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Panitumumab Plus FOLFOX Significantly Improves Survival in RAS/BRAF Wild-Type Locally Advanced Colon Cancer

  • Exploratory findings from the FOxTROT trial reveal that adding panitumumab to neoadjuvant FOLFOX chemotherapy significantly reduced recurrence and improved survival in patients with RAS/BRAF wild-type locally advanced colon cancer.
  • The combination therapy demonstrated impressive results with a 49% reduction in disease-free survival risk (HR, 0.51), 77% reduction in colon cancer death risk (HR, 0.23), and 64% improvement in overall survival (HR, 0.36) compared to FOLFOX alone.
  • These results provide the first evidence that anti-EGFR therapy can improve long-term cancer control in locally advanced colon cancer, validating molecular selection for targeted therapy in non-metastatic disease.

Novel Antibody PLT012 Targets Fat Metabolism to Overcome Immunotherapy Resistance in Cancer

  • Ludwig Cancer Research scientists developed PLT012, a humanized antibody that blocks the CD36 fat transporter to restore immune function in tumors that exploit fat metabolism for immune evasion.
  • Preclinical studies in hepatocellular carcinoma and colon cancer liver metastases demonstrated PLT012's effectiveness both as monotherapy and in combination with checkpoint inhibitors.
  • The FDA granted PLT012 orphan drug status, and the therapy showed promise in human tumor samples while demonstrating favorable safety profiles in animal models.
  • This metabolic immunotherapy approach could address a broad range of cancers with lipid-rich microenvironments that resist conventional checkpoint blockade therapies.

Lundbeck Presents Phase II Data for Amlenetug in Multiple System Atrophy at International Congress

  • Lundbeck presented results from the AMULET phase II trial investigating amlenetug, a monoclonal antibody targeting α-synuclein, as a potential treatment for multiple system atrophy (MSA).
  • The company shared new insights from the TALISMAN natural history study, providing critical data on early disease progression in MSA patients to support phase III development.
  • Patient perspectives from the AMULET trial informed the design of the upcoming phase III MASCOT trial, demonstrating Lundbeck's commitment to patient-centered drug development.
  • MSA remains a rare, rapidly progressing neurodegenerative disease with no approved therapies and significant unmet medical need.
NCT05104476Active, Not RecruitingPhase 2
H. Lundbeck A/S
Posted 11/16/2021

Phase III Clinical Trials Reveal Advances in Non-Infectious Uveitis Treatment Options

  • Multiple phase III trials demonstrate that locally delivered corticosteroid implants, including fluocinolone acetonide and dexamethasone devices, effectively control inflammation in non-infectious uveitis but carry significant risks of glaucoma surgery and cataract formation.
  • Adalimumab emerges as a proven biologic therapy, with VISUAL I and II trials showing 50% reduction in treatment failure risk and 43% delay in uveitis relapse, though associated with higher rates of serious adverse events including infections.
  • Comparative studies reveal that intravitreal treatments outperform periocular injections for uveitic macular edema, while suprachoroidal triamcinolone acetonide offers promising results with lower intraocular pressure elevation risks.
  • Systemic immunomodulatory therapy demonstrates comparable efficacy to methotrexate and mycophenolate mofetil as first-line treatments, with the FAST trial showing similar 67% and 57% success rates respectively in achieving uveitis control.
NCT02374060CompletedPhase 3
JHSPH Center for Clinical Trials
Posted 6/16/2015
NCT01358266CompletedPhase 3
Santen Inc.
Posted 5/1/2011
NCT01138657CompletedPhase 3
AbbVie (prior sponsor, Abbott)
Posted 8/1/2010
NCT01124838CompletedPhase 3
AbbVie (prior sponsor, Abbott)
Posted 8/1/2010
NCT00132691CompletedPhase 4
JHSPH Center for Clinical Trials
Posted 9/1/2005
NCT02623426CompletedPhase 3
JHSPH Center for Clinical Trials
Posted 3/9/2017
NCT00995709CompletedPhase 3
Novartis Pharmaceuticals
Posted 10/1/2009
NCT01385826CompletedPhase 2
Assistance Publique - Hôpitaux de Paris
Posted 6/29/2011
NCT01232920CompletedPhase 3
University of California, San Francisco
Posted 10/1/2010
NCT01694186CompletedPhase 3
EyePoint Pharmaceuticals, Inc.
Posted 8/2/2013
NCT01965145TerminatedPhase 3
Institut de Recherches Internationales Servier
Posted 11/1/2012
NCT00407082CompletedPhase 2
Bausch & Lomb Incorporated
Posted 12/1/2000
NCT01829295CompletedPhase 3
University of California, San Francisco
Posted 8/1/2013

