pradusinstobart (LVGN3616) / Lyvgen - LARVOL DELTA

CD40 Agonist and PD-1 Inhibitor in HNSCC (clinicaltrials.gov) - P1 | N=27 | Active, not recruiting | Sponsor: University of Pennsylvania | Recruiting ➔ Active, not recruiting | N=20 ➔ 27

Enrollment change • Enrollment closed • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=352 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Esophageal Cancer • Eye Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40

Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov) - P1 | N=126 | Active, not recruiting | Sponsor: Lyvgen Biopharma Holdings Limited | Recruiting ➔ Active, not recruiting | Phase classification: P1a/1b ➔ P1 | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Combination therapy • Enrollment closed • Metastases • Phase classification • Trial completion date • Trial primary completion date • Oncology

CD40 Agonist and PD-1 Inhibitor in HNSCC (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: University of Pennsylvania | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CD40 Agonist and PD-1 Inhibitor in HNSCC (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: University of Pennsylvania

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=352 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jul 2023 ➔ Feb 2027 | Trial primary completion date: Jul 2023 ➔ Feb 2027

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Esophageal Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40

Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov) - P1a/1b | N=126 | Recruiting | Sponsor: Lyvgen Biopharma Holdings Limited | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology

Early safety and efficacy from a phase I open-label clinical study of LVGN7409 (CD40 agonist antibody) in patients with advanced or metastatic malignancies. (ASCO 2022) - P1a/1b | "An open-label, first in human phase 1 study of LVGN7409 as a single agent, combined with LVGN3616 (anti-PD-1 antibody), and combined with LVGN3616 and LVGN6051 (CD137 agonist antibody) is ongoing. Preliminary evidence showed LVGN7409 monotherapy was well tolerated up to 2mg/kg. Approximately 44% of stable diseases were observed in these heavily treated patients. The favorable safety profile and preliminary antitumor activity warrant further evaluation of LVGN7409 as a single agent and in combination with other cancer therapeutics in patients with advanced malignancies."

Clinical • IO biomarker • P1 data • Immune Modulation • Inflammation • Oncology • CD40

Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov) - P1a/1b | N=126 | Recruiting | Sponsor: Lyvgen Biopharma Holdings Limited | Trial completion date: Apr 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Oncology

Study of LVGN3616 and LVGN6501±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=352; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2022 ➔ Nov 2021

Combination therapy • Enrollment open • Trial initiation date • Esophageal Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40

Study of LVGN3616 and LVGN6501±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=352; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center

Combination therapy • New P1 trial • Esophageal Cancer • Eye Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma • CD40

Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov) - P1a/1b; N=126; Recruiting; Sponsor: Lyvgen Biopharma Holdings Limited; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Oncology