AU2020378263A1 - BCMA-targeted CAR-T cell therapy of multiple myeloma - Google Patents

BCMA-targeted CAR-T cell therapy of multiple myeloma Download PDF

Info

Publication number
AU2020378263A1
AU2020378263A1 AU2020378263A AU2020378263A AU2020378263A1 AU 2020378263 A1 AU2020378263 A1 AU 2020378263A1 AU 2020378263 A AU2020378263 A AU 2020378263A AU 2020378263 A AU2020378263 A AU 2020378263A AU 2020378263 A1 AU2020378263 A1 AU 2020378263A1
Authority
AU
Australia
Prior art keywords
cells
car
dose
cmax
subject
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
AU2020378263A
Other languages
English (en)
Inventor
Xiaohu FAN
Dong GENG
Jordan Mark SCHECTER
Enrique ZUDAIRE UBANI
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.)
Legend Biotech Ireland Ltd
Janssen Biotech Inc
Original Assignee
Legend Biotech Ireland Ltd
Janssen Biotech Inc
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 Legend Biotech Ireland Ltd, Janssen Biotech Inc filed Critical Legend Biotech Ireland Ltd
Publication of AU2020378263A1 publication Critical patent/AU2020378263A1/en
Assigned to JANSSEN BIOTECH, INC., LEGEND BIOTECH IRELAND LIMITED reassignment JANSSEN BIOTECH, INC. Request for Assignment Assignors: JANSSEN BIOTECH, INC.
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K39/0005—Vertebrate antigens
    • A61K39/0011—Cancer antigens
    • A61K39/001102—Receptors, cell surface antigens or cell surface determinants
    • A61K39/001111—Immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/70517—CD8
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/10—Cellular immunotherapy characterised by the cell type used
    • A61K40/11—T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/30—Cellular immunotherapy characterised by the recombinant expression of specific molecules in the cells of the immune system
    • A61K40/31—Chimeric antigen receptors [CAR]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
    • A61K40/41—Vertebrate antigens
    • A61K40/42—Cancer antigens
    • A61K40/4202—Receptors, cell surface antigens or cell surface determinants
    • A61K40/4214—Receptors for cytokines
    • A61K40/4215—Receptors for tumor necrosis factors [TNF], e.g. lymphotoxin receptor [LTR], CD30
    • 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
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/7051—T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578—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
    • C07K16/2878—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
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0634—Cells from the blood or the immune system
    • C12N5/0636—T lymphocytes
    • 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
    • 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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/515—Animal cells
    • A61K2039/5156—Animal cells expressing foreign proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/38—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the cancer treated
    • A61K2239/48—Blood cells, e.g. leukemia or lymphoma
    • 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
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02—Fusion polypeptide containing a localisation/targetting motif containing a signal sequence
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/03—Fusion polypeptide containing a localisation/targetting motif containing a transmembrane segment
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/33—Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2510/00—Genetically modified cells

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Toxicology (AREA)
  • Biotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Mycology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Developmental Biology & Embryology (AREA)
  • Virology (AREA)
AU2020378263A 2019-11-05 2020-11-04 BCMA-targeted CAR-T cell therapy of multiple myeloma Pending AU2020378263A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962931065P 2019-11-05 2019-11-05
US62/931,065 2019-11-05
US201962943627P 2019-12-04 2019-12-04
US62/943,627 2019-12-04
PCT/US2020/058788 WO2021091945A1 (en) 2019-11-05 2020-11-04 Bcma-targeted car-t cell therapy of multiple myeloma

Publications (1)

Publication Number Publication Date
AU2020378263A1 true AU2020378263A1 (en) 2022-06-23

Family

ID=73598214

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020378263A Pending AU2020378263A1 (en) 2019-11-05 2020-11-04 BCMA-targeted CAR-T cell therapy of multiple myeloma

Country Status (13)