ImmuneWalk's IW-601 Shows Positive Phase 1 Results in Novel Monocyte-Targeting Approach for Inflammatory Diseases

  • ImmuneWalk Therapeutics announced positive topline Phase 1 data for IW-601, a first-in-class monoclonal antibody targeting MOSPD2 on myeloid cells, demonstrating safety and tolerability across all tested doses.
  • The POINTGUARD study met all primary and secondary endpoints, showing dose-proportional pharmacokinetics with a 4-week half-life and mechanistic validation through dose-dependent binding to monocytes and neutrophils.
  • IW-601's novel mechanism prevents immune cell migration into inflamed tissues without depleting blood cells, offering potential advantages over traditional therapies for multiple inflammatory conditions.
  • The company secured $7 million in seed financing and presented data at EULAR 2025, with multiple ascending dose results expected later in 2025.

Vigil Neuroscience Advances Dual TREM2 Programs with Promising Results for Neurodegenerative Diseases

  • Vigil Neuroscience is on track to report final analysis from the IGNITE Phase 2 trial of iluzanebart for adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) in Q2 2025, with plans to pursue accelerated approval.
  • The company's small molecule TREM2 agonist VG-3927 demonstrated positive Phase 1 results for Alzheimer's disease, showing favorable safety, CNS penetration, and robust target engagement, with Phase 2 trials planned for Q3 2025.
  • Preclinical data presented at the AD/PD™ 2025 conference highlighted VG-3927's unique synergistic activation with endogenous TREM2 ligands like amyloid-beta, potentially enhancing potency in regions of pathology.

Biogen Advances LEQEMBI Treatment with Subcutaneous Formulation for Alzheimer's Disease

• Biogen is developing a subcutaneous formulation of LEQEMBI for maintenance therapy, which could simplify treatment for Alzheimer's patients after 18 months of biweekly infusions.
• The subcutaneous administration option may increase patient adherence, reduce burden on infusion centers, and provide better accessibility for patients in rural settings.
• Fujirebio's in-vitro diagnostic tool is expected to facilitate earlier diagnosis of Alzheimer's disease, allowing treatment before significant neuronal damage occurs.

Dupilumab Shows Sustained Lung Function Improvements in COPD Patients with Type 2 Inflammation

  • Pooled data from phase 3 BOREAS and NOTUS trials demonstrate that dupilumab significantly improves lung function in COPD patients with type 2 inflammation, marking a potential advancement in personalized treatment strategies.
  • The monoclonal antibody targets interleukin-4 and interleukin-13 pathways, offering a targeted approach for this specific COPD subgroup that could transform treatment paradigms.
  • Real-world data also show dupilumab provides sustained improvements in severe asthma patients over 2 years, with over half achieving remission within 1-2 years of treatment.
NCT04039113CompletedPhase 2
AstraZeneca
Posted 7/30/2019

Bimekizumab Demonstrates Sustained Three-Year Efficacy in Psoriatic Arthritis and Axial Spondyloarthritis

  • UCB announced three-year data from Phase 3 trials showing bimekizumab maintained sustained control of inflammation in patients with active psoriatic arthritis and axial spondyloarthritis.
  • In psoriatic arthritis patients, 59.5% of treatment-naïve and 59.1% of TNF inhibitor-inadequate response patients achieved elimination of swollen joints at three years.
  • Axial spondyloarthritis patients demonstrated sustained clinical responses with 60.4% of non-radiographic and 60.1% of radiographic patients achieving ASAS40 response at three years.
  • Comprehensive safety analysis from pooled studies showed bimekizumab was well tolerated with no new safety signals identified over extended treatment periods.

Federal Court Dismisses Sanofi's Appeal, Orders Amgen's Repatha Patent Applications to Proceed in Australia

• The Federal Court of Australia has dismissed Sanofi's appeal against Amgen's PCSK9 antibody patents, ordering that Amgen's Repatha patent applications proceed to grant under Australia's pre-2013 patent laws.
• This Australian ruling contrasts with decisions in the US, where the Supreme Court invalidated similar Amgen patents for lack of enablement, highlighting significant jurisdictional differences in antibody patent protection.
• The case provides important precedent for other valuable antibody patents approaching the end of their term that are still subject to Australia's old Patent Act as biosimilars seek market entry.

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