) is an ongoing open label Phase I/II study that will enrol up to 26 patients with unresectable stage III or stage IV melanoma who are either treatment-naive (18 patients) or whose disease is not responding to PD-1 blockade or has progressed during or after treatment with PD-1 blockade (8 patients). The primary objective of the trial is to assess the safety and efficacy of the combination of IMM-101 with nivolumab. Secondary objectives include overall survival and progression-free survival at 18 months.

Posters

The CICON 2019 poster can be viewed here
The Pancreatic Cancer Symposium 2019 poster can be viewed here
The BSI 2019 poster can be viewed here