Claims for Patent: 6,569,430

Summary for Patent: 6,569,430

Title:	Antibodies to the antigen Campath-1
Abstract:	An antibody is produced, which will bind effectively with the antigen Campath-1, and which has at least one complementarity determining region of rat origin, as identified in FIG. 2, which may be combined with a range of different foreign variable domain framework regions as desired, including framework regions of human origin.
Inventor(s):	Waldmann; Herman (Cambridge, GB), Clark; Michael R. (Cambridge, GB), Winter; Gregory P. (Cambridge, GB), Riechmann; Lutz (La Jolla, CA)
Assignee:	BTG International Limited (London, GB)
Application Number:	08/407,620
Patent Claims:	1. An antibody which binds effectively to the antigen Campath-1, said antibody comprising a constant region of human origin, heavy and light chain variable domain framework regions which are of human origin, and complementarity determining regions defined by amino acid residues 31 to 35, 50 to 65 and 95 to 102 of the heavy chain as shown in FIG. 2a, and amino acid residues 24-34, 50-56 and 89-97 of the light chain as shown in FIG. 2b. 2. The antibody of claim 1, wherein the constant region is of the IgG class. 3. A composition for administration to patients comprising an antibody which binds effectively to the antigen Campath-1 and a physiologically acceptable diluent or carrier, said antibody comprising a constant region of human origin, heavy and light chain variable domain framework regions which are of human origin, and complementarity determining regions defined by amino acid residues 31 to 35, 50 to 65 and 95 to 102 of the heavy chain as shown in FIG. 2a, and amino acid residues 24-34, 50-56 and 89-97 of the light chain as shown in FIG. 2b. 4. The composition of claim 3, wherein the constant region is the IgG class. 5. A method of treating a human patient having a lymphoid malignancy, comprising administering to said patient an antibody which binds effectively to the antigen Campath-1, said antibody comprising a constant region of human origin, heavy and light chain variable domain framework regions which are of human origin, and complementarity determining regions defined by amino acid residues 31 to 35, 50 to 65 and 95 to 102 of the heavy chain as shown in FIG. 2a, and amino acid residues 24-34, 50-56 and 89-97 of the light chain as shown in FIG. 2b. 6. The method of claim 5, wherein the constant region is of the IgG class. 7. A method for treating a human patient having a lymphoid malignancy, comprising administering to said patient an antibody which binds effectively to the antigen Campath-1, said antibody comprising a light chain variable domain containing amino acid residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, a heavy chain variable domain containing amino acid residues 1 to 26, 28, 29 and 31 to 113, as identified in the upper lines of sequence information in FIG. 2a, wherein residue 27 of said heavy chain variable domain is phenylalanine, and heavy chain constant regions of human origin of the IgG class. 8. A method for treating a human patient having a lymphoid malignancy, comprising administering to said patient an antibody which binds effectively to the antigen Campath-1, said antibody comprising a light chain variable domain containing amino acid residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, a heavy chain variable domain containing amino acid residues 1 to 26, 28, 29 and 31 to 113, as identified in the upper lines of sequence information in FIG. 2a, wherein residue 27 of said heavy chain variable domain is phenylalanine and residue 30 of said heavy chain variable domain is threonine, and heavy chain constant regions of human origin of the IgG class. 9. The method of claim 7, wherein the patient has a lymphoma. 10. The method of claim 8, wherein the patient has a lymphoma. 11. The method of claim 7, wherein the heavy chain constant regions are of the IgG.sub.1 type. 12. The method of claim 8, wherein the heavy chain constant regions are of the IgG.sub.1 type. 13. An isolated DNA molecule comprising a sequence encoding an antibody which binds effectively to the antigen Campath-1, said antibody comprising a constant region of human origin, heavy and light chain variable domain framework regions which are of human origin, and complementarity determining regions defined by amino acid residues 31 to 35, 50 to 65 and 95 to 102 of the heavy chain as shown in FIG. 2a, and amino acid residues 24-34, 50-56 and 89-97 of the light chain as shown in FIG. 2b. 14. An isolated DNA molecule comprising a sequence encoding an antibody which binds effectively to the antigen Campath- 1, said antibody comprising a light chain variable domain containing amino acid residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, a heavy chain variable domain containing residues amino acid residues 1 to 26, 28, 29 and 31 to 113, as identified in the upper lines of sequence information in FIG. 2a, wherein the residue 27 of said heavy chain variable domain is phenylalanine, and heavy chain constant regions of human origin of the IgG class. 15. An isolated DNA molecule comprising a sequence encoding an antibody which binds effectively to the antigen Campath-1, said antibody comprising a light chain variable domain containing amino acid residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, a heavy chain variable domain containing residues amino acid residues 1 to 26, 28, 29 and 31 to 113, as identified in the upper lines of sequence information in FIG. 2a, wherein the residue 27 of said heavy chain variable domain is phenylalanine and residue 30 of said heavy chain variable domain is threonine, and heavy chain constant regions of human origin of the IgG class. 16. A cell line which expresses an antibody which binds effectively to the antigen Campath-1, said antibody comprising a constant region of human origin, heavy and light chain variable domain framework regions which are of human origin, and complementarity determining regions defined by amino acid residues 31 to 35, 50 to 65 and 95 to 102 of the heavy chain as shown in FIG. 2a, and amino acid residues 24-34, 50-56 and 89-97 of the light chain as shown in FIG. 2b. 17. A cell line which expresses an antibody which binds effectively to the antigen Campath-1, said antibody comprising a light chain variable domain containing amino acid residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, a heavy chain variable domain containing residues amino acid residues 1 to 26, 28, 29 and 31 to 113, as identified in the upper lines of sequence information in FIG. 2a, wherein the residue 27 of said heavy chain variable domain is phenylalanine, and heavy chain constant regions of human origin of the IgG class. 18. A cell line which expresses an antibody which binds effectively to the antigen Campath-1, said antibody comprising a light chain variable domain containing amino acid residues 1 to 108 as identified in the upper lines of sequence information in FIG. 2b, a heavy chain variable domain containing residues amino acid residues 1 to 26, 28, 29 and 31 to 113, as identified in the upper lines of sequence information in FIG. 2a, wherein the residue 27 of said heavy chain variable domain is phenylalanine and residue 30 of said heavy chain variable domain is threonine, and heavy chain constant regions of human origin of the IgG class.

Details for Patent 6,569,430

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2020-05-27
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2020-05-27
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2020-05-27

International Patent Family for US Patent 6,569,430

Country	Patent Number	Estimated Expiration
Austria	E95068
Australia	3062689
Australia	618989
Canada	1339198