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iBio's IBIO-610 Activin E Antibody Shows 100-Day Human Half-Life Potential for Twice-Yearly Obesity Treatment

Monoclonal Antibody
  • iBio announces new non-human primate data for IBIO-610, a potentially first-in-class Activin E antibody, showing a 33.2-day half-life in obese primates and predicting up to 100 days in humans.
  • The extended half-life could enable twice-yearly dosing for obesity treatment, potentially improving patient experience compared to current frequent injection regimens.
  • Previous mouse model data demonstrated that IBIO-610 drives fat-selective weight loss, synergizes with GLP-1 therapies, and prevents weight regain after GLP-1 discontinuation.
  • The findings will be presented at ObesityWeek 2025, highlighting IBIO-610's potential as a next-generation therapy addressing biology beyond appetite control.

ArkBio Launches Phase II Trial of AK0610 Monoclonal Antibody for RSV Prevention in Infants

Monoclonal Antibody
  • Shanghai Ark Biopharmaceutical has initiated a Phase II clinical trial of AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus infection in healthy infants.
  • The multicenter, randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, and pharmacokinetics across five centers in China, led by Beijing Children's Hospital and West China Second Hospital.
  • AK0610 targets the pre-fusion F protein of RSV and demonstrates robust neutralizing activity across RSV variants, with preclinical data showing strong antiviral activity and an excellent safety profile.
  • The antibody's extended half-life may enable season-long protection with a single dose, addressing the significant healthcare burden of RSV infections in China's large infant population.

Mayo Clinic Develops Novel Approach to Enhance Cancer Immunotherapy by Targeting Myeloid Cells

Monoclonal Antibody
  • Mayo Clinic researchers have identified myeloid cells as key targets to enhance cancer immunotherapy, with two collaborative teams demonstrating that manipulating these "first-responder" immune cells can boost tumor-killing T cell activity.
  • The research teams developed an antibody called H1A that prevents PD-L1 protein recycling in myeloid cells, leading to enhanced T cell activation and improved cancer-fighting capacity.
  • A paradigm shift in PD-L1 immunotherapy has emerged, showing that macrophages can be directly reprogrammed to become more pro-inflammatory and better T cell activators.
  • Based on these findings, Mayo Clinic is planning a phase 1 clinical trial of H1A to address immunotherapy resistance and expand treatment options for cancer patients.

CounterX Therapeutics' Anti-Fentanyl Antibody CTRX-101 Reverses Overdose in Preclinical Study

Monoclonal Antibody
  • CounterX Therapeutics published preclinical data in The Journal of Pharmacology and Experimental Therapeutics showing CTRX-101 rapidly reverses fentanyl-induced respiratory depression.
  • The monoclonal antibody works by binding to fentanyl and sequestering it in the bloodstream, preventing lethal effects on the brain and respiratory system.
  • CTRX-101 is being developed as a long-acting subcutaneous injection for preventing fentanyl overdose in high-risk patients with opioid use disorder.
  • The therapy addresses a critical medical need, as fentanyl overdose causes approximately 50,000 deaths and over 700,000 emergency department visits annually in the US.

Johnson & Johnson Launches First Head-to-Head FcRn Blocker Study in Myasthenia Gravis

Monoclonal Antibody
  • Johnson & Johnson announced the EPIC Phase 3b study, the first head-to-head comparison of FcRn blockers IMAAVY and efgartigimod in generalized myasthenia gravis patients.
  • New pediatric data from the Vibrance-MG study showed IMAAVY achieved sustained 73% reduction in IgG levels and maintained disease control through 72 weeks in patients aged 12 and older.
  • IMAAVY is currently the only FcRn blocker approved for both adult and pediatric gMG patients with anti-AChR or anti-MuSK antibodies, offering sustained disease control across key antibody subtypes.

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

NCT05265273RecruitingPhase 2
Janssen Research & Development, LLC
Posted 7/20/2022

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

NCT04119050RecruitingPhase 2
Janssen Research & Development, LLC
Posted 8/15/2019

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

NCT05379634Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 7/5/2022

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

NCT06449651RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/11/2024

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT05327114RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/23/2022

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

NCT04882878CompletedPhase 2
Janssen Research & Development, LLC
Posted 8/20/2021

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

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

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

NCT05912517RecruitingPhase 3
Janssen Research & Development, LLC
Posted 12/20/2023

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

NCT03842189CompletedPhase 2
Janssen Research & Development, LLC
Posted 4/5/2018

A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

NCT04968912CompletedPhase 2
Janssen Research & Development, LLC
Posted 9/21/2021

UCB Presents New Clinical Data for Two Myasthenia Gravis Therapies at Major Medical Conferences

