Granted Patent B2

US 12,435,138 · App. 17/816,550 · Granted Oct 7, 2025

Inventors: Henricus Gerardus Van Hooren (Nijmegen, NL); Maarten Jaap Frijlink (Nijmegen, NL); Ypke Vincentius Johannes Maria Van Oosterhout (Nijmegen, NL)

Assignee: Philikos B.V.

C07K16/2809A61K9/08A61K9/19A61K47/183A61K47/26A61K47/6827A61K47/6849A61P37/06

Abstract

Claims (29)

1. A pharmaceutical composition comprising:

(i) 0.05 to 0.5 mg/mL, optionally 0.2 mg/mL, of a monoclonal antibody molecule that specifically recognises CD3 and which is conjugated to at least one ricin toxin A (RTA), and/or

0.05 to 0.5 mg/mL, optionally 0.2 mg/mL, of a monoclonal antibody molecule that specifically recognises CD7 and which is conjugated to at least one RTA;

(ii) 5 to 20 mM, optionally 10 mM, of a citrate buffer;

(iii) 50 to 300 mM, optionally: a) 75 to 200 mM; or b) 125 mM, of L-arginine or a pharmaceutically acceptable salt thereof;

(vi) 0.01 to 0.1% (w/v), optionally 0.05% (w/v), of a polysorbate,

wherein the composition is in water and has a pH in the range 6 to 7.5, optionally 6.5.

2. The composition of claim 1 , wherein:

(a) the antibody molecule that specifically recognises CD3 is a murine IgG2b isotype monoclonal antibody that selectively binds human CD3; and/or

(b) the antibody molecule that specifically recognises CD7 is a murine IgG2a isotype monoclonal antibody that selectively binds human CD7.

3. The composition according to claim 2 , the antibody molecule that specifically recognises CD3 is SPV-T3a and/or the antibody molecule that specifically recognises CD7 is WT1.

4. The composition according to claim 3 , wherein both SPV-T3a and WT1 are both present and each is conjugated to an average of between 1 and 2 deglycosylated RTA (dgRTA) molecules per antibody molecule, and wherein the conjugation is via an 4-succinimidyloxycarbonyl-alpha-methyl-a(2-pyridyldithio) toluene crosslinker.

5. The composition according to claim 1 , wherein:

(a) the citrate buffer comprises sodium citrate or potassium citrate;

(b) the L-arginine salt is L-arginine·HCl; and/or

(c) the polysorbate 20.

6. The composition according to claim 1 , further comprising at least one agent selected from:

120 to 160 mM maltose;

100 to 150 mM, optionally 125 mM, trehalose;

25 to 75 mM, optionally 50 mM, glycine; and

80 to 120 mM, optionally 100 mM, mannitol.

7. The composition according to claim 6 , wherein the at least one agent is 130 to 150 mM, optionally 140 mM, maltose monohydrate.

8. The composition according to claim 1 , comprising:

(i) 0.2 mg/mL of SPV-T3a-dgRTA and 0.2 mg/ml WT1-dgRTA;

(ii) 10 mM sodium citrate/citric acid buffer;

(iii) 125 mM of L-arginine·HCl;

(iv) 0.05% (w/v) polysorbate 20;

(v) 140 mM maltose monohydrate

wherein the composition is in water for injection and has a pH of 6.5.

Assignments (2)

Priority Claims (1)

Continuity (2)

References Cited (110)