2025
Plain language summary of publication to understand the ROSALIA study: a new biosimilar denosumab for bone health
Eastell R, Jeka S, Lustberg M, Edgerton C, Żuchowski P, Vogg B. Plain language summary of publication to understand the ROSALIA study: a new biosimilar denosumab for bone health. Therapeutic Advances In Musculoskeletal Disease 2025, 17: 1759720x251335147. PMID: 40322084, PMCID: PMC12046156, DOI: 10.1177/1759720x251335147.Peer-Reviewed Original ResearchPostmenopausal osteoporosisBone densityAnti-drug antibodiesRisk of fractureIncreased bone densityNon-clinical studiesResults of switchingDenosumabAdverse eventsBone healthClinical studiesImmune systemMineral ResearchOsteoporosisTreatment groupsJournal of BoneChange treatmentPatient advocacy groupsBoneTreatmentPatientsAntibodiesWomenPlasma microRNAs to Select Optimal Patients for Antibody Production from Anti-Addiction Vaccines
Kosten T, Koirala A, Nielsen D, Domingo C, Thomas Y, Gunaratne P, Coarfa C. Plasma microRNAs to Select Optimal Patients for Antibody Production from Anti-Addiction Vaccines. Vaccines 2025, 13: 181. PMID: 40006728, PMCID: PMC11860428, DOI: 10.3390/vaccines13020181.Peer-Reviewed Original ResearchDE-miRsAnti-drug antibodiesPlasma microRNAsAnti-addiction vaccinesAnti-cocaine vaccinePotential response biomarkersMiR-150Vaccine trial participantsIllicit amphetamineNon-respondersResponse biomarkersMiRsAntibody respondersAnti-addictiveAntibody levelsAntibody productionStudy predictorsVaccineTrial participantsMicroRNAsCocaineAntibodiesLow ABFalse discovery ratePatients
2024
HLA DQA1*05 and risk of anti-TNF treatment failure and anti-drug antibody development in children with Crohn's Disease: HLA DQA1*05 and Pediatric Crohn's Disease.
Adler J, Galanko J, Ammoury R, Benkov K, Bousvaros A, Boyle B, Cabrera J, Chun K, Dorsey J, Ebach D, Firestine A, Gulati A, Herfarth H, Jester T, Kaplan J, Leibowitz I, Linville T, Margolis P, Minar P, Molle-Rios Z, Moses J, Olano K, Pashankar D, Pitch L, Saeed S, Samson C, Sandberg K, Steiner S, Strople J, Sullivan J, Wali P, Kappelman M. HLA DQA1*05 and risk of anti-TNF treatment failure and anti-drug antibody development in children with Crohn's Disease: HLA DQA1*05 and Pediatric Crohn's Disease. The American Journal Of Gastroenterology 2024 PMID: 39423015, DOI: 10.14309/ajg.0000000000003135.Peer-Reviewed Original ResearchHLA-DQA1*05Anti-drug antibodiesDQA1*05Anti-drug antibody developmentTreatment failureCrohn's diseaseAnti-TNFPositive patientsDevelopment of anti-drug antibodiesAnti-TNF treatment failureTumor necrosis factor antagonistsIndicator of treatment failureAnti-TNF monotherapyPediatric Crohn's diseaseIncreased treatment failureTrial of childrenYears of ageRandomized trial of childrenOral methotrexatePositive participantsRisk stratificationPediatric dataRandomized trialsIncreased riskPrimary outcomeA Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx® in Healthy Chinese Male Subjects
Yao F, Wang C, Ding J, Zhang Q, Zheng L, Zhang Q, Yang T, Zhang X, Shan Y, Hou S, Wang H, Zhou R, Hu W. A Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx® in Healthy Chinese Male Subjects. Drug Design Development And Therapy 2024, 18: 3891-3901. PMID: 39224901, PMCID: PMC11368109, DOI: 10.2147/dddt.s470619.Peer-Reviewed Original ResearchConceptsHealthy Chinese male subjectsChinese male subjectsGeometric mean ratiosAnti-drug antibodiesDouble-blindMale subjectsRates of anti-drug antibodiesPK parametersNon-radiographic axial spondyloarthritisIncidence of TEAEsPhase I studyPrimary study endpointInterleukin (IL)-17AArea under the curveEnthesitis-related arthritisTreatment of psoriasisConfidence intervalsSafety profileSingle doseHidradenitis suppurativaSecukinumabStudy endpointAdverse eventsAxial spondyloarthritisImmunogenicity analysisPhase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure
