KAN-101 / Anokion - LARVOL DELTA

SynCeD: A Study of Efficacy, Safety, and Tolerability of KAN-101 in People with Celiac Disease (clinicaltrials.gov) - P2 | N=55 | Completed | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Active, not recruiting ➔ Completed

Trial completion • Celiac Disease • Immunology

Anokion Announces Positive Symptom Data from its Phase 2 Trial Evaluating KAN-101 for the Treatment of Celiac Disease (Businesswire) - P1b/2 | N=126 | NCT05574010 | Sponsor: Kanyos Bio, Inc | "Anokion SA...announced positive symptom data from its Phase 2 ACeD-it trial evaluating its lead candidate, KAN-101, in individuals with celiac disease. The study data serves as the first symptomatic clinical proof of concept for KAN-101 and its potential as a disease-modifying treatment for celiac disease...Preliminary analysis showed that KAN-101 demonstrated clinically meaningful reductions across multiple individual symptoms and celiac-specific patient reported outcome composite measures following gluten exposure at all dose levels. KAN-101 was safe and tolerated at all dose levels investigated."

P1/2 data • Celiac Disease

SynCeD: A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Jan 2025

Enrollment closed • Trial completion date • Celiac Disease • Immunology

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it) (clinicaltrials.gov) - P1/2 | N=126 | Active, not recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Recruiting ➔ Active, not recruiting

Enrollment closed • Celiac Disease • Immunology • IL2

Pharmacodynamic Demonstration of Immunological Tolerance Induced by KAN-101, a Novel Liver-targeted Therapy for Celiac Disease (FOCIS 2024) - P1 | "In conclusion, the ACeD Ph1 clinical trial demonstrated that KAN-101 was safe and tolerated in CeD patients, induced immunological tolerance to gliadin and modulated a biomarker of clinical efficacy. KAN-101 is currently being tested in Ph2 studies in CeD patients."

PK/PD data • Celiac Disease • Immunology • Inflammation • IL10 • IL2

Pharmacodynamic Demonstration of Immunological Tolerance Induced by KAN-101, a Novel Liver-targeted Therapy for Celiac Disease (FOCIS 2024) - P1 | "In conclusion, the ACeD Ph1 clinical trial demonstrated that KAN-101 was safe and tolerated in CeD patients, induced immunological tolerance to gliadin and modulated a biomarker of clinical efficacy. KAN-101 is currently being tested in Ph2 studies in CeD patients."

PK/PD data • Celiac Disease • Immunology • Inflammation • IL10 • IL2

3445: Basic & Clinical Intestinal Disorders (BCID) Section Distinguished Abstract Plenary (DDW 2024) - "Learning Objectives: Explain the role of fibroblast heterogeneity in intestinal fibrosis and its potential as a therapeutic target for inflammatory bowel disease (IBD). , Evaluate the potential of KAN-101 as a treatment for celiac disease by analyzing phase 1B data on immune tolerance."

Clinical • Celiac Disease • Fibrosis • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

ASSESSMENT OF KAN-101 IN CED AND IMMUNE TOLERANCE (ACED-IT) STUDY, PH1B DATA WITH HIGHER DOSE LEVELS OF KAN-101, A NOVEL IMMUNE TOLERANCE THERAPY FOR CELIAC DISEASE (DDW 2024) - "KAN-101 dose levels up to 3mg/kg were safe and tolerated in CeD patients, exhibited a PK profile in keeping with lower dose levels, and modulated cytokine responses after GC, indicating development of immunological tolerance and immunoregulatory responses. These data extend the findings from the Ph1 and provide additional dose levels for inclusion in Ph2. 1."

Celiac Disease • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • IL2

Clinical And Preclinical Evidence that Liver-Targeted Antigen Therapies Induce Regulatory T Cells and Control Immune Responses in Diseased Tissues (IMMUNOLOGY 2024) - "Investigational therapies composed of a liver-targeting glycosylation signature conjugated to peptides are currently in clinical studies for treatment of both Celiac Disease (KAN-101) and Multiple Sclerosis (ANK-700). Liver-educated Tregs traffic to the site of inflammation, display a distinct phenotype and mediate bystander suppression. These data support that liver-targeted antigen is a viable approach to expand antigen-specific Tregs in vivo and has therapeutic potential in a variety of inflammatory condition, including indications where multiple antigens may be driving disease."

