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 focused on bringing the potential of IMM-101 closer to patients diagnosed with immunologically ‘cold’ tumours, including pancreatic 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 Has Differentiated Potential Based on Compelling Phase II IMAGE-1 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 Highlights

  • 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
  • 8 patients lived up to 46.5 months

Safety Highlights

  • IMM-101 was well tolerated and with no added toxicity
  • Most AEs are reversible injection site reactions
  • Of 12 IMM-101 treatment-related SAEs reported:
    • 10 occurred in a study where IMM-101 was combined with gemcitabine
    • 9 of these SAEs were considered to also be related to gemcitabine
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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

IMM-101 to Move into Registrational Study

Immodulon is currently prioritizing the initiation of a Phase III Bayesian adaptive platform study for IMM-101 in PDAC that can be expanded to evaluate IMM-101 in other immunologically ‘cold’ tumours across multiple parallel arms.