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Clinical Trial News

SpikImm Secures Worldwide License for Anti-BK Virus Monoclonal Antibodies to Protect Transplant Patients

Monoclonal Antibody
  • SpikImm signed an exclusive worldwide licensing agreement with SATT Conectus for potent monoclonal antibodies targeting BK virus, addressing a critical unmet need in transplant medicine.
  • The HuMABK monoclonal antibodies were developed by leading French research institutes and demonstrate remarkable effectiveness in neutralizing BK virus, which causes serious complications in immunocompromised patients.
  • BK virus reactivation in transplant recipients can lead to kidney graft loss, bladder cancer risk, and severe hemorrhagic cystitis, with no current specific antiviral therapies available.
  • SpikImm plans to initiate first-in-human studies by 2026, having already completed GMP manufacturing cell line development for these prophylactic treatments.

AstriVax Therapeutics Appoints Former Bayer Pharma CEO Dieter Weinand as Board Chairman

Leadership Change
  • AstriVax Therapeutics has appointed Dieter Weinand, former CEO of Bayer Pharma with over 25 years of pharmaceutical industry experience, as Chair of the Board of Directors effective June 12, 2025.
  • The leadership change comes as the clinical-stage immunotherapy company advances its proprietary Launch-iT technology platform for treating chronic infectious diseases, including hepatitis B virus and human papilloma virus infections.
  • The appointment follows AstriVax's recent initiation of its second Phase 1 clinical trial evaluating AVX70371 for chronic hepatitis B virus infection, marking a significant milestone in the company's clinical development program.
  • Outgoing Chair Dr. Jeanne Bolger, who served since 2022, will remain on the Board as a non-executive independent director to continue contributing her expertise to the company's therapeutic advancement.

Enterome Secures $19 Million to Advance Novel OncoMimics Immunotherapy for Indolent Non-Hodgkin Lymphoma

  • Enterome SA raised $19 million in private financing to advance EO2463 OncoMimics immunotherapy through Phase 1/2 trials for indolent non-Hodgkin lymphoma treatment.
  • The Institute for Follicular Lymphoma Innovation invested $9 million as a new investor, while existing shareholders contributed $10 million to support the clinical development program.
  • EO2463 demonstrated robust clinical efficacy and exceptional safety in "watch-and-wait" iNHL patients, who currently have no approved treatment options available.
  • The company received positive regulatory guidance from both FDA and EMA, establishing a clear path toward registration for marketing authorization in the watch-and-wait population.

CRISPR Therapeutics Reports Breakthrough Results from In Vivo Gene Therapy CTX310 for Heart Disease

CAR-T
  • CRISPR Therapeutics reported initial top-line results from an early-stage study on CTX310, showing peak reductions of up to 82% in triglycerides and 81% in LDL cholesterol with a single dose.
  • The investigational in vivo CRISPR-based gene therapy targets ANGPTL3 for treating atherosclerotic heart disease, representing a significant advancement in direct gene delivery technology.
  • CTX310 results have generated excitement for the company's other in vivo candidate CTX320, targeting lipoprotein(a) for heart disease, with initial data expected by month's end.
  • The positive data provides momentum for CRISPR Therapeutics beyond its approved therapy Casgevy, as the company prepares for multiple pipeline readouts throughout 2025.

Samsung Bioepis Reports Sustained Safety Profile for EPYSQLI Biosimilar in Long-Term PNH Study

  • Samsung Bioepis presented long-term safety data for EPYSQLI (eculizumab biosimilar) showing consistent safety outcomes between the initial 52-week period and extended treatment up to 158 weeks in PNH patients.
  • The study found no new safety signals or fatal cases throughout the entire treatment period, with exposure-adjusted event rates remaining comparable between periods (0.13 vs 0.17, p=0.76).
  • EPYSQLI has received regulatory approval from the European Commission for PNH and aHUS treatment, with the biosimilar administered at 900 mg every two weeks during maintenance therapy.
  • All serious adverse events during the extended treatment period resolved completely without permanent treatment discontinuation, supporting the drug's long-term tolerability profile.

