By Donald Zuhn --
Last month, Epitomics Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 7,431,927, which is directed to monoclonal antibodies that neutralize TNF-alpha activity. The Burlingame, California-based biotech company also announced that the USPTO has issued U.S. Patent No. 7,429,487, which is directed to a rabbit-derived immortal B-lymphocyte capable of fusion with a rabbit splenocyte to produce a hybrid cell that produces an antibody. The '927 and '487 patents are Epitomics' second and third U.S. patents; the company is also named as an assignee on three U.S. patent application publications.
According to Epitomics' press release on the '927 patent, the patent is directed to "a broad grouping" of anti-TNF-alpha antibodies and further bolsters the company's patent portfolio of TNF-alpha-neutralizing antibodies. These antibodies can be used for treating cancer and a variety of inflammatory diseases, including Crohn's disease (adult and pediatric), ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Epitomics' statement noted that the anti-TNF-alpha antibodies of the '927 patent exploit the company's unique humanization technology that allows amino acids in the antibody's antigen-binding region to be substituted without significant loss in antibody activity. Epitomics CEO Dr. Guo-Liang Yu stated that as a result of the company's humanization technology, the '927 patent was "unlike any other antibody patent." Dr. Yu added that Epitomics was "pleased the USPTO recognized the uniqueness of [the company's] amino-acid substitution technology." Epitomics' press release also noted that a government report determined that the global market for anti-TNF-alpha therapies is expected to reach $12 billion by 2015.
In Epitomics announcement regarding the '487 patent, the company stated that the patent "which covers the next generation of cells for producing rabbit monoclonal antibodies[,] further establishes Epitomics' unique position as the rabbit monoclonal antibody company." The company's press release describes the production of monoclonal antibodies as involving the fusion of spleen cells from an animal with a fusion partner -- an immortalized B-lymphocyte -- to produce hybridomas that produce antibodies. According to the Epitomics' press release, the '487 patent encompasses any rabbit-derived fusion partner that does not produce immunoglobulin heavy chain, as well as methods of using the rabbit-derived fusion partner to produce monoclonal antibodies. Epitomics notes that the '487 patent is significant because a hybridoma produced using the claimed fusion partner has increased antibody production, and no contamination from the immunoglobulin heavy chain of the fusion partner. Dr. Yu added that the '487 patent was important because "rabbit monoclonal antibodies demonstrate significant advantages over mouse antibodies in every meaningful category: affinity, specificity, and bioavailability."
The '927 patent issued from U.S. Application No. 11/090,105, filed March 24, 2005. Independent claims 1 and 4 of the '927 patent recites:
1. A monoclonal antibody comprising:
a) a variable domain comprising:
i. a heavy c[ha]in var[i]able domain comprising a CDR1 region identical to amino acid residues 30-34 of SEQ ID NO: 31, a CDR2 region identical to amino acid residues 49-64 of SEQ ID NO: 31 and a CDR3 region identical to amino acid [residues] 97-109 of SEQ ID NO: 31; and
ii. a light chain variable domain comprising a CDR1 region identical to amino acid residues 23-33 of SEQ ID NO: 75, a CDR2 region identical to amino acid residues 49-55 of SEQ ID NO: 75 and a CDR3 region identical to amino acid residues 88-99 of SEQ ID NO: 75; or
b) a variant of said variable domain of part a) that is otherwise identical to said variable domain except for up to 4 amino acid substitutions in said CDR regions;
wherein said monoclonal antibody neutralizes TNF-alpha activity.
4. A monoclonal antibody comprising:
a heavy chain variable domain comprising a CDR1 region identical to amino acid residues 30-34 of SEQ ID NO: 31, a CDR2 region identical to amino acid residues 49-55 of SEQ ID NO: 75 and CDR3 region identical to amino acid residues 97-109 of SEQ ID NO: 31[;] and
a light chain var[i]able domain comprising a CDR1 region identical to amino acid residues 23-33 of SEQ ID NO: 75, CDR2 region identical to amino acid resi[d]ues 49-55 SEQ ID NO: 75 and a CDR3 region identical to amino acid residues 88-99 of SEQ ID NO: 75;
wherein said monoclonal antibody neutralizes TNF-alpha activity.
The '487 patent issued from U.S. Application No. 11/476,277, filed June 27, 2006, which claims the benefit of U.S. Provisional Application No. 60/697,014, filed July 5, 2005. Independent claim 1 of the '487 patent recites:
1. A rabbit-derived immortal B-lymphocyte capable of fusing with a rabbit splenocyte to produce a hybrid cell that produces an immunoglobulin, wherein immunoglobulin heavy chain mRNA expression of said rabbit derived immortal B-lymphocyte is not detectable by RT-PCR and said rabbit-derived immortal B-lymphocyte does not detectably express immunoglobulin heavy chain.
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