CA3211407A1 - Anti-gprc5dxbcmaxcd3 trispecific antibody and use thereof - Google Patents

Anti-gprc5dxbcmaxcd3 trispecific antibody and use thereof Download PDF

Info

Publication number
CA3211407A1
CA3211407A1 CA3211407A CA3211407A CA3211407A1 CA 3211407 A1 CA3211407 A1 CA 3211407A1 CA 3211407 A CA3211407 A CA 3211407A CA 3211407 A CA3211407 A CA 3211407A CA 3211407 A1 CA3211407 A1 CA 3211407A1
Authority
CA
Canada
Prior art keywords
amino acid
seq
acid sequence
antibody
set forth
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3211407A
Other languages
English (en)
French (fr)
Inventor
Wei Xu
Wanwan SHEN
Li Li
Xuan Wang
Chenjuan ZHU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innovent Biologics (Suzhou) Co Ltd
Original Assignee
Innovent Biologics (Suzhou) Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innovent Biologics (Suzhou) Co Ltd filed Critical Innovent Biologics (Suzhou) Co Ltd
Publication of CA3211407A1 publication Critical patent/CA3211407A1/en
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cell Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
CA3211407A 2021-02-19 2022-02-18 Anti-gprc5dxbcmaxcd3 trispecific antibody and use thereof Pending CA3211407A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN202110189359.8 2021-02-19
CN202110189359 2021-02-19
PCT/CN2022/076832 WO2022174813A1 (zh) 2021-02-19 2022-02-18 抗GPRC5DxBCMAxCD3三特异性抗体及其用途

Publications (1)

Publication Number Publication Date
CA3211407A1 true CA3211407A1 (en) 2022-08-25

Family

ID=82932102

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3211407A Pending CA3211407A1 (en) 2021-02-19 2022-02-18 Anti-gprc5dxbcmaxcd3 trispecific antibody and use thereof

Country Status (8)

