Clinical Study – IMM-101 Phase II data

IMM-101 is a broad spectrum immunomodulator

IMM-101’s diverse immune related mode of action and the potential safe promotion of a broad systemic innate and adaptive immune response provides a strong rationale for targeting a range of cancers. Immodulon is initially focusing on the high unmet needs of pancreatic cancer patients with further opportunities in other cancers including melanoma and colorectal cancer.

 

“IMM-101 uniquely boosts the innate immune response, enhances T-cell mediated immunity and suppresses the chronic inflammatory response. It’s the only agent that can do this”

Prof Angus Dalgleish

MD FRCP FRACP FRCPath Fmed Sci

IMM-101 compelling phase II pancreatic cancer data

Immodulon has generated promising phase II data with IMM-101 in first line patients with advanced pancreatic ductal adenocarcinoma (PDAC) in combination with gemcitabine (IMAGE-1 study).  These data show that IMM-101 is well-tolerated and effective, with the potential to prolong progression-free survival for patients compared to gemcitabine alone.  The data also suggest a beneficial effect on survival in patients with metastatic disease.
Efficacy

  • Median overall survival of metastatic pancreatic cancer patients receiving gemcitabine + IMM-101 improved from 4.4 months to 7 months (p<0.01)
  • Performance Status 2 (PS2) patients performed equally as well as PS1 and PS0 patients

Safety 

  • IMM-101 was well tolerated and with no added toxicity
new graph
Source: (Dalgleish et al. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer. Br J Cancer 2016; 115(7):789–796

Registration Study

Immodulon is planning to advance IMM-101 in a pivotal study in metastatic pancreatic ductal adenocarcinoma (mPDAC) patients . The study will evaluate IMM-101 combined with the current standard of care, Gemcitabine/Nab-Paclitaxel (Gem/Nab-P), versus Gem/Nab-P alone.  The study aims to demonstrate improved median OS in elderly patients with mPDAC and in younger patients for whom a FOLFIRINOX regimen is not suitable.