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Rituximab Outperforms Cladribine in Real-World Multiple Sclerosis Study

Monoclonal AntibodyReal World Evidence
  • A Norwegian observational study of 285 RRMS patients found rituximab demonstrated superior disease control compared to cladribine, with only 17% showing new MRI activity versus 57% for cladribine over 4 years.
  • Rituximab-treated patients experienced significantly lower relapse rates (6% vs 17%) and treatment discontinuation rates (7% vs 21%), with patients remaining free from new MRI activity for an average of 16.8 months longer.
  • The study showed rituximab patients had better disability improvement outcomes (21% vs 4%) and were 15.9 times more likely to achieve NEDA-3 status, though hospitalization rates for adverse effects were comparable between treatments.
  • Both treatments demonstrated similar safety profiles overall, with no deaths reported and comparable infection rates, though more rituximab patients were hospitalized for COVID-19 during the pandemic period.

Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)

NCT04121403CompletedPhase 3
Oslo University Hospital
Posted 10/16/2019

Celldex's Barzolvolimab Phase 2 Trial Provides Key Insights into Mast Cell Role in Eosinophilic Esophagitis

Monoclonal Antibody
  • Celldex Therapeutics' Phase 2 study of barzolvolimab in eosinophilic esophagitis met its primary endpoint, achieving profound mast cell depletion with statistical significance (p<0.0001).
  • Despite achieving a 65% reduction in esophageal mast cells, the treatment failed to improve clinical symptoms or endoscopic disease measures compared to placebo.
  • The results provide direct evidence that mast cells are not primary drivers of EoE pathogenesis, leading Celldex to discontinue development in this indication.
  • Barzolvolimab demonstrated a favorable safety profile and continues development in other mast cell-driven conditions including chronic urticaria and atopic dermatitis.

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

NCT05368285CompletedPhase 2
Celldex Therapeutics
Posted 5/19/2022

A Study of CDX-0159 in Patients With Eosinophilic Esophagitis

NCT05774184Active, Not RecruitingPhase 2
Celldex Therapeutics
Posted 6/1/2023

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

NCT06455202RecruitingPhase 3
Celldex Therapeutics
Posted 7/19/2024

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

NCT06445023RecruitingPhase 3
Celldex Therapeutics
Posted 7/11/2024

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

NCT05583227Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/10/2022

A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

NCT04538794CompletedPhase 1
Celldex Therapeutics
Posted 9/24/2020

FDA Approves Nipocalimab for Myasthenia Gravis as Pipeline Advances with 20+ Novel Therapies

Drug ApprovalMonoclonal Antibody
  • The FDA approved nipocalimab (Imaavy) in May 2025 as the first therapy targeting the underlying cause of generalized myasthenia gravis in patients aged 12 and older with specific antibodies.
  • Over 20 companies are developing 22+ novel myasthenia gravis therapies, including promising candidates like Descartes-08, Telitacicept, and batoclimab showing sustained efficacy in Phase 2b and Phase 3 trials.
  • Recent clinical developments include Cartesian Therapeutics reporting 12-month sustained improvement with Descartes-08 and RemeGen sharing positive Phase 3 results for Telitacicept at the 2025 AAN Annual Meeting.

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

NCT04951622Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 7/15/2021

Descartes-08 for Patients With Systemic Lupus Erythematosus

NCT06038474RecruitingPhase 2
Cartesian Therapeutics
Posted 2/12/2024

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

NCT05403541Active, Not RecruitingPhase 3
Immunovant Sciences GmbH
Posted 6/27/2022

Study of Telitacicept in Generalized Myasthenia Gravis

NCT05737160CompletedPhase 3
RemeGen Co., Ltd.
Posted 3/28/2023

FDA Issues Complete Response Letter for Darzalex Faspro in Newly Diagnosed Multiple Myeloma

Monoclonal AntibodyDrug Approval
  • The FDA issued a complete response letter for Johnson & Johnson's supplemental biologics license application for Darzalex Faspro in combination with VRd for newly diagnosed, transplant-ineligible multiple myeloma patients.
  • The CRL cited observations from facility inspections and was not related to safety and efficacy data, with no additional clinical studies requested by the FDA.
  • The phase 3 CEPHEUS trial demonstrated that D-VRd achieved significantly higher minimal residual disease negativity rates (60.9% vs 39.4%) compared to standard VRd treatment.
  • Darzalex Faspro remains available for all nine currently approved multiple myeloma indications in the United States with no impact on supply or availability.