Country Link
US (1) US20250074996A1 (enExample)
EP (1) EP4296286A4 (enExample)
JP (1) JP2024510098A (enExample)
CN (1) CN116897166A (enExample)
AU (1) AU2022223152B2 (enExample)
CA (1) CA3211407A1 (enExample)
TW (1) TWI830151B (enExample)
WO (1) WO2022174813A1 (enExample)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022068809A1 (zh) * 2020-09-29 2022-04-07 信达生物制药(苏州)有限公司 抗cd3抗体以及其用途
WO2022175255A2 (en) 2021-02-16 2022-08-25 Janssen Pharmaceutica Nv Trispecific antibody targeting bcma, gprc5d, and cd3
WO2023236889A1 (zh) * 2022-06-06 2023-12-14 山东先声生物制药有限公司 靶向bcma、gprc5d和t细胞的多特异性抗体及其应用
EP4585615A4 (en) * 2022-09-09 2026-07-08 Beijing Mabworks Biotech Co Ltd Multispecific antibody binding to BCMA, GPRC5D and CD3 and its use
CN117924485A (zh) * 2022-10-25 2024-04-26 上海祥耀生物科技有限责任公司 一种抗gprc5d的多特异性抗体
TW202434644A (zh) 2023-02-07 2024-09-01 大陸商上海齊魯製藥研究中心有限公司 三特異性抗原結合分子及其應用
EP4725970A1 (en) 2023-06-06 2026-04-15 Fortvita Biologics Inc. Preparation and use of anti-gprc5d/bcma/cd3 trispecific antibody
WO2025056013A1 (zh) * 2023-09-13 2025-03-20 江苏恒瑞医药股份有限公司 一种包含特异性结合gprc5d和cd3的双特异性抗体的药物组合物
WO2025076113A1 (en) 2023-10-05 2025-04-10 Capstan Therapeutics, Inc. Ionizable cationic lipids with conserved spacing and lipid nanoparticles
US20250127728A1 (en) 2023-10-05 2025-04-24 Capstan Therapeutics, Inc. Constrained Ionizable Cationic Lipids and Lipid Nanoparticles
AU2024370890A1 (en) 2023-10-30 2026-06-11 Leads Biolabs Inc. Antibody binding to bcma and multispecific antibody comprising same
CN122349420A (zh) * 2023-12-04 2026-07-07 山东先声再明生物制药有限公司 一种多特异性抗体的组合物及其制备方法和应用
WO2025134050A1 (en) * 2023-12-21 2025-06-26 Janssen Biotech, Inc Trispecific antibody targeting bcma, gprc5d and cd3 for the treatment of multiple myeloma
WO2025134049A1 (en) * 2023-12-21 2025-06-26 Janssen Biotech, Inc Trispecific antibody targeting bcma, gprc5d and cd3 for the treatment of al amyloidosis
WO2025131077A1 (zh) * 2023-12-21 2025-06-26 上海君实生物医药科技股份有限公司 抗cd3多特异性抗体及用途
CN117843788B (zh) * 2024-01-09 2025-02-11 四川大学 一种抗gprc5d的抗体及其多特异性抗体和相关应用
CN120647761A (zh) * 2024-03-15 2025-09-16 信达生物制药(苏州)有限公司 抗dll3抗体及其用途
WO2025194478A1 (en) * 2024-03-22 2025-09-25 Biofront Ltd Antibodies binding to cd3 and gprc5d, and uses thereof
WO2025217454A2 (en) 2024-04-11 2025-10-16 Capstan Therapeutics, Inc. Ionizable cationic lipids and lipid nanoparticles
WO2025217452A1 (en) 2024-04-11 2025-10-16 Capstan Therapeutics, Inc. Constrained ionizable cationic lipids and lipid nanoparticles
WO2026026893A1 (zh) * 2024-08-01 2026-02-05 上海齐鲁制药研究中心有限公司 结合人gprc5d/bcma/cd3的三特异性抗体制剂及其用途
WO2026109053A1 (zh) * 2024-11-25 2026-05-28 江苏恒瑞医药股份有限公司 特异性结合bcma、gprc5d和cd3的抗原结合分子及其医药用途
WO2026119236A1 (zh) * 2024-12-05 2026-06-11 信达生物制药(苏州)有限公司 抗gprc5d/bcma/cd3三特异性抗体的制备及其用途
WO2026149576A1 (zh) * 2025-01-13 2026-07-16 上海橙帆医药有限公司 多特异性抗体及其用途

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993011794A1 (en) 1991-12-13 1993-06-24 Xoma Corporation Methods and materials for preparation of modified antibody variable domains and therapeutic uses thereof
SG176219A1 (en) * 2009-05-27 2011-12-29 Hoffmann La Roche Tri- or tetraspecific antibodies
GB201411320D0 (en) * 2014-06-25 2014-08-06 Ucb Biopharma Sprl Antibody construct
US10428155B2 (en) * 2014-12-22 2019-10-01 Xencor, Inc. Trispecific antibodies
EP3297672B1 (en) * 2015-05-21 2021-09-01 Harpoon Therapeutics, Inc. Trispecific binding proteins and methods of use
EP3156417A1 (en) * 2015-10-13 2017-04-19 Affimed GmbH Multivalent fv antibodies
GB201522391D0 (en) * 2015-12-18 2016-02-03 Ucb Biopharma Sprl Antibody molecules
US11291721B2 (en) * 2016-03-21 2022-04-05 Marengo Therapeutics, Inc. Multispecific and multifunctional molecules and uses thereof
CN109069638B (zh) * 2016-03-24 2022-03-29 璟尚生物制药公司 用于癌症治疗的三特异性抑制剂
RU2680011C2 (ru) * 2016-04-29 2019-02-14 Закрытое Акционерное Общество "Биокад" Триспецифические антитела против il-17a, il-17f и другой провоспалительной молекулы
TWI781108B (zh) * 2016-07-20 2022-10-21 比利時商健生藥品公司 抗gprc5d抗體、結合gprc5d與cd3之雙特異性抗原結合分子及其用途
WO2019005637A2 (en) * 2017-06-25 2019-01-03 Systimmune, Inc. MULTIPECIFIC ANTIBODIES AND METHODS OF PRODUCTION AND USE THEREOF
CN109970860A (zh) * 2017-12-27 2019-07-05 信达生物制药(苏州)有限公司 三链抗体、其制备方法及其用途
TWI829667B (zh) 2018-02-09 2024-01-21 瑞士商赫孚孟拉羅股份公司 結合gprc5d之抗體
WO2019220368A1 (en) * 2018-05-16 2019-11-21 Janssen Biotech, Inc. Bcma/cd3 and gprdc5d/cd3 bispecific antibodies for use in cancer therapy
CN113811546B (zh) * 2019-05-07 2025-03-11 免疫里森公司 前体三特异性抗体构建体及其使用方法
CN112062851B (zh) * 2019-06-11 2022-09-09 南京驯鹿医疗技术有限公司 靶向bcma嵌合抗原受体的抗体及其应用

