Sym022 / Servier, Sino Biopharm - LARVOL DELTA

TQB2223-AK105-Ib-01: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=34 ➔ 22 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Nov 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial primary completion date • Trial termination • Hepatocellular Cancer • Oncology • Solid Tumor

TQB2223 in Combination with Penpulimab in Patients with Relapsed or Refractory Lymphoma: Primary Analysis of an Open-Label Phase I Study (ASH 2024) - P1 | "Among 14 HL patients, 12 were previously treated with anti-PD-1/L1 and 7 were previously treated with Brentuximab vedotin. Conclusions : TQB2223 in combination with penpulimab was generally safe, well-tolerated and demonstrated encouraging efficacy in patients with lymphoma, especially in patients with Hodgkin lymphoma who has received extensive prior treatments including anti-PD-1/L1. A complex of TQB2223 and penpulimab was prepared and more clinical studies were planned."

Clinical • Combination therapy • P1 data • Atopic Dermatitis • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Dermatology • Diffuse Large B Cell Lymphoma • Dyslipidemia • Endocrine Disorders • Hematological Malignancies • Hodgkin Lymphoma • Hypertriglyceridemia • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Melanoma • Metabolic Disorders • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Primary Mediastinal Large B-Cell Lymphoma • Respiratory Diseases • Solid Tumor • T Cell Non-Hodgkin Lymphoma • LAG3

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: Symphogen A/S | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=78 | Active, not recruiting | Sponsor: Symphogen A/S | N=148 ➔ 78 | Trial completion date: Jan 2025 ➔ Jun 2024

Combination therapy • Enrollment change • Metastases • Trial completion date • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=148 | Active, not recruiting | Sponsor: Symphogen A/S | Phase classification: P1b ➔ P1

Phase classification • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1

A phase I study of Sym021, an anti-PD-1 antibody (Ab), alone and in combination with Sym022 (anti-LAG-3) or Sym023 (anti-TIM-3) (ESMO 2019) - P1; "Sym021 alone was well tolerated and demonstrated both immune modulation and antitumor activity. Evaluation of single agent dose-escalation trials of Sym022 and Sym023 and of the Sym021/Sym022 and Sym021/Sym023 combination arms are ongoing. Results from these studies will be presented."

Combination therapy • P1 data • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology

[VIRTUAL] Phase I studies of Sym021, an anti-PD-1 antibody, alone and in combination with Sym022 (anti-LAG-3) or Sym023 (anti-TIM-3) (ESMO 2020) - P1 | "Funding: Symphogen. Clinical trial identification: NCT03311412; NCT03489369; NCT03489343."

Combination therapy • IO biomarker • P1 data • Hematological Malignancies • Oncology • Solid Tumor

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov) - P1b | N=148 | Active, not recruiting | Sponsor: Symphogen A/S | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov) - P1b | N=148 | Recruiting | Sponsor: Symphogen A/S | N=100 ➔ 148 | Trial primary completion date: Dec 2024 ➔ Apr 2024

Combination therapy • Enrollment change • Trial primary completion date • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1

Sym021 Monotherapy, in Combination With Sym022 or Sym023, and in Combination With Both Sym022 and Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas (clinicaltrials.gov) - P1 | N=91 | Completed | Sponsor: Symphogen A/S | Active, not recruiting ➔ Completed | Trial completion date: Oct 2022 ➔ Mar 2022 | Trial primary completion date: Oct 2022 ➔ Mar 2022

Combination therapy • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas (clinicaltrials.gov) - P1b; N=100; Recruiting; Sponsor: Symphogen A/S; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Biliary Cancer • Biliary Tract Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1

Sym021 Monotherapy, in Combination With Sym022 or Sym023, and in Combination With Both Sym022 and Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas (clinicaltrials.gov) - P1; N=91; Active, not recruiting; Sponsor: Symphogen A/S; Recruiting ➔ Active, not recruiting; Trial completion date: Nov 2021 ➔ Oct 2022; Trial primary completion date: Nov 2021 ➔ Oct 2022

Clinical • Combination therapy • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas (clinicaltrials.gov) - P1b; N=100; Active, not recruiting; Sponsor: Symphogen A/S; N=200 ➔ 100

Clinical • Combination therapy • Enrollment change • Biliary Cancer • Biliary Tract Cancer • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1

Sym021 in Combination With Either Sym022 or Sym023 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1b; N=200; Active, not recruiting; Sponsor: Symphogen A/S; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Sym021 in Combination With Either Sym022 or Sym023 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1b; N=200; Recruiting; Sponsor: Symphogen A/S

Clinical • Combination therapy • New P1 trial • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Sym021 Monotherapy and in Combination With Sym022 or Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas (clinicaltrials.gov) - P1; N=102; Recruiting; Sponsor: Symphogen A/S; Trial completion date: Nov 2020 ➔ Nov 2021; Trial primary completion date: Nov 2019 ➔ Nov 2021

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date

Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas (clinicaltrials.gov) - P1; N=15; Completed; Sponsor: Symphogen A/S; Active, not recruiting ➔ Completed; Trial completion date: Aug 2020 ➔ Jan 2020

Clinical • Trial completion • Trial completion date

Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas (clinicaltrials.gov) - P1; N=15; Active, not recruiting; Sponsor: Symphogen A/S; Recruiting ➔ Active, not recruiting; N=30 ➔ 15; Trial primary completion date: Nov 2019 ➔ Feb 2020

Clinical • Enrollment change • Enrollment closed • Trial primary completion date

Sym021 Monotherapy and in Combination With Sym022 or Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas (clinicaltrials.gov) - P1; N=102; Recruiting; Sponsor: Symphogen A/S; Trial primary completion date: May 2019 ➔ Nov 2019

Clinical • Combination therapy • Monotherapy • Trial primary completion date

Symphogen publishes discovery and pre-clinical data on first chicken-derived antibody to enter human clinical trials (GlobeNewswire, Symphogen A/S) - Sym021 a novel anti-PD1 compound currently in Phase 1 clinical trials. The publication “Sym021, a promising anti-PD1 clinical candidate antibody derived from a new chicken antibody discovery platform.” by Gjetting T et al. In the journal article authored by Symphogen scientists, detailed epitope mapping analysis showed that Sym021 bound to PD1 on a unique epitope distinct from the epitopes of the clinically approved PD1 antibodies pembrolizumab and nivolumab. Based on these promising results and positive findings from a Phase 1 clinical trial evaluating safety and tolerability of Sym021 monotherapy (Part 1), Symphogen has initiated Part 2 of the study where Sym021 is being evaluated in combination with either LAG3- or TIM3-targeted clinical antibody candidates, Sym022 or Sym023 respectively.

P1 data • Preclinical • Trial status

Sym021 Monotherapy and in Combination With Sym022 or Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas (clinicaltrials.gov) - P1; N=102; Recruiting; Sponsor: Symphogen A/S; N=24 ➔ 102

Clinical • Combination therapy • Enrollment change • Monotherapy