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Last Updated: March 28, 2024

Claims for Patent: 10,111,954


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Summary for Patent: 10,111,954
Title:Combination therapy for inducing immune response to disease
Abstract: The present invention concerns combinations of two or more agents for inducing an immune response to cancer or infectious disease. Agents may include leukocyte redirecting complexes, antibody-drug conjugates, interferons (preferably interferon-.alpha.), and/or checkpoint inhibitor antibodies. The leukocyte redirecting complexes have at least one binding site for a leukocyte antigen and at least one binding site for an antigen on a diseased cell or pathogen. Preferably, the complex is a DNL.TM. complex. More preferably, the complex comprises a bispecific antibody (bsAb). Most preferably, the bsAb is an anti-CD3.times. anti-CD19 bispecific antibody, although antibodies against other leukocyte antigens and/or disease-associated antigens may be used. The complex is capable of targeting effector T cells, NK cells, monocytes or neutrophils to induce leukocyte-mediated cytotoxicity of cells associated with cancer or infectious disease. The cytotoxic immune response is enhanced by co-administration of interferon, checkpoint inhibitor antibody and/or ADC.
Inventor(s): Chang; Chien-Hsing (Downingtown, PA), Goldenberg; David M. (Mendham, NJ), Rossi; Edmund A. (Woodland Park, NJ), Rossi; Diane (Woodland Park, NJ), Hansen; Hans J. (Diamondhead, MS)
Assignee: IBC Pharmaceuticals, Inc. (Morris Plains, NJ)
Application Number:15/287,329
Patent Claims:1. A method of treating a Trop-2+ cancer comprising: a) administering to a human subject with a Trop-2+ cancer a trivalent T-cell redirecting complex comprising a bispecific antibody, wherein the bispecific antibody comprises (i) an anti-CD3 antibody moiety conjugated to an AD (anchoring domain) moiety from an AKAP protein, wherein the amino acid sequence of the AD moiety is SEQ ID NO:4 and (ii) an anti-Trop-2 antibody moiety conjugated to a DDD (dimerization and docking domain) moiety with an amino acid sequence of residues 1-44 of human protein kinase A (PKA) regulatory subunit RII.alpha., wherein two copies of the DDD moiety form a dimer that binds to one copy of the AD moiety to form a complex; and b) administering to the subject a checkpoint inhibitor antibody selected from the group consisting of pembrolizumab (MK-3475), nivolumab (BMS-936558), and pidilizumab (CT-011).

2. The method according to claim 1, wherein the complex comprises a first antibody moiety and a second antibody moiety.

3. The method according to claim 2, wherein the first antibody moiety is an IgG antibody and the second antibody moiety is an antigen-binding antibody fragment.

4. The method of claim 2, wherein the first and second antibody moieties are antigen-binding antibody fragments.

5. The method of claim 4, wherein the antibody fragments are selected from the group consisting of a F(ab').sub.2, a Fab', a F(ab).sub.2, a Fab, a scFv, and a single domain antibody.

6. The method of claim 1, further comprising administering to the individual interferon-.alpha..

7. The method of claim 1, further comprising inducing a T-cell mediated cytotoxic immune response against the cancer.

8. The method of claim 6, wherein the combination of interferon and T-cell redirecting complex is more effective than interferon alone and T-cell redirecting complex alone.

9. The method of claim 6, wherein the interferon is administered before, simultaneously with, or after the T-cell redirecting complex.

10. The method of claim 1, wherein the checkpoint inhibitor antibody is administered before, simultaneously with, or after the T-cell redirecting complex.

11. The method of claim 1, wherein the cancer is selected from the group consisting of colon cancer, rectal cancer, stomach cancer, lung cancer, breast cancer, ovarian cancer, prostate cancer, uterine cancer, urinary bladder cancer, pancreatic cancer, kidney cancer, and esophageal cancer.

12. The method of claim 1, wherein the T-cell redirecting complex is administered intravenously or subcutaneously.

13. The method of claim 1, wherein the checkpoint inhibitor antibody is pembrolizumab.

Details for Patent 10,111,954

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Corp. KEYTRUDA pembrolizumab For Injection 125514 09/04/2014 ⤷  Try a Trial 2032-08-14
Merck Sharp & Dohme Corp. KEYTRUDA pembrolizumab Injection 125514 01/15/2015 ⤷  Try a Trial 2032-08-14
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 12/22/2014 ⤷  Try a Trial 2032-08-14
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 10/04/2017 ⤷  Try a Trial 2032-08-14
Bristol-myers Squibb Company OPDIVO nivolumab Injection 125554 08/27/2021 ⤷  Try a Trial 2032-08-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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