Also Published As

Publication number Publication date
TWI830151B (zh) 2024-01-21
US20250074996A1 (en) 2025-03-06
JP2024510098A (ja) 2024-03-06
TW202237661A (zh) 2022-10-01
EP4296286A1 (en) 2023-12-27
EP4296286A4 (en) 2025-09-17
CN116897166A (zh) 2023-10-17
WO2022174813A1 (zh) 2022-08-25
AU2022223152B2 (en) 2026-02-19
AU2022223152A1 (en) 2023-08-31

Similar Documents

Publication Publication Date Title
AU2022223152B2 (en) Anti-gprc5d×bcma×cd3 trispecific antibody and use thereof
TWI894157B (zh) 包含血管舒緩素相關肽酶2抗原結合域之蛋白質及其用途
JP2021524249A (ja) 抗cd3抗体及びその使用
JP2024501403A (ja) ガンマ-デルタt細胞受容体に結合する抗体
US20250206820A1 (en) Ilt3 and cd3 binding agents and methods of use thereof
US20250092135A1 (en) Antibody and use thereof
US20240141071A1 (en) Antibodies that bind cd123 and gamma-delta t cell receptors
KR20260051069A (ko) 안정화된 cd3 항원 결합제 및 그 사용 방법
WO2024175030A1 (zh) 抗Nectin-4抗体和包含其的多特异性抗体
JP2023544140A (ja) 新規の抗クローディン18抗体
US20250163182A1 (en) Enpp3 and cd3 binding agents and methods of use thereof
WO2024251154A1 (zh) 抗gprc5d/bcma/cd3三特异性抗体的制备及其用途
WO2025077822A1 (en) Anti-tslp antibodies and uses thereof
US20250109204A1 (en) Compositions comprising antibodies that bind gamma-delta t cell receptors
CA3281557A1 (en) Trispecific antigen-binding molecule and use thereof
KR20240113488A (ko) 신규 항-il-36r 항체
CN120936627A (zh) Muc1抗体及使用方法
EA053202B1 (ru) Антитела, которые связывают гамма-дельта т-клеточные рецепторы
CN118165107A (zh) 结合tigit的抗体分子

Legal Events

Date Code Title Description
W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST TO REGISTER A DOCUMENT RECEIVED

Effective date: 20241016

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 3RD ANNIV.) - STANDARD

Year of fee payment: 3

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250115

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20250115

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250115

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20250401

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST TO REGISTER A DOCUMENT RECEIVED

Effective date: 20250401

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 4TH ANNIV.) - STANDARD

Year of fee payment: 4

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20251225

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-1-1-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20251226

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D11-D117 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION RECEIVED

Effective date: 20260217

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-1-1-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260217

D00 Search and/or examination requested or commenced

Free format text: ST27 STATUS EVENT CODE: A-1-1-D10-D00-D118 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REQUEST FOR EXAMINATION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260304

D11 Substantive examination requested

Free format text: ST27 STATUS EVENT CODE: A-1-2-D10-D11-D155 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: ALL REQUIREMENTS FOR EXAMINATION DETERMINED COMPLIANT

Effective date: 20260304

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260304

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260721

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260721

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: REGISTER A DOCUMENT REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260721