IdeS: Therapeutic enzyme to cleave the human and NHP heavy chains of IgG. The cleavage of IgG leads to the elimination of IgG as well as Fc-dependent effector functions, including CDC and antibody-dependent cell-mediated cytotoxicity (ADCC).
Tested at 2 mg/kg, intravenously. More in https://pubmed.ncbi.nlm.nih.gov/37864433/
Key Results: IdeS successfully cleaved rhesus IgG in vitro. Robust reduction of total and antigen-specific IgG was observed within one day following IdeS administration. Rapid rebound of all IgG antibody populations was observed, with antibody levels returning to baseline around day 14 post-infusion. Total IgM level was not affected by IdeS. Interestingly, a comparable reduction in antibody populations was observed after the second dose of IdeS.
Each vial contains frozen (-80C) IdeS produced in E. coli and qualified for in vivo use in NHPs.
Example Handling Protocol (Kindly shared by TNPRC colleagues)
Day 1
1. Remove need vials from -80C and place at 4C overnight for a slow thaw.
2. On day of administration remove from 4C and keep on ice.
3. Combine contents from vials into one sterile container, keeping on ice.
4. Aseptically prepare one syringe per animal with volume needed for 1.5mg/kg dose.
5. Deliver to the building clinic on ice.
6. Aseptically remove 0.3 mL aliquot from remaining stock prep and store at -80C.
Label vial 0.3mL IdeS Prep Date
7. Place remaining stock prep at 4C for use the next day.
Day 2 - 5
1. Remove need vials from -80C and place at 4C overnight for a slow thaw.
2. On day of administration remove previous stock and newly thawed vials from 4C
and keep on ice.
3. Aseptically remove 0.3 mL aliquot from yesterday's stock prep and store at -80C.
Label vial 0.3mL IdeS Thaw Date, Use Date
4. Combine contents from yesterday's stock and newly thawed vials into one sterile
container, keeping on ice.
5. Aseptically prepare one syringe per animal with volume needed for 1.5mg/kg dose.
6. Deliver to the building clinic on ice.
7. Aseptically remove 0.3 mL aliquot from remaining stock prep and store at -80C.
Label vial 0.3mL IdeS Prep, Administration Date
8. Place remaining stock prep at 4C for use the next day.
Repeat Day 2 -5 procedure for each administration day.
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