IP Library Granted Patent US 12,735,503
Granted Patent B2
US 12,735,503 · App. 18/547,663 · Granted Sep 15, 2026

Anti-MUC1-C antibodies and CAR-T structures

Inventors: Katherine Harris (Thousand Oaks, CA); Brian Avanzino (Thousand Oaks, CA); Nathan Trinklein (Thousand Oaks, CA); Karen Chang (Thousand Oaks, CA); Nicole Allen (Thousand Oaks, CA)
Assignee: TeneoBio, Inc.
C07K16/3092A61K40/11A61K40/31A61K40/4257A61P35/00C07K14/7051C12N5/0636A61K2239/31A61K2239/38A61K2239/49A61K2239/59C07K2317/569C07K2317/92C07K2319/33C12N2510/00
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Quick Facts
Patent No.
US 12,735,503
App. No.
18/547,663
Granted
Sep 15, 2026
Kind
B2
Abstract

Anti-MUC1-C antibodies (e.g., UniAbs™) and CAR-T structures are disclosed, along with methods of making such antibodies and CAR-T structures, compositions, including pharmaceutical compositions, comprising such antibodies and CAR-T structures, and their use to treat disorders that are characterized by the expression of MUC1-C.

Claims (17)

1 . An isolated antibody that binds to MUC1-C, comprising a heavy chain variable region comprising:

(a) a CDR1 sequence of SEQ ID NO: 1, a CDR2 sequence of SEQ ID NO: 2, and a CDR3 sequence of SEQ ID NO: 3; or

(b) a CDR1 sequence of SEQ ID NO: 4, a CDR2 sequence of SEQ ID NO: 5, and a CDR3 sequence of SEQ ID NO: 6.

2 . A CAR-T cell comprising a CAR comprising an extracellular antigen-binding domain that binds to MUC1-C, comprising a heavy chain variable region comprising:

(a) a CDR1 sequence of SEQ ID NO: 1, a CDR2 sequence of SEQ ID NO: 2, and a CDR3 sequence of SEQ ID NO: 3; or

(b) a CDR1 sequence of SEQ ID NO: 4, a CDR2 sequence of SEQ ID NO: 5, and a CDR3 sequence of SEQ ID NO: 6.

3 . The CAR-T cell of claim 2 , wherein the CDR1, CDR2 and CDR3 sequences are present in a human VH framework.

4 . The CAR-T cell of claim 2 , wherein the heavy chain variable region comprises a CDR1 sequence of SEQ ID NO: 1, a CDR2 sequence of SEQ ID NO: 2, and a CDR3 sequence of SEQ ID NO: 3.

5 . The CAR-T cell of claim 2 , wherein the heavy chain variable region comprises a CDR1 sequence of SEQ ID NO: 4, a CDR2 sequence of SEQ ID NO: 5, and a CDR3 sequence of SEQ ID NO: 6.

6 . The CAR-T cell of claim 2 , wherein the extracellular antigen-binding domain that binds to MUC1-C comprises a heavy chain variable region having at least 95% sequence identity to SEQ ID NO: 7 or SEQ ID NO: 8.

7 . The CAR-T cell of claim 6 , wherein the extracellular antigen-binding domain that binds to MUC1-C comprises a heavy chain variable region sequence selected from the group consisting of: SEQ ID NOs: 7 and 8.

8 . The CAR-T cell of claim 7 , wherein the extracellular antigen-binding domain that binds to MUC1-C comprises the heavy chain variable region sequence of SEQ ID NO: 7.

9 . The CAR-T cell of claim 7 , wherein the extracellular antigen-binding domain that binds to MUC1-C comprises the heavy chain variable region sequence of SEQ ID NO: 8.

10 . A pharmaceutical composition comprising the CAR-T cell of claim 2 .

11 . A kit comprising the CAR-T cell of claim 2 and instructions for use.

12 . The kit of claim 11 , further comprising at least one additional reagent.

