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Inmagene Initiates Phase 2b Trial of IMG-007 Anti-OX40 Antibody for Moderate-to-Severe Atopic Dermatitis

Monoclonal Antibody
  • Inmagene Biopharmaceuticals has dosed the first patient in its ADAPTIVE Phase 2b trial evaluating IMG-007, a non-depleting anti-OX40 monoclonal antibody, for moderate-to-severe atopic dermatitis treatment.
  • The randomized, placebo-controlled trial will enroll approximately 220 patients across four treatment arms to evaluate multiple subcutaneous dose regimens over 52 weeks total.
  • IMG-007 features an extended half-life of 34.7 days and silenced antibody-dependent cell-mediated cytotoxicity function, potentially minimizing safety risks while enabling convenient dosing.
  • Topline results from the dose-finding study are expected in Q4 2026 and will guide optimal dosing regimens for future Phase 3 clinical trials.

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

NCT07037901RecruitingPhase 2
Inmagene LLC
Posted 6/17/2025

Bio Usawa and Bioeq AG Partner to Bring Ranibizumab Biosimilar to Sub-Saharan Africa

Monoclonal Antibody
  • Bio Usawa Biotechnology and Bioeq AG announced a partnership to commercialize ranibizumab biosimilar BioUcenta™ across Sub-Saharan Africa, targeting diabetic macular edema and wet age-related macular degeneration.
  • The collaboration addresses a critical healthcare gap as more than 24 million Africans lived with diabetes in 2024, with diabetic retinopathy threatening sight in up to one-third of patients.
  • BioUcenta™, already approved in Europe and the United States, will be administered via intravitreal injection to block abnormal blood vessel growth and prevent fluid leakage in the retina.
  • This partnership represents a new model for global health equity, demonstrating how strategic collaborations can extend life-saving medical advances to underserved populations facing preventable blindness.

Oncternal Therapeutics Sells ROR1-Targeting Programs to Ho'ola Therapeutics for $68 Million Deal

Monoclonal AntibodyCAR-T
  • Oncternal Therapeutics has sold its zilovertamab monoclonal antibody and ONCT-808 CAR-T cell therapy programs to Ho'ola Therapeutics for $3 million upfront and up to $65 million in milestone payments.
  • Both investigational therapies target ROR1 (Receptor Tyrosine Kinase-Like Orphan Receptor 1), with zilovertamab being a monoclonal antibody and ONCT-808 an autologous CAR-T therapy using zilovertamab's binding domain.
  • Following the asset sale completed on June 27, 2025, Oncternal has appointed Craig R. Jalbert to oversee the company's wind-down operations and future distribution of milestone payments.
  • The milestone structure includes up to $5 million for development achievements, $40 million for regulatory approvals, and $20 million for sales thresholds across major markets including the US, Europe, and Japan.

Amgen's Bemarituzumab Shows Significant Survival Benefit in Phase 3 Gastric Cancer Trial

Monoclonal AntibodyTargeted TherapyOncology
  • Amgen's Phase 3 FORTITUDE-101 trial met its primary endpoint, demonstrating that bemarituzumab plus chemotherapy significantly improved overall survival compared to chemotherapy alone in patients with FGFR2b-positive gastric cancer.
  • The study enrolled 547 patients across 300 sites in 37 countries, targeting those with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who were non-HER2 positive.
  • Bemarituzumab represents the first positive Phase 3 results for an FGFR2b-targeted monoclonal antibody in gastric cancer, addressing a critical unmet need in a disease that causes over 650,000 deaths globally each year.
  • While the treatment showed efficacy, ocular adverse events occurred with greater frequency and severity in the bemarituzumab arm compared to the Phase 2 experience.

Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

NCT05052801Active, Not RecruitingPhase 3
Amgen
Posted 3/7/2022

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

NCT05111626Active, Not RecruitingPhase 3
Amgen
Posted 3/14/2022

WuXi Biologics Launches WuXiHigh²2.0 Platform Achieving Record 230 mg/mL Protein Concentrations

Monoclonal Antibody
  • WuXi Biologics has launched WuXiHigh²2.0, a high-throughput formulation development platform that enables protein concentrations up to 230 mg/mL, surpassing the current FDA-approved maximum of 200 mg/mL.
  • The platform reduces viscosity by up to 90% while maintaining formulation stability through proprietary excipient blends and high-throughput prediction instruments.
  • High-concentration biologics offer significant advantages including reduced injection volumes, improved dosing efficiency, and enhanced patient adherence, with over 20% of FDA-approved monoclonal antibodies now using high-concentration formulations.
  • The technology addresses key manufacturing challenges of high viscosity and aggregation that typically complicate production and compromise product stability in high-concentration biologics.

