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
  • Are PD-1 Negative

*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

CAR-CIK Products Approved CAR-T Products
Allogeneic (healthy donors, requires only low-resolution tissue match enabling off-the-shelf availability) Autologous (complex logistics and supply chain)
Little to no toxicity (allows repeat dosing, no SAEs to date) Toxicity limits patient eligibility
CIK cells resistant to inducing GVHD Problems with GVHD and neurotoxicity
Dual killing mechanisms (antigen dependent and independent) Single killing mechanism
Inexpensive non-viral genetic modification (more efficient than virus) Viral genetic modification significantly increases COGs, potential safety issues
Simplified manufacturing process (multiple doses/run) No economy of scale

Compared to other allogeneic CAR-Ts under development, CAR-CIK products do not require additional genetic engineering to reduce immunogenicity or immunosuppression of the patient

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

  • 21 evaluable patients
  • 75% of patients achieved CR at highest dose and 73% of CRs were minimal residual disease negative
  • No GVHD or neurotoxicity observed
  • One-third of patients had only a 50% tissue match, but no differences noted vs. full matches
  • 48% of patients that achieved a CR still in CR at 1 year
  • Persistence of CARCIK-CD19 measurable up to 21 months in responding patients

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

0%
0%
0%
0%

CR rate 28 days Post-infusion at highest Dose N=12

Of CRs minimal residual disease negative

Serious adverse events
Dose limiting toxicities

GVHD, Neurotoxicity