Spreafico A, Couselo E, Irmisch A, Bessa J, Au-Yeung G, Bechter O, Svane I, Sanmamed M, Gambardella V, McKean M, Callahan M, Dummer R, Klein C, Umaña P, Justies N, Heil F, Fahrni L, Opolka-Hoffmann E, Waldhauer I, Bleul C, Staack R, Karanikas V, Fowler S. Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure. Frontiers In Oncology 2024, 14: 1346502. PMID: 38577337, PMCID: PMC10991832, DOI: 10.3389/fonc.2024.1346502.Peer-Reviewed Original ResearchTreatment-related adverse eventsAnti-drug antibodiesCytokine release syndromeFirst-in-humanT-cell engagersCheckpoint inhibitorsMetastatic melanomaT cellsDrug exposureDevelopment of anti-drug antibodiesActive drugImmune responseFirst-in-human studyDrug activity in vitroDose-escalation studyDose-escalation trialTumor necrosis factor-alphaB cell interactionsImpact of immune responsesActive drug exposureNecrosis factor-alphaAnti-tumor activityLoss of efficacyAssociated with developmentDose escalation
2023
CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors.
Rodriguez Rivera I, Hafez N, Tolcher A, LoRusso P, Wilks S, Tripathy D, Gara M, Pearson P, DeCillis A, Meric-Bernstam F. CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2023, 41: 3087-3087. DOI: 10.1200/jco.2023.41.16_suppl.3087.Peer-Reviewed Original ResearchTreatment-related AEsOvarian cancerBreast cancerFrequent treatment-related AEsHER2-negative breast cancerPlatinum-resistant ovarian cancerDaily x 3Daily x 5Hormone receptor positiveSingle-agent antitumor activityMetastatic solid tumorsPhase 1 trialAnti-drug antibodiesNegative breast cancerAnti-tumor activityAntibody-drug conjugatesFebrile neutropeniaRECIST v1.1WBC decreaseExpansion cohortFIH studiesPlasma PKTumor cell membranesHuman studiesSolid tumorsOsteonecrosis in Gaucher disease in the era of multiple therapies: Biomarker set for risk stratification from a tertiary referral center
Basiri M, Ghaffari M, Ruan J, Murugesan V, Kleytman N, Belinsky G, Akhavan A, Lischuk A, Guo L, Klinger K, Mistry P. Osteonecrosis in Gaucher disease in the era of multiple therapies: Biomarker set for risk stratification from a tertiary referral center. ELife 2023, 12: e87537. PMID: 37249220, PMCID: PMC10317498, DOI: 10.7554/elife.87537.Peer-Reviewed Original ResearchConceptsEnzyme replacement therapySubstrate reduction therapyAvascular osteonecrosisTertiary referral centerGaucher diseaseReferral centerTreatment initiationGD patientsImiglucerase enzyme replacement therapyResidual disease activityAnti-drug antibodiesYears of treatmentType of therapyRare inborn errorMixed-effects logistic modelGD1 patientsSpleen statusDisease activityClinical outcomesRisk stratificationReplacement therapyIndependent correlatesMultiple therapiesReduction therapyHigh riskComparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn’s Disease: A Pragmatic Randomized Trial
