MedPath

Tagged News

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.

Influenza Pipeline Surges with 120+ Therapies as Moderna, AstraZeneca Lead Innovation Wave

Monoclonal AntibodyDrug Approval
  • The global influenza pipeline has expanded to include 120+ companies developing 120+ treatment therapies, with breakthrough innovations spanning vaccines, antibodies, and combination therapies.
  • Moderna's mRNA-1083 combination vaccine achieved primary endpoints in Phase III trials, demonstrating stronger immune responses than licensed comparator vaccines for both influenza and COVID-19.
  • AstraZeneca launched FluMist Home in August 2025, marking the first FDA-approved influenza vaccine for self-administration or caregiver delivery at home.
  • Leading pipeline candidates include Moderna's mRNA-1010 seasonal vaccine, SAB Biotherapeutics' broadly neutralizing antibody SAB-176, and innovative intranasal therapies targeting multiple respiratory viruses.

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.

Acumen Pharmaceuticals Advances Alzheimer's Pipeline with JCR Partnership and ALTITUDE-AD Phase 2 Trial

Monoclonal Antibody
  • Acumen Pharmaceuticals expects topline results from its Phase 2 ALTITUDE-AD study evaluating sabirnetug for early Alzheimer's disease in late 2026, with the trial having enrolled 542 participants.
  • The company announced a collaboration with JCR Pharmaceuticals to develop Enhanced Brain Delivery therapy combining Acumen's oligomer-targeting antibodies with JCR's blood-brain barrier-penetrating technology.
  • Sabirnetug demonstrated 8,750-fold selectivity for amyloid beta oligomers over monomers and achieved the highest binding affinities among tested monoclonal antibodies in surface plasmon resonance testing.
  • The company maintains $166.2 million in cash reserves expected to support operations into early 2027, while implementing cost-efficient screening strategies that reduced trial costs by approximately 40%.

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

NCT06335173Active, Not RecruitingPhase 2
Acumen Pharmaceuticals
Posted 2/29/2024

Early Long COVID Trials of Paxlovid and Monoclonal Antibodies Show No Significant Benefits, But Research Continues

Monoclonal Antibody
  • Three prominent clinical trials testing Paxlovid and monoclonal antibodies for Long COVID failed to show significant health improvements compared to placebo groups.
  • The trials were designed as "proof of concept" studies to test viral persistence theory, with researchers acknowledging they expected challenging results but hoped for better outcomes.
  • Future trials are being designed with longer treatment durations, larger patient populations, and more specific biomarkers to better target viral persistence in Long COVID patients.
  • New monoclonal antibody trials are underway, including sipavibart at Nova Southeastern University and planned studies with Pemgarda, which may offer longer-lasting effects than short-course antivirals.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.