Claims for Patent: 8,512,703

Summary for Patent: 8,512,703

Title:	Idiotypic vaccine
Abstract:	The invention concerns the use of recombinant clonotypic immunoglobulins (Ig) as a vaccine in the treatment of HCV-related and non HCV-related lymphoproliferations, in particular the use of recombinant proteins with immunogenic properties derived from protein segments VK3-20 and VK3-15 of Ig light chains derived from patients with lymphoproliferations.
Inventor(s):	Dolcetti; Riccardo (Cordenons, IT), Guidoboni; Massimo (Castellina in Chianti, IT), De Re; Valli (Sacile, IT), Gasparotto; Daniela (Azzano Decimo, IT), Castiglioni; Sonia (Milan, IT), Nolli; Maria Luisa (Milan, IT)
Assignee:	Areta International S.R.L. (Milan, IT)
Application Number:	12/670,949
Patent Claims:	1. An immunogenic composition for an HCV-related or nonHCV-related lymphoproliferative pathology, the composition comprising at least one recombinant protein segment chosen between VK3-20 (SEQ ID NO: 35) and VK3-15 (SEQ ID NO: 36). 2. The composition according to claim 1 comprising both the recombinant protein segments VK3-20 and VK3-15. 3. A method for immunization against lymphoproliferative pathologies comprising the step of administering a composition comprising at least one recombinant protein segment selected from the group consisting of VK3-20 (SEQ ID NO: 35), VK3-15 (SEQ ID NO: 36), VK3-20 and VK3-15, and mixtures of the same to a patient in need thereof. 4. A method for immunization against HCV-related and nonHCV-related lymphoproliferative pathologies comprising the step of administering a composition of claim 1 to a patient in need thereof. 5. An immunogenic composition for immunization against lymphoproliferations which comprises at least one recombinant protein segment chosen between VK3-20 (SEQ ID NO: 35) and VK3-15(SEQ ID NO: 36), in a mixture with at least one pharmaceutically acceptable excipient. 6. The composition according to claim 5 which comprises both the recombinant protein segments VK3-20 and VK3-15. 7. The composition according to claim 5 for oral, parenteral or topic administration, which is from 0.1 to 1 mg of the recombinant protein segment. 8. A process for production of at least one recombinant protein segment chosen between VK3-20 (SEQ ID NO: 35) and VK3-15 (SEQ ID NO: 36) which comprises insertion of a nucleotide sequence encoding the recombinant protein segment in a suitable expression vector, fermentation, isolation and purification of said recombinant protein segment. 9. The process according to claim 8, wherein said nucleotide sequence is inserted in a kanamicin-resistant bacterial expression vector pET26b to form recombinant bacterial strain pET26b/VK3-20/VK3-15. 10. The process according to claim 8, wherein said at least one recombinant protein segment chosen between VK3-20 and VK3-15 is identified and quantified with mAb anti-VK. 11. The process according to claim 9, wherein said fermentation comprises inoculation of 1% of said recombinant bacterial strain pET26b/VK3-20/VK3-15 in SB medium. 12. The process according to claim 11, wherein said SB medium is buffered. 13. The process according to claim 12, wherein said medium is buffered with phosphate buffer and contains 1% (w/w) glucose. 14. The process according to claim 11, wherein said recombinant bacterial strain is kept in culture at 37.degree. C. for 8-12 hours. 15. The process according to claim 8, wherein said at least one recombinant protein segment chosen between VK3-20 and VK3-15 is isolated either from culture medium or bacterial periplasmic space by elution on ion exchange resin Q Sepharose FF (Amersham-GE). 16. The process according to claim 15, wherein eluate is purified on cation exchange resin S Sepharose FF (Amersham-GE). 17. The composition of claim 5 further comprising sargramostim and/or recombinant IFN-.alpha.2a. 18. The composition of claim 5, which is 0.5 mg of recombinant protein segment, and further comprising sargramostim GM-CSF at 50 .mu.g/m.sup.2/dose. 19. The composition of claim 5, which is 0.5 mg of recombinant protein segment, and further comprising recombinant IFN-.alpha.2a at 1,000,000 UI/m.sup.2/dose. 20. The composition of claim 5, which is 0.5 mg of recombinant protein segment, and further comprising sargramostim GM-CSF at 50 .mu.g/m.sup.2/dose and recombinant IFN-.alpha.2a at 1,000,000 UI/m.sup.2/dose. 21. The method of claim 4, wherein the HCV-related lymphoproliferative pathology is selected from the group consisting of B-cell non-Hodgkin lymphoma, hepatocellular carcinoma, and thyroid cancer, wherein the non-HCV-related lymphoproliferative pathology is selected from the group consisting of follicular lymphoma (FL), chronic lymphocyte leukemia (CLL), lymphoma of mucosa-associated lymphoid tissue (MALT), lymphoma associated with rheumatoid arthritis, and lymphoma associated with Sjogren's syndrome.

Details for Patent 8,512,703

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Partner Therapeutics, Inc.	LEUKINE	sargramostim	For Injection	103362	03/05/1991		2027-07-27
Partner Therapeutics, Inc.	LEUKINE	sargramostim	Injection	103362	03/05/1991		2027-07-27