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Clinical Trial News

Scinai Immunotherapeutics Secures $1.38M Funding as CDMO Business Accelerates Toward $2M Revenue Target

  • Scinai Immunotherapeutics raised $1.38 million through its Standby Equity Purchase Agreement with Yorkville Advisors to strengthen its balance sheet and advance both CDMO growth and R&D programs.
  • The company's CDMO business showed rapid growth in Q1 2025, nearly matching full-year 2024 revenues in just the first quarter, with 2025 revenue guidance set at approximately $2 million.
  • Scinai implemented cost-reduction measures expected to lower annual employment-related expenses by $815,000 while preserving core scientific talent for its dual-focus strategy.
  • The company anticipates its CDMO unit will reach breakeven by end of 2026, with long-term revenue potential of $12 million annually under a single production shift.

Biofrontera Inc. Negotiates Strategic Partnership Changes with German Parent Company

  • Biofrontera Inc. and Biofrontera AG are negotiating potential company combination or license agreement adjustments that could transfer rights and reduce transfer pricing for US products.
  • The discussions may result in fundamental changes to the cooperation between the US subsidiary and German parent company, though no definitive terms have been established.
  • Biofrontera Inc. specializes in photodynamic therapy for dermatological conditions, commercializing Ameluz with RhodoLED devices for treating actinic keratosis and conducting trials for skin cancers and acne.

Alys Pharmaceuticals Advances First-in-Class Mast Cell-Selective c-Kit Inhibitor ALY-301 to Clinical Trials for Cold Urticaria

  • Alys Pharmaceuticals has submitted a Clinical Trial Application to Germany's Paul-Ehrlich-Institut for ALY-301, a first-in-class bispecific antibody targeting c-Kit and CD-203c with mast cell selectivity.
  • The Phase 1/1b study will evaluate ALY-301's safety and efficacy in healthy volunteers and patients with Cold Urticaria, a subtype of Chronic Inducible Urticaria.
  • ALY-301's selective targeting approach is designed to enable safe chronic dosing by avoiding off-target effects associated with conventional c-Kit inhibitors.
  • The trial represents the first clinical program from Alys' Granular platform and could potentially address multiple mast cell-mediated diseases beyond urticaria.

Hoth Therapeutics Secures Japanese Patent for Novel Mast Cell-Targeting Platform HT-KIT

Orphan DrugOncology
  • Hoth Therapeutics received Japan Patent No. 7677628 for its HT-KIT platform, providing exclusive protection until August 27, 2039.
  • The patented technology uses splice-switching oligonucleotides to selectively disrupt KIT gene expression in mast cells implicated in chronic hives and rare cancers.
  • The patent positions HT-KIT for orphan indications and expedited regulatory pathways, with potential applications in mast cell-driven inflammatory and oncologic conditions.
  • The company sees strategic licensing opportunities across Asia as it advances this novel therapeutic platform.

Volition's Nu.Q H3.1 Biomarker Shows Promise for Sepsis Assessment in Large ICU Study

  • A peer-reviewed study of 1,713 ICU patients demonstrates that Volition's Nu.Q H3.1 biomarker is significantly associated with sepsis presence and organ failure severity.
  • Patients with acute kidney injury, disseminated intravascular coagulation, and acute respiratory distress syndrome showed significantly higher H3.1 nucleosome levels compared to those without these conditions.
  • The biomarker reflects NETosis, a biological process at the intersection of infection, organ failure, and inflammation, positioning it as a dynamic tool for prognostic enrichment and therapeutic targeting.
  • The findings support the emerging paradigm of "treatable traits" and biologically-informed risk stratification in critically ill patients.

