vislarafusp-alfa (IMM2902) / ImmuneOnco Biopharma - LARVOL DELTA

IMM2902, a HER2/SIRPα Bispecific MAb-Trap Antibody-receptor Fusion Protein, in Patients with HER2-expressing Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=135 | Suspended | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Recruiting ➔ Suspended | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial primary completion date • Trial suspension • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • CTCs

Development and evaluation of a human CD47/HER2 bispecific antibody for Trastuzumab-resistant breast cancer immunotherapy. (PubMed, Drug Resist Updat) - "Moreover, IMM2902 demonstrated a high safety profile regarding anemia and non-specific cytokines release. Collectively, our results highlighted a novel therapeutic approach for the treatment of HER2+ BCs and this approach exhibits significant anti-tumor efficacy without causing off-target toxicity in trastuzumab-resistant BC cells."

Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • Oncology • Solid Tumor • CXCL10

'New Stock Performance' Immune Onco (01541.HK) opened 14% higher at 21.2 yuan [Google translation] (Yahoo Finance) - "It is expected that the net proceeds raised will be approximately 235 million yuan, of which approximately 40% and 28% will be used for the core product IMM01 respectively., as well as ongoing and planned clinical trials, preparation for registration applications and planned commercial launch of core products IMM0306, IMM2902 and IMM2520; approximately 10% will be used for planned clinical trials of IMM47 (CD24 monoclonal antibody)."

Commercial • Oncology

Preliminary results of a phase I, first-in-human, dose escalation study of IMM2902 in patients with HER2-expressing advanced solid tumors. (ASCO 2023) - "IMM2902 showed an encouraging preliminary safety, tolerability and anti-tumor activity up to 2.0 mg/kg. The phase I/II study is ongoing. Clinical trial information: ChiCTR20212375."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Genetic Disorders • Hematological Disorders • HER2 Breast Cancer • Oncology • Skin Cancer • Solid Tumor • CD8 • HER-2 • SIRPA

Preclinical development of a novel bispecific mAb-Trap fusion protein, IMM2902, targeting both HER2 and CD47 as cancer immunotherapy (AACR 2023) - P1 | "In preclinical research, IMM2902 has demonstrated a much stronger antitumor activity with excellent tolerability in a mouse model of human breast cancer (dose range 3.5 - 10 mg/kg) and a mouse model of human gastric cancer (dose range 1 -18 mg/kg) than that of trastuzumab (targeting HER2 only) alone, IMM01 (a SIRPα-Fc fusion protein) alone, and the combination of trastuzumab and IMM01. Given the strong preclinical antitumor activity as well as the favorable safety profile, IMM2902 may serve as a potent immunotherapy for HER2-expressing cancers via dual blockade of CD47 and HER2. A Phase 1 clinical trial exploring safety, tolerability, and preliminary efficacy of IMM2902 in patients with HER2-expressing advanced solid tumors is currently ongoing in both China (CXSL2101035) and USA (NCT05076591)."

IO biomarker • Preclinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • CD47 • HER-2 • SIRPA

IMM2902 in Patients With Advanced Solid Tumors Expressing HER2 (clinicaltrials.gov) - P1/2 | N=105 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Metastases • New P1/2 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2

IMM2902, a HER2/SIRPα Bispecific mAb-Trap Antibody-receptor Fusion Protein, in Patients With HER2-expressing Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=135 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Not yet recruiting ➔ Recruiting | N=40 ➔ 135 | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • CTCs

The Synergistic Anti-Tumor Activities of CD47-Based Bispecific Molecules in Experimental Solid Tumors Are Dependent on Interaction of Tumor Targets (PEGS 2022) - "Surprisingly, while four bispecific mAb-Traps (IMM0306: CD47/CD20, IMM2902: CD47/Her2, IMM2520: CD47/PD-L1, IMM5601: CD47/CD38) revealed potent synergistic anti-tumor activities, two (IMM0404: CD47/EGFR, IMM3202: CD47/VEGFR2), did not generate such effect. In those two mAb-Trap molecules, linkage of CD47 ligand trap (SIRPa decoy) onto EGFR antibody or VEGFR2 antibody actually reduced therapeutic effects. Thus the synergistic anti-tumor activities of CD47-based bi-specific molecules in experimental solid tumors are dependent on interaction of tumor targets; structural design and target selection deserve careful consideration."

Oncology • Solid Tumor • CD20 • HER-2 • PD-L1 • SIRPA

Preclinical development of a bispecific antibody-trap selectively targeting CD47 and HER2 for the treatment of breast as well as gastric cancer (AACR 2022) - "IMM2902 has no impact on hemagglutination, nor does it have significant hemotoxicity following single as well as multiple administrations in non-human primate animals at different dosage. Our study suggests that IMM2902 has the potential to be an alternative promising treatment option for patients with her2-positive cancers refractory to trastuzumab treatment."

Preclinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD47 • FCGR3A • HER-2

IMM2902, a HER2/SIRPα Bispecific mAb-Trap Antibody-receptor Fusion Protein, in Patients With HER2-expressing Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd | Initiation date: Jan 2022 ➔ May 2022

Trial initiation date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

IMM2902, a HER2/SIRPα Bispecific mAb-Trap Antibody-receptor Fusion Protein, in Patients With HER2-expressing Advanced Solid Tumors (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd

Clinical • New P1 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2