Kappelman M, Wohl D, Herfarth H, Firestine A, Adler J, Ammoury R, Aronow J, Bass D, Bass J, Benkov K, Tobi C, Boccieri M, Boyle B, Brinkman W, Cabera J, Chun K, Colletti R, Dodds C, Dorsey J, Ebach D, Entrena E, Forrest C, Galanko J, Grunow J, Gulati A, Ivanova A, Jester T, Kaplan J, Kugathasan S, Kusek M, Leibowitz I, Linville T, Lipstein E, Margolis P, Minar P, Molle-Rios Z, Moses J, Olano K, Osaba L, Palomo P, Pappa H, Park K, Pashankar D, Pitch L, Robinson M, Samson C, Sandberg K, Schuchard J, Seid M, Shelly K, Steiner S, Strople J, Sullivan J, Tung J, Wali P, Zikry M, Weinberger M, Saeed S, Bousvaros A. Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn’s Disease: A Pragmatic Randomized Trial. Gastroenterology 2023, 165: 149-161.e7. PMID: 37004887, PMCID: PMC10330864, DOI: 10.1053/j.gastro.2023.03.224.Peer-Reviewed Original ResearchConceptsPediatric Crohn's diseaseNecrosis factor inhibitorsPatient-reported outcomesAdverse eventsTreatment failureCombination therapyCrohn's diseaseSerious AEsFactor inhibitorsTumor necrosis factor inhibitorsAnti-drug antibody developmentAnti-TNF monotherapyCombination therapy armCrohn's disease therapyMethotrexate combination therapyTolerable safety profileLow-dose methotrexateMore adverse eventsSerious adverse eventsAnti-drug antibodiesPragmatic Randomized TrialDisease therapyLoss of responseOral methotrexateTherapy arm
2022
Dose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors.
Johnson M, Abdul-Karim R, Sommerhalder D, Hafez N, Wang S, Li C, Liu Y, Yang L, Collins S, Parot X, Strauss J. Dose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors. Journal Of Clinical Oncology 2022, 40: 2503-2503. DOI: 10.1200/jco.2022.40.16_suppl.2503.Peer-Reviewed Original ResearchTreatment-related adverse eventsMetastatic solid tumorsAnti-drug antibodiesPhase 1b/2 studySolid tumorsDose escalationAttenuated cytokineGrade 4 thrombocytopeniaManageable safety profileMedian prior linesPhase 2 doseStrong clinical responseDose-escalation phaseInfusion-related reactionsDose-limiting toxicityProof of mechanismPreclinical mouse modelsImmune cell activationDose range 0.1IgG4 monoclonal antibodyQ3W dosingStable diseaseCheckpoint inhibitorsRefractory/Adverse eventsPhase 1 study of anti-CD47 monoclonal antibody CC-90002 in patients with relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndromes
Zeidan AM, DeAngelo DJ, Palmer J, Seet CS, Tallman MS, Wei X, Raymon H, Sriraman P, Kopytek S, Bewersdorf JP, Burgess MR, Hege K, Stock W. Phase 1 study of anti-CD47 monoclonal antibody CC-90002 in patients with relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndromes. Annals Of Hematology 2022, 101: 557-569. PMID: 34981142, PMCID: PMC9414073, DOI: 10.1007/s00277-021-04734-2.Peer-Reviewed Original ResearchConceptsAnti-drug antibodiesAcute myeloid leukemiaDose-limiting toxicityRefractory acute myeloid leukemiaHigh-risk myelodysplastic syndromeMyelodysplastic syndromeMyeloid leukemiaCommon treatment-emergent adverse eventsTreatment-emergent adverse eventsADA-positive patientsPhase 2 dosePresence/frequencyUnexpected safety findingsPhase 1 studyAnti-CD47 antibodyCD47-SIRPα interactionMacrophage-mediated killingHematological cancer cell linesFebrile neutropeniaMonotherapy activityCancer cell linesPrimary endpointSecondary endpointsAdverse eventsObjective response
2021
ATHN Transcends: A Natural History Cohort Study of the Safety, Effectiveness and Practice of Treatment in People with Non-Neoplastic Hematologic Disorders
