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Immuncell-LC

Product Immuncell-LC
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Partnering to Advance
Liver Cancer Care

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In hepatocellular carcinoma (HCC), the most common type of liver cancer, a significant number of patients are diagnosed in the early stage, providing the potential for a cure through ablation or resection. However, the lack of effective drugs to prevent HCC recurrence after resection underscores the critical need for potential adjuvant therapy options for this population.

  • Liver Cancer
  • 6thmost common cancer [1]
  • 1million +
  • global cases annually
  • About 30% of patient eligible for resection or transplantation[2]
  • 70% recurrence rates
  • in 5 year [3]
  • Clinical Unmet Needs High
  • : no approved therapy for
  • adjuvant setting[4]
  • [1]Llovet, J. M., Kelley, Hepatocellular carcinoma. Nature reviews. Disease primers, 7(1), 6.
  • [2]Hepatocellular carcinoma. Nature reviews. Disease primers, 7(1), 6.
  • [3]N Engl J Med. 2019 Apr 11;380(15):1450-1462
  • [4]NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Hepatocellular Carcinoma, Version 1.2023

The Only Approved HCC Adjuvant Therapy Globally

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Product

Immunecell-LC (Autologous Cytokine Induced Killer Cells)

Indication

Adjuvant therapy for patients whose tumor has been removed after curative resection for hepatocellular carcinoma

Treatment Regimen for Immuncell-LC (16 cycles)
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Immuncell-LC An Autologous Cell Therapy
with a Long-standing Track Record

Efficacy Data

Clinical Trial Phase 3 in HCC adjuvant
(Extended 5 years Follow-up Study)
  • Recurrence-Free Survival
    Recurrence-Free Survival(RES) graph01
    Recurrence-Free Survival(RES) graph01
  • Overall Survival
    Overall Survival graph01
    Overall Survival graph01
  • Phase HR for RFS** HR for OS***
    Ph3
    (3 years)    		 0.63 (P=0.010) 0.21 (P=0.008)
    Ph4
    (Extended 5 years)    		 0.67 (P=0.010) 0.33 (P=0.006)

    The 5 years follow-up starts with the enrollment of last patient.
    ** RFS: Recurrence Free Survival *** OS: Overall Survival

    Ref.1. Gastroenterology (2015) 148:1383-1391,
    2. Cancer Immunol Immunother. (2019) 68(1): 23-32,
    3. NCT00699816

  • Overall Survival graph03
    Overall Survival graph03
Real World Data in HCC adjuvant
  • Recurrence-Free Survival
    Recurrence-Free Survival graph04
    Recurrence-Free Survival graph04
  • Real World Data
    Phase HR for RFS HR for OS
    Real World Data 0.42 (P=0.006) 0.30 (P=0.170)

    Real World Data was obtained from 118 patients

    • Phase 3 clinical trial:
      37%risk of recurrence
    • Real World Data:
      58%risk of recurrence
    Real World Data is better than Phase III clinical data

Safety Data

Highly safe and tolerable cell therapy with long-term follow-up data.

  • 10,000

    10,000 +

    of accumulated
    patients treated

  • 90

    up to 90 months

    of long-term
    follow-up data

  • No

    NOCytokine Release

    Syndrome or Immune effector Cell-Associated Neurotoxicity Syndrome

  • 0%

    0%Patients who

    delayed/stopped treatment due to serious adverse events
    (Grade 3 or 4)

Ref. 1. BMC Cancer (2019) 19(1):523 , 2. Gastroenterology (2015) 148(7):1383-1391

Manufacturing Process

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    Sampling & Seperation
    Blood collection from patient
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    Expansion (Avg 14 days)
    Obtain multiple does with single blood draw
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    Quality Test
    Confirmation of cell stability and efficacy
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    I. V. Infusion
    The outpatient setting maximizes patient convenience

Insights into Immuncell-LC : Mechanism of Action

Dual Tumor Killing Effect by MHC Restricted & Unrestricted Cytotoxicity

  • 1

    The elimination of tumor cells occurs as CTL binds to MHC Class I via TCR.

  • 2

    CIK eliminates tumor cells lacking MHC Class I expression by interacting with NKG2D and NKG2D ligands present on the tumor cell surface.

  • Collectively, these cells efficiently eliminate tumor cells by preventing tumor cells from escaping immune surveillances

History

Immuncell -LC received South Korean MFDS approval for HCC immunotherapy in 2007 and
the US FDA’s Orphan Drug Designation for the treatment of liver cancer, brain, and pancreatic cancer.

  • 2007
    Approved curative
    adjuvant treatment for HCC
    in Korea
  • 2015
    Announcement of results of HCC phase III clinical trials
  • 2017
    Announcement of results of long-term follow-up phase III clinical trials
  • 2018
    Orphan drug designation for pancreatic cancer, liver cancer, Giloblastoma by FDA
  • 2019
    Published the Real World Data(HCC)
  • 2021
    Updated approval by newly established ATMP
    regulation in Korea
  • DISEASE
  • IMMUNCELL-LC
  • Efficacy & Safety
  • Manufacturing
  • Mechanism
  • History