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Article: Translational Learnings in the Development of Chemo-Immunotherapy Combination to Bypass the Cold Tumor Microenvironment in Pancreatic Ductal Adenocarcinoma.

Kaplon, Hélène

2022 Volume 12, Page(s) 835502

Abstract: Pancreatic ductal adenocarcinoma (PDAC) is among the most lethal cancers, with a 5-year relative survival rate of 5%. The desmoplastic stroma found in the tumor microenvironment of PDAC is suggested to be partly responsible for the resistance to most ... ...

Abstract	Pancreatic ductal adenocarcinoma (PDAC) is among the most lethal cancers, with a 5-year relative survival rate of 5%. The desmoplastic stroma found in the tumor microenvironment of PDAC is suggested to be partly responsible for the resistance to most therapeutic strategies. This review outlines the clinical results obtained with an immune checkpoint inhibitor in PDAC and discusses the rationale to use a combination of chemotherapy and immune checkpoint therapy. Moreover, essential parameters to take into account in designing an efficient combination have been highlighted.
Language	English
Publishing date	2022-05-18
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2022.835502
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Article ; Online: Antibodies to watch in 2021.

Kaplon, Hélène / Reichert, Janice M

mAbs

2021 Volume 13, Issue 1, Page(s) 1860476

Abstract: ... In this ... ...

Abstract	In this 12
MeSH term(s)	Animals ; Antibodies/adverse effects ; Antibodies/therapeutic use ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; COVID-19/diagnosis ; COVID-19/drug therapy ; COVID-19/virology ; Diffusion of Innovation ; Drug Approval ; Drug Development/trends ; Drug Discovery/trends ; Drug Repositioning/trends ; Forecasting ; Host-Pathogen Interactions ; Humans ; SARS-CoV-2/drug effects ; SARS-CoV-2/immunology
Chemical Substances	Antibodies ; Antiviral Agents
Language	English
Publishing date	2021-01-18
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2537838-7
ISSN	1942-0870 ; 1942-0870
ISSN (online)	1942-0870
ISSN	1942-0870
DOI	10.1080/19420862.2020.1860476
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Article ; Online: Antibodies to watch in 2024.

Crescioli, Silvia / Kaplon, Hélène / Chenoweth, Alicia / Wang, Lin / Visweswaraiah, Jyothsna / Reichert, Janice M

mAbs

2024 Volume 16, Issue 1, Page(s) 2297450

Abstract: The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In ...

Abstract	The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
MeSH term(s)	Antineoplastic Agents ; Trastuzumab ; Immunoconjugates ; Biological Products
Chemical Substances	Antineoplastic Agents ; Trastuzumab (P188ANX8CK) ; Immunoconjugates ; Biological Products
Language	English
Publishing date	2024-01-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	2537838-7
ISSN	1942-0870 ; 1942-0870
ISSN (online)	1942-0870
ISSN	1942-0870
DOI	10.1080/19420862.2023.2297450
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Article ; Online: Repenser la place des lymphocytes B et des structures lymphoïdes tertiaires dans l’immunothérapie des cancers.

Germain, Claire / Kaplon, Hélène / Dieu-Nosjean, Marie-Caroline

Medecine sciences : M/S

2021 Volume 37, Issue 2, Page(s) 130–133

Title translation	Rethinking the place of B lymphocyte and tertiary lymphoid structures in oncoimmunotherapy.
MeSH term(s)	Antigen-Antibody Complex ; B-Lymphocytes/immunology ; B-Lymphocytes/physiology ; Humans ; Immunity, Cellular ; Immunotherapy ; Lymphocytes, Tumor-Infiltrating ; Monosaccharides ; Neoplasms/immunology ; Neoplasms/therapy ; T-Lymphocytes/immunology ; Tertiary Lymphoid Structures/immunology
Chemical Substances	2,3,4,6-tetra-O-acetyl-glucopyranosyl bismethoxyphosphoramidate ; Antigen-Antibody Complex ; Monosaccharides
Language	French
Publishing date	2021-02-16
Publishing country	France
Document type	News ; Research Support, Non-U.S. Gov't
ZDB-ID	632733-3
ISSN	1958-5381 ; 0767-0974
ISSN (online)	1958-5381
ISSN	0767-0974
DOI	10.1051/medsci/2020276
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Article ; Online: Antibodies to watch in 2019.

Kaplon, Hélène / Reichert, Janice M

mAbs

2018 Volume 11, Issue 2, Page(s) 219–238

Abstract: For the past 10 years, the annual 'Antibodies to watch' articles have provided updates on key events in the late-stage development of antibody therapeutics, such as first regulatory review or approval, that occurred in the year before publication or were ...

