ALT-801 / ImmunityBio - LARVOL DELTA

A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=12 | Terminated | Sponsor: Altor BioScience | N=52 ➔ 12 | Unknown status ➔ Terminated; The study was terminated early due to low enrollment.

Enrollment change • Trial termination • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer (clinicaltrials.gov) - P1/2 | N=68 | Completed | Sponsor: Altor BioScience | Unknown status ➔ Completed

Combination therapy • Metastases • Trial completion • Bladder Cancer • Genito-urinary Cancer • Kidney Cancer • Oncology • Solid Tumor • Urethral Cancer • Urothelial Cancer

TREATMENT WITH RESMETIROM IN PHASE 3 MAESTRO-NAFLD-1 NASH STUDY OPEN LABEL ARM: EFFECTS ON BIOMARKERS AND IMAGING (NASH-TAG 2021) - P3 | "Animals with biopsy-confirmed steatosis (score ≥2) and fibrosis (stage ≥1) received ALT-801 (10 nmol/kg; SC), semaglutide, a GLP-1 agonist (10 nmol/ kg; SC), elafibranor, a PPARα/δ agonist (78μmol/kg; PO) or vehicle (PO/SC) for 12 weeks. In this 52 week Phase 3 open label study, NASH patients identified using non-invasive imaging and biomarkers were treated with resmetirom 100 mg and demonstrated rapid reduction in hepatic fat, biomarkers and atherogenic lipids after 12-16 weeks of treatment, potentially supporting use of non-invasive tests to monitor individual NASH patient response to resmetirom treatment."

Biomarker • Clinical • P3 data • Diabetes • Dyslipidemia • Fibrosis • Hepatology • Hypertension • Immunology • Inflammation • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • APOB • COL1A1 • MRI

ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: Altimmune, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatology • Non-alcoholic Steatohepatitis • Obesity • MRI

[VIRTUAL] Giant Cell Hepatitis Due to Drug-Induced Autoimmune Hepatitis from Dupilumab (ACG 2020) - "Labs on admission were AST 973 (u/L), ALT 801 (u/L), AP 225 (u/L), total bilirubin 16.6 (mg/dL), direct bilirubin 11.2 (mg/dL), INR 2.4, absolute eosinophil count 20.4 (k/uL)...Management included discontinuation of dupilumab and IV methylprednisolone which was transitioned to a prolonged prednisone taper at discharge...Our patient’s negative serologic workup, biopsy findings, and timing of dupilumab initiation to acute hepatitis makes drug-induced autoimmune hepatitis the most likely etiology. There have been no previous reports that dupilumab has been implicated in drug-induced liver injury, drug-induced AIH or has been responsible for the pathologic diagnosis of Giant Cell Hepatitis."

Anorexia • Asthma • Crohn's disease • Eosinophilia • Fibrosis • Hepatitis C Virus • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Liver Failure • Oncology • Pain • Respiratory Diseases • MRI

ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability (clinicaltrials.gov) - P1; N=84; Not yet recruiting; Sponsor: Altimmune, Inc.

Clinical • New P1 trial • Hepatology • Non-alcoholic Steatohepatitis • Obesity

[VIRTUAL] GLP-1/glucagon dual receptor agonist ALT-801 is superior to semaglutide in improving NASH endpoints in a biopsy-confirmed DIO mouse model (EASL-ILC-I 2020) - "This study provides evidence for the beneficial effects of glucagon receptor activation in the therapeutic treatment of NASH. The return of body weight to lean normal and metabolic improvement with improvement of liver pathology highlights ALT-801 as a new candidate for the treatment of NASH."

Preclinical • Fibrosis • Hepatology • Immunology • Non-alcoholic Steatohepatitis • CD146 • CD36 • COL1A1 • FASN • TLR4

A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2; N=66; Active, not recruiting; Sponsor: Altor Bioscience Corporation; Trial primary completion date: Aug 2014 ->Sep 2015

Trial primary completion date • Biosimilar • Hematological Malignancies • Multiple Myeloma • Oncology

Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma (clinicaltrials.gov) - P1/2; N=25; Completed; Sponsor: Altor Bioscience Corporation; Active, not recruiting -> Completed

Trial completion • Biosimilar • Melanoma • Oncology • Reperfusion Injury

Inhibition of IL-2 responsiveness by IL-6 is required for the generation of GC-T cells. (PubMed, Sci Immunol) - "Mechanistically, we found that IL-6 inhibited up-regulation of IL-2Rβ (CD122) by preventing association of STAT5 with the Il2rb locus, thus allowing GC-T cells to receive sustained TCR signaling and produce IL-2 without initiating a TCR/IL-2 inhibitory feedback loop. Collectively, our results identify a regulatory mechanism that controls the generation of GC-T cells."

IO Biomarker • Journal • Infectious Disease

A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1/2; N=52; Recruiting; Sponsor: Altor Bioscience Corporation; Trial primary completion date: Sep 2015 ➔ Sep 2016

Trial primary completion date • Biosimilar • Oncology

Glp-1/glucagon dual receptor agonist alt-801 is superior to semaglutide in improving nash endpoints in a biopsy-confirmed dio mouse model (EASL-ILC 2020) - No abstract available

Preclinical

Altimmune to host key opinion leader call on ALT-801 for the treatment of NASH - "Altimmune, Inc...a clinical-stage biopharmaceutical company, today announced that it will host a Key Opinion Leader (KOL) call on ALT-801, the Company’s GLP-1/glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH), on Thursday, December 5th at 11am Eastern Time. The call will feature a presentation by Stephen A. Harrison, MD...a leading expert in the field of NASH, who will provide an overview of current and future treatment approaches for this disorder. Dr. Harrison will be available to answer questions at the conclusion of the call."

Toll Like Receptor 2 Mobilizes Regulatory T Cell Lymphatic Migration by Stimulating Lymphotoxin Expression (ATC 2019) - "TLR2 signaling preferentially promotes LT expression and Treg migration, which enhances their suppressive function. Islets express TLR2 ligands and directly stimulate Treg. These results demonstrate a previously unexplored link between TCR/IL-2R and TLR2 signaling in Treg that leads to modulation of LT expression and regulation of T cell lymphatic migration and suppression."

IO Biomarker