NEGATIVELY CHARGED NUCLEIC ACID COMPRISING COMPLEXES FOR IMMUNOSTIMULATION

1 . A pharmaceutical composition comprising:

(A) a complex, comprising:

a) cationic and/or polycationic components comprising PEI and lipidic cationic components; and

b) at least one RNA molecule;

wherein the charge of complex (A) is negative; and

wherein the complex does not include a mRNA encoding an antigen,

and

(B) at least one polypeptide antigen selected from the group consisting of:

(i) an antigen from a pathogen associated with infectious disease;

(ii) an antigen associated with allergy or allergic disease;

(iii) an antigen associated with autoimmune disease; and

(iv) an antigen associated with a cancer or tumour disease,

or an antigenic fragment of said antigen.

2 . The pharmaceutical composition of claim 1 , wherein the charge of complex (A) is negative and wherein the cationic and/or polycationic components and the RNA molecule comprised in said complex (A) are present in an N/P ratio of below 1.

3 . The pharmaceutical composition of claim 1 , wherein in complex (A) the cationic and/or polycationic component of the carrier and the RNA molecule comprised in said complex are present in a N/P ratio of below 1.

4 . (canceled)

5 . The pharmaceutical composition of claim 3 , wherein the N/P ratio is below 0.7.

6 - 12 . (canceled)

13 . The pharmaceutical composition of claim 1 , wherein said RNA molecule is an immunostimulatory RNA (isRNA).

14 - 15 . (canceled)

16 . The pharmaceutical composition of claim 1 , wherein said complex includes said polypeptide antigen.

17 - 18 . (canceled)

19 . The pharmaceutical composition of claim 1 , wherein the lipidic cationic components and the RNA molecule comprised in complex (A) are provided in a “cationic component”: “RNA molecule” mass ratio in the range of 1:1.2 to 1:15.

20 . A kit or kit of parts comprising:

(A) a complex as defined according to claim 1 ; and

(B) at least one polypeptide antigen.

21 - 24 . (canceled)

25 . A pharmaceutical package, including:

(A) a complex as defined according to claim 1 ; and

(B) instructions describing the use of said complex in therapy in combination with at least one polypeptide antigen.

26 - 27 . (canceled)

28 . The pharmaceutical composition of claim 1 , wherein the charge of complex (A) is negative.

29 . The pharmaceutical composition of claim 1 , wherein the polypeptide antigen is selected from the group consisting of: an antigen from a pathogen associated with infectious disease; and an antigen associated with a cancer or tumour disease.

30 . The pharmaceutical composition of claim 29 , wherein the polypeptide antigen is from a pathogen selected from the list consisting of: Influenza virus, Rabies virus, Hepatitis B virus, human Papilloma virus (hPV), Bacillus anthracis , Respiratory syncytial virus (RSV), Herpes simplex virus (HSV), and Mycobacterium tuberculosis.

31 . The pharmaceutical composition of claim 30 , wherein the polypeptide antigen is Hemagglutinin (HA), Neuraminidase (NA), Nucleoprotein (NP), M1 protein, M2 protein, NS 1 protein, NS2 protein, PA protein, PB 1 protein, PB 1-F2 protein and/or PB2 protein of Influenza virus;

32 . The pharmaceutical composition of claim 29 , wherein the polypeptide antigen is associated with a cancer or tumour disease and is selected from the list consisting of: p53, CA125, EGFR, Her2/neu, hTERT, PAP, MAGE-A1, MAGE-A3, Mesothelin, MUC-1, NY-ESO-1, GP100, MART-1, Tyrosinase, PSA, PSCA, PSMA VEGF, VEGFR1, VEGFR2, Ras, CEA and WT1.

33 . The pharmaceutical composition of claim 3 , wherein the N/P ratio is below 0.9.

34 . The pharmaceutical composition of claim 33 , wherein the N/P ratio is in the range of 0.1-0.9.

35 . The pharmaceutical composition of claim 34 , wherein the N/P ratio is in the range of 0.4-0.9.

36 . The pharmaceutical composition of claim 35 , wherein the N/P ratio is in the range of 0.5-0.9.

37 . The pharmaceutical composition of claim 19 , wherein the mass ratio is in the range of 1:1.5 to 1:10.