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Clinical Trial News

Sun Pharma's European Partner Withdraws Melanoma Therapy Application from EMA Due to Data Delays

Oncology
  • Sun Pharma's European biotech partner Philogen voluntarily withdrew the marketing authorization application for Nidlegy, an investigational melanoma therapy, from the European Medicines Agency.
  • The withdrawal was due to delays in providing essential Chemistry, Manufacturing and Controls data and additional clinical information needed to establish the therapy's benefit-risk profile.
  • Nidlegy is being developed as a neoadjuvant treatment for locally advanced, resectable melanoma and has been administered to over 450 patients with various skin cancers.
  • Philogen plans to resubmit an updated application after addressing EMA's regulatory requirements and remains committed to making the therapy available to melanoma patients.

Neoadjuvant L19IL2/L19TNF- Pivotal Study

NCT02938299RecruitingPhase 3
Philogen S.p.A.
Posted 7/1/2016

Valorum Biologics Secures Exclusive Rights to Commercialize Formycon's Eylea Biosimilar in North America

Drug Approval
  • Valorum Biologics LLC has secured exclusive commercialization rights for FYB203/AHZANTIVE®, Formycon's biosimilar to Eylea®, in the United States and Canada through a licensing agreement with Klinge Biopharma GmbH.
  • The FDA-approved biosimilar treats serious retinal diseases including wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion by inhibiting VEGF.
  • Formycon will participate in mid-single-digit to low-double-digit percentage range of all payment streams and manage the supply chain, while Canadian regulatory approval is expected by the end of 2024.
  • The partnership leverages Valorum's experienced management team with proven track records at major pharmaceutical companies including Johnson & Johnson, Merck, and Roche to maximize market penetration.

Circulating Tumor DNA Testing Transforms Breast Cancer Monitoring and Treatment Selection

Precision Medicine
  • Circulating tumor DNA (ctDNA) testing is increasingly used alongside tissue biopsies to rapidly identify molecular targets in metastatic hormone receptor-positive breast cancer patients.
  • Serial ctDNA monitoring at disease progression detects emerging resistance mutations like ESR1, enabling timely treatment adjustments based on evolving tumor biology.
  • Current symptom-driven surveillance often detects recurrence at advanced stages, but ctDNA testing offers potential for earlier intervention before clinical symptoms emerge.
  • Ongoing trials are evaluating ctDNA-guided adjuvant therapy decisions, including CDK4/6 inhibitors for hormone receptor-positive disease and targeted agents for other breast cancer subtypes.

Galderma Launches Phase II Trials of Nemolizumab for Systemic Sclerosis and Chronic Pruritus of Unknown Origin

Monoclonal AntibodyRare Disease
  • Galderma has initiated two phase II clinical trials investigating nemolizumab, an IL-31 receptor alpha-targeting monoclonal antibody, for treating systemic sclerosis and chronic pruritus of unknown origin.
  • The systemic sclerosis trial will be a multicenter, randomized, double-blind, placebo-controlled study beginning enrollment in H2 2025 with completion anticipated in 2028.
  • The chronic pruritus of unknown origin trial will explore nemolizumab's efficacy in treating persistent itch lasting more than six weeks without identified cause, with enrollment starting in H2 2025 in the U.S.
  • Both conditions represent significant unmet medical needs, with systemic sclerosis being a potentially fatal autoimmune disease and chronic pruritus of unknown origin having no currently approved treatments.

LTS and Nualtis Form Strategic Partnership to Scale Oral Thin Film Drug Delivery Manufacturing

  • LTS LOHMANN Therapie-Systeme AG and Nualtis announced a strategic collaboration to provide robust, high-quality large-scale manufacturing capabilities for oral thin film drug delivery technologies.
  • The partnership leverages LTS's global manufacturing expertise to help Nualtis scale their innovative OTF products and deliver them to patients worldwide.
  • The collaboration combines Nualtis' formulation platform with LTS's manufacturing capabilities to accelerate patient-centric therapeutic solutions across multiple disease indications.
  • Together, the companies will support pharmaceutical partners through every phase of drug development and commercialization with scalable OTF solutions.