Malec L, Hirsh N, O'Neill C, Watson C, Recht M. ATHN Transcends: A Natural History Cohort Study of the Safety, Effectiveness and Practice of Treatment in People with Non-Neoplastic Hematologic Disorders. Blood 2021, 138: 4242. DOI: 10.1182/blood-2021-148209.Peer-Reviewed Original ResearchFDA-approved therapiesNon-neoplastic hematological disordersObservational cohort studyLong-term safetyHematological disordersCohort studyHematological conditionsClotting disordersEuropean Haemophilia Safety SurveillanceNatural history cohort studyConfidence intervalsTreatment-emergent side effectsAcquired hematologic disorderPractice of treatmentSide effects of therapyCongenital platelet disordersInstitutional review board approvalAmerican ThrombosisAnti-drug antibodiesConnective tissue disordersReview board approvalTransfusion-transmitted infectionsPotential new therapiesVon Willebrand diseaseEffects of therapy
2019
A Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results
Zeidan A, DeAngelo D, Palmer J, Seet C, Tallman M, Wei X, Li Y, Hock N, Burgess M, Hege K, Stock W. A Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results. Blood 2019, 134: 1320. DOI: 10.1182/blood-2019-125363.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsR AMLHigh-risk myelodysplastic syndromeAnti-drug antibodiesAcute myeloid leukemiaMyelodysplastic syndromeADC therapeuticsJazz PharmaceuticalsDaiichi SankyoCelgene CorporationFebrile neutropeniaDose levelsDevelopment of ADAGrade treatment-emergent adverse eventsSerious treatment-emergent adverse eventsGeneral physical health deteriorationPhase I multicenter studyPrior stem cell transplantRefractory acute myeloid leukemiaRed blood cell transfusionBCR-ABL kinase domainAdvisory CommitteeAnti-CD47 monoclonal antibodyExcess blasts-2Grade 4 sepsis
2015
Changes in the amino acid sequence of the recombinant human factor VIIa analog, vatreptacog alfa, are associated with clinical immunogenicity
Mahlangu J, Weldingh K, Lentz S, Kaicker S, Karim F, Matsushita T, Recht M, Tomczak W, Windyga J, Ehrenforth S, Knobe K, Investigators F, Weltermann A, de Paula E, Cerqueira M, Zupancic‐Salek S, Katsarou O, Economou M, Nemes L, Boda Z, Santagostino E, Tagariello G, Hanabusa H, Fukutake K, Shima M, Serban M, Elezovic I, Savic A, Shen M, Chuansumrit A, Angchaisuksiri P, Kavakli K, Sasmaz I, Madan B, Giangrande P, Kempton C, Young G, Quon D, Ameri A, Kuriakose P, Obzut D, Wang M, Ortiz I. Changes in the amino acid sequence of the recombinant human factor VIIa analog, vatreptacog alfa, are associated with clinical immunogenicity. Journal Of Thrombosis And Haemostasis 2015, 13: 1989-1998. PMID: 26362483, DOI: 10.1111/jth.13141.Peer-Reviewed Original ResearchMeSH KeywordsAmino Acid SequenceAmino Acid SubstitutionAntibody SpecificityAntigen-Antibody ReactionsCross ReactionsEpitopesFactor VIIaHemophilia AHemorrhageHLA-D AntigensHumansImmunoglobulin GIsoantibodiesNeutralization TestsProtein Structure, TertiaryRecombinant ProteinsStructure-Activity RelationshipConceptsRecombinant human factor VIIaAnti-drug antibodiesVatreptacog alfaPhase III trialsIII trialsHemophilia patientsDevelopment of anti-drug antibodiesClinical immunogenicityAnti-drug antibody developmentImmunoglobulin G subtypeConfirmatory phase III trialTreatment of bleedingProlonged elimination phaseFollow-up evaluationHuman factor VIIaCross-reactive antibodiesEpitope mappingPost hoc analysisB patientsDouble-blindG subtypesAcute bleedingHemophilia AFactor VIIaPK profiles
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