Formulation & Performance
The source directly names CICL-207 and the F50 nanoparticle composition. Reporter expression, immune-cell outcomes and rat tolerability are documented separately; none establishes clinical efficacy or an intrinsic effect of the neat lipid.
Patent Example 17 identifies CICL-207 with a (2S,4R) pyrrolidine core and four nonanoate tails. The structure shown here follows that identity, with formula C56H100N2O14 and calculated average molecular weight 1025.416.
Formulation components and molecular-weight conversion
| Component | DC Chemicals product | Molecular weight | Molar ratio | Mass at 1 µmol total lipid (mg) |
|---|---|---|---|---|
| CICL-207 | DC67515 | 1025.416 | Not assigned | Not calculable from disclosed data |
| DSPC | DC57005 | 790.15 | Not assigned | Not calculable from disclosed data |
| Cholesterol | DCD-041 | 386.65 | Not assigned | Not calculable from disclosed data |
| DSG-PEG2000 | Not uniquely mapped | Not established | Not assigned | Not calculable from disclosed data |
| DSPE-PEG2000-maleimide | Not uniquely mapped | Not established | Not assigned | Not calculable from disclosed data |
The patent describes F50 as a five-lipid system with a targeting ligand in the immune-cell studies. DSG-PEG2000 is a distinct ingredient from DMG-PEG2000. Ingredient names are provided for source identification; antibody-bearing and undecorated particles must be distinguished when interpreting biological results.
Component mass calculator
Not all inputs are assigned to a single verified study formulation; unassigned fields are blank. Enter your own values to calculate a research scenario. Molecular weights and ratios are editable. Results are calculated, not measured study data. No N/P or RNA dose is inferred.
| Component | MW | Molar ratio | Mass (mg) | Mass % |
|---|---|---|---|---|
| CICL-207 | ||||
| DSPC | ||||
| Cholesterol | ||||
| DSG-PEG2000 | ||||
| DSPE-PEG2000-maleimide |
Source identity and formulation context
| Evidence item | Finding | Source |
|---|---|---|
| Exact molecule | CICL-207, (2S,4R) stereochemistry; C56H100N2O14 | Example 17 |
| Reporter and immune-cell studies | F50 nanoparticles are evaluated in ligand-decorated and undecorated forms | Examples 66 and 69–72 |
| PEG identity | DSG-PEG2000 and DSPE-PEG2000-maleimide are named; DMG-PEG2000 is not an interchangeable identity | Example 66 |
US20250127728A1. Biological results describe the complete formulation, cargo and targeting context.
Measured particle attributes
| Attribute | F50 value | Interpretation |
|---|---|---|
| Diameter | 82 nm | Table 9 formulation-specific measurement |
| PDI | 0.05 | Table 9 |
| Encapsulation efficiency | 99% | Table 9 |
| Apparent pKa | 6.51 | TNS assay of the nanoparticle, not a measured free-lipid pKa |
Example 66, Table 9. Table 13 lists the same formulation with less-rounded particle data; avoid treating these as independent replicate experiments.
Reporter delivery in mice
| Endpoint | Reported finding | Evidence limit |
|---|---|---|
| Splenic T-cell reporter expression | The patent describes effective expression in the tested targeted nanoparticle context | Figure 2; qualitative comparison, no independently extracted cell-percentage claim |
| Comparison with CICL-1 formulation | F50 and F9 showed broadly similar performance in the evaluated cell types | Example 66; comparisons must retain their complete formulation context |
| Organ expression | The CICL-207 targeted formulation showed lower liver reporter expression than BF1 comparators while retaining spleen expression | Example 70, Figure 8; reporter signal is not the percentage of lipid reaching an organ |
US20250127728A1, Examples 66 and 70; Figures 2 and 8. Do not convert luminescence into tissue concentration or percent injected dose.
Immune-cell research findings
| Study context | Reported outcome | Boundary |
|---|---|---|
| Humanized mouse T-cell study | F50 and F9 showed comparable CAR-expression readouts and B-cell depletion in the reported short observation window | Example 69, Figure 7; research evidence for complete targeted nanoparticles |
| Humanized hematopoietic-cell model | The patent reports functional delivery to human hematopoietic-cell populations | Example 71, Figures 9–11; distinct targeting context from the T-cell study |
These preclinical studies do not establish efficacy of unformulated CICL-207 or clinical suitability.
Tolerability observations
| Model | Observation | Limitation |
|---|---|---|
| Male Sprague-Dawley rats; undecorated F50 | Minimal liver-enzyme increases were reported; acute-phase proteins were mildly elevated | Example 72, Figure 12 |
| Inflammatory readouts | Cytokine elevations were transient and resolved by 24 hours in the patent assessment | No numerical source-data file or independent repeat study was available |
| Clinical observations | The patent reports no associated clinical observations in the evaluated experiment | Short-term formulation-specific evidence; not a general claim of no toxicity |
Example 72. The undecorated rat formulation must not be substituted for the antibody-decorated immune-cell formulations when summarizing safety.
Original study figures
Patent Figures 2 and 7–12: reporter expression, immune-cell outcomes and rat tolerability — Original source figures.