Pharmaceutical compositions of IL-2

1. A liquid pharmaceutical composition ready for injection to a patient, consisting essentially of:

(i) a non-lyophilized interleukin-2 having a specific activity of 8 to 18 MIU/mg of protein, which is present at a concentration of 0.1 to 20 million IU/mL (MIU/mL),

(ii) a buffering agent at a concentration from 5 mM to 25 mM, wherein the buffering agent is selected from the group consisting of phosphoric acid, Tris(hydroxymethyl)aminomethane hydrochloride (TRIS-HCl), TRIS-glycine, citrate, borate, citrate/phosphate, bicarbonate, glutaric acid, succinic acid, salts thereof, and combinations thereof, and

(iii) a surfactant at a concentration from 0.05 to 5 mg/mL, wherein the surfactant is selected from the group consisting of C 8 -C 20 alkylsulfate salts, lauroyl sarcosinate salts, cholate salts, deoxycholate salts, and combinations thereof,

in water.

2. The liquid pharmaceutical composition of claim 1 , wherein the interleukin-2 is present at a concentration of 2 to 12 MIU/ml.

3. The liquid pharmaceutical composition of claim 1 , wherein the surfactant is a C 8 -C 20 alkylsulfate salt selected from the group consisting of an alkali metal salt of dodecyl sulphate and an alkaline-earth metal salt of dodecyl sulphate.

4. The liquid pharmaceutical composition of claim 1 , wherein the surfactant is present at a concentration of 0.05 to 0.5 mg/mL.

5. The liquid pharmaceutical composition of claim 1 , wherein the weight ratio of the surfactant to interleukin-2 is from 0.04 to 5.0.

6. The liquid pharmaceutical composition of claim 1 , wherein the interleukin-2 is human interleukin-2 or aldesleukin.

7. The liquid pharmaceutical composition of claim 1 , which is devoid of mannitol and/or albumin.

8. The liquid pharmaceutical composition according to claim 1 , consisting essentially of

a non-lyophilized interleukin-2 at a concentration of 2 to 12 MIU/mL,

sodium dodecyl sulfate (SDS) at a concentration of about 0.05 to 0.5 mg/mL,

a buffer selected from monobasic sodium phosphate, dibasic sodium phosphate and combinations thereof present at a concentration ranging from 5 mM to 25 mM,

water, and

optionally an osmolarity adjusting agent.

9. The liquid pharmaceutical composition according to claim 1 , which is characterized by at least one of the following features:

the pH of the composition is from 7.1 to 7.8,

the buffering agent is a phosphate buffer,

interleukin-2 is aldesleukin,

the weight ratio of the surfactant to IL-2 is from 0.1 to 3,

the liquid pharmaceutical composition is suitable for a packaging in a delivery device for injection,

the pharmaceutical composition is devoid of any lyophilization stabilizer, and/or

the liquid pharmaceutical composition is stable at 5° C. for at least 6 months.

10. The liquid pharmaceutical composition according to claim 1 , which is suitable for subcutaneous injection.

11. A pharmaceutical kit comprising a vial or a cartridge comprising the liquid composition as defined in claim 1 , and means for subcutaneous injection.

12. The liquid pharmaceutical composition of claim 1 , which is contained in a delivery system for subcutaneous injection.

13. The liquid pharmaceutical composition of claim 1 , further comprising an excipient selected from the group consisting of antioxidants, osmolarity adjusting agents and preservatives.

14. The liquid pharmaceutical composition of claim 1 , wherein the surfactant is sodium dodecyl sulfate (SDS) or lithium dodecyl sulfate.

15. The liquid pharmaceutical composition of claim 1 , wherein the weight ratio of the surfactant to interleukin-2 is from 0.1 to 3.0.

16. The liquid pharmaceutical composition of claim 8 , wherein the interleukin-2 is present at a concentration of 4 to 10 MIU/ml.

17. The liquid pharmaceutical composition of claim 8 , wherein the interleukin-2 has a specific activity of 12±3 MIU/mg of protein.