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Article ; Online: Dynamic human immune and tumour cells cross-talk in PDX-humanised mice warrants checkpoint inhibitor cancer immunotherapies assessment.

Poirier, Nicolas / Vanhove, Bernard

2018 Volume 67, Issue 10, Page(s) 1753–1754

MeSH term(s)	Animals ; CTLA-4 Antigen ; Cross Reactions ; Humans ; Immunotherapy ; Mice ; Neoplasms
Chemical Substances	CTLA-4 Antigen
Language	English
Publishing date	2018-04-26
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	80128-8
ISSN	1468-3288 ; 0017-5749
ISSN (online)	1468-3288
ISSN	0017-5749
DOI	10.1136/gutjnl-2018-316467
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Article ; Online: Corneal Xenotransplantation: Anterior Lamellar Keratoplasty.

Vabres, Bertrand / Vanhove, Bernard / Blancho, Gilles

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

2020 Volume 2110, Page(s) 245–251

Abstract: Corneal transplantation for the treatment of corneal blindness is challenging in many countries due to the shortage of graft procurement. Xenocorneal transplantation is an interesting alternative to explore despite immunologic rejection, which mainly ... ...

Abstract	Corneal transplantation for the treatment of corneal blindness is challenging in many countries due to the shortage of graft procurement. Xenocorneal transplantation is an interesting alternative to explore despite immunologic rejection, which mainly involves endothelial cells. As anterior lamellar keratoplasty, when indicated, shows less immunologic reaction, we developed and describe below a pig-to-non-human-primate model of anterior lamellar corneal xenograft. This model can be used to assess the efficacy of corneas from genetically modified pigs.
MeSH term(s)	Animals ; Animals, Genetically Modified ; Corneal Diseases/etiology ; Corneal Diseases/surgery ; Corneal Transplantation/adverse effects ; Corneal Transplantation/methods ; Graft Survival/immunology ; Heterografts ; Macaca fascicularis ; Male ; Postoperative Care ; Swine ; Transplantation, Heterologous/adverse effects ; Transplantation, Heterologous/methods
Language	English
Publishing date	2020-01-30
Publishing country	United States
Document type	Journal Article
ISSN	1940-6029
ISSN (online)	1940-6029
DOI	10.1007/978-1-0716-0255-3_16
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Article ; Online: A novel assay based on pre-equilibrium titration curves for the determination of enzyme inhibitor binding kinetics.

Noppen, Bernard / Vanbelle, Anouk / Stitt, Alan W / Vanhove, Marc

European biophysics journal : EBJ

2021 Volume 50, Issue 7, Page(s) 1037–1043

Abstract: Selection of pharmacological agents based on potency measurements performed at equilibrium fail to incorporate the kinetic aspects of the drug-target interaction. Here we describe a method for screening or characterization of enzyme inhibitors that ... ...

Abstract	Selection of pharmacological agents based on potency measurements performed at equilibrium fail to incorporate the kinetic aspects of the drug-target interaction. Here we describe a method for screening or characterization of enzyme inhibitors that allows the concomitant determination of the equilibrium inhibition constant in unison with rates of complex formation and dissociation. The assay is distinct from conventional enzymatic assays and is based on the analysis of inhibition curves recorded prior to full equilibration of the system. The methodology is illustrated using bicyclic peptide inhibitors of the serine protease plasma kallikrein.
MeSH term(s)	Enzyme Inhibitors/pharmacology ; Kinetics ; Protein Binding ; Serine Endopeptidases
Chemical Substances	Enzyme Inhibitors ; Serine Endopeptidases (EC 3.4.21.-)
Language	English
Publishing date	2021-06-22
Publishing country	Germany
Document type	Journal Article
ZDB-ID	283671-3
ISSN	1432-1017 ; 0175-7571
ISSN (online)	1432-1017
ISSN	0175-7571
DOI	10.1007/s00249-021-01554-0
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Article ; Online: Les futures générations d’anticorps modulateurs des points de contrôle de la réponse immunitaire.

