CAR-CIK

Chimeric Antigen Receptor (CAR) modified Cytokine Induced Killer (CIK) cells

Why use CIK cells?

  • CIK cells do not occur naturally in the body
  • Strong graft vs. tumor effect with greatly reduced graft vs. host effect compared to T cells*
  • Lower toxicity, with no SAEs seen in all 21 patients infused

*BLOOD (2008) 112(6):2563

Highly efficient proprietary non-viral gene transfer technology: Sleeping Beauty 100X (SB100X)**

  • CoImmune holds exclusive world-wide license
  • Simple electroporation step
  • Consistently high gene transfer rate (60%-90% genetically modified cells)
  • Faster next generation product development timelines achievable with no need for virus stocks
sleeping_beauty_tech

**Crit. Rev. in Biochem and Mol Bio (2017) 52(4):355–380

Streamlined manufacturing process

Production based on material from healthy donors reduces lot-to-lot variability compared to autologous CAR-T therapies

CAR-CIK therapy offers numerous advantages over traditional CAR-T therapy

Traditional CAR-T therapy CAR-CIK Therapy
Manufacturing logistics Complexities due to autologous setting Greatly simplified due to allo healthy donor
Functionality 1 mechanism to kill target cells Multiple mechanisms including T cell + NK cell methods
Cost $350K-$450K per dose Greatly reduced
Distribution Limited to certified academic centers No limitations
Toxicity Potentially severe CRS and neurotoxicity No serious adverse events observed to date
Quality Highly inconsistent lot-to-lot variability due to heterogeneity patient starting material Greatly improved lot-to-lot consistency due to healthy donor starting material
Gene transfer Recombinant retrovirus (biggest cost driver) SB100X transposase system (inexpensive and highly efficient)

Clinical experience with CMN-005

Allogeneic Phase 1/2a CARCIK-CD19 (CMN-005) dose escalation Clinical Trial***

clinical_experience_cmn-005
  • IST trial conducted at 2 sites in Italy
  • Adult and pediatric patients with B-cell precursor ALL who are either chemo-refractory or relapsed after allogeneic HSCT
  • 4 pediatric/17 adult patients treated
  • All patients progressing at time of enrollment
  • Single infusion after lymphodepletion
  • N=21 evaluable patients

Interim Results

  • Data reported on the first 13 evaluable patients (4 pediatric, 9 adults)
  • Ages 1 year to 62 years (69% of patients not eligible for approved CAR-T therapies due to age >25 years)
  • No manufacturing failures
  • Persistence observed up to 10 months by PCR

***J Clin Invest. (2020) 130(11):6021

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CR rate 28 days Post-infusion at highest Dose N=7

In CR and minimal residual disease negative N=6

Serious adverse events
Dose limiting toxicities

GVHD, Neurotoxicity