IPN60300 / Ipsen, Foreseen Biotech, Escugen Biotechnology - LARVOL DELTA

Safety Study of Intravenous MiraMSC in Older Adults With Mild to Moderate Frailty Syndrome (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Miracle Biomedical Co., Ltd.

New P1 trial • Geriatric Disorders

CLIN-60300-450: A study to assess the safety, tolerability, pharmacokinetic, pharmacodynamic, immunogenicity and antitumour activity of IPN60300 in adults with locally advanced or metastatic solid tumours (clinicaltrialsregister.eu) - P1/2 | N=55 | Recruiting | Sponsor: Ipsen Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

Identification of a first-in-class therapeutic target using machine learning enabled translational-optimized proteomics system (TPS) (AACR 2026) - "Our translational-optimized proteomics system (TPS) has led to the discovery of ITGA2, a novel tumor-associated antigen (TAA) and enabled the development of FS001(IPN60300)."

Machine learning • Colorectal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • ITGA2

Integrin alpha-2 (ITGA2) is a novel and well-suited antibody-drug conjugate (ADC) target (AACR 2026) - P1/2 | "The ITGA2 expression pattern makes it a well-suited ADC target, and IPN60300 efficacy in preclinical models is dependent on ITGA2 expression. These findings support IPN60300 as a promising first-in-class ADC for individuals harboring ITGA2-expressing tumors. IPN60300 is advancing to a First-in-Human clinical trial (NCT07213817)."

ADC • First-in-human • Biliary Cancer • Cholangiocarcinoma • Gastric Cancer • Oncology • Solid Tumor • ITGA2

Preclinical characterization of IPN60300, a first-in-class ITGA2 antibody-drug conjugate for cancer therapy (AACR 2026) - P1/2 | "These preclinical findings support IPN60300 as a promising first-in-class ITGA2-targeting ADC, combining potent anti-tumor efficacy with a favorable safety profile. IPN60300 holds potential to improve clinical outcomes for patients with ITGA2-expressing malignancies and is advancing to First-in-Human clinical trial (NCT07213817)."

ADC • First-in-human • Preclinical • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CTSC • ITGA2

Phase I/II FIH study of IPN60300, a first-in-class ADC targeting ITGA2, to assess the safety, tolerability, PK, biomarkers, immunogenicity and antitumor activity in adults with locally advanced solid tumors (AACR 2026) - P1/2 | "Based on results from phase I, a phase II dose expansion study will be included via protocol amendment. Enrolment for Phase Ia is ongoing.Clinical trial information: NCT07213817"

ADC • Biomarker • Clinical • First-in-human • Metastases • P1/2 data • Biliary Cancer • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CTSC • ITGA2

CLIN-60300-450: A study to assess the safety, tolerability, pharmacokinetic, pharmacodynamic, immunogenicity and antitumour activity of IPN60300 in adults with locally advanced or metastatic solid tumours (clinicaltrialsregister.eu) - P1/2 | N=55 | Not yet recruiting | Sponsor: Ipsen Pharma | N=28 ➔ 55

Enrollment change • First-in-human • Oncology • Solid Tumor

CLIN-60300-450: A study to assess the safety, tolerability, pharmacokinetic, pharmacodynamic, immunogenicity and antitumour activity of IPN60300 in adults with locally advanced or metastatic solid tumours (clinicaltrialsregister.eu) - P1/2 | N=28 | Not yet recruiting | Sponsor: Ipsen Pharma

First-in-human • New P1/2 trial • Oncology • Solid Tumor

A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1/2 | N=102 | Recruiting | Sponsor: Ipsen | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Oncology • Solid Tumor

A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1/2 | N=102 | Not yet recruiting | Sponsor: Ipsen

First-in-human • New P1/2 trial • Oncology • Solid Tumor

Ipsen and Foreseen Biotechnology announce exclusive global licensing agreement for antibody-drug conjugate with first-in-class potential (GlobeNewswire) - "Ipsen...and Foreseen Biotechnology...announced an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential. FS001 targets a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis....The agreement gives Ipsen exclusive worldwide rights to develop, manufacture and commercialize FS001....Foreseen Biotechnology is eligible to receive up to $1.03bn comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on global sales, contingent upon successful development and regulatory approvals. Under the terms of the agreement, Ipsen will assume responsibility for Phase I preparation activities, including submission of the Investigational New Drug (IND) application, and all subsequent clinical-development, manufacturing, and global commercialization activities."

Licensing / partnership • Solid Tumor