Claims for Patent: 6,333,169

Summary for Patent: 6,333,169

Title:	HER2 extracellular domain
Abstract:	An extracellular portion of the HER2 molecule, essentially free of transmembrane and cytoplasmic portions, which is antigenic in animals. Isolated DNA encoding the extracellular portion; an expression vector containing the isolated DNA; and a cell containing the expression vector. A process for producing the extracellular domain. A vaccine containing the extracellular domain.
Inventor(s):	Hudziak; Robert Michael (San Francisco, CA), Shepard; H. Michael (San Francisco, CA), Ullrich; Axel (San Francisco, CA)
Assignee:
Application Number:	08/422,734
Patent Claims:	1. A process for producing a secreted, glycosylated extracellular domain of the HER2 receptor, comprising the steps of: (a) culturing an eukaryotic host comprising DNA encoding the extracellular domain, wherein said DNA terminates 1 base pair to about 24 base pairs upstream of DNA encoding the transmembrane domain of said HER2 receptor, under conditions suitable for expression of said DNA and secretion of said extracellular domain; and (b) isolating said extracellular domain from said host, wherein said isolated exracellular domain is immunogenic in a human and provokes a humoral and cell-mediated response against HER2 receptor upon administration to a patient. 2. The process of claim 1 wherein the DNA in step (a) terminates about 24 base pairs upstream of the DNA encoding the transmembrane domain of said HER2 receptor. 3. The process of claim 1 wherein said isolated extracellular domain at step (b) has a molecular weight of about 103 kD. 4. A method for making a polypeptide fusion comprising an extracellular domain of the HER2 receptor conjugated to a Fc portion of an immunoglobulin molecule, comprising: (a) culturing a host cell comprising DNA encoding said polypeptide fusion under conditions suitable for expression of said DNA; and (b) recovering said polypeptide fusion from said host cell. 5. The method of claim 4 wherein said host cell in step (a) is a prokaryote. 6. The method of claim 5 wherein said prokaryote is a bacterium. 7. The method of claim 4 wherein said host cell in step (a) is a eukaryote. 8. A method for making a vaccine useful for Active Specific Immunotherapy, comprising: (a) culturing a host cell comprising DNA encoding the extracellular domain of the HER2 receptor or a portion thereof which provokes a humoral and cell-mediated response against HER2 receptor in a patient vaccinated therewith under conditions suitable for expression of said DNA; (b) recovering said extracellular domain or portion thereof from said host cell; and (c) combining said recovered extracellular domain or portion thereof with an adjuvant which is safe and effective in humans so as to generate a vaccine which provokes a humoral and cell-mediated response against HER2 receptor in a patient vaccinated therewith. 9. The method of claim 8 wherein the adjuvant at step (c) is selected from the group consisting of alum, Bacillus calmette-Guerin (BCG), an adjuvant derived from BCG cell walls, Detox, Syntex-1, Corynebacterium parvum, interferon gamma, interleukin 1, interleukin 2 and interleukin 6. 10. The method of claim 8 wherein the DNA in step (a) encodes the extracellular domain portion thereof conjugated to a peptide having immunogenic properties in a human. 11. The method of claim 8 wherein said host cell in step (a) is a prokaryote. 12. The method of claim 11 wherein said prokaryote is a bacterium. 13. The method of claim 8 wherein said host cell in step (a) is a eukaryote. 14. The method of claim 13 wherein said extracellular domain or portion thereof covered at step (b) is glycosylated. 15. The method of claim 8 wherein said DNA in step (a) encodes said extracellular domain of the HER2 receptor. 16. The method of claim 8 wherein said DNA in step (a) encodes said portion of the extracellular domain of the HER2.

Details for Patent 6,333,169

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2018-12-25