dalnicastobart (LVGN7409) / 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

Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Lyvgen Biopharma Holdings Limited | Terminated ➔ Completed

IO biomarker • Metastases • Trial completion • Tumor mutational burden • Oncology • CD4 • CD40 • IFNG • IL12A • IL6 • PD-L1 • TMB • TNFA

Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy (clinicaltrials.gov) - P1 | N=33 | Terminated | Sponsor: Lyvgen Biopharma Holdings Limited | N=93 ➔ 33 | Trial completion date: Apr 2024 ➔ Dec 2023 | Recruiting ➔ Terminated; The study was terminated due to product development strategy adjustment,there were no safety concerns

Enrollment change • IO biomarker • Metastases • Trial completion date • Trial termination • Tumor mutational burden • Oncology • CD4 • CD40 • IFNG • IL12A • IL6 • PD-L1 • TMB • TNFA

Harnessing the potential of CD40 agonism in cancer therapy. (PubMed, Cytokine Growth Factor Rev) - "In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them."

IO biomarker • Journal • Review • Oncology • CD40 • CD40LG • CD8 • TNFA

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

Lyvgen Announces Phase 2 Clinical Collaboration with Bristol Myers Squibb to Evaluate LVGN7409 in Combination with Nivolumab in Non-Small Cell Lung Cancer Patients (PRNewswire) - "Lyvgen Biopharma...announced today an open label, phase 2, multicenter, randomized trial of LVGN7409 plus docetaxel or, in collaboration with Bristol Myers Squibb, nivolumab in patients with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC)....LVGN7409, a recombinant monoclonal antibody that targets CD40 for activation optimally in tumor microenvironment, which is a member of the tumor necrosis factor (TNF) receptor family (TNFRSF5)....Under the terms of the Agreement, Lyvgen will sponsor the study and Bristol Myers Squibb will provide nivolumab for the combination trial....Combination study to begin in 1st half 2023."

Licensing / partnership • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Study of LVGN7409 (CD40 Agonist Antibody) in Locally Advanced, Metastatic or Recurrent/Refractory Malignancy (clinicaltrials.gov) - P1; N=93; Recruiting; Sponsor: Lyvgen Biopharma Holdings Limited

Clinical • New P1 trial • Oncology • Solid Tumor • CD4

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