Country Link
US (2) US12522645B2 (enExample)
EP (1) EP4055049A1 (enExample)
JP (2) JP2023500338A (enExample)
KR (1) KR20220100612A (enExample)
CN (1) CN114929747A (enExample)
AU (1) AU2020378263A1 (enExample)
BR (1) BR112022008633A2 (enExample)
CA (1) CA3159808A1 (enExample)
IL (1) IL292701A (enExample)
JO (1) JOP20220099A1 (enExample)
MX (1) MX2022005443A (enExample)
PH (1) PH12022551032A1 (enExample)
WO (1) WO2021091945A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2021266428A1 (en) * 2020-05-04 2023-01-19 Bio-Diagnostics Limited A diagnostic device
AU2023373360A1 (en) * 2022-11-02 2025-06-12 Janssen Biotech, Inc. Bcma-targeted car-t cell therapy of multiple myeloma
CN117186229B (zh) * 2022-12-06 2024-03-29 成都赛恩吉诺生物科技有限公司 具有长cdr3序列的抗人bcma纳米抗体及car-t和应用
CA3205511A1 (en) * 2023-04-19 2025-03-17 Legend Biotech Usa Inc. Bcma-targeted car-t cell therapy for multiple myeloma
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
WO2025217452A1 (en) 2024-04-11 2025-10-16 Capstan Therapeutics, Inc. Constrained ionizable cationic lipids and lipid nanoparticles
WO2025217454A2 (en) 2024-04-11 2025-10-16 Capstan Therapeutics, Inc. Ionizable cationic lipids and lipid nanoparticles
WO2026072671A1 (en) 2024-09-24 2026-04-02 City Of Hope Methods comprising oncolytic viruses expressing bcmat and bcma-targeted therapies
WO2026165530A1 (en) 2025-02-03 2026-08-06 Renagade Therapeutics Management Inc. Hydrophilic polymer lipids for use in lipid nanoparticles

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4235871A (en) 1978-02-24 1980-11-25 Papahadjopoulos Demetrios P Method of encapsulating biologically active materials in lipid vesicles
US4501728A (en) 1983-01-06 1985-02-26 Technology Unlimited, Inc. Masking of liposomes from RES recognition
US5019369A (en) 1984-10-22 1991-05-28 Vestar, Inc. Method of targeting tumors in humans
GB8601597D0 (en) 1986-01-23 1986-02-26 Wilson R H Nucleotide sequences
US4837028A (en) 1986-12-24 1989-06-06 Liposome Technology, Inc. Liposomes with enhanced circulation time
ATE159548T1 (de) 1990-11-13 1997-11-15 Immunex Corp Bifunktionelle wählbare fusionsgene
AU6953394A (en) 1993-05-21 1994-12-20 Targeted Genetics Corporation Bifunctional selectable fusion genes based on the cytosine deaminase (cd) gene
US5464758A (en) 1993-06-14 1995-11-07 Gossen; Manfred Tight control of gene expression in eucaryotic cells by tetracycline-responsive promoters
US5814618A (en) 1993-06-14 1998-09-29 Basf Aktiengesellschaft Methods for regulating gene expression
US5885827A (en) 1996-01-23 1999-03-23 The Regents Of The Universtiy Of California Eukaryotic high rate mutagenesis system
FR2814642B1 (fr) 2000-10-03 2005-07-01 Ass Pour Le Dev De La Rech En Souris transgenique pour la recombinaison ciblee mediee par la cre-er modifiee
JP5675109B2 (ja) 2007-02-20 2015-02-25 アナプティスバイオ インコーポレイティッド ライブラリーの生成方法及びその使用
AU2015330017A1 (en) 2014-10-07 2017-04-27 Cellectis Method for modulating car-induced immune cells activity
CN105384825B (zh) 2015-08-11 2018-06-01 南京传奇生物科技有限公司 一种基于单域抗体的双特异性嵌合抗原受体及其应用
US20190112380A1 (en) 2016-03-29 2019-04-18 University Of Southern California Chimeric antigen receptors targeting cancer
CA3020599A1 (en) 2016-04-15 2017-10-19 The Children's Hospital Of Philadelphia Compositions and methods of chimeric alloantigen receptor t cells
CN105837693A (zh) 2016-05-30 2016-08-10 李斯文 一种基于bcma的抗原嵌合受体及其制备方法和应用
PL3896091T3 (pl) * 2016-08-10 2024-04-29 Legend Biotech Ireland Limited Chimeryczne receptory antygenowe nakierowane na bcma i sposoby ich zastosowania
BR112022011964A2 (pt) 2019-12-17 2022-09-06 Shenzhen Feipeng Biological Therapy Co Ltd Anticorpo de ligação a bcma e uso do mesmo
WO2022116086A1 (en) 2020-12-03 2022-06-09 Janssen Biotech, Inc. Bcma-targeted car-t cell therapy for multiple myeloma
IL308345A (en) 2021-05-11 2024-01-01 Janssen Biotech Inc Methods for Minimizing Neurotoxicity Associated with Chimeric Antigen Receptor (CAR) T Cell Therapy
WO2023077343A1 (en) 2021-11-04 2023-05-11 Janssen Biotech, Inc. Bcma-targeted car-t cell therapy for multiple myeloma
JP2024540275A (ja) 2021-11-04 2024-10-31 ヤンセン バイオテック, インク. Bcmaを標的とする、多発性骨髄腫のためのcar-t細胞療法関連出願の相互参照
JP2025507678A (ja) 2022-02-28 2025-03-21 ヤンセン バイオテック, インク. Bcmaを標的とする、多発性骨髄腫のためのcar-t細胞療法
AU2023373360A1 (en) 2022-11-02 2025-06-12 Janssen Biotech, Inc. Bcma-targeted car-t cell therapy of multiple myeloma
CA3205511A1 (en) 2023-04-19 2025-03-17 Legend Biotech Usa Inc. Bcma-targeted car-t cell therapy for multiple myeloma