Preclinical • Celiac Disease • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • IL10 • IL2

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it) (clinicaltrials.gov) - P1/2 | N=126 | Recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Active, not recruiting ➔ Recruiting | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Celiac Disease • Immunology • IL2

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it) (clinicaltrials.gov) - P1/2 | N=132 | Active, not recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Recruiting ➔ Active, not recruiting

Enrollment closed • Celiac Disease • Immunology • IL2

SynCeD: A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Not yet recruiting ➔ Recruiting | Phase classification: P2a ➔ P2

Enrollment open • Phase classification • Celiac Disease • Immunology

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it) (clinicaltrials.gov) - P1/2 | N=132 | Recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Phase classification: P1b ➔ P1/2

Phase classification • Celiac Disease • Immunology • IL2

PHARMACODYNAMIC DEMONSTRATION OF IMMUNOLOGICAL TOLERANCE INDUCED BY KAN-101, A NOVEL LIVER-TARGETED THERAPY FOR COELIAC DISEASE, PERSISTS FOLLOWING DRUG CLEARANCE (UEGW 2023) - P1 | "KAN-101 was found to be safe and tolerated in CeD patients and reduced gliadin-specific T cell responses after GC in a Ph1 study. While the clearance of KAN-101 after administration occurs within hours, the pharmacodynamic effects can be observed for at least 3 weeks after the start of treatment. Gliadin-specific T cells are increased following KAN-101 treatment but display an exhausted phenotype, are functionally anergic and do not expand further after GC."

IO biomarker • PK/PD data • Celiac Disease • Immunology • Inflammation • CD4 • IL2 • LAG3 • PD-1

SynCeD: A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease (clinicaltrials.gov) - P2a | N=52 | Not yet recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

New P2a trial • Celiac Disease • Immunology • IL2

Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. (PubMed, Lancet Gastroenterol Hepatol) - P1 | "KAN-101 has an acceptable safety profile in patients with coeliac disease with no dose-limiting toxicities and no maximum tolerated dose was observed. Rapid systemic clearance of KAN-101 was observed and no accumulation on repeated dosing. A future study will evaluate the safety and efficacy, including biomarker responses with a gluten challenge, of KAN-101 at doses 0·6 mg/kg and greater in patients with coeliac disease."

Journal • P1 data • Celiac Disease • Immunology • Pain

Harnessing natural tolerance pathways in the liver to treat autoimmune diseases: evidence from KAN-101 for the treatment of celiac disease (IMMUNOLOGY 2023) - "Sponsor: Sponsored by the AAI Clinical Immunology Committee"

Celiac Disease • Immunology

PHARMACODYNAMIC DEMONSTRATION OF IMMUNOLOGICAL TOLERANCE INDUCED BY KAN-101, A NOVEL LIVER-TARGETED THERAPY FOR CELIAC DISEASE, PERSISTS FOLLOWING DRUG CLEARANCE (DDW 2023) - P1 | "While the clearance of KAN-101 after administration occurs within hours, the pharmacodynamic effects can be observed for at least 3 weeks after the start of treatment. Gliadin-specific T cells are increased following KAN-101 treatment but display an exhausted phenotype, are functionally anergic and do not expand further after GC. In patients receiving placebo, Tet+ CD4+ cells are only observed following GC and respond upon antigen re-stimulation."

IO biomarker • PK/PD data • Celiac Disease • Immunology • Inflammation • CD4 • IL2 • LAG3 • PD-1

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease (clinicaltrials.gov) - P1b | N=138 | Recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA | Not yet recruiting ➔ Recruiting

Enrollment open • Celiac Disease • Immunology • IL2

A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease (clinicaltrials.gov) - P1b | N=138 | Not yet recruiting | Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

New P1 trial • Celiac Disease • Immunology • IL2

SAFETY, TOLERABILITY AND PHARMACODYNAMIC ASSESSMENT OF KAN-101, A NOVEL LIVER-TARGETED THERAPY TO INDUCE IMMUNOLOGICAL TOLERANCE TO GLIADIN IN CELIAC DISEASE (DDW 2022) - "Conclusion s: KAN-101 was safe and tolerated in CeD patients and reduced gliadin-specific T cell responses after GC. These data represent the first demonstration of induction of immunological tolerance in autoimmune patients using Anokion’s novel, liver-targeting platform technology."

Clinical • PK/PD data • Celiac Disease • Immunology • Inflammation • CD8 • IFNG • IL2

Assessment of KAN-101 in Celiac Disease (ACeD) (clinicaltrials.gov) - P1; N=41; Completed; Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA; Active, not recruiting ➔ Completed

Clinical • Trial completion • Celiac Disease • Immunology • HLA-DQA1 • HLA-DQB1

Assessment of KAN-101 in Celiac Disease (ACeD) (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Celiac Disease • Immunology • HLA-DQA1 • HLA-DQB1

Assessment of KAN-101 in Celiac Disease (ACeD) (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA; Trial completion date: Jul 2021 ➔ Oct 2021; Trial primary completion date: Jul 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Celiac Disease • Immunology

Assessment of KAN-101 in Celiac Disease (ACeD) (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA; Trial primary completion date: Nov 2020 ➔ Jul 2021; Trial completion date: Dec 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Celiac Disease • Immunology