CMV Treatment Pipeline Expands with 20+ Therapies from Leading Pharmaceutical Companies

  • DelveInsight's 2025 assessment reveals 15+ companies are developing over 20 cytomegalovirus (CMV) infection treatment therapies across various clinical development phases.
  • Recent clinical milestones include Kamada's post-marketing research initiative for CYTOGAM, ACTG's encouraging HIV-CMV study results, and Fortress Biotech's Phase 2 trial initiation for Triplex vaccine.
  • The CMV pipeline encompasses diverse therapeutic approaches including mRNA vaccines, T-cell therapies, immune globulins, and antiviral compounds from companies like Moderna, Merck Sharp & Dohme, and Chimerix.
  • Market growth is driven by increasing CMV prevalence and research activities, though high treatment costs and healthcare infrastructure limitations present ongoing challenges.

A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects with Chronic HCV

NCT05904470CompletedPhase 2
Atea Pharmaceuticals, Inc.
Posted 5/30/2023

Chlorhexidine-Impregnated Central Venous Catheters Reduce ICU Bloodstream Infections by 70.5% in Multinational Study

  • A multinational prospective cohort study of over 6,670 ICU patients across eight countries demonstrated a 70.5% reduction in central line-associated bloodstream infections (CLABSIs) with chlorhexidine-impregnated catheters compared to plain catheters.
  • The study found lower incidence of infection-causing pathogens including gram-negative bacteria, gram-positive bacteria, and fungi in patients using Arrowg+ard Blue and Arrowg+ard Blue Plus CVCs.
  • Despite patients with impregnated catheters having longer ICU stays and higher device utilization ratios, infection rates remained significantly lower, demonstrating effectiveness even in high-risk populations.
  • The research suggests unprotected CVCs may be an independent risk factor for CLABSI, even when proper insertion training and maximal barrier precautions are maintained across both groups.

Vascarta's Vasceptor Receives FDA Orphan Drug Designation for Sickle Cell Disease Treatment

Rare Disease
  • Vascarta Inc. announced that the FDA has granted Orphan Drug Designation to Vasceptor (VAS-101), a patented topical curcumin formulation for treating Sickle Cell Disease.
  • The designation provides seven years of market exclusivity upon approval, tax credits for clinical trials, and exemption from certain FDA fees for this rare disease therapy.
  • Preclinical results demonstrate that VAS-101's novel approach targets red blood cell instability, neuro-inflammation and vascular inflammation to reduce pain and improve therapeutic efficacy.
  • The drug is currently in Phase 1 clinical trials at the Foundation for Sickle Cell Disease Research in Hollywood, Florida, using patented transdermal technology to overcome curcumin's poor oral bioavailability.

ADC Therapeutics Secures $100 Million Financing to Advance ZYNLONTA Development Through 2028

  • ADC Therapeutics raised $100 million through a private placement financing to extend its cash runway into 2028 and fund ZYNLONTA clinical development programs.
  • The company will implement a strategic restructuring plan including a 30% workforce reduction and UK facility closure to reduce operating expenses by approximately $6-7 million.
  • Key clinical catalysts include LOTIS-7 Phase 1b trial results in second half of 2025 and LOTIS-5 Phase 3 confirmatory trial topline data expected in late 2025 or first half of 2026.
  • The company will advance its preclinical PSMA-targeting ADC program while discontinuing other solid tumor development efforts to focus resources on hematologic malignancies.

Dyne Therapeutics Reports Breakthrough Preclinical Results for FSHD Gene Therapy DYNE-302

Rare Disease
  • Dyne Therapeutics' DYNE-302 demonstrated functional improvement in a severe FSHD mouse model, with a single intravenous dose restoring treadmill running ability at peak muscle weakness.
  • The siRNA-based therapy targets DUX4 mRNA and showed correction of muscle damage and inflammation markers in skeletal muscle tissue analysis.
  • Results suggest that preexisting and severe skeletal muscle disease in FSHD may be reversible through DUX4 mRNA targeting, offering hope for the estimated 16,000-38,000 affected individuals in the United States.
  • The findings will be presented at the 32nd Annual FSHD Society's International Research Congress in Amsterdam on June 13, 2025.

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