Claims for Patent: 8,114,969

Summary for Patent: 8,114,969

Title:	Immunotoxin derived from a recombinant human autoantibody and method of using thereof
Abstract:	The invention is directed to an immunotoxin directed at fetal AchR, wherein the immunotoxin may comprises a human Fab fragment based on a human autoantibody or human combinatorial CDNA library and may be a pseudomonas exotoxin A-based single chain Fv IT (35-scFV-ETA). The invention is further directed to method of treating a patient with soft tissue tumor comprising the step of exposing the patient to the immunotoxin of the invention.
Inventor(s):	Vincent; Angela (Wellington Square, GB), Marx; Alexander (Wurzburg, GB), Gattenlohner; Stefan (Wurzburg, GB)
Assignee:	ISIS Innovation, Ltd. (Oxford, GB)
Application Number:	10/950,677
Patent Claims:	1. An immunotoxin directed at fetal AChR.gamma., comprising a single chain scFv35-V.sub.L-V.sub.H, wherein said scFv35-V.sub.L-V.sub.H comprises a heavy chain V (V.sub.H) comprising a peptide encoded by a nucleotide sequence set forth in SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 27, SEQ ID NO: 28, SEQ ID NO: 29, SEQ ID NO: 30 or SEQ ID NO: 31, wherein said scFv35-V.sub.L-V.sub.H comprises a peptide as set forth in SEQ ID NO: 13, and wherein said immunotoxin is directed at fetal AchR.gamma.. 2. A method of treating a patient with soft tissue tumour comprising the step of exposing the patient to an immunotoxin according to claim 1. 3. The method of claim 2, wherein said soft tissue tumour comprises nicotinic AChR. 4. The method of claim 2, wherein said soft tissue tumour comprises fetal AChR. 5. A method of treating a patient with sarcoma comprising the step of exposing the patient to an immunotoxin according to claim 1. 6. The method of claim 5, wherein said sarcoma is Rhabdomyosarcoma (RMS). 7. A method of killing cells comprising the step of contacting the cells with an immunotoxin according to claim 1. 8. The method of claim 7, wherein said cells are RMS cells. 9. The method of claim 7, wherein said cells comprising nicotinic AChR. 10. The method of claim 7, wherein said cells comprising fetal AChR. 11. The method of claim 7, wherein prior to said step of contacting the cells with immunotoxin according to claim 1, the cells are contacted with a chemotherapeutic agent. 12. A method of delaying the development of RMS in a patient comprising the step of exposing the patient to the immunotoxin of claim 1. 13. A method of delaying the development of RMS cells, comprising the step of contacting the RMS cells with an immunotoxin according to claim 1. 14. A pharmaceutical composition comprising the immunotoxin of claim 1, or the scFv35-V.sub.L-V.sub.H of claim 1. 15. A method according to claim 11, wherein said chemotherapeutic agent is selected from the group consisting of a DNA-interactive agent, alkylating agent, antimetabolite, tubulin-interactive agent, hormonal agent, Asparaginase and hydroxyurea. 16. A method according to claim 11, wherein said chemotherapeutic agent is selected from the group consisting of Asparaginase, hydroxyurea, Cisplatin, Cyclophosphamide, Altretamine, Bleomycin, Dactinomycin, Doxorubicin, Etoposide, Teniposide, paclitaxel, cytoxan, 2-methoxycarbonylaminobenzimidazole carbamate and Plicamycin. 17. The immunotoxin of claim 1, wherein said scFv-V.sub.L-V.sub.H comprises a light chain V (V.sub.L) comprising a peptide encoded by a nucleotide sequence set forth in SEQ ID NO.: 42, SEQ ID NO.: 43, SEQ ID NO.: 44, SEQ ID NO.: 45, SEQ ID NO.: 46, SEQ ID NO.: 47, SEQ ID NO.: 48, SEQ ID NO.: 49 or SEQ ID NO.:50. 18. The immunotoxin of claim 1, further comprising a toxic domain comprising a toxic polypeptide. 19. The immunotoxin of claim 18, wherein said toxic polypeptide is ricin, Pseudomonas exotoxin, Pseudomonas exotoxin A (ETA), bryodin, gelonin, .alpha.-sarcin, aspergillin, restrictocin, angiogenin, saporin, abrin, pokeweed antiviral protein or diphtheria toxin, or a functional fragment thereof. 20. The immunotoxin of claim 1, wherein said immunotoxin comprises a Pseudomonas exotoxin A-based single chain Fv immunotoxin, 35-scFV35V.sub.L-V.sub.H-ETA. 21. The immunotoxin of claim 18, wherein said scFv-V.sub.L-V.sub.H comprises a heavy chain V (V.sub.H) comprising peptide encoded by a nucleotide sequence set forth in SEQ ID NO: 29 and a light chain V (V.sub.L)) comprising the peptide encoded by the nucleotide sequence set forth in SEQ ID NO: 46.

Details for Patent 8,114,969

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2023-10-01