Faron Research Reveals Novel Immune Evasion Mechanism, Validates Bexmarilimab's Therapeutic Approach

Monoclonal Antibody
  • Faron-supported research published in Theranostics identified secreted Clever-1 (sClever-1) as a key immunosuppressive mediator that impairs T-cell responses and contributes to anti-PD-1 therapy resistance in cancer patients.
  • The study analyzed plasma samples from 139 breast cancer patients and 193 bexmarilimab-treated participants, demonstrating that sClever-1 levels were significantly elevated in cancer patients compared to healthy individuals.
  • Bexmarilimab treatment significantly reduced circulating sClever-1 levels in patients, correlating with decreased T-cell engagement and providing mechanistic validation for the drug's immune-activating properties.
  • High sClever-1 levels were associated with resistance to anti-PD-1 checkpoint inhibitors, suggesting potential utility as a biomarker for guiding immunotherapy treatment strategies.

argenx Advances ARGX-119 to Registrational Study for Ultra-Rare Congenital Myasthenic Syndromes

Monoclonal Antibody
  • argenx announced plans to advance ARGX-119, a first-in-class muscle-specific kinase agonist antibody, to registrational studies following positive Phase 1b results in DOK7 congenital myasthenic syndromes.
  • The Phase 1b study demonstrated favorable safety and tolerability with consistent functional improvements across multiple efficacy measures including Six-Minute Walk Test, QMG score, and MG-ADL score over 12 weeks.
  • ARGX-119 represents the sixth molecule from argenx's Immunology Innovation Program to show proof-of-concept, targeting an ultra-rare disorder affecting approximately 1.2 per million people with no approved treatments.

Seven-Year US Safety Data Confirms Brodalumab's Stable Risk Profile in Psoriasis Treatment

Monoclonal Antibody
  • A comprehensive seven-year US pharmacovigilance analysis of brodalumab covering 5,449 patients and 7,845 patient-years of exposure shows no completed suicides and only one suicide attempt in year 3.
  • The study confirms brodalumab's consistent safety profile with arthralgia remaining the most common adverse event (140 cases) and low rates of serious infections (2.17/100 patients) compared to other biologic therapies.
  • Adverse event rates for major safety concerns including cardiovascular events (0.24/100 patients), malignancy (1.01/100 patients), and inflammatory bowel disease (0.06/100 patients) remained lower than comparative registry data.
  • The analysis reinforces that brodalumab maintains good tolerability with no new safety signals emerging during the extended monitoring period despite its boxed warning for suicidal ideation.

Alzheimer's Drug Market Sees 780% Investment Surge Following Leqembi and Kisunla Approvals

Monoclonal AntibodyDrug Approval
  • Total M&A deal value in Alzheimer's disease jumped from $2 billion in 2022 to $18 billion in 2024, representing a 780% increase following the approval of disease-modifying treatments.
  • Biogen's Leqembi demonstrates superior safety with 12.6% ARIA-E incidence compared to Lilly's Kisunla at 24%, positioning it for greater market share despite both drugs' modest initial sales performance.
  • Major pharmaceutical companies including AbbVie, Sanofi, and Johnson & Johnson have made significant acquisitions totaling billions, signaling renewed confidence in Alzheimer's therapeutic development.
  • The FDA-approved Lumipulse blood test provides cost-effective diagnostic support for Leqembi at $200-$300 versus traditional PET scans costing $3,000-$5,000, improving patient access and clinical workflow integration.

FDA Approves Gamifant as First Treatment for Macrophage Activation Syndrome in Still's Disease

Drug ApprovalMonoclonal AntibodyRare Disease
  • The FDA has approved Gamifant (emapalumab-lzsg) as the first-ever treatment for adults and children with macrophage activation syndrome in Still's disease, marking a significant breakthrough for patients with this life-threatening condition.
  • Clinical trials demonstrated that 54% of patients achieved complete response at week 8, with 82% reaching clinical MAS remission, providing new hope for managing severe hyperinflammation.
  • This approval addresses a critical unmet medical need for patients with MAS, offering an alternative to high-dose glucocorticoids and potentially reducing reliance on conventional therapies with significant side effects.

Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE

NCT05001737CompletedPhase 3
Swedish Orphan Biovitrum
Posted 12/15/2021

Phase 3 Efficacy and Safety Study of GTX-102 in Pediatric Subjects With Angelman Syndrome (AS)

NCT06617429Active, Not RecruitingPhase 3
Ultragenyx Pharmaceutical Inc
Posted 12/3/2024

A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)

NCT03311854CompletedPhase 2
Swedish Orphan Biovitrum
Posted 2/20/2018

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