Abstract	For the past 10 years, the annual 'Antibodies to watch' articles have provided updates on key events in the late-stage development of antibody therapeutics, such as first regulatory review or approval, that occurred in the year before publication or were anticipated to occur during the year of publication. To commemorate the 10th anniversary of the article series and to celebrate the 2018 Nobel Prizes in Chemistry and in Physiology or Medicine, which were given for work that is highly relevant to antibody therapeutics research and development, we expanded the scope of the data presented to include an overview of all commercial clinical development of antibody therapeutics and approval success rates for this class of molecules. Our data indicate that: 1) antibody therapeutics are entering clinical study, and being approved, in record numbers; 2) the commercial pipeline is robust, with over 570 antibody therapeutics at various clinical phases, including 62 in late-stage clinical studies; and 3) Phase 1 to approval success rates are favorable, ranging from 17-25%, depending on the therapeutic area (cancer vs. non-cancer). In 2018, a record number (12) of antibodies (erenumab (Aimovig), fremanezumab (Ajovy), galcanezumab (Emgality), burosumab (Crysvita), lanadelumab (Takhzyro), caplacizumab (Cablivi), mogamulizumab (Poteligeo), moxetumomab pasudodox (Lumoxiti), cemiplimab (Libtayo), ibalizumab (Trogarzo), tildrakizumab (Ilumetri, Ilumya), emapalumab (Gamifant)) that treat a wide variety of diseases were granted a first approval in either the European Union (EU) or United States (US). As of November 2018, 4 antibody therapeutics (sacituzumab govitecan, ravulizumab, risankizumab, romosozumab) were being considered for their first marketing approval in the EU or US, and an additional 3 antibody therapeutics developed by Chinese companies (tislelizumab, sintilimab, camrelizumab) were in regulatory review in China. In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019. Finally, we found that approximately half (18 of 33) of the late-stage pipeline of antibody therapeutics for cancer are immune checkpoint modulators or antibody-drug conjugates. Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
MeSH term(s)	Antibodies, Monoclonal ; Humans ; Immunotherapy/trends
Chemical Substances	Antibodies, Monoclonal
Language	English
Publishing date	2018-12-22
Publishing country	United States
Document type	Journal Article
ISSN	1942-0870
ISSN (online)	1942-0870
DOI	10.1080/19420862.2018.1556465
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Article ; Online: Antibodies to watch in 2018.

Kaplon, Hélène / Reichert, Janice M

mAbs

2018 Volume 10, Issue 2, Page(s) 183–203

Abstract: The pace of antibody therapeutics development accelerated in 2017, and this faster pace is projected to continue through 2018. Notably, the annual number of antibody therapeutics granted a first approval in either the European Union (EU) or United States ...

Abstract	The pace of antibody therapeutics development accelerated in 2017, and this faster pace is projected to continue through 2018. Notably, the annual number of antibody therapeutics granted a first approval in either the European Union (EU) or United States (US) reached double-digits (total of 10) for the first time in 2017. The 10 antibodies granted approvals are: brodalumab, dupilumab, sarilumab, guselkumab, benralizumab, ocrelizumab, inotuzumab ozogamicin, avelumab, duvalumab, and emicizumab. Brodalumab, however, had already been approved in Japan in 2016. As of December 1, 2017, nine antibody therapeutics (ibalizumab, burosumab, tildrakizumab, caplacizumab, erenumab, fremanezumab, galcanezumab, romosozumab, mogamulizumab) were in regulatory review in the EU or US, and regulatory actions on their marketing applications are expected by the end of 2018. Based on company announcements and estimated clinical study primary completion dates, and assuming the study results are positive, marketing applications for at least 12 antibody therapeutics that are now being evaluated in late-stage clinical studies may be submitted by the end of 2018. Of the 12 candidates, 8 are for non-cancer indications (lanadelumab, crizanlizumab, ravulizumab, eptinezumab, risankizumab, satralizumab, brolucizumab, PRO140) and 4 are for cancer (sacituzumab govitecan, moxetumomab pasudotox, cemiplimab, ublituximab). Additional antibody therapeutics to watch in 2018 include 19 mAbs undergoing evaluation in late-stage studies with primary completion dates in late 2017 or during 2018. Of these mAbs, 9 are for non-cancer indications (lampalizumab, roledumab, emapalumab, fasinumab, tanezumab, etrolizumab, NEOD001, gantenerumab, anifrolumab) and 10 are for cancer indications (tremelimumab, isatuximab, BCD-100, carotuximab, camrelizumab, IBI308, glembatumumab vedotin, mirvetuximab soravtansine, oportuzumab monatox, L19IL2/L19TNF). Positive clinical study results may enable marketing application submissions in 2018. Brief summaries of these antibody therapeutics are provided in this installment of the 'Antibodies to watch' article series.
MeSH term(s)	Antibodies, Monoclonal ; Drug Discovery/trends ; Humans
Chemical Substances	Antibodies, Monoclonal
Language	English
Publishing date	2018-01-16
Publishing country	United States
Document type	Journal Article
ISSN	1942-0870
ISSN (online)	1942-0870
DOI	10.1080/19420862.2018.1415671
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Antibodies to watch in 2022.