SNIPR Biome Doses First Patient with CRISPR-Armed Phage Therapy SNIPR001 for Drug-Resistant E. coli Prevention

Precision Medicine
  • SNIPR Biome has dosed the first patient in its Phase 1b trial of SNIPR001, a CRISPR-armed phage therapy targeting fluoroquinolone-resistant E. coli in hematological cancer patients undergoing stem cell transplantation.
  • The therapy combines four engineered bacteriophages that specifically target drug-resistant E. coli in the gut microbiome while preserving beneficial bacteria, addressing a critical unmet need in cancer care.
  • The randomized, double-blind, placebo-controlled trial will evaluate safety, tolerability, and efficacy in 24 patients across eight US centers, building on promising Phase 1a safety data in healthy volunteers.
  • E. coli causes 25-30% of bacteremia cases in neutropenic hematological cancer patients, with up to 65% showing fluoroquinolone resistance, making this precision approach potentially transformative for vulnerable patient populations.

Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli PreTransplant

NCT06938867RecruitingPhase 1
SNIPR Biome Aps.
Posted 2/25/2025

Cytovale's IntelliSep Diagnostic Reduces Sepsis Mortality by 39% in Large Real-World Study

Real World Evidence
  • Cytovale's FDA-cleared IntelliSep diagnostic achieved a 39% relative reduction in sepsis mortality in a real-world study of over 12,000 patients at Our Lady of the Lake Regional Medical Center.
  • The rapid diagnostic test delivers results in eight minutes from a routine blood draw and reduced average hospital length of stay by 0.76 days for sepsis patients.
  • The study demonstrated improved resource allocation with a 40% decrease in blood culture usage for low-risk patients and an 8% increase for high-risk cases.
  • Following successful validation, the health system has expanded IntelliSep implementation across four additional sites within Franciscan Missionaries of Our Lady Health System.

MRO Acquires Q-Centrix to Create Comprehensive Clinical Data Management Platform

  • MRO Corp. has acquired Q-Centrix, an enterprise clinical data management platform from TPG Growth, creating a category-defining solution for healthcare data exchange.
  • The combined entity will serve over 2,000 hospitals and health systems, more than 7,000 clinics, and nearly 250 payers across the healthcare ecosystem.
  • The acquisition aims to transform fragmented clinical data into actionable insights, supporting better patient care, operational efficiency, and breakthrough research.
  • The deal is backed by healthcare technology investors including Parthenon Capital, though financial terms were not disclosed.

Cognito Therapeutics' Spectris AD Demonstrates Significant Delay in Alzheimer's Disease Progression Through Non-Invasive Neuromodulation

  • Cognito Therapeutics' Spectris AD therapy showed meaningful delays in Alzheimer's disease progression, preserving daily activities for 4.83 months and delaying cognitive decline by 4.56 months in a post hoc analysis of the OVERTURE trial.
  • The non-invasive device uses synchronized light and sound stimulation at 40Hz gamma frequency to restore disrupted brain electrical activity in Alzheimer's patients, representing a physics-based alternative to traditional pharmacological approaches.
  • The therapy demonstrated strong safety profile with over 80% adherence rates and no observed ARIA risk, while currently being evaluated in the pivotal HOPE trial with FDA Breakthrough Device Designation.

Qlaris Bio Develops Novel Fixed-Dose Combination Therapy Targeting Unaddressed Component of Glaucoma Treatment

  • Qlaris Bio announced development of QLS-111-FDC, a preservative-free fixed-dose combination therapy combining QLS-111 and latanoprost for glaucoma treatment.
  • Phase 2 clinical data demonstrated QLS-111 achieved over 3 mmHg additional IOP reduction compared to latanoprost monotherapy without causing hyperemia or adverse events.
  • The combination targets episcleral venous pressure, the only component of intraocular pressure not addressed by currently FDA-approved glaucoma treatments.
  • QLS-111-FDC is being developed for patients with primary open-angle glaucoma, normal-tension glaucoma, and ocular hypertension requiring enhanced IOP control.

Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients

NCT06249152CompletedPhase 2
Qlaris Bio, Inc.
Posted 4/21/2024

Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients

NCT06016972CompletedPhase 2
Qlaris Bio, Inc.
Posted 3/5/2024

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