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Lipid 01-1
Formulation & Performance
Serum antibody expression
| Cargo | mRNA1 encoding a CD19/CD3 bispecific antibody |
| Administration | Intravenous (tail vein) |
| N/P ratio | Not reported for the cited experiment |
| Exact formulation | 01-1 / DSPC / cholesterol / PEG lipid. Exact molar percentages and PEG-lipid identity are not resolved for this experiment. |
| Model | NOD/SCID mice |
| Dose | 1 μg mRNA per mouse, single dose |
| Timepoints shown | 24 and 48 hours |
| Comparators | 03-135, 03-208, 02-1 and 02-3 |
Figure 3B shows serum antibody expression following delivery with 01-1. Among the five formulations plotted, 03-135 has the highest mean expression at 24 and 48 hours; this comparison does not establish 01-1 as the expression leader.
Original patent and figures: WO2024131874A1
WO2024131874A1, Example 7, paragraph [0362], Figure 3B (PDF p. 137).
Antitumor activity in a humanized leukemia model
| Cargo | mRNA1 encoding a CD19/CD3 bispecific antibody |
| Administration | Intravenous (tail vein) |
| N/P ratio | Not reported for the cited experiment |
| Exact formulation | 01-1 / DSPC / cholesterol / PEG lipid. Exact molar percentages and PEG-lipid identity are not resolved for this experiment. |
| Model | Human PBMC-engrafted M-NSG mice with Nalm6-luc leukemia |
| Dose | 3 μg mRNA per mouse, single dose |
| Comparators | PBS; non-specific mRNA (mRNA-NST), 3 μg/mouse once; recombinant antibody (blinatumomab), 3 μg/mouse daily for three administrations |
| Endpoint | Tumor bioluminescence (total flux), followed through day 14 |
The patent explicitly identifies 01-1 as the cationic lipid used in this experiment. The mRNA1-LNP group had lower tumor bioluminescence than the control groups and the recombinant antibody regimen. Figure 4A marks p < 0.01 for the indicated day-14 comparison with recombinant protein. This is a comparison of complete treatment regimens, not equal cumulative doses or proof of tumor eradication.
Original patent and figures: WO2024131874A1
Original patent and figures: WO2024131874A1
WO2024131874A1, Example 7, paragraph [0363], Figures 4A–4B (PDF pp. 138–139). No 01-1-specific subcutaneous or non-human-primate experiment is reported here.