Kaplon, Hélène / Chenoweth, Alicia / Crescioli, Silvia / Reichert, Janice M

mAbs

2021 Volume 14, Issue 1, Page(s) 2014296

Abstract: In this 13th annual installment of the annual 'Antibodies to Watch' article series, we discuss key events in commercial antibody therapeutics development that occurred in 2021 and forecast events that might occur in 2022. Regulatory review of antibody ... ...

Abstract	In this 13th annual installment of the annual 'Antibodies to Watch' article series, we discuss key events in commercial antibody therapeutics development that occurred in 2021 and forecast events that might occur in 2022. Regulatory review of antibody therapeutics that target the SARS-CoV-2 coronavirus proceeded at an unprecedented pace in 2021, resulting in both emergency use authorizations and full approvals for sotrovimab, regdanvimab, REGEN-COV2, as well as others, in numerous countries. As of November 1, a total of 11 antibody therapeutics had been granted first approvals in either the United States or European Union in 2021 (evinacumab, dostarlimab loncastuximab tesirine, amivantamab, aducanumab, tralokinumab, anifrolumab, bimekizumab, tisotumab vedotin, regdanvimab, REGEN-COV2). The first global approvals of seven products, however, were granted elsewhere, including Japan (pabinafusp alfa), China (disitamab vedotin, penpulimab, zimberelimab), Australia (sotrovimab, REGEN-COV2), or the Republic of Korea (regdanvimab). Globally, at least 27 novel antibody therapeutics are undergoing review by regulatory agencies. First actions by the Food and Drug Administration on the biologics license applications for faricimab, sutimlimab, tebentafusp, relatlimab, sintilimab, ublituximab and tezepelumab are expected in the first quarter of 2022. Finally, our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline of antibody therapeutics grew by over 30% in the past year. Of those in late-stage development, marketing applications for at least 22 may occur by the end of 2022.
MeSH term(s)	Antibodies, Monoclonal/immunology ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Viral/immunology ; Antibodies, Viral/therapeutic use ; Antibody Specificity ; Antigens, Viral/immunology ; Asia ; Australia ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19/therapy ; Clinical Trials as Topic ; Compassionate Use Trials ; Drug Approval ; European Union ; Forecasting ; Humans ; SARS-CoV-2/immunology ; United States ; United States Food and Drug Administration
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Viral ; Antigens, Viral
Language	English
Publishing date	2021-12-31
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2537838-7
ISSN	1942-0870 ; 1942-0870
ISSN (online)	1942-0870
ISSN	1942-0870
DOI	10.1080/19420862.2021.2014296
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Article ; Online: Antibodies to watch in 2023.

Kaplon, Hélène / Crescioli, Silvia / Chenoweth, Alicia / Visweswaraiah, Jyothsna / Reichert, Janice M

mAbs

2022 Volume 15, Issue 1, Page(s) 2153410

Abstract: In this 14th installment of the annual Antibodies to Watch article series, we discuss key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecast events that might occur in 2023. As of mid-November, 12 ... ...