Bonnefoy, Nathalie / Olive, Daniel / Vanhove, Bernard

Medecine sciences : M/S

2020 Volume 35, Issue 12, Page(s) 966–974

Abstract: Immune checkpoints balance initial antigen-driven T cell stimulation by enhancing or dampening activation, allowing co-existence of efficient immune responses and maintenance of self-tolerance. In oncology, checkpoints currently targeted by inhibitors to ...

Title translation	Next generation of anti-immune checkpoints antibodies.
Abstract	Immune checkpoints balance initial antigen-driven T cell stimulation by enhancing or dampening activation, allowing co-existence of efficient immune responses and maintenance of self-tolerance. In oncology, checkpoints currently targeted by inhibitors to amplify activity of T cell, NK cells or myeloid cells responses comprise CTLA-4 (cytolytic T-lymphocyte-associated antigen 4 or CD152), PD-1 (programmed cell death 1, or CD279), PD-L1 ( programmed cell death-ligand 1, or CD274), LAG-3 (Lymphocyte-activation gene 3, or CD223), TIM3 (T-cell immunoglobulin and mucin-domain containing-3), TIGIT (T cell immunoreceptor with Ig and ITIM domains ), VISTA (V-domain Ig suppressor of T cell activation), B7/H3 (or CD276), KIR (killer-cell immunoglobulin-like receptor), NKG2A, CD39, CD73, CSF1R (colony-stimulating factor 1 receptor), CD47 or CD172a. Other "checkpoints" are being pharmacologically triggered in order to directly amplify T cell co-stimulation. Among these molecules, CD28, CD137 (also called 4-1BB), OX40 [also called tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)], GITR (Glucocorticoid-induced tumor necrosis factor receptor family-related protein) or CD40 are also tested in oncology, most often in combination with an inhibitory checkpoint inhibitor. In autoimmune and inflammatory diseases, checkpoint inhibitors or activators (LAG-3, CD28, CD40L) are also being tested. In this review, we focus on some modulators of immune checkpoints for which the mechanism of action has been particularly studied. As this description cannot be exhaustive, we have grouped in Table I all monoclonal antibodies (MAbs) or recombinant proteins in clinical use (to our knowledge), modulating the action of a control point of the immune system.
MeSH term(s)	Animals ; Antibodies, Monoclonal/therapeutic use ; Antineoplastic Agents, Immunological/therapeutic use ; Cell Cycle Checkpoints/drug effects ; Cell Cycle Checkpoints/immunology ; Humans ; Immunologic Factors/therapeutic use ; Immunotherapy/methods ; Immunotherapy/trends ; Neoplasms/immunology ; Neoplasms/pathology ; Neoplasms/therapy ; Protein Kinase Inhibitors/therapeutic use
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents, Immunological ; Immunologic Factors ; Protein Kinase Inhibitors
Language	French
Publishing date	2020-01-06
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/2019193
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Zs.B 2872: Show issues

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Article ; Online: Polyclonal antibodies selectively inhibit tumor growth and invasion and synergize with immune checkpoint inhibitors.

Ciron, Carine / Morice, Pierre / Rousse, Juliette / Roy, Patrice / Royer, Pierre-Joseph / Gauthier, Olivier / Brouard, Sophie / Duvaux, Odile / Bassissi, Firas / Vanhove, Bernard

JCI insight

2024 Volume 9, Issue 3

Abstract: Heterologous polyclonal antibodies (pAb) were shown to possess oncolytic properties a century ago with reported clinical responses. More recent preclinical models confirmed pAb efficacy, though their ability to tackle complex target antigens reduces ... ...