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

NCT03652064Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/6/2018

āshibio Licenses Vantictumab for Rare Bone Disease ADO2 in Strategic Pipeline Expansion

Monoclonal AntibodyRare Disease
  • āshibio has secured an exclusive global licensing agreement with Mereo BioPharma for vantictumab, a first-in-class monoclonal antibody targeting autosomal dominant osteopetrosis type 2 (ADO2).
  • ADO2 affects 1 in 20,000 births and causes dense, brittle bones leading to multiple fractures, poor healing, and nerve compression, with no currently approved therapies available.
  • Vantictumab inhibits Wnt signaling pathways and has demonstrated favorable safety profiles in previous oncology trials, with biomarker data supporting its activity on osteoclast function.
  • The licensing agreement grants āshibio worldwide development and commercialization rights excluding Europe, where Mereo retains commercial rights.

Invivyd's PEMGARDA Maintains Neutralizing Activity Against Dominant XFG COVID-19 Variant

Monoclonal Antibody
  • Invivyd announced that PEMGARDA (pemivibart) demonstrates continued neutralizing activity against the currently dominant XFG SARS-CoV-2 variant, maintaining efficacy as COVID-19 infections rise across 34 U.S. states.
  • The company's next-generation monoclonal antibody candidate VYD2311 showed similarly consistent and highly potent neutralization results against XFG and other circulating variants.
  • Both antibodies target structurally stable epitopes on the SARS-CoV-2 spike protein, with Invivyd estimating that every clinical variant since Omicron BA.2 has remained susceptible to pemivibart.
  • The neutralization data will be provided to the FDA imminently for potential inclusion in PEMGARDA's healthcare provider fact sheet, supporting continued use in immunocompromised patients.

First-in-Class Monoclonal Antibody Shows Promise Against Sepsis-Induced Immune Dysregulation

Monoclonal Antibody
  • Researchers at University of Virginia and University of Michigan developed a humanized monoclonal antibody targeting citrullinated histone H3 to combat sepsis, which kills approximately 11 million people worldwide annually.
  • Initial mouse studies demonstrate the antibody can prevent cytokine storms and restore macrophage function without unwanted immune suppression, showing potential for treating ARDS and autoimmune disorders.
  • The team received $800,000 from Virginia Catalyst to launch clinical trials, with the antibody engineered for clinical application alongside a diagnostic platform called PEdELISA.
  • The research identified molecular mechanisms in macrophages that drive sepsis-related inflammatory feedback loops, which the antibody successfully interrupts.

Novel Monoclonal Antibody Stapokibart Demonstrates Significant Efficacy in Severe Chronic Rhinosinusitis with Nasal Polyps

Monoclonal Antibody
  • A 24-week double-blind, placebo-controlled trial published in JAMA showed stapokibart, a novel monoclonal antibody, significantly reduced nasal polyp size and symptom severity when combined with daily intranasal corticosteroids.
  • Stapokibart targets the interleukin-5 receptor alpha subunit (IL-5Rα) on eosinophils and basophils, effectively curtailing eosinophil survival and tissue infiltration to attenuate chronic inflammation responsible for polyp proliferation.
  • Patients treated with stapokibart reported notable improvements in nasal obstruction, rhinorrhea, facial pressure, and olfactory dysfunction, with clinically meaningful declines in SNOT-22 scores.
  • The therapy demonstrated a favorable safety profile with mild and transient side effects including nasopharyngitis and headache, with no serious adverse events or immunogenicity concerns reported.

Genentech Initiates First Patent Litigation Against Pertuzumab Biosimilar HLX11

Monoclonal AntibodyFDA Approval
  • Genentech filed the first BPCIA litigation against Shanghai Henlius Biotech and Organon on August 14, 2025, alleging infringement of 24 patents by their proposed pertuzumab biosimilar HLX11.
  • The lawsuit represents the first patent challenge for a pertuzumab biosimilar, with Henlius and Organon's aBLA being the only publicly announced application currently pending with the FDA.
  • Genentech asserted 24 of the 47 patents it had listed during the BPCIA patent dance, including 10 method of treatment patents and 10 manufacturing patents.
  • The litigation seeks injunctive relief to prevent commercialization of HLX11 and damages for alleged patent infringement under the BPCIA framework.

Cantargia Appoints Biotech Veteran Dr. Hilde Steineger as CEO to Lead IL1RAP-Targeted Therapy Development

Monoclonal AntibodyOncology
  • Cantargia has appointed Dr. Hilde Steineger as Chief Executive Officer effective September 1, bringing extensive biotech leadership experience including a $480M deal with Novo Nordisk.
  • The appointment comes as Cantargia advances two IL1RAP-targeted product candidates in clinical trials, including nadunolimab for cancer treatment and CAN10 for autoimmune diseases.
  • Dr. Steineger will lead the company's strategic partnership with Otsuka Pharmaceuticals and build on the recent CAN10 program acquisition deal.
  • The leadership transition reflects Cantargia's maturation as a clinical-stage biotechnology company with significant pharmaceutical partnerships.

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