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Last Updated: March 29, 2024

Claims for Patent: 10,066,019


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Summary for Patent: 10,066,019
Title:Optimised heavy chain and light chain signal peptides for the production of recombinant antibody therapeutics
Abstract: Antibodies of interest comprising a heavy chain signal peptide and/or a light chain signal peptide or combination thereof and compositions are described. The method of determining the signal peptide including creating data set of antibodies signal peptides, clustering, selecting and creating recombinant antibodies for enhanced expression and secretion are described.
Inventor(s): Song; Zhiwei (Singapore, SG)
Assignee: Agency for Science, Technology and Research (Singapore, SG)
Application Number:14/435,094
Patent Claims:1. An optimized heavy chain signal peptide and light chain signal peptide for a recombinant antibody, wherein said recombinant antibody is selected from the group consisting of trastuzumab (Herceptin, CAS number 180288-69-1), bevacizumab (Avastin, CAS number 216974-75-3), infliximab (Remicade, CAS number 170277-31-3), rituximab (Rituxan, CAS number 174722-31-7) and adalimumab (Humira, CAS number 331731-18-1); wherein a C-terminal end of said heavy chain signal peptide is fused to a heavy chain of said recombinant antibody, wherein said heavy chain signal peptide comprises an amino acid sequence selected from the group consisting of MELGLSWIFLLAILKGVQC (H1, SEQ ID NO: 5), MELGLRWVFLVAILEGVQC (H2, SEQ ID NO: 6), MDWTWRFLFVVAAATGVQS (H5, SEQ ID NO: 1), MEFGLSWLFLVAILKGVQC (H6, SEQ ID NO: 9), MEFGLSWVFLVALFRGVQC (H7, SEQ ID NO: 3) and MDLLHKNMKHLWFFLLLVAAPRWVLS (H8, SEQ ID NO: 10); and wherein a C-terminal end of said light chain signal peptide is fused to a light chain of the recombinant antibody, wherein the N-terminus of said light chain signal peptide comprises an amino acid sequence selected from the group consisting of MDMRVP (SEQ ID NO: 311) and MKYLLP (SEQ ID NO: 312).

2. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody according to claim 1, wherein the C-terminus of said light chain signal peptide comprises SGARC (SEQ ID NO: 313) or QPAMA (SEQ ID NO: 314).

3. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 1, wherein the heavy chain signal peptide comprises an amino acid sequence of SEQ ID NO: 1, and wherein the recombinant antibody is trastuzumab (Herceptin, CAS number 180288-69-1).

4. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 1, wherein the heavy chain signal peptide comprises an amino acid sequence of SEQ ID NO: 3, and wherein the recombinant antibody is bevacizumab (Avastin, CAS number 216974-75-3).

5. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 1, wherein the heavy chain signal peptide comprises an amino acid sequence of SEQ ID NO: 3, and wherein the recombinant antibody is infliximab (Remicade, CAS number 170277-31-3).

6. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 1, wherein the heavy chain signal peptide comprises an amino acid sequence of SEQ ID NO: 3, and wherein the recombinant antibody is rituximab (Rituxan, CAS number 174722-31-7).

7. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 1, wherein the heavy chain signal peptide comprises an amino acid sequence of SEQ ID NO: 3, and wherein the recombinant antibody is adalimumab (Humira, CAS number 331731-18-1).

8. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 1, wherein the light chain signal peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 4.

9. The optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 8, wherein the light chain signal peptide comprises an amino acid sequence of SEQ ID NO: 2, and wherein the antibody of interest is adalimumab (Humira, CAS number 331731-18-1).

10. A polynucleotide sequence encoding the optimized heavy chain signal peptide and light chain signal peptide for recombinant antibody of claim 1.

11. An amino acid sequence comprising a) the amino acid sequence for trastuzumab (Herceptin, CAS number 180288-69-1); b) a heavy chain signal peptide of SEQ ID NO: 1, wherein a C-terminal end of said heavy chain signal peptide is fused to the heavy chain amino acid sequence of trastuzumab; and c) a light chain signal peptide of SEQ ID NO: 2, wherein a C-terminal end of said light chain signal peptide is fused to the light chain amino acid sequence of trastuzumab.

12. A polynucleotide sequence encoding the amino acid sequence according to claim 11.

13. An amino acid sequence comprising a) the amino acid sequence for bevacizumab (Avastin, CAS number 216974-75-3); b) a heavy chain signal peptide of SEQ ID NO: 3, wherein a C-terminal end of said heavy chain signal peptide is fused to the heavy chain amino acid sequence of bevacizumab; and c) a light chain signal peptide of SEQ ID NO: 2, wherein a C-terminal end of said light chain signal peptide is fused to the light chain amino acid sequence of bevacizumab.

14. An amino acid sequence comprising a) the amino acid sequence for infliximab (Remicade, CAS number 170277-31-3); b) a heavy chain signal peptide of SEQ ID NO: 3, wherein a C-terminal end of said heavy chain signal peptide is fused to the heavy chain amino acid sequence of infliximab; and c) a light chain signal peptide of SEQ ID NO: 4, wherein a C-terminal end of said light chain signal peptide is fused to the light chain amino acid sequence of infliximab.

15. An amino acid sequence comprising a) the amino acid sequence for rituximab (Rituxan, CAS number 174722-31-7); b) a heavy chain signal peptide of SEQ ID NO: 3, wherein a C-terminal end of said heavy chain signal peptide is fused to the heavy chain amino acid sequence of rituximab; and c) a light chain signal peptide of SEQ ID NO: 4, wherein a C-terminal end of said light chain signal peptide is fused to the light chain amino acid sequence of rituximab.

16. An amino acid sequence comprising a) the amino acid sequence for adalimumab (Humira, CAS number 331731-18-1); b) a heavy chain signal peptide of SEQ ID NO: 3, wherein a C-terminal end of said heavy chain signal peptide is fused to the heavy chain amino acid sequence of adalimumab; and c) a light chain signal peptide of SEQ ID NO: 2, wherein a C-terminal end of said light chain signal peptide is fused to the light chain amino acid sequence of adalimumab.

Details for Patent 10,066,019

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2032-10-12
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2032-10-12
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2032-10-12
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2032-10-12
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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