Also Published As

Publication number Publication date
PH12022551032A1 (en) 2023-04-24
JP2026113477A (ja) 2026-07-07
WO2021091945A1 (en) 2021-05-14
KR20220100612A (ko) 2022-07-15
CN114929747A (zh) 2022-08-19
BR112022008633A2 (pt) 2022-07-19
US20210128618A1 (en) 2021-05-06
US12522645B2 (en) 2026-01-13
CA3159808A1 (en) 2021-05-14
IL292701A (en) 2022-07-01
JP2023500338A (ja) 2023-01-05
US20260217788A1 (en) 2026-07-30
MX2022005443A (es) 2022-08-10
EP4055049A1 (en) 2022-09-14
JOP20220099A1 (ar) 2023-01-30

Similar Documents

Publication Publication Date Title
US12522645B2 (en) BCMA-targeted CAR-T cell therapy of multiple myeloma
JP7303749B2 (ja) Tim-1を標的とするキメラ抗原受容体
US20230074800A1 (en) Car-t cell therapies with enhanced efficacy
US20200399383A1 (en) Chimeric antigen receptor therapy in combination with il-15r and il15
CA3032054A1 (en) Combination therapies of chimeric antigen receptors and pd-1 inhibitors
IL262321B2 (en) Compositions and methods for selective protein expression
CA3030837A1 (en) Treatment and prevention of cytokine release syndrome using a chimeric antigen receptor in combination with a kinase inhibitor
US20230277589A1 (en) Bcma-targeted car-t cell therapy for multiple myeloma
CN113784980B (zh) 人源化抗Claudin18.2嵌合抗原受体及其用途
US20220265710A1 (en) Bcma-targeted car-t cell therapy for multiple myeloma
WO2023077343A1 (en) Bcma-targeted car-t cell therapy for multiple myeloma
US20240156962A1 (en) Bcma-targeted car-t cell therapy of multiple myeloma
JP2024012258A (ja) Cd22に特異的なヒト化抗体およびそれを用いたキメラ抗原受容体
HK40072824A (en) Bcma-targeted car-t cell therapy of multiple myeloma
WO2024206329A1 (en) Nucleic acid molecules encoding bi-specific secreted engagers and uses thereof

Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ ZUDAIRE UBANI, ENRIQUE; FAN, XIAOHU; GENG, DONG AND SCHECTER, JORDAN MARK.

PC1 Assignment before grant (sect. 113)

Owner name: JANSSEN BIOTECH, INC.

Free format text: FORMER APPLICANT(S): JANSSEN BIOTECH, INC.

Owner name: LEGEND BIOTECH IRELAND LIMITED

Free format text: FORMER APPLICANT(S): JANSSEN BIOTECH, INC.