SPX-101 / Spyryx Biosci - LARVOL DELTA

Arovella Therapeutics well-placed to advance iNKT cell therapy cancer treatment towards first-in-human clinical trials (Proactiveinvestors) - "Arovella Therapeutics Ltd...capped off the December quarter in a 'solid financial position' with pro-forma cash and cash equivalents of $4.76 million to continue advancing its iNKT cell therapy platform for cancer treatment...On the manufacturing front, Arovella completed the GMP manufacturing and release of the ALA-101 lentiviral vector, a key component required for GMP manufacturing of its lead CD-19-targeting iNKT cell product...the company also continued its manufacturing process development and scale-up activities, with process optimisation remaining on track to support the clinical manufacture of ALA-101 for phase I clinical trials in the first half of 2024...SPX-101, has completed all preclinical proof-of-concept, safety and specificity studies and toxicology studies required to commence a phase 1 trial to treat gastric cancers....Initial proof-of-concept data to demonstrate the potential of this approach is expected to be available in the first half of 2024."

Commercial • New P1 trial • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

First clinical trials of novel ENaC targeting therapy, SPX-101, in healthy volunteers and adults with cystic fibrosis. (PubMed, Pulm Pharmacol Ther) - P1 | "SPX-101 was well-tolerated across a range of doses and had little/no systemic exposure in healthy adults and adults with CF, thus supporting further study in patients with CF. CLINICALTRIAL."

Clinical • Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

SPX-101 is stable in and retains function after exposure to cystic fibrosis sputum. (PubMed, J Cyst Fibros) - "Our results demonstrate that SPX-101, but not SPLUNC1 or S18, is stable in CF sputum. These results support the therapeutic development of SPX-101 for the treatment of cystic fibrosis."

Journal • Cystic Fibrosis • Fibrosis • Immunology • Respiratory Diseases

The ENaC Regulatory Peptide SPX-101 Is Resistant to Proteolytic Degradation in Diseased Sputum (ATS 2018) - "Incubation of sputum samples with sivelestat, a neutrophil elastase inhibitor, was not sufficient to prevent SPLUNC1 degradation implicating additional proteases in the breakdown of the protein. SPLUNC1 protein is absent in the majority of sputum samples from patients with disease characterized by mucus dehydration and decreased mucociliary clearance. SPX-101, a therapeutically-optimized peptide which mimics SPLUNC1s ENaC regulatory function, is stable in sputum samples and retains pharmacological activity thereafter."

Biosimilar • Chronic Obstructive Pulmonary Disease • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

HOPE-1: An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (clinicaltrials.gov) - P2; N=91; Completed; Sponsor: Spyryx Biosciences, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

SPLUNC1 Degradation by the Cystic Fibrosis Mucosal Environment Drives Airway Surface Liquid Dehydration. (PubMed, Eur Respir J) - "Unlike SPLUNC1, the novel SPLUNC1-dervied peptide, SPX-101, resisted protease degradation, bound apically to HBECs, inhibited ENaC and prevented ASL dehydration following extended pre-incubation with CF sputum. Our data indicate CF mucosal secretions drive ASL hyperabsorption and protease-resistant peptides, like SPX-101, can reverse this effect to re-hydrate CF ASL."

Journal

An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (clinicaltrials.gov) - P2; N=91; Active, not recruiting; Sponsor: Spyryx Biosciences, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed