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Real-World Study Reveals Lower Immune-Related Adverse Events in Latin American Liver Cancer Patients Treated with Atezolizumab-Bevacizumab

Monoclonal AntibodyOncologyReal World Evidence
  • A multinational study of 99 Latin American patients with unresectable hepatocellular carcinoma found only 18% experienced immune-related adverse events (irAEs) with atezolizumab-bevacizumab therapy, significantly lower than clinical trial rates.
  • Most irAEs were mild to moderate, primarily affecting the liver and thyroid, with half resolving within 30 days and only eight patients requiring steroid treatment.
  • Patients with elevated baseline alpha-fetoprotein levels (≥400 ng/mL) showed significantly higher risk for developing irAEs, potentially serving as a predictive biomarker.
  • The occurrence of immune-related side effects did not impact overall survival, with both groups achieving identical median survival of 18.5 months.

Enhanced Premedication Protocol Reduces Infusion Reactions in NSCLC Patients Receiving Amivantamab

Monoclonal AntibodyTargeted Therapy
  • The SKIPPirr trial demonstrated that an enhanced premedication protocol significantly reduced infusion-related reactions (IRRs) for amivantamab from 67% to 22.5% in NSCLC patients.
  • The protocol includes dexamethasone 8 mg twice daily for two days prior to infusion plus standard premedications with diphenhydramine and acetaminophen.
  • Current NSCLC management faces critical gaps including optimal approaches for early-stage disease, tumor heterogeneity challenges, and understanding immunotherapy nonresponse mechanisms.
  • Institutional hypersensitivity guidelines are recommended for common NSCLC treatments including platinum agents, taxanes, monoclonal antibodies, and immunotherapy agents.

Novel Nasal Spray Foralumab Shows Promise in Reducing Brain Inflammation in Alzheimer's Patient

Monoclonal Antibody
  • Researchers at Mass General Brigham have repurposed foralumab, a monoclonal antibody nasal spray initially developed for multiple sclerosis, to target brain inflammation in Alzheimer's disease.
  • The first Alzheimer's patient to receive the treatment, Joe Walsh, has shown reduced brain inflammation after six months, with his wife reporting improved social engagement despite continued language difficulties.
  • Unlike traditional Alzheimer's treatments that target amyloid plaques and tau tangles, foralumab works by inducing regulatory cells that suppress inflammation, potentially slowing disease progression with minimal side effects.

FDA Sets October 2025 Decision Date for Xbrane's Ranibizumab Biosimilar Application

Monoclonal Antibody
  • Xbrane Biopharma has received an FDA decision date of October 21, 2025 for its biosimilar candidate to Lucentis (ranibizumab) following BLA resubmission in December 2024.
  • The approval remains contingent on successful re-inspections of manufacturing sites, which have already addressed previous FDA observations and submitted required documentation.
  • If approved, Xbrane's biosimilar aims to provide a cost-effective alternative for patients with age-related macular degeneration, retinal vein occlusion, and myopic choroidal neovascularization.

Boehringer Ingelheim Reports Promising Results for SIRP Inhibitors in Cancer Immunotherapy Trials

Monoclonal AntibodyOncology
  • Boehringer Ingelheim's SIRP inhibitor BI 765063, when combined with PD-1 inhibitor ezabenlimab and cetuximab, showed manageable safety and promising antitumor activity in patients with recurrent/metastatic head and neck cancer.
  • The company's next-generation SIRP inhibitor, BI 770371, demonstrated good tolerability both alone and in combination with ezabenlimab in patients with advanced solid tumors, with no dose-limiting toxicities observed.
  • Both antibodies work by blocking the "don't eat me" signal cancer cells use to evade immune detection, potentially enabling immune cells like macrophages to better recognize and destroy tumor cells.

RWJBarnabas Health and Rutgers Cancer Institute to Present 45 Groundbreaking Studies at ASCO 2025

OncologyPrecision MedicineMonoclonal Antibody
• Researchers from RWJBarnabas Health and Rutgers Cancer Institute will showcase 45 innovative cancer studies at the 2025 ASCO Annual Meeting, highlighting advances across multiple tumor types and treatment approaches.
• A notable multisite randomized trial demonstrated that problem-solving skills training significantly improved depression, anxiety, and quality of life in young adults newly diagnosed with cancer compared to standard care.
• New research revealed that patients living in both food and clinical trial deserts had 27% lower likelihood of breast cancer trial enrollment, highlighting how geographic and socioeconomic barriers impact cancer care access.

Shilpa Biologicals Expands ADC Capabilities with New Bioconjugation Facility in India

OncologyMonoclonal Antibody
  • Shilpa Biologicals has opened a dedicated bioconjugation suite at its Dharwad, India site, positioning itself among select global CDMOs capable of providing end-to-end antibody-drug conjugate manufacturing services.
  • The new facility features 200L single-use bioconjugation reactors and lyophilization capacity of up to 65 kg, with validation underway and client program onboarding expected by September 2025.
  • This strategic expansion strengthens India's biopharma manufacturing sector and addresses growing global demand for ADCs and other advanced bioconjugate therapies for targeted cancer treatment.

FDA Approves GSK's Nucala for COPD Treatment, Expanding Options for "Smoker's Lung"

Monoclonal AntibodyDrug Approval
  • The FDA has approved GSK's monoclonal antibody Nucala as an add-on treatment for patients with chronic obstructive pulmonary disease (COPD), commonly known as "smoker's lung."
  • In late-stage clinical trials, Nucala reduced COPD exacerbations by 21% compared to placebo when combined with standard inhaled maintenance therapy over a 104-week period.
  • The approval expands treatment options for COPD, joining Sanofi/Regeneron's Dupixent and Verona Pharma's Ohtuvayre in addressing this condition that is the fourth leading cause of death worldwide.

Biogen Sues Neurimmune Over Rights to Novel Alzheimer's Bispecific Antibody Technology

NeurologyMonoclonal Antibody
  • Biogen has filed a lawsuit against Neurimmune seeking declaratory judgment that their 2007 Collaboration Agreement does not give Neurimmune rights to Biogen's bispecific antibody technology for Alzheimer's disease.
  • The disputed technology features a bispecific antibody that targets both the transferrin receptor on the blood-brain barrier and amyloid-beta plaques, potentially offering a novel approach to Alzheimer's treatment.
  • Biogen claims the antibody is part of their proprietary Tissue-Enhanced Delivery Platform designed to help molecules cross the blood-brain barrier, which was developed independently of their collaboration with Neurimmune.

AstraZeneca's Gremubamab Shows Promise in Reducing Pseudomonas Infection in Bronchiectasis Patients

Monoclonal Antibody
  • Phase II trial results presented at ATS 2025 demonstrate gremubamab's ability to significantly reduce Pseudomonas aeruginosa bacterial load in bronchiectasis patients, potentially offering an alternative to antibiotics.
  • The bispecific monoclonal antibody showed meaningful improvements in quality of life measures, with over 38% of treated patients achieving clinically significant improvements in respiratory questionnaire scores versus 8.3% on placebo.
  • Higher-dose gremubamab (1,500mg) significantly prolonged time to first exacerbation compared to placebo, suggesting potential clinical benefits beyond bacterial load reduction.

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