Frequently Asked Questions

Technologies

  • Only 2 of 10 umbilical cords have NK cells suitable for expansion
  • Our proprietary bioassay selects cords for optimal expansion upon receipt of the cord
  • Cords can be frozen or immediately expanded
  • NK Cells are taken for donor cell quality assessment and cryopreserved
  • We are building a bank of cord blood NK cells with high expansion potential
  • All banks have been released tested
  • K562 feeder cells expressing membrane-bound IL-21 and 4-1BB ligand are used in the manufacturing
  • All manufacturing is done under cGMP conditions
  • We use both a master cell bank and working cell bank
  • CAR NK cells are expanded a 1,500-2,000-fold order of magnitude from a single umbilical cord source and a proprietary feeder cell line
  • Allows for repeat dosing to > 20 patients without creating immune cell exhaustion
  • NK cells offer an allogeneic, off-the-shelf therapy
  • No issues with graft vs host disease
  • Controlled immune expansion
  • Low risk of CRS and ICANS
  • High cytolytic capacity
  • Broad outpatient potential
  • Cord blood derived NK cells have high genomic stability
  • Consistent function and phenotype
  • No HLA-matching required
  • Proprietary expansion
  • Sustained activity following cryopreservation
  • Broad outpatient potential
  • Gamida
  • Artiva
  • Senti Bio
  • There might be others (information not disclosed)
  • Unlike membrane bound IL-15, soluble IL-15 can act on NK cells and also other surrounding cells
  • Activates NK cell proliferation, cytotoxicity, and survival
  • Stimulates T cell expansion
  • Reactivates anti-tumor immunity in immune-suppressed solid tumor microenvironments

We are the only company with engineered NK cells that have all of the following

  • Solid tumor & hematological malignancy indications
  • NK cells with high genomic stability
  • No HLA matching required
  • NK and T cell trans-activation using soluble IL-15
  • NK cells with enhanced cytotoxicity and persistence
  • Multi-antigen targeting with our dual CAR construct and Coalescent™ Platform with CAR and bispecific NK engager (BiKE) capabilities in one vector

Manufacturing

  • Fully Integrated In-house clinical GMP manufacturing facility for cells and virus
  • 37,000 ft in-house cGMP manufacturing capacity for 4,000 doses per year
  • Phase II expansion 40,000 doses per year
  • The initial GMP runs for the PD-L1 project produced approximately 30 billion cells
  • A single NK cell product candidate is thawed with 90% viability
  • We have demonstrated consistent transduction with 50 – 80% efficiency
  • Our CAR is stable in vitro, in vivo and post thaw following cryopreservation
  • We have performed GMP runs with our engineered NK cells
  • >100 billion cells
  • > 75 doses
  • ~$2,000 per dose*
  • * Assumes 75 doses of 1 billion cells, per batch

Corporate

  • Our NK cell engineering platform builds on Drs. Caligiuri’s and Yu’s 54 years of collective laboratory investigation of NK cells, their treatment of over 1,000 patients with therapies modulating NK cells in man, and their prior success in engineering T cells
  • We licensed our proprietary technologies from the laboratories of Drs. Michael Caligiuri and Jianhua Yu at the City of Hope National Medical Center (COH)
  • Michael A. Caligiuri and Rich Santulli are long time friends
  • Rich Santulli is the Chairman
  • Christina Coughlin, MD, PhD is the CEO
  • Michael A. Caligiuri, M.D is the Chief Medical Officer
  • Aleksey Krylov, CFA is the Chief Financial Officer
  • José Vidal is the Chief Operating Officer

We have 3 locations

  • Cytoimmune Therapeutics, Inc.
    1218 S 5th Ave,
    Monrovia, CA 91016
  • CytoImmune Therapeutics Puerto Rico, LLC
    Carr. 865 KM 5.4 Int.
    Expreso de Diego,
    Bo. Candelaria Arenas,
    Toa Baja, Puerto Rico, 00951
  • Cytoimmune Australia Pty Ltd
    Floor 17, HWT Tower,
    40 City Road, Southbank,
    VIC 3006
  • Yes subsidies need to be invested back into the PR ecosystem
  • There are no other restrictions around the use of cash
  • We would expect to fill these seats in advance of the IPO
  • The pre-clinical/IND enabling work has been estimated around $2.9M
  • Clinical/phase 1 work was quoted at $2.5M, combined $5.4M
  • This study assumes one siteat City of Hope
  • We have not assessed the impact of multi-site approach on the clinical study costs
  • CYTO-102 (PD-L1+ NK cells) NSCLC IND filing in Q3 2021
  • CYTO-201 (FLT3 CAR NK) AML IND filing in Q4 2022
  • Favorable tax credits
  • $~15M tax credit, 2021 and projected credit ~$20M/year

Intellectual Property

NK cell platform

  • Multiple pending applications
  • Compositions and methods of cord selection expansion/treatment
  • Automation freeze/thaw technology
  • Proprietary cell-line
  • Expiry ~2032 to ~2038

Engineered NK Lung Cancer –NK 102

  • Claims to various solid tumor targeting constructs & treatment methods
  • Licensed from COH
  • Expiry ~2039

CAR targets PSCA, FLT3, CD-19/CD-22

  • 3 US patents (bispec, EGFR and FLT3) and multiple pending US/OUS/PCT applications
  • Additional granted patents in foreign jurisdictions
  • Claims to various CAR targeting constructs & treatment methods
  • FLT3 CAR-T development and License for China, could be combo with CAR-NK
  • Expiry ~2036 to ~2039

CAR-NK with bi-specific

  • Pending US/OUS/PCT apps
  • CAR-NK/T with BiKES and BiTES plus
  • Expiry ~2040