Monoclonal AntibodyDrug ApprovalRare Disease
  • UCB will present 18 abstracts at the 2025 AANEM Annual Meeting and MGFA Scientific Session, showcasing new data on rozanolixizumab (RYSTIGGO) and zilucoplan (ZILBRYSQ) for generalized myasthenia gravis treatment.
  • Key presentations include post hoc analyses on corticosteroid dose tapering with rozanolixizumab from the Phase 3 MycarinG study and quality of life improvements with zilucoplan from the RAISE-XT trial.
  • The data encompasses long-term safety profiles, treatment effectiveness, and real-world insights from patient management applications, reinforcing UCB's commitment to advancing gMG care.

Domain Therapeutics Initiates First-in-Human Trial of DT-7012 Anti-CCR8 Antibody for Advanced Solid Tumors

Monoclonal Antibody
  • Domain Therapeutics has dosed the first patients in its Phase I/II DOMISOL trial of DT-7012, a differentiated Treg-depleting anti-CCR8 monoclonal antibody for treating advanced solid tumors.
  • DT-7012 demonstrates unique properties including unprecedented selectivity in depleting intratumoral regulatory T cells while maintaining depletion efficiency in challenging tumor microenvironments.
  • The open-label, multicenter trial is evaluating safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in adult patients with selected advanced solid tumors across Australian clinical sites.
  • The therapy targets a significant unmet need by addressing Treg-mediated immune suppression that drives resistance to immune checkpoint inhibitors and limits their effectiveness in cancer treatment.

Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors

NCT06819735RecruitingPhase 1
Domain Therapeutics Australia Pty Ltd
Posted 6/25/2025

Genentech's Gazyva Shows Significant Efficacy in Phase III Trial for Pediatric Idiopathic Nephrotic Syndrome

Monoclonal Antibody
  • Gazyva (obinutuzumab) demonstrated statistically significant superiority over mycophenolate mofetil in achieving sustained complete remission at week 52 in children and young adults with idiopathic nephrotic syndrome.
  • The INShore study represents the first global Phase III trial of a targeted therapy for this chronic kidney disease commonly diagnosed in early childhood.
  • Key secondary endpoints showed clinically meaningful benefits including increased relapse-free survival, reduced cumulative corticosteroid dose, and fewer relapses compared to standard treatment.
  • If approved, Gazyva could provide a steroid-sparing treatment option for a patient population with limited therapeutic alternatives and high relapse rates exceeding 70%.

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

NCT05627557Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 3/29/2023

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

NCT04963296Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/26/2021

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

NCT04221477Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 8/10/2020

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

NCT04629248Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 6/25/2021

Fate Therapeutics Advances Two Phase 1 CAR-T Cell Therapy Studies for Advanced Solid Tumors

CAR-TMonoclonal Antibody
  • Fate Therapeutics is conducting two Phase 1 clinical studies evaluating off-the-shelf CAR-T cell therapies FT836 and FT825 for advanced solid tumors including lung, colorectal, breast, ovarian, and HER2-positive cancers.
  • The FT836 study, which began in October 2025, tests the therapy alone or combined with chemotherapy and monoclonal antibodies like trastuzumab and cetuximab to establish recommended Phase 2 dosing.
  • The FT825 study, initiated in January 2024, focuses on HER2-positive and other advanced solid tumors, evaluating the therapy with or without cetuximab to assess safety, tolerability, and antitumor activity.
  • Both studies represent significant advances in off-the-shelf CAR-T cell therapy development, potentially positioning Fate Therapeutics as a leader in innovative cancer treatments for solid tumors.

FDA Approves Simplified Single-Injection Maintenance Regimen for Lilly's Omvoh in Ulcerative Colitis

Drug ApprovalMonoclonal Antibody
  • The FDA has approved a single-injection, once-monthly maintenance regimen for Omvoh (mirikizumab-mrkz) in adults with moderately to severely active ulcerative colitis, replacing the previous two-injection regimen.
  • The approval is based on a Phase 1 bioequivalence study demonstrating that one 200 mg/2 mL subcutaneous injection delivers the same proven results as two 100 mg/1 mL injections.
  • The simplified dosing regimen will be available in the U.S. via prefilled pen or prefilled syringe in early 2026, following recent European Union authorization for the same indication.
  • This marks the third FDA approval for Omvoh in 2025, following approvals for Crohn's disease and a citrate-free formulation, reinforcing Lilly's commitment to improving patient treatment experience.

A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

NCT05767021Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 5/17/2023

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

NCT03519945Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 7/18/2018

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