13 . The kit of claim 12 , wherein the at least one additional reagent comprises a chemotherapeutic drug.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 13, 2024
From: HARRIS, KATHERINE; AVANZINO, BRIAN; TRINKLEIN, NATHAN; CHANG, KAREN; ALLEN, NICOLE
To: TENEOBIO, INC.
Reel/Frame 066757/0346 →
Continuity (2)
Provisional Application 63154618 · Feb 26, 2021
Related Publication 20240182597A1 · Jun 6, 2024
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A Report of an Epitope-exchange Study on the Binding of Vicky-1 to BCMA Epitope Cluster 3, Cited on Feb. 24, 2023, In the EP Opposition for EP2780375, 6 Pages. [cited by applicant]
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Alanine-Scanning Report, In the EP Opposition for EP2780375, Cited on Feb. 23, 2023, 9 Pages. [cited by applicant]
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Amiri S.A., et al., “A Novel Anti-CD22 scFV-apoptin Fusion Protein Induces Apoptosis in Malignant B-cells,” AMB Express, Dec. 2017, vol. 7, No. 1: 112, 11 Pages, ISSN 0004931985. [cited by applicant]
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Anonymous: “Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants with Relapsed or Refractory Multiple Myeloma (MajesTEC-1),” National Institutes of Health, U.S. National Librar… [cited by applicant]
Anonymous: “SinoBiological Inc—Antibody-Catalogue,” 2016, 150 Pages, Retrieved from URL: https://cdnl.sinobiological.com/reagent/catalogue/antibody-catalogue-EN.pdf. [cited by applicant]
Anonymous (TeneoBio, Inc.): “A Study of TNB-383B in Subjects with Relapsed or Refractory Multiple Myeloma,” U.S National Library of Medicine, May 1, 2019, 8 Pages, Retrieved from URL: https://clinicaltrials.gov/ct2/show… [cited by applicant]
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“BCMA Monoclonal Antibody (Vicky-1),” Invitrogen, Datasheet, Lot No. VD2967484, cited on Feb. 24, 2023 in the EP Opposition for EP2780375, 1 Page. [cited by applicant]
“BCMA Monoclonal Antibody (Vicky-1),” Vicky-1 Datasheet, Invitrogen, cited on Feb. 24, 2023, in the EP Opposition for EP2780375, 1 Page. [cited by applicant]
“BCMA/TNFRSF17 Antibody (Vicky-1)—BSA Free,” Vicky-1 Datasheet, Novus Biologicals, cited on Feb. 24, 2023 in the EP Opposition for EP2780375, 3 Pages. [cited by applicant]
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Bellucci R., et al., “Complete Response to Donor Lymphocyte Infusion in Multiple Myeloma is Associated with Antibody Responses to Highly Expressed Antigens,” Blood, Jan. 15, 2004, vol. 103, No. 2, pp. 656-663. [cited by applicant]
Bellucci R., et al., “Complete Response to Donor Lymphocyte Infusion in Patients with Multiple Myeloma is Associated with Antibody Response to BCMA, a Plasma Cell Membrane Receptor,” Journal of the American Society of H… [cited by applicant]
Bellucci R., et al., “Graft-versus-tumor Response in Patients with Multiple Myeloma is Associated with Antibody Response to BCMA, a Plasma-Cell Membrane Receptor,” Blood, May 15, 2005, vol. 105, No. 10, pp. 3945-3950. [cited by applicant]
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Bruggemann M., et al., “Human Antibody Production in Transgenic Animals,” Archivum Immunologiae et Therapiae Experimentalis, Birkahaeser Verlag AG, 2015, vol. 63, No. 2, pp. 101-108, Published online on Dec. 3, 2014. [cited by applicant]
Buelow B., et al., “Development of a Fully Human T Cell Engaging Bispecific Antibody for the Treatment of Multiple Myeloma,” Tenebio, Jun. 1, 2017, vol. 35 Supplement, No. 15, 8017 (Poster), 1 Page, DOI: 10.1200/JCO.201… [cited by applicant]
Buelow B., et al., “Development of a Fully Human T-cell Engaging Bispecific Antibody for the Treatment of Multiple Myeloma,” Journal of Clinical Oncology, Meeting Info: 2018 ASCO-SITC Clinical Immuno-Oncology Symposium,… [cited by applicant]
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Buelow B., et al., “Evaluation of Monovalent Versus Biparatopic CD3xPSMA Bispecific Antibodies for Tcell Mediated Killing of Prostate Tumor Cells with Minimal Cytokine Release,” Journal of Clinical Oncology, Meeting Inf… [cited by applicant]
Buelow B., et al., “Pre-Clinical Development of TNB-383B, a Fully Human T-cell Engaging Bispecific Antibody Targeting BCMA for the Treatment of Multiple Myeloma,” Journal of Clinical Oncology, May 20, 2018, vol. 36, No.… [cited by applicant]
Buelow B., et al., “TNB383B.0001: A Multicenter, Phase 1, Open-Label, Dose-Escalation Andexpansion Study of TNB-383B, a Bispecific Antibodytargeting BCMA in Subjects with Relapsed or Refractorymultiple Myeloma,” Blood, … [cited by applicant]
Buelow B., et al., “TNB585.001 : A Multicenter, Phase 1, Open-Label, Dose-Escalation and Expansion Study of TNB-585, a Bispecific T-Cell Engager Targeting PSMA in Subjects with Metastatic Castrate Resistant Prostate Can… [cited by applicant]
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Canfield S.M., et al., “The Binding Affinity of Human IgG for its High Affinity Fc Receptor Is Determined by Multiple Amino Acids in the CH2 Domain and Is Modulated by the Hinge Region,” Journal of Experimental Medicine… [cited by applicant]
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CD3 Ortholog Alignment, Cited on Apr. 17, 2023 in the EP Opposition for EP2780375, 1 Page. [cited by applicant]
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