fidasimtamab (IBI315) / Hanmi, Innovent Biologics - LARVOL DELTA

New weapon discovered for HER2 stomach cancer that is refractory to targeted anticancer drugs [Google translation] (Health Korea News) - "A new weapon has emerged against HER2-positive gastric cancer that is refractory to human epidermal growth factor receptor type 2 (HER2)-targeted anticancer drugs. The main character is a bispecific antibody that acts simultaneously on immune checkpoint proteins and PD-1 and HER2....'Fidasimtamab' is a bispecific antibody that simultaneously targets PD-1 on the surface of T cells and HER2 expressed in tumor cells, and is applied by Pentambody...It is the world's first HER2+PD-1 bispecific antibody innovative new drug (first-in-class)."

Clinical • Gastric Cancer

A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor (clinicaltrials.gov) - P1a/1b | N=55 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | N=191 ➔ 55 | Trial completion date: Dec 2025 ➔ Jun 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Anti-PD-1/Her2 Bispecific Antibody IBI315 Enhances the Treatment Effect of Her2-Positive Gastric Cancer through Gasdermin B-Cleavage Induced Pyroptosis. (PubMed, Adv Sci (Weinh)) - "Notably, GSDMB is found to be elevated in Her2-positive gastric cancer cells, providing a rationale for IBI315's efficacy. IBI315 is supported here as a promising bispecific antibody-based immunotherapy approach for Her2-positive gastric cancer in preclinical studies, broadening the therapeutic landscape of this patient population."

IO biomarker • Journal • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • GSDMB • IFNG

Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advanced/Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes (clinicaltrials.gov) - P1/2 | N=45 | Not yet recruiting | Sponsor: Henan Cancer Hospital

IO biomarker • New P1/2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Innovent Releases Preliminary Results of the Phase Ia Dose-Escalation study of IBI315 (Anti-Her2/PD-1 Bispecific Antibody) in Patients with Advanced Solid Tumors at CSCO Annual Meeting 2021 (PRNewswire) - P1, N=191; NCT04162327; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; "Innovent Biologics...released the preliminary results of the Phase Ia study of IBI315...in an oral presentation at the 2021 Annual Meeting of Chinese Society of Clinical Oncology (CSCO)....By data cutoff date of May 25, 2021, 27 patients have been enrolled and received IBI315 at one of seven pre-specified dose levels of 0.03mg/kg QW to 15mg/kg Q3W. No dose limited toxicity (DLT) was observed, and maximum tolerated dose (MTD) has not been reached. Among 15 patients who have completed at least one post-treatment tumor assessment at active dose levels (≥1mg/kg), objective response rate (ORR) was 20%."

P1 data • Oncology • Solid Tumor

A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor (clinicaltrials.gov) - P1a/1b; N=191; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • HER2

Innovent announces first patient dosed in phase I clinical trial of anti-PD-1/HER2 bispecific antibody in China (PRNewswire) - "Innovent Biologics...jointly announced with Beijing Hanmi Pharmaceutical Co., Ltd. (a subsidiary of Hanmi Pharmaceutical Co., Ltd.) ('Hanmi') that the first patient has been successfully dosed in a Phase I clinical trial (CIBI315A101) of a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and human epidermal growth factor receptor 2 (HER2) (IBI315), an innovative antibody co-developed by both companies."

Enrollment open

Newly added product (PRNewswire) - P1, Oncology

Pipeline update