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

Monoclonal Antibody
  • 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.

Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting

NCT04799990Withdrawn
AbbVie
Posted 6/23/2021

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

Monoclonal Antibody
• 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.

ZyVersa's IC 100 Shows Promise as Disease-Modifying Treatment for Parkinson's Disease

Monoclonal Antibody
  • New research validates that microglia-driven inflammation plays a pivotal role in Parkinson's disease progression, with studies showing IC 100 can block NLRP1 inflammasome activation and reduce toxic alpha-synuclein accumulation.
  • ZyVersa Therapeutics' Inflammasome ASC Inhibitor IC 100 demonstrates potential as a disease-modifying therapy by targeting both inflammasome formation and protein aggregation, addressing underlying disease mechanisms rather than just symptoms.
  • The findings, supported by the Michael J. Fox Foundation, could represent a significant advancement for the 10 million Parkinson's patients worldwide, with ZyVersa preparing to initiate proof-of-concept studies in animal models later this year.

City of Hope to Present Groundbreaking Cancer Research at AACR Annual Meeting 2025

AIOncologyMonoclonal AntibodyPrecision Medicine
  • City of Hope researchers will present over 74 sessions at the AACR Annual Meeting 2025, showcasing innovative work in AI, precision medicine, and immunotherapies for various cancers.
  • A phase 3 clinical trial led by Dr. Aditya Shreenivas demonstrated that penpulimab combined with chemotherapy significantly improved progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma.
  • Novel AI tools and spatial transcriptomic technologies developed at City of Hope are advancing precision medicine approaches and revealing unique genetic changes in early-onset colorectal cancer among Hispanic and Latino patients.

CatalYm's Visugromab Shows Promise in Enhancing Antibody-Drug Conjugate Efficacy by Blocking GDF-15

Monoclonal AntibodyOncology
  • New preclinical data reveals that visugromab, CatalYm's GDF-15-neutralizing antibody, significantly enhances the anti-tumor activity of antibody-drug conjugates (ADCs) in multiple solid tumor models.
  • Research demonstrates that ADC treatment triggers GDF-15 expression as a potential resistance mechanism, which visugromab effectively counteracts by improving immune cell infiltration and activation in the tumor microenvironment.
  • These findings build on CatalYm's previous clinical evidence showing visugromab's ability to induce durable responses in relapsed/refractory solid tumors and mitigate cancer-associated cachexia.

First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)

NCT04725474Active, Not RecruitingPhase 1
CatalYm GmbH
Posted 12/9/2020

Avidicure Launches with $50M to Develop Novel Multifunctional Antibody Platform for Cancer

Monoclonal AntibodyOncology
  • Netherlands-based Avidicure has secured $50 million in seed financing to develop its AVC-Boosters platform, a novel multifunctional antibody modality designed to harness both innate and adaptive immune responses against cancer.
  • The company's lead product, AVC-S-101, targets Trop2 protein and is being developed for non-small cell lung cancer and other indications, with potential to deliver targeted and potent cancer monotherapy with reduced toxicity.
  • Avidicure's platform leverages decades of antibody engineering expertise and offers plug-and-play functionality for multiple product development, positioning it to potentially surpass first-generation antibodies, checkpoint inhibitors, and ADCs.

CN Bio and Pharmaron Partner to Advance Organ-on-a-Chip Technology for Drug Development

Drug DiscoveryMonoclonal Antibody
  • CN Bio has formed a strategic partnership with Pharmaron to validate and integrate its PhysioMimix organ-on-a-chip technology across drug discovery applications, reducing reliance on animal testing.
  • The collaboration will initially focus on disease modeling, toxicity testing, and ADME studies, with plans to expand into novel applications addressing unmet needs in pharmaceutical R&D.
  • This partnership aligns with recent FDA announcements to phase out animal testing requirements for monoclonal antibodies, as the global organ-on-a-chip market is projected to reach $388 million by 2028.

FDA Sets Q3 2025 Approval Dates for Three Breakthrough Therapies Targeting Rare Diseases

Drug ApprovalRare DiseaseMonoclonal AntibodyOrphan Drug
  • The FDA has established PDUFA target action dates for three promising therapies in Q3 2025: sepiapterin for phenylketonuria (July 29), apitegromab for spinal muscular atrophy (September 22), and paltusotine for acromegaly (September 25).
  • PTC Therapeutics' sepiapterin demonstrated a 63% reduction in blood phenylalanine levels in PKU patients, with 84% achieving therapeutic control and over 97% able to liberalize their protein-restricted diets.
  • Scholar Rock's apitegromab showed statistically significant motor function improvements in SMA patients already receiving standard care, while Crinetics' paltusotine achieved IGF-1 normalization in 83% of acromegaly patients switching from injectable treatments.
  • These approvals could provide significant therapeutic advances for patients with rare genetic disorders who currently have limited treatment options or face challenges with existing therapies.

Vaccinex's Pepinemab Shows Promise in Turning "Cold" Tumors "Hot" Through Enhanced Immune Response

Monoclonal Antibody
  • Vaccinex will present new clinical data at ASCO 2025 showing that neoadjuvant treatment with pepinemab induces mature tertiary lymphoid structures that correlate with improved pathologic response in head and neck cancer patients.
  • The SEMA4D-blocking antibody pepinemab demonstrates potential to transform immunologically "cold" tumors into "hot" immune centers by enhancing dendritic cell function and T cell interactions within organized immune structures.
  • Clinical studies reveal that pepinemab combination therapy enhanced tertiary lymphoid structure maturity and correlated with longer recurrence-free survival in metastatic melanoma patients without compounding toxicities.
  • The drug candidate shows promise for treating HPV-negative head and neck cancers and other immunologically resistant tumors that typically respond poorly to checkpoint inhibitor therapy alone.

Cemiplimab Shows Significant Survival Benefit in NSCLC Patients with Brain Metastases and High PD-L1 Expression

Monoclonal AntibodyDrug ApprovalOncology
  • First-line cemiplimab (Libtayo) monotherapy demonstrated a remarkable survival advantage over chemotherapy in advanced NSCLC patients with PD-L1 ≥50% and brain metastases, with median OS of 52.4 vs 20.7 months.
  • The EMPOWER-Lung 1 trial's 5-year follow-up data confirms cemiplimab's long-term clinical benefits across all PD-L1 expression levels, with the greatest benefit observed in patients with PD-L1 ≥90%.
  • Patients receiving cemiplimab experienced fewer grade ≥3 adverse events compared to chemotherapy (18.3% vs 39.9%), while also reporting improved quality of life measures including better emotional functioning and reduced fatigue.

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03088540CompletedPhase 3
Regeneron Pharmaceuticals
Posted 5/29/2017

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018

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