pradusinstobart (LVGN3616) / Lyvgen - LARVOL DELTA

A prospective trial of single-dose neoadjuvant PD-1 blockade with or without a CD40 agonist in HPV-negative HNSCC (MHNCS 2026) - "Materials/ We enrolled 20 patients with locally advanced resectable HPV-negative HNSCC; 10 received a single intravenous dose of PD-1 inhibitor (LVGN3616, 300mg), and 10 received a PD-1 inhibitor (LVGN3616, 300mg) in combination with a CD40 agonist (LVGN7409, 1mg/kg), administered prior to surgical resection (window, 4-28 days). Compared to single agent PD-1 blockade alone in resectable HPV-negative HNSCC, single-dose neoadjuvant PD-1 blockade combined with a CD40 agonist was safe, did not delay surgery, was associated with immune activation, and produced modestly improved pathologic regressions that correlated with an inflammatory score based on baseline LCN2 and SAA levels."

Clinical • IO biomarker • Head and Neck Cancer • Laryngeal Cancer • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD40 • IL15 • PD-L1

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