Evotec Joins NURTuRE-AKI Consortium to Advance Multi-Omics Research for Acute Kidney Injury Treatment

Precision MedicineDrug Discovery
  • Evotec has joined the NURTuRE-AKI consortium led by Kidney Research UK to establish the world's most comprehensive patient cohort for acute kidney injury research.
  • The longitudinal study will collect multi-omics data from 950 patients across three cohorts, including cardiac surgery patients and those experiencing AKI-to-CKD progression.
  • The initiative aims to identify novel therapeutic targets and biomarkers for AKI, a condition affecting millions worldwide with no current preventive or therapeutic treatments available.

VCU Researchers Develop Fusion Superkine Therapy for Glioblastoma with Novel Blood-Brain Barrier Delivery System

  • Researchers at Virginia Commonwealth University's Massey Comprehensive Cancer Center have developed a novel "Fusion Superkine" (FSK) therapy that combines IL-24S and IL-15 cytokines to both kill glioblastoma tumor cells and activate immune responses.
  • The therapy utilizes a groundbreaking focused ultrasound with double microbubbles (FUS-DMB) delivery system to safely penetrate the blood-brain barrier and deliver the treatment directly to brain tumors.
  • In immunocompetent mouse models, the FSK demonstrated superior tumor regression and prolonged survival compared to either cytokine alone, with enhanced infiltration of immune cells including T cells, dendritic cells, and NK cells.
  • Clinical trials are planned for 2026, with researchers aiming to provide a potential cure for glioblastoma, which currently has a recurrence rate of over 90% within six to nine months of treatment.

Liminatus Pharma Advances Second-Generation CD47 Inhibitor IBA101 Toward 2027 Clinical Trials

  • Liminatus Pharma's IBA101, a second-generation CD47 inhibitor, demonstrated strong safety profile in primate studies with no observed anemia or thrombocytopenia at doses up to 100 mg/kg/week.
  • The company plans to initiate Phase 1 trials in early 2027 through strategic collaboration with Professor Se-Hoon Lee at Samsung Medical Center in Seoul, Korea.
  • IBA101 is engineered to avoid red blood cell and platelet binding, addressing the severe cytopenia issues that halted earlier CD47 programs from Gilead and Pfizer.
  • Preclinical combination studies with PD-1/PD-L1 inhibitors showed complete tumor regression in mouse models, positioning IBA101 for the post-patent checkpoint inhibitor market.

Clinicians Develop New Monitoring Strategies for Hypercortisolism Medical Management

  • Medical management of hypercortisolism requires distinct monitoring approaches for steroidogenesis inhibitors versus glucocorticoid receptor antagonists, with synthesis inhibitors tracked through cortisol level reductions while receptor antagonists require clinical parameter monitoring.
  • Glucocorticoid receptor antagonists like mifepristone carry significant risks of hypokalemia and hypertension, prompting experts to recommend prophylactic spironolactone therapy for all patients starting treatment.
  • Traditional 24-hour urinary-free cortisol collection faces poor patient adherence, leading clinicians toward multimodal monitoring combining late-night salivary cortisol for efficacy assessment with morning cortisol levels for safety monitoring.
  • Treatment selection depends on patient-specific factors including underlying hypercortisolism cause and comorbidities, with most medications potent enough for monotherapy rather than complex combination regimens.

ZetrOZ Systems' sam® 2.0 Wearable Ultrasound Device Receives Arthritis Foundation's Ease of Use Certification

  • ZetrOZ Systems' sam® 2.0 wearable ultrasound device has received the Arthritis Foundation's Ease of Use® Certification, recognizing its accessibility for people living with arthritis and chronic pain.
  • The FDA-cleared device uses sustained acoustic medicine technology to treat knee osteoarthritis and soft-tissue injuries through continuous, multi-hour high-frequency ultrasound treatment.
  • Clinical validation includes over 30 studies and more than 3.7 million patient treatments nationwide, demonstrating the device's effectiveness in accelerating healing through mechanobiological mechanisms.
  • The certification addresses a significant unmet need, as nearly 60 million U.S. adults have been diagnosed with arthritis and experience pain that limits daily activities.

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