Claims for Patent: 8,778,345

Summary for Patent: 8,778,345

Title:	Anti-CD40 antibodies
Abstract:	The present invention provides high affinity anti-CD40 monoclonal antibodies and related compositions, which may be used in any of a variety of therapeutic methods for the treatment of cancer and other diseases.
Inventor(s):	Zhang; Yongke (Palo Alto, CA), Yu; Guo-Liang (Hillsborough, CA), Zhu; Weimin (San Francisco, CA)
Assignee:	Apexigen, Inc. (Burlingame, CA)
Application Number:	13/458,730
Patent Claims:	1. An isolated antibody, or an antigen-binding fragment thereof, that binds to CD40, comprising (i) a heavy chain variable region comprising the VHCDR1, VHCDR2, and VHCDR3 set forth in SEQ ID NOs:3-5; and (ii) a light chain variable region comprising the VLCDR1, the VLCDR2, and the VLCDR3 set forth in SEQ ID NOs:6-8; or a variant of said antibody, or an antigen-binding fragment thereof, comprising heavy and light chain variable regions identical to the heavy and light chain variable regions of (i) and (ii) except for up to 8 amino acid substitutions in said CDR regions. 2. The isolated antibody, or antigen-binding fragment thereof, of claim 1 wherein the heavy chain variable region comprises the amino acid sequence set forth in SEQ ID NO:9. 3. The isolated antibody, or antigen-binding fragment thereof, of claim 1 wherein the light chain variable region comprises the amino acid sequence set forth in SEQ ID NO:10. 4. An isolated antibody, or an antigen-binding fragment thereof, that binds to CD40, comprising a heavy chain variable region comprising the amino acid sequence set forth in SEQ ID NO:9 and a light chain variable region which comprises an amino acid sequence having at least 90% identity to the amino acid sequence set forth in SEQ ID NO:10. 5. The isolated antibody, or an antigen-binding fragment thereof, of claim 4 comprising a light chain variable region which comprises the amino acid sequence set forth in SEQ ID NO:10. 6. An isolated antibody, or an antigen-binding fragment thereof, that binds to CD40, comprising a light chain variable region comprising the amino acid sequence set forth in SEQ ID NO:10 and a heavy chain variable region which comprises an amino acid sequence having at least 90% identity to the amino acid sequence set forth in SEQ ID NO:9. 7. The isolated antibody of claim 1, wherein the antibody is humanized. 8. The isolated antibody, or antigen-binding fragment thereof, of claim 1 that binds CD40 with a KD of 0.96 nM or lower. 9. The isolated antibody, or antigen-binding fragment thereof of claim 8, wherein the isolated antibody, or antigen-binding fragment thereof: a) blocks binding of CD40 to CD40L; b) is a CD40 agonist; c) activates antigen presenting cells; d) stimulates cytokine release from antigen presenting cells; e) induces tumor cell apoptosis; f) inhibits tumor cell proliferation; g) kills tumor cells via induction of effector functions selected from the group consisting of antibody dependent cellular cytotoxicity, complement dependent cytotoxicty, and antibody dependent cellular phagocytosis; h) stimulates anti-tumor T cell responses; i) reduces established tumors; j) inhibits rituximab-resistant tumors and other CD40 expressing tumors; or k) a combination of any one or more of a)-j). 10. A composition comprising a physiologically acceptable carrier and a therapeutically effective amount of the isolated antibody or antigen-binding fragment thereof according to claim 1. 11. A composition comprising a physiologically acceptable carrier and a therapeutically effective amount of the isolated antibody or antigen-binding fragment thereof according to claim 5. 12. The isolated antibody of claim 1 wherein the antibody is selected from the group consisting of a single chain antibody, a ScFv, a univalent antibody lacking a hinge region, and a minibody. 13. The isolated antibody of claim 1 wherein the antibody is a Fab or a Fab' fragment. 14. The isolated antibody of claim 1 wherein the antibody is a whole antibody. 15. The isolated antibody of claim 1 wherein the isolated antibody comprises an IgG1 Fc region.

Details for Patent 8,778,345

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-02-26
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-02-26
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2039-02-26