Abstract	Heterologous polyclonal antibodies (pAb) were shown to possess oncolytic properties a century ago with reported clinical responses. More recent preclinical models confirmed pAb efficacy, though their ability to tackle complex target antigens reduces susceptibility to tumor escape. Owing to the recent availability of glyco-humanized pAb (GH-pAb) with acceptable clinical toxicology profile, we revisited use of pAb in oncology and highlighted their therapeutic potential against multiple cancer types. Murine antitumor pAb were generated after repeated immunization of rabbits with murine tumor cell lines from hepatocarcinoma, melanoma, and colorectal cancers. Antitumor pAb recognized and showed cytotoxicity against their targets without cross-reactivity with healthy tissues. In vivo, pAb are effective alone; moreover, these pAb synergize with immune checkpoint inhibitors like anti-PD-L1 in several cancer models. They elicited an antitumor host immune response and prevented metastases. The anticancer activity of pAb was also confirmed in xenografted NMRI nude mice using GH-pAb produced by repeated immunization of pigs with human tumor cell lines. In conclusion, the availability of bioengineered GH-pAb allows for revisiting of passive immunotherapy with oncolytic pAb to fight against solid tumor and cancer metastasis.
MeSH term(s)	Humans ; Rabbits ; Animals ; Mice ; Swine ; Immune Checkpoint Inhibitors ; Mice, Nude ; Immunization ; Melanoma/therapy ; Cell Line, Tumor ; Antibodies, Neoplasm/pharmacology
Chemical Substances	Immune Checkpoint Inhibitors ; Antibodies, Neoplasm
Language	English
Publishing date	2024-02-08
Publishing country	United States
Document type	Journal Article
ISSN	2379-3708
ISSN (online)	2379-3708
DOI	10.1172/jci.insight.166231
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Article ; Online: First-in-human Study With LIS1, a Next-generation Porcine Low Immunogenicity Antilymphocyte Immunoglobulin in Kidney Transplantation.

Viklicky, Ondrej / Slatinska, Janka / Janousek, Libor / Rousse, Juliette / Royer, Pierre-Joseph / Toutain, Pierre-Louis / Cozzi, Emanuele / Galli, Cesare / Evanno, Gwenaelle / Duvaux, Odile / Bach, Jean-Marie / Soulillou, Jean-Paul / Giral, Magali / Vanhove, Bernard / Blancho, Gilles

Transplantation

2024

Abstract: Background: Polyclonal rabbit antithymocyte globulins (ATGs) are commonly used in organ transplantation as induction. Anti-N-glycolylneuraminic acid carbohydrate antibodies which develop in response to rabbit carbohydrate antigens might lead to unwanted ...

Abstract	Background: Polyclonal rabbit antithymocyte globulins (ATGs) are commonly used in organ transplantation as induction. Anti-N-glycolylneuraminic acid carbohydrate antibodies which develop in response to rabbit carbohydrate antigens might lead to unwanted systemic inflammation. LIS1, the first new generation of antilymphocyte globulins (ALGs) derived from double knockout swine, lacking carbohydrate xenoantigens was already tested in nonhuman primates and rodent models. Methods: This open-label, single-site, dose escalation, first-in-human, phase 1 study evaluated the safety, T cell depletion, pharmacokinetics, and pharmacodynamics of LIS1. In an ascending dose cohort (n = 5), a primary kidney transplant recipient at low immunologic risk (panel reactive antibody [PRA] < 20%), received LIS1 for 5 d at either 0.6, 1, 3, 6, or 8 mg/kg. After each patient completed treatment, the data safety monitoring board approved respective dose escalation. In the therapeutic dose cohort (n = 5) in patients with PRA <50% without donor specific antibodies, 2 patients received 8 mg/kg and 3 patients 10 mg/kg. Results: CD3+ T cell depletion <100/mm3 at day 2 was observed in all patients who received 6, 8, and 10 mg/kg of LIS1. The terminal half-life of LIS1 was 33.7 d with linearity in its disposition. Lymphocyte repopulation was fast and pretransplant lymphocyte subpopulation counts recovered within 2-4 wk. LIS1 was well tolerated, neither cytokine release syndrome nor severe thrombocytopenia or leukopenia were noticed. Antibodies to LIS1 were not detected. Conclusions: In this first-in-human trial, genome-edited swine-derived polyclonal LIS1 ALG was well tolerated, did not elicit antidrug antibodies, and caused time-limited T cell depletion in low- and medium-risk kidney transplant recipients.
Language	English
Publishing date	2024-02-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	208424-7
ISSN	1534-6080 ; 0041-1337
ISSN (online)	1534-6080
ISSN	0041-1337
DOI	10.1097/TP.0000000000004967
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Zs.A 488: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 509: Show issues

