MedPath

Tagged News

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 Study of CDX-0159 in Patients With Eosinophilic Esophagitis

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

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.

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.

Accord BioPharma Launches IMULDOSA Biosimilar at 92% Discount to STELARA

Monoclonal Antibody
  • Accord BioPharma has commercially launched IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA, with prefilled syringes priced at the lowest wholesaler acquisition cost among branded ustekinumab biosimilars at a 92% discount.
  • The FDA-approved biosimilar is indicated for the same conditions as STELARA, including moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adult and pediatric patients.
  • The company is offering a $0 co-pay program for eligible patients to expand access to this proven targeted biologic therapy for millions of Americans suffering from chronic immune-mediated inflammatory conditions.
  • This launch represents Accord BioPharma's third in-market biosimilar and establishes the foundation for their immunology franchise, backed by parent company Intas Pharmaceuticals' 50-year heritage.

CHOP Researchers Discover Novel RNA Fragments as Immunotherapy Targets for Pediatric Brain Tumors

CAR-TMonoclonal Antibody
  • Researchers at Children's Hospital of Philadelphia identified missing messenger RNA fragments called microexons in pediatric high-grade glioma tumors that could enhance immunotherapy effectiveness.
  • The study revealed that glioma cells skip specific NRCAM microexons, creating a tumor-specific protein variant essential for cancer cell migration and invasion.
  • Scientists developed a monoclonal antibody targeting the glioma-specific NRCAM protein that successfully marks tumor cells for destruction by T cells in preclinical studies.
  • The findings could lead to safer CAR-T cell therapies for brain tumors and may apply to other solid tumors including glioblastoma multiforme.

Pfizer's Inclacumab Fails Phase III Trial for Sickle Cell Disease, Marking Second Setback from Global Blood Therapeutics Acquisition

Monoclonal Antibody
  • Pfizer's investigational P-selectin inhibitor inclacumab failed to meet its primary endpoint of reducing vaso-occlusive crises in a Phase III trial for sickle cell disease.
  • The 48-week THRIVE-131 study enrolled 241 participants aged 16 and older but showed no significant difference in VOC rates compared to placebo.
  • This represents the second major disappointment from Pfizer's $5.4 billion acquisition of Global Blood Therapeutics, following Oxbryta's market withdrawal in 2024.
  • Despite the setback, Pfizer maintains its commitment to developing treatments for sickle cell disease patients and advancing research in this therapeutic area.

A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

NCT05348915Active, Not RecruitingPhase 3
Pfizer
Posted 3/29/2022

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

NCT04935879CompletedPhase 3
Pfizer
Posted 10/4/2021

MacroGenics Names Eric Risser as New CEO, Succeeding 24-Year Leader Scott Koenig

Leadership ChangeMonoclonal AntibodyOncologyFDA Approval
  • MacroGenics appointed Eric Risser as President and CEO effective August 13, 2025, replacing Scott Koenig who led the company for 24 years.
  • Risser brings nearly 30 years of biotech experience and has generated over $1.6 billion in non-dilutive capital through corporate development efforts since joining MacroGenics in 2009.
  • The leadership transition comes as MacroGenics focuses on developing innovative monoclonal antibody-based cancer therapeutics, with three FDA-approved products already in its portfolio.
  • Risser aims to create a more focused and capital-efficient biotechnology company that delivers high-value cancer therapies to patients.

Engineered CD40 Antibody Achieves Complete Cancer Remission in Phase 1 Trial

Monoclonal Antibody
  • A modified CD40 agonist antibody called 2141-V11 demonstrated remarkable efficacy in a phase 1 clinical trial, with six of 12 patients experiencing significant tumor reduction and two achieving complete remission.
  • The drug showed systemic anti-tumor effects when injected directly into tumors, causing cancer disappearance at both injected and distant sites without the severe toxicities associated with previous CD40 therapies.
  • Tissue analysis revealed the formation of tertiary lymphoid structures within tumors, creating immune-rich microenvironments that replaced cancerous tissue with organized immune cell aggregates.
  • Nearly 200 patients are now enrolled in follow-up phase 1 and phase 2 trials investigating the drug's effectiveness against specific aggressive cancers including bladder cancer, prostate cancer, and glioblastoma.

A Study Investigating the Safety and Tolerability of an Immune Treatment in Cancer Patients With Lesions to the Skin

NCT04059588CompletedPhase 1
Rockefeller University
Posted 1/16/2020

Alvotech Reports Record First Half 2025 Results with Over 200% Product Revenue Growth

Monoclonal Antibody
  • Alvotech achieved over 200% year-on-year growth in product revenues for the first six months of 2025, reaching $204.7 million compared to $65.9 million in the same period of 2024.
  • The company reported its best quarter in history for operating cash flows and completed strategic acquisitions including Xbrane's R&D facilities in Sweden and Ivers-Lee Group in Switzerland.
  • New commercial partnerships were expanded with Advanz Pharma covering four biosimilar candidates and a collaboration agreement was signed with Dr. Reddy's for AVT32, a pembrolizumab biosimilar.
  • Alvotech successfully raised approximately SEK 789 million through Swedish offerings and achieved its third stock exchange listing on Nasdaq Stockholm in May 2025.

Pilatus Biosciences Partners with Roche for First-in-Human Trial of PLT012 in Hepatocellular Carcinoma

Monoclonal Antibody
  • Pilatus Biosciences announced a clinical trial collaboration with Roche to evaluate PLT012 in combination with atezolizumab in a first-in-human Phase 1 trial for hepatocellular carcinoma patients.
  • PLT012 is designed to reprogram the immunosuppressive tumor microenvironment by targeting CD36-mediated lipid uptake, potentially enhancing immune activation when combined with checkpoint inhibitors.
  • The collaboration aims to overcome resistance mechanisms in hepatocellular carcinoma, where current checkpoint inhibitor monotherapies often fail to generate durable responses.
  • Hepatocellular carcinoma remains one of the leading causes of cancer-related death worldwide, representing a significant unmet medical need.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.