Claims for Patent: 10,344,093

Summary for Patent: 10,344,093

Title:	Antibody gene expression-secretion system
Abstract:	It is an object of the present invention to provide signal sequence information capable of secreting an antibody to the outside of cells in generation of the antibody by microorganisms of genus Bifidobacterium, and an antibody expression vector capable of secreting an antibody to the outside of cells by utilizing the signal sequence information. As a means for achieving the aforementioned object, there is prepared Bifidobacterium longum, which is transformed with a vector having inserted thereinto a DNA insert comprising the 5\'-terminus of an antibody gene linked to the 3\'-terminus of a DNA encoding a signal peptide-linker conjugate having a linker linked to the C-terminus of a signal peptide consisting of an amino acid sequence shown in SEQ ID NO: 1.
Inventor(s):	Taniguchi; Shun-ichiro (Nagano, JP), Akiyama; Yasuto (Shizuoka, JP), Masaki; Takeshi (Nagano, JP), Shimizu; Hitomi (Nagano, JP)
Assignee:	Shinshu University (Nagano, JP)
Application Number:	15/308,452
Patent Claims:	1. A DNA insert, wherein the 5'-terminus of an antibody gene is linked to the 3'-terminus of a DNA encoding a signal peptide consisting of an amino acid sequence described in SEQ ID NO: 1 or SEQ ID NO: 107. 2. The DNA insert according to claim 1, wherein the antibody gene is the gene of an antibody having an anticancer activity. 3. The DNA insert according to claim 2, wherein the antibody having an anticancer activity is Trastuzumab. 4. The DNA insert according to claim 3, wherein the Trastuzumab is a Trastuzumab single-chain antibody. 5. The DNA insert according to claim 1, wherein the DNA encoding a signal peptide consists of the nucleotide sequence shown in SEQ ID NO: 2 or SEQ ID NO: 108. 6. The DNA insert according to claim 1, wherein the 5'-terminus of an antibody gene is linked to the 3'-terminus of a DNA encoding a signal peptide consisting of an amino acid sequence described in SEQ ID NO: 1 or SEQ ID NO: 107, via a DNA encoding a linker peptide. 7. The DNA insert according to claim 6, wherein the antibody gene is a gene of an antibody having an anticancer activity. 8. The DNA insert according to claim 7, wherein the antibody having an anticancer activity is Trastuzumab. 9. The DNA insert according to claim 8, wherein the Trastuzumab is a Trastuzumab single-chain antibody.

Details for Patent 10,344,093

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	September 25, 1998		2035-04-17
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	February 10, 2017		2035-04-17
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	May 18, 2016		2035-04-17
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	March 08, 2019		2035-04-17
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	February 28, 2019		2035-04-17

International Patent Family for US Patent 10,344,093

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2015166641
United States of America	2017218072
Singapore	11201609108T
Singapore	10201809464R
South Korea	20160147778
Japan	WO2015166641
Japan	6573398