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Article ; Online: Anti-SARS-CoV-2 glyco-humanized polyclonal antibody XAV-19: phase II/III randomized placebo-controlled trial shows acceleration to recovery for mild to moderate patients with COVID-19.

Poulakou, Garyfallia / Royer, Pierre-Joseph / Evgeniev, Nikolay / Evanno, Gwénaëlle / Shneiker, Françoise / Marcelin, Anne-Geneviève / Vanhove, Bernard / Duvaux, Odile / Marot, Stéphane / Calvez, Vincent

Frontiers in immunology

2024 Volume 15, Page(s) 1330178

Abstract: Introduction: XAV-19 is a glyco-humanized swine polyclonal antibody targeting SARS-CoV-2 with high neutralizing activity. The safety and clinical efficacy of XAV-19 were investigated in patients with mild to moderate COVID-19.: Methods: This phase II/ ...

Abstract	Introduction: XAV-19 is a glyco-humanized swine polyclonal antibody targeting SARS-CoV-2 with high neutralizing activity. The safety and clinical efficacy of XAV-19 were investigated in patients with mild to moderate COVID-19. Methods: This phase II/III, multicentric, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety and clinical efficacy of XAV-19 in patients with a seven-point WHO score of 2 to 4 at randomization, i.e., inpatients with COVID-19 requiring or not requiring low-flow oxygen therapy, and outpatients not requiring oxygen (EUROXAV trial, NCT04928430). Adult patients presenting in specialized or emergency units with confirmed COVID-19 and giving their consent to participate in the study were randomized to receive 150 mg of XAV-19 or placebo. The primary endpoint was the proportion of patients with aggravation within 8 days after treatment, defined as a worsening of the seven-point WHO score of at least one point between day 8 and day 1 (inclusion). The neutralization activity of XAV-19 against variants circulating during the trial was tested in parallel. Results: From March 2021 to October 2022, 279 patients received either XAV-19 (N = 140) or placebo (N = 139). A slow enrollment and a low rate of events forced the termination of the premature trial. XAV-19 was well tolerated. Underpowered statistics did not allow the detection of any difference in the primary endpoint between the two groups or in stratified groups. Interestingly, analysis of the time to improvement (secondary endpoint) showed that XAV-19 significantly accelerated the recovery for patients with a WHO score of 2 or 3 (median at 7 days vs. 14 days, p = 0.0159), and even more for patients with a WHO score of 2 (4 days vs. 14 days, p = 0.0003). The neutralizing activity against Omicron and BA.2, BA.2.12.1, BA.4/5, and BQ.1.1 subvariants was shown. Discussion: In this randomized placebo- controlled trial with premature termination, reduction of aggravation by XAV-19 at day 8 in patients with COVID-19 was not detectable. However, a significant reduction of the time to improvement for patients not requiring oxygen was observed. XAV-19 maintained a neutralizing activity against SARS-CoV-2 variants. Altogether, these data support a possible therapeutic interest for patients with mild to moderate COVID-19 requiring anti-SARS-CoV-2 neutralizing antibodies. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT04928430; https://www.clinicaltrialsregister.eu/about.html (EudraCT), identifier 2020-005979-12.
MeSH term(s)	Humans ; Male ; Female ; Middle Aged ; SARS-CoV-2/immunology ; COVID-19/immunology ; COVID-19/therapy ; Antibodies, Viral/immunology ; Antibodies, Viral/therapeutic use ; Double-Blind Method ; Aged ; COVID-19 Drug Treatment ; Antibodies, Neutralizing/immunology ; Antibodies, Neutralizing/therapeutic use ; Adult ; Treatment Outcome ; Severity of Illness Index
Chemical Substances	Antibodies, Viral ; Antibodies, Neutralizing
Language	English
Publishing date	2024-04-17
Publishing country	Switzerland
Document type	Journal Article ; Clinical Trial, Phase II ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Multicenter Study ; Clinical Trial, Phase III
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2024.1330178
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Article: Anticorps monoclonaux en transplantation.

