LIS1 / Xenothera - LARVOL DELTA

PALT1: Polyspecific Antibodies in Lymphoproliferative T-cell Disorders (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: Xenothera SAS | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

First-in-human Study With LIS1, a Next-generation Porcine Low Immunogenicity Antilymphocyte Immunoglobulin in Kidney Transplantation. (PubMed, Transplantation) - "In this first-in-human trial, genome-edited swine-derived polyclonal LIS1 ALG was well tolerated, did not elicit antidrug antibodies, and caused time-limited T cell depletion in low- and medium-risk kidney transplant recipients."

Journal • P1 data • Preclinical • Hematological Disorders • Inflammation • Leukopenia • Solid Organ Transplantation • Thrombocytopenia • Transplantation

PALT1: Polyspecific Antibodies in Lymphoproliferative T-cell Disorders (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: Xenothera SAS

New P1/2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

First-in-human Study With LIS1, a Next-generation Porcine Low Immunogenicity Antilymphocyte Immunoglobulin in Kidney Transplantation. (PubMed, Transplantation) - "In this first-in-human trial, genome-edited swine-derived polyclonal LIS1 ALG was well tolerated, did not elicit antidrug antibodies, and caused time-limited T cell depletion in low- and medium-risk kidney transplant recipients."

Journal • P1 data • Preclinical • Hematological Disorders • Inflammation • Leukopenia • Solid Organ Transplantation • Thrombocytopenia • Transplantation

LIS1, a glyco-humanized swine polyclonal anti-lymphocyte globulin, as a novel induction treatment in solid organ transplantation. (PubMed, Front Immunol) - "Anti-thymocyte or anti-lymphocyte globulins (ATGs/ALGs) are immunosuppressive drugs used in induction therapies to prevent acute rejection in solid organ transplantation. Compared with rabbit ATG, GH-ALG induced transient depletion (less than one week) of target T cells in the peripheral blood (<100 lymphocytes/L) but was equivalent in preventing allograft rejection in a skin allograft model. The novel therapeutic modality of GH-ALG might present advantages in induction treatment during organ transplantation by shortening the T-cell depletion period while maintaining adequate immunosuppression and reducing immunogenicity."

Journal • Infectious Disease • Solid Organ Transplantation • Transplant Rejection • Transplantation • CD4 • CD8

First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients (clinicaltrials.gov) - P1/2 | N=10 | Completed | Sponsor: Xenothera SAS | Active, not recruiting ➔ Completed

Trial completion • Transplantation • CRP • IL6

First-in-human Study Of Lis1, A Novel Glyco-humanized Anti-lymphocyte Swine Polyclonal Antibody, In Kidney Transplantation: Safety And Efficacy (ATC 2022) - "LIS1 at a dose of 8-10 mg/kg is safe and well tolerated and allows a controlled-in-time selective depletion of target CD3+ T cells. Phase II multicentric double blind study is planned."

Clinical • P1 data • Immunology • Inflammation • Transplant Rejection • Transplantation • CD4 • CD8

First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients (clinicaltrials.gov) - P1/2 | N=10 | Active, not recruiting | Sponsor: Xenothera SAS | Recruiting ➔ Active, not recruiting

Enrollment closed • Transplantation • CRP • IL6 • TNFA

First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients (clinicaltrials.gov) - P1/2; N=10; Recruiting; Sponsor: Xenothera SAS; Trial completion date: Jul 2021 ➔ Mar 2022; Trial primary completion date: Jul 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Transplantation • CRP • IL6 • TNFA

First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients (clinicaltrials.gov) - P1/2; N=10; Recruiting; Sponsor: Xenothera SAS; Trial completion date: Dec 2020 ➔ Jul 2021; Trial primary completion date: Dec 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Transplantation • CRP • IL6