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Clinical Trial News

OncoC4's ONC-841 Shows Promise as First-in-Class Alzheimer's Disease Immunotherapy in Preclinical Studies

Monoclonal Antibody
  • OncoC4 unveiled preclinical data showing ONC-841, a first-in-class anti-SIGLEC 10 monoclonal antibody, reduced amyloid plaques and improved memory in Alzheimer's disease mouse models.
  • SIGLEC 10 was identified as a genetic driver for amyloid plaque formation, with transgenic mice expressing the unmutated human gene developing Alzheimer's hallmarks.
  • The therapy demonstrated enhanced microglia function, including improved migration and phagocytosis of amyloid plaques, while normalizing microglia morphology.
  • ONC-841 represents a novel immunotherapy approach targeting the SIGLEC 10-CD24 innate immune checkpoint pathway with potential applications in both cancer and neurodegeneration.

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors

NCT06352359RecruitingPhase 1
OncoC4, Inc.
Posted 8/23/2024

Cumulus Neuroscience Validates At-Home Digital Biomarkers Show Greater Sensitivity Than Standard Alzheimer's Assessment Scale

  • Cumulus Neuroscience's CNS-101 study demonstrated that at-home digital cognitive endpoints showed greater separation with Alzheimer's pathology (pTau217) than the benchmark ADAS-Cog 13 scale over the study time-course.
  • The study validated that passive EEG markers and naturalistic language-based markers collected via the NeuLogiq Platform are similarly powerful at detecting dementia progression as ADAS-Cog 13, which requires trained clinicians and 45 minutes to administer.
  • The 12-month observational study included 59 dementia patients and 60 healthy controls across 7 UK sites, demonstrating that repeated real-world measurements at home provide higher statistical power than traditional clinic-based assessments.
  • Individual digital endpoints can enable streamlined study designs that may reduce overall costs and accelerate results, leading to earlier go/no-go decisions in Alzheimer's drug development.

IsoBio Secures $5 Million Series Seed Funding to Advance Antibody-Isotope Conjugates for Cancer Treatment

Monoclonal AntibodyOncologyTargeted Therapy
  • IsoBio, Inc. has closed a $5 million Series Seed financing round led by ASP Isotopes Inc. to develop antibody-isotope conjugates (AICs) targeting both validated and novel tumor antigens for cancer treatment.
  • The strategic partnership with ASP Isotopes and its subsidiary PET Labs aims to address critical isotope supply chain challenges that have historically constrained radiotherapy development and commercialization.
  • IsoBio is developing radiotherapeutics containing Lutetium-177, Actinium-225, Terbium-161, and other novel radioisotopes using proprietary linker and conjugation technology.
  • The company is led by radiation oncologist Bruce Turner, M.D., Ph.D., who previously co-led the merger creating Immunome and has extensive experience in targeted oncology therapeutics.

FDA Issues Warning Letter to Glenmark Pharmaceuticals Following Manufacturing Quality Violations

Drug Recall
  • The FDA issued a warning letter to Glenmark Pharmaceuticals citing serious manufacturing violations at its Madhya Pradesh factory, including delayed safety testing that contributed to recalls of potentially deadly medications.
  • More than 50 million potassium chloride extended-release capsules were recalled due to dissolution problems that could cause fatal cardiac events, with eight deaths reported to the FDA between July and December 2023.
  • The warning letter highlighted systematic failures across multiple Glenmark manufacturing sites, with three of five factories producing drugs for the U.S. market having regulatory violations since 2019.
  • FDA inspectors found that Glenmark's safety testing was overdue by three months or longer for a large proportion of samples, with some potassium chloride tests taking 100 days to complete.

AIM ImmunoTech Reports Promising Mid-Year Results from Phase 2 Pancreatic Cancer Combination Therapy Study

OncologyOrphan Drug
  • AIM ImmunoTech's Phase 2 DURIPANC study evaluating Ampligen combined with AstraZeneca's Imfinzi shows encouraging safety and efficacy signals in metastatic pancreatic cancer patients post-FOLFIRINOX treatment.
  • The combination therapy demonstrated no significant toxicity with 21% of patients achieving progression-free survival greater than 6 months and 64% of patients surviving beyond 6 months.
  • The study builds on previous monotherapy data from over 50 patients treated under compassionate use, representing a potential breakthrough in a disease with historically limited immunotherapy responsiveness.
  • Results suggest superior outcomes compared to historical data for maintenance or second-line immunotherapies in pancreatic cancer, a disease that kills over 500,000 people worldwide annually.

Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy

NCT05927142RecruitingPhase 1
Joachim Aerts, MD PhD
Posted 1/9/2024

RenovoRx Launches Multi-Center PanTheR Registry Study to Evaluate Real-World Safety of RenovoCath Device

Targeted TherapyOncology
  • RenovoRx has launched the PanTheR Post-Marketing Registry Study, a multi-center observational study designed to evaluate the long-term safety and real-world effectiveness of the FDA-cleared RenovoCath drug-delivery device in patients with solid tumors.
  • The University of Vermont Cancer Center will be the first site to initiate patient enrollment, with additional cancer centers expected to commence enrollment before the end of September 2025.
  • The registry study will capture real-world data across diverse cancer types and clinical environments, potentially informing future clinical trial designs and evidence-based treatment strategies.
  • Participating cancer centers will purchase RenovoCath devices from RenovoRx for use in the study, representing a revenue-generating opportunity for the company.

PanTheR Registry Trial

NCT06805461Recruiting
RenovoRx
Posted 8/1/2025

Filgotinib Meets Primary Endpoint in Phase 3 Trial for Axial Spondyloarthritis

  • Alfasigma's filgotinib, an oral JAK1 preferential inhibitor, successfully met the primary endpoint in the OLINGUITO Phase 3 trial for active axial spondyloarthritis (axSpA).
  • The study demonstrated efficacy across both radiographic and non-radiographic forms of axSpA, with a safety profile consistent with previous filgotinib studies.
  • Alfasigma plans to submit regulatory applications to the EMA and MHRA for market authorization, potentially offering a new oral treatment option for a condition where only 40-50% of patients achieve adequate response with current therapies.

A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

NCT03117270CompletedPhase 2
Galapagos NV
Posted 3/7/2017

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

NCT05785611Active, Not RecruitingPhase 3
Alfasigma S.p.A.
Posted 4/5/2023

China Medical System Secures NMPA Acceptance for ZUNVYL Alzheimer's Drug Application

Drug Approval
  • China Medical System Holdings announced that China's National Medical Products Administration has accepted the new drug application for ZUNVYL, a treatment for mild-to-moderate Alzheimer's dementia.
  • ZUNVYL is a next-generation acetylcholinesterase inhibitor that demonstrated gastrointestinal adverse events of less than 2% across all studies, potentially addressing tolerability issues that cause 55% of patients to discontinue medication after one year.
  • The drug was previously approved by the FDA in July 2024 and represents only the second oral therapy approved for Alzheimer's disease treatment in the past decade.
  • China has approximately 9.83 million patients with Alzheimer's dementia, with 7.93 million classified as mild-to-moderate cases, highlighting significant market potential for improved treatment options.

FDA Accepts Bone Mineral Density as Primary Endpoint for Entera Bio's Oral Osteoporosis Drug Phase 3 Trial

  • The FDA has agreed to accept bone mineral density (BMD) as the primary endpoint for Entera Bio's Phase 3 trial of EB613, marking a significant shift from traditional fracture-based endpoints in osteoporosis drug development.
  • This regulatory breakthrough allows for a smaller, shorter trial with just 400 patients over 24 months, reducing development costs by an estimated 70% compared to traditional fracture studies requiring 10,000+ patients.
  • EB613 is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, potentially addressing poor adherence rates of current injectable therapies in the $2.3 billion anabolic therapy market.
  • The decision is supported by SABRE initiative data showing that a 1% increase in total hip BMD corresponds to a 12-15% reduction in fracture risk, with a correlation strength of R² = 0.73.

Boehringer Ingelheim Partners with Re-Vana for $1B Extended-Release Eye Therapy Development

  • Boehringer Ingelheim and Re-Vana Therapeutics announced a strategic collaboration to develop extended-release ophthalmic therapies using Re-Vana's drug delivery technology that releases treatments over 6-12 months.
  • The partnership allows Boehringer to add up to three development programs per year, with potential total deal value exceeding $1 billion for the initial three targets plus royalty payments.
  • Re-Vana's technology aims to reduce injection frequency for eye disease patients, potentially improving treatment compliance and therapeutic outcomes.
  • Boehringer will combine the delivery platform with its existing eye health pipeline, which includes four assets currently in Phase II trials.

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