Vanhove, Bernard

Medecine sciences : M/S

2009 Volume 25, Issue 12, Page(s) 1121–1125

Abstract: Polyclonal anti-lymphoyctes antibodies were first successfully used in the 1970 in organ transplantation, but ten years later, monoclonal antibodies (mAb) emerged as a new class of immunosuppressive agents in transplantation with the potential to target ... ...

Title translation	Monoclonal antibodies in organ transplantation.
Abstract	Polyclonal anti-lymphoyctes antibodies were first successfully used in the 1970 in organ transplantation, but ten years later, monoclonal antibodies (mAb) emerged as a new class of immunosuppressive agents in transplantation with the potential to target highly specifically immune cells responsible for acute rejection. Some have proved their efficacy, such as mAb recognizing CD3- and CD25-positive T cells and have been extensively studied in clinical trials. Others such as mAb against CD52 and CD20, are still under investigation; finally, the next challenge is, based on our improved understanding of the mechanisms of immune recognition and allograft rejection, to use these mAb either alone or in combination with standard immunosuppressive regimens to manipulate the allogenic response to reach antigen-specific tolerance desired in solid-organ transplantation.
MeSH term(s)	Animals ; Antibodies, Monoclonal/therapeutic use ; Antigens, CD/immunology ; Antigens, CD20/immunology ; Antigens, Neoplasm/immunology ; Antilymphocyte Serum/therapeutic use ; CD52 Antigen ; Clinical Trials as Topic ; Drug Evaluation, Preclinical ; Glycoproteins/immunology ; Graft Rejection/prevention & control ; Humans ; Immunosuppressive Agents/therapeutic use ; Interleukin-2 Receptor alpha Subunit/immunology ; Muromonab-CD3/therapeutic use ; T-Lymphocytes, Regulatory/drug effects ; T-Lymphocytes, Regulatory/immunology ; Transplantation Immunology
Chemical Substances	Antibodies, Monoclonal ; Antigens, CD ; Antigens, CD20 ; Antigens, Neoplasm ; Antilymphocyte Serum ; CD52 Antigen ; CD52 protein, human ; Glycoproteins ; IL2RA protein, human ; Immunosuppressive Agents ; Interleukin-2 Receptor alpha Subunit ; Muromonab-CD3
Language	French
Publishing date	2009-12
Publishing country	France
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	632733-3
ISSN	1958-5381 ; 0767-0974
ISSN (online)	1958-5381
ISSN	0767-0974
DOI	10.1051/medsci/200925121121
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Article ; Online: Systemic exposure following intravitreal administration of therapeutic agents: an integrated pharmacokinetic approach. 2. THR-687.

Vanhove, Marc / Wagner, Jean-Marc / Noppen, Bernard / Jonckx, Bart / Vermassen, Elke / Stitt, Alan W

Journal of pharmacokinetics and pharmacodynamics

2021 Volume 48, Issue 6, Page(s) 837–849

Abstract: Intravitreal (IVT) injection remains the preferred administration route of pharmacological agents intended for the treatment of back of the eye diseases such as diabetic macular edema (DME) and neovascular age-related macular degeneration (nvAMD). The ... ...

