reltecimod (AB103) / Atox Bio - LARVOL DELTA

ABL103-1001: A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: ABL Bio, Inc. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Solid Tumor

ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: ABL Bio, Inc.

New P1/2 trial • Solid Tumor

ABL103-1001: A Study with ABL103 in Subjects with Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: ABL Bio, Inc. | Trial primary completion date: Nov 2024 ➔ Jun 2025

Trial primary completion date • Oncology • Solid Tumor

A Phase 1 Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: ABL Bio, Inc.

Metastases • New P1 trial • Oncology • Solid Tumor

Immune Checkpoint Inhibitors (ICI) Promote Neutrophil-Platelet Aggregate and NET Formation in Tumor-Bearing Mice (ASH 2022) - "Neutrophils were then blocked using 5% FBS and stained, without permeabilization, using rabbit monoclonal anti-histone H3 (citrulline R2+R8+R17) antibody (ab5103, Abcam)... Circulating neutrophils from ICI-treated, tumor bearing mice demonstrate increased spontaneous NET release. Moreover, elevated levels of circulating platelet-neutrophil doublets and aggregates are present in ICI-treated mice compared to those treated with control IgG. These results suggest a potential mechanism of ICI-induced thrombosis, and that platelet-neutrophil interactions may stimulate NET release in ICI-treated mice."

Checkpoint inhibition • IO biomarker • Preclinical • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Immune Modulation • Inflammation • Oncology • Solid Tumor • Thrombosis • ITGA2B • ITGAM • SELP

A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103). (PubMed, Ann Surg) - "Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status."

Clinical • Journal • P3 data • Immune Modulation • Infectious Disease • Inflammation

Invited Commentary on: Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod. (PubMed, Ann Surg) - No abstract available

Clinical • Journal • P3 data

SA-AKI: Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P3; N=58; Terminated; Sponsor: Atox Bio Ltd; N=120 ➔ 58; Trial completion date: Mar 2021 ➔ Dec 2019; Recruiting ➔ Terminated; Trial primary completion date: Dec 2020 ➔ Dec 2019; Very slow enrollment of target patient population

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock

ACCUTE: Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections (clinicaltrials.gov) - P3; N=290; Completed; Sponsor: Atox Bio Ltd; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

Atox Bio announces independent safety monitoring committee recommendation to continue phase 3 study of AB103 in necrotizing soft tissue infections (PRNewswire) - P3, N=290; NCT02469857; Sponsor: Atox Bio; "Atox Bio...today announced the independent Data Monitoring Committee (DMC) completed its pre-planned safety review of the first 50 patients enrolled in the company's ACCUTE trial...the DMC reviews are designed to examine the safety data accumulated during the trial and are scheduled to occur after 50, 100, and 200 patients have completed 28 days of study follow-up." 

DSMB • Immunology

SA-AKI: Phase 2 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Atox Bio Ltd; Trial completion date: Sep 2019 ➔ Mar 2020; Trial primary completion date: Jun 2019 ➔ Dec 2019

Trial completion date • Trial primary completion date • Biosimilar • Immunology • Renal Disease

In Vitro Cytokine Removal: Comparison of Conventional High-Flux Dialyzers and Middle-Cut-Off Dialyzer (Theranova HDx) (KIDNEY WEEK 2019) - "In addition to cytokines, albumin and total serum protein concentrations were measured (LEGEND MAX Human IL-6/IL-10/TNF-α; Cobas Mira Plus; Roche LT-AB0103, LT-TP0253)...This opens up new treatment options for both acute and chronic dialysis patients. However, clinical studies are still necessary to assess the significance in patient treatment."

Preclinical

SA-AKI: Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Atox Bio Ltd; Phase classification: P2 ➔ P3; Trial completion date: Mar 2020 ➔ Mar 2021; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Phase classification • Trial completion date • Trial primary completion date

ACCUTE: Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections (clinicaltrials.gov) - P3; N=290; Active, not recruiting; Sponsor: Atox Bio Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Interview: Atox aims for reltecimod ok in 2020 (Scripintelligence) - "The Israeli biotech is eagerly awaiting Phase III data on its therapy for necrotizing soft tissue infections before the end of 2019."

P3 data

Acute kidney injury: emerging pharmacotherapies in current clinical trials. (PubMed, Pediatr Nephrol) - "Here we review emerging pharmacotherapies for AKI that are currently in clinical trials. Categorized by their general mechanism of action, the therapies discussed include anti-inflammatory agents (recAP, AB103, ABT-719), antioxidants (iron chelators, heme arginate), vasodilators (levosimendan), apoptosis inhibitors (QPI-1002), and repair agents (THR-184, BB-3, mesenchymal stem cells)."

Journal