HDIT101 / Heidelberg ImmunoTherap - LARVOL DELTA

Safety and efficacy of monoclonal antibody therapy in patients with chronic herpes simplex virus-2 genital infections: MATCH-2, a randomized double-blinded, parallel-group phase 2 multi-center trial. (PubMed, Pharmacol Res) - P2 | "At each recurrence during the 180-day trial period patients in the HDIT101 arm received episodic oral valacyclovir placebo (twice daily for 3 days) or valacyclovir (500mg twice daily for 3 days) in the control arm. Meanwhile, complementary studies confirming immunomodulatory effects mediated by the HDIT101 antibody as its key mode of action support the rationale for further clinical investigation. (CinicalTrials.gov NCT04165122)."

Clinical • Journal • P2 data • Herpes Simplex • Infectious Disease

Development of a highly effective combination monoclonal antibody therapy against Herpes simplex virus. (PubMed, J Biomed Sci) - "This biochemical and immunological study showcases the potential of an effective combination therapy with two monoclonal anti-gB IgGs for the treatment of HSV-1/2 induced disease conditions."

Journal • Herpes Simplex • Infectious Disease

MATCH-1: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection (clinicaltrials.gov) - P2 | N=761 | Terminated | Sponsor: Heidelberg ImmunoTherapeutics GmbH | Active, not recruiting ➔ Terminated; stopped for futility in interim analysis

Trial termination • Herpes Simplex • Infectious Disease

MATCH-1: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection (clinicaltrials.gov) - P2 | N=761 | Active, not recruiting | Sponsor: Heidelberg ImmunoTherapeutics GmbH | Trial completion date: Apr 2024 ➔ Jul 2023 | Trial primary completion date: Apr 2024 ➔ May 2023

Trial completion date • Trial primary completion date • Herpes Simplex • Infectious Disease

MATCH-1: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection (clinicaltrials.gov) - P2 | N=761 | Active, not recruiting | Sponsor: Heidelberg ImmunoTherapeutics GmbH | Recruiting ➔ Active, not recruiting | N=138 ➔ 761 | Trial completion date: Oct 2023 ➔ Apr 2024 | Trial primary completion date: Oct 2022 ➔ Apr 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Herpes Simplex • Infectious Disease

First-in-human, randomized, double-blind, placebo-controlled, dose escalation trial of the anti-herpes simplex virus monoclonal antibody HDIT101 in healthy volunteers. (PubMed, Clin Transl Sci) - "No immunogenic effects following HDIT101 exposure were observed at any of the applied doses. HDIT101 demonstrated the expected PK properties of a monoclonal antibody was well-tolerated, and could be safely administered even at excessively high doses that may be required for treatment of patients with septical HSV spread."

Clinical • Journal • P1 data • Herpes Simplex

MATCH-2: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection (clinicaltrials.gov) - P2; N=122; Completed; Sponsor: Heidelberg ImmunoTherapeutics GmbH; Active, not recruiting ➔ Completed

Clinical • Trial completion • Herpes Simplex • Infectious Disease

MATCH-2: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection (clinicaltrials.gov) - P2; N=125; Active, not recruiting; Sponsor: Heidelberg ImmunoTherapeutics GmbH; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Herpes Simplex • Infectious Disease

MATCH-1: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection (clinicaltrials.gov) - P2; N=138; Recruiting; Sponsor: Heidelberg ImmunoTherapeutics GmbH; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Herpes Simplex • Infectious Disease

Development and Validation of an LC-MS-Based Quantification Assay for New Therapeutic Antibodies: Application to a Novel Therapy against Herpes Simplex Virus. (PubMed, ACS Omega) - "This work presents a generic workflow for the development of MS-based quantification assays of new therapeutic antibodies that allows reaching high immunopurification recovery (>98% for HDIT101 over the full calibration range with a precision of 6.9% CV). Surrogate peptide and stable isotopically labeled internal standard were stable, and batch-to-batch accuracies and precisions at the four quality standard levels ranged between -2 and 5% bias and 8 and 11% CV, respectively."

Journal • Preclinical • Herpes Simplex

MATCH-1: Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection (clinicaltrials.gov) - P2; N=138; Not yet recruiting; Sponsor: Heidelberg ImmunoTherapeutics GmbH

Clinical • New P2 trial • Herpes Simplex • Infectious Disease