Abstract	Intravitreal (IVT) injection remains the preferred administration route of pharmacological agents intended for the treatment of back of the eye diseases such as diabetic macular edema (DME) and neovascular age-related macular degeneration (nvAMD). The procedure enables drugs to be delivered locally at high concentrations whilst limiting whole body exposure and associated risk of systemic adverse events. Nevertheless, intravitreally-delivered drugs do enter the general circulation and achieving an accurate understanding of systemic exposure is pivotal for the evaluation and development of drugs administered in the eye. We report here the full pharmacokinetic properties of THR-687, a pan RGD integrin antagonist currently in clinical development for the treatment of DME, in both rabbit and minipig. Pharmacokinetic characterization included description of vitreal elimination, of systemic pharmacokinetics, and of systemic exposure following IVT administration. For the latter, we present a novel pharmacokinetic model that assumes clear partition between the vitreous humor compartment itself where the drug is administered and the central systemic compartment. We also propose an analytical solution to the system of differential equations that represent the pharmacokinetic model, thereby allowing data analysis with standard nonlinear regression analysis. The model accurately describes circulating levels of THR-687 following IVT administration in relevant animal models, and we suggest that this approach is relevant to a range of drugs and analysis of subsequent systemic exposure.
MeSH term(s)	Animals ; Diabetic Retinopathy/drug therapy ; Intravitreal Injections ; Macular Edema/drug therapy ; Rabbits ; Swine ; Swine, Miniature ; Vitreous Body
Language	English
Publishing date	2021-07-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2041601-5
ISSN	1573-8744 ; 1567-567X
ISSN (online)	1573-8744
ISSN	1567-567X
DOI	10.1007/s10928-021-09774-9
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Article ; Online: Systemic exposure following intravitreal administration of therapeutic agents: an integrated pharmacokinetic approach. 1. THR-149.

Vanhove, Marc / Noppen, Bernard / Wagner, Jean-Marc / Van Bergen, Tine / Barbeaux, Philippe / Stitt, Alan W

Journal of pharmacokinetics and pharmacodynamics

2021 Volume 48, Issue 6, Page(s) 825–836

Abstract: Intravitreal (IVT) injection of pharmacological agents is an established and widely used procedure for the treatment of many posterior segment of the eye diseases. IVT injections permit drugs to reach high concentrations in the retina whilst limiting ... ...

Abstract	Intravitreal (IVT) injection of pharmacological agents is an established and widely used procedure for the treatment of many posterior segment of the eye diseases. IVT injections permit drugs to reach high concentrations in the retina whilst limiting systemic exposure. Beyond the risk of secondary complications such as intraocular infection, the potential of systemic adverse events cannot be neglected. Therefore, a detailed understanding of the rules governing systemic exposure following IVT drug administration remains a prerequisite for the evaluation and development of new pharmacological agents intended for eye delivery. We present here a novel mathematical model to describe and predict circulating drug levels following IVT in the rabbit eye, a species which is widely used for drug delivery, pharmacokinetic, and pharmacodynamic studies. The mathematical expression was derived from a pharmacokinetic model that assumes the existence of a compartment between the vitreous humor compartment itself and the systemic compartment. We show that the model accurately describes circulating levels of THR-149, a plasma kallikrein inhibitor in development for the treatment of diabetic macular edema. We hypothesize that the model based on the rabbit eye has broader relevance to the human eye and can be used to analyze systemic exposure of a variety of drugs delivered in the eye.
MeSH term(s)	Animals ; Diabetic Retinopathy/drug therapy ; Macular Edema/drug therapy ; Macular Edema/metabolism ; Pharmaceutical Preparations/metabolism ; Rabbits ; Retina/metabolism ; Vitreous Body/metabolism
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2021-07-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2041601-5
ISSN	1573-8744 ; 1567-567X
ISSN (online)	1573-8744
ISSN	1567-567X
DOI	10.1007/s10928-021-09773-w
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