Abstract	In this 14th installment of the annual Antibodies to Watch article series, we discuss key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecast events that might occur in 2023. As of mid-November, 12 antibody therapeutics had been granted first approvals in either the United States or European Union (tebentafusp (Kimmtrak), faricimab (Vabysmo), sutimlimab (Enjaymo), relatlimab (Opdualag), tixagevimab/cilgavimab (Evusheld), mosunetuzumab (Lunsumio), teclistamab (TECVAYLI), spesolimab (SPEVIGO), tremelimumab (Imjudo; combo with durvalumab), nirsevimab (Beyfortus), mirvetuximab soravtansine (ELAHERE™), and teplizumab (TZIELD)), including 4 bispecific antibodies and 1 ADC. Based on FDA action dates, several additional product candidates could be approved by the end of 2022. An additional seven were first approved in China or Japan in 2022, including two bispecific antibodies (cadonilimab and ozoralizumab). Globally, at least 24 investigational antibody therapeutics are undergoing review by regulatory agencies as of mid-November 2022. Our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline grew by ~20% in the past year to include nearly 140 investigational antibody therapeutics that were designed using a wide variety of formats and engineering techniques. Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine).
MeSH term(s)	Humans ; Antibodies, Bispecific ; COVID-19
Chemical Substances	relatlimab ; tusamitamab ravtansine (DSS3BE2ZXN) ; Antibodies, Bispecific ; faricimab
Language	English
Publishing date	2022-12-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	2537838-7
ISSN	1942-0870 ; 1942-0870
ISSN (online)	1942-0870
ISSN	1942-0870
DOI	10.1080/19420862.2022.2153410
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Article ; Online: Identification of Tertiary Lymphoid Structure-Associated Follicular Helper T Cells in Human Tumors and Tissues.

Couillault, Coline / Germain, Claire / Dubois, Bertrand / Kaplon, Hélène

Methods in molecular biology (Clifton, N.J.)

2018 Volume 1845, Page(s) 205–222

Abstract: Follicular helper T (Tfh) cells are major components of the humoral immune response due to their pivotal role in germinal center formation and antibody affinity maturation following B-cell isotype switching. This ... ...

Abstract	Follicular helper T (Tfh) cells are major components of the humoral immune response due to their pivotal role in germinal center formation and antibody affinity maturation following B-cell isotype switching. This CD4
MeSH term(s)	Biomarkers ; Data Analysis ; Flow Cytometry ; Fluorescent Antibody Technique ; Humans ; Immunophenotyping/methods ; Neoplasms/immunology ; Neoplasms/metabolism ; Neoplasms/pathology ; T-Lymphocyte Subsets/immunology ; T-Lymphocyte Subsets/metabolism ; T-Lymphocytes, Helper-Inducer/immunology ; T-Lymphocytes, Helper-Inducer/metabolism ; Tertiary Lymphoid Structures/immunology ; Tertiary Lymphoid Structures/metabolism ; Tertiary Lymphoid Structures/pathology ; Tumor Microenvironment
Chemical Substances	Biomarkers
Language	English
Publishing date	2018-08-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1940-6029
ISSN (online)	1940-6029
DOI	10.1007/978-1-4939-8709-2_12
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Article ; Online: Quel avenir pour les lymphocytes B infiltrant les tumeurs solides - Marqueur pronostique et/ou cible thérapeutique ?

Kaplon, Hélène / Dieu-Nosjean, Marie-Caroline

Medecine sciences : M/S

2018 Volume 34, Issue 1, Page(s) 72–78

Abstract: The role of B lymphocytes in tumor immuno-surveillance has been neglected for a long time because it has been often considered to be ineffective if not pro-tumoral. Extensive studies of the tumor immune microenvironment, particularly in humans, has now ... ...

Title translation	Which future for B lymphocytes infiltrating solid tumors: prognostic biomarker and/or therapeutic target?
Abstract	The role of B lymphocytes in tumor immuno-surveillance has been neglected for a long time because it has been often considered to be ineffective if not pro-tumoral. Extensive studies of the tumor immune microenvironment, particularly in humans, has now made it possible to specify the nature of the interactions between B cells and their cellular partners. This review will present a number of parameters that dictate the fate of B cells toward a pro-tumor versus an anti-tumor function. Thus, the ability to elicit a B cell-and/or an antibody-dependent anti-tumor immunity involves a wide variety of molecular and cellular mechanisms, some of which may represent novel therapeutic targets in oncology.
MeSH term(s)	Animals ; B-Lymphocytes/physiology ; Biomarkers, Tumor/analysis ; Biomarkers, Tumor/immunology ; Humans ; Immunotherapy/methods ; Immunotherapy/trends ; Lymphocytes, Tumor-Infiltrating/physiology ; Medical Oncology/methods ; Medical Oncology/trends ; Molecular Targeted Therapy/methods ; Molecular Targeted Therapy/trends ; Neoplasms/diagnosis ; Neoplasms/immunology ; Neoplasms/therapy ; Prognosis ; Tumor Microenvironment/immunology
Chemical Substances	Biomarkers, Tumor
Language	French
Publishing date	2018-01-31
Publishing country	France
Document type	Journal Article ; Review
ZDB-ID	632733-3
ISSN	1958-5381 ; 0767-0974
ISSN (online)	1958-5381
ISSN	0767-0974
DOI	10.1051/medsci/20183401016
Database	MEDical Literature Analysis and Retrieval System OnLINE

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