Debio 0228/0328

ITM-91/ ITM-94D (Debio 0228/0328) is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and now exclusively licensed to ITM. ITM-94D (Debio 0328) ([68Ga]Ga-DPI-4452) is a PET imaging agent that may be used independently and is designed to identify patients whose cancers overexpress CA IX. Once identified, these patients may be treated with the lutetium-labelled radioligand, ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452), which is designed to deliver targeted radiation to the tumor with the aim to destroy it from the inside. The recently launched GaLuCi™ study, a multi-center, non-randomized phase 1/2 clinical trial, is investigating the theranostic pair in patients with locally advanced renal, pancreatic, and colorectal cancer.

Product Snapshot

Radioligand Therapy Targeting CA IX

Delivery of high-dose radiation to tumors

Being researched in:

Clear Cell Renal Cell Carcinoma
Pancreatic Duodenal Adenocarcinoma
Colorectal Cancer

In short

Initially discovered by the German biotech, 3B Pharmaceuticals (3BP), the peptide-based ligand demonstrates high selectivity and specificity for CA IX.

The first in human phase 1/2 GaLuCi™ study investigates the safety, tolerability and performance of the imaging compound, Debio 0328 and the therapeutic agent, Debio 0228.

Focus on the Mode of Action

The Debio 0228/0328 theranostic pair avoids damaging healthy tissues by delivering radioactive particles directly inside the tumor via the CA IX surface protein. Traveling through the bloodstream, the diagnostic radioligand lights up the tumor if the receptor is present, confirming the therapeutic radioligand can be used to treat the patient. The therapeutic radioligand attaches to the CA IX surface protein and delivers the radiation, minimizing the effects on healthy organs, and offering personalized, targeted cancer therapy.

Focus on the Theranostic Approach

This specific targeted approach, known as a “theranostic” approach, refers to the diagnosis and treatment of cancers using radiotracers. Through this two-pronged approach, potential responders are qualified for their personalized therapy via diagnostic molecular imaging evaluating target expression in their tumor lesions, allowing only those patients, who might potentially benefit, to receive the treatment.

Insights from experts

Focus on the GaLuCi™ phase 1/2 trial

Patients with ccRCC, PDAC, and CRC

The GaLuCi™ trial is the first-in-human, multicenter, non-randomized phase 1/2 clinical trial assessing safety and tolerability, imaging characteristics, and the efficacy of the theranostic pair Debio 0228/0328 in patients with unresectable, locally advanced, or metastatic solid tumors. This theranostic trial is being carried out in three stages. The ongoing Part A is evaluating the safety and performance of the imaging agent in detecting CA IX-expressing solid tumors. Part B will assess escalating doses of the therapeutic agent, Debio 0228 in patients, whose tumors show high uptake of imaging tracer. Finally, based on the recommended dose from part B, Part C of the study will further assess the safety and preliminary efficacy of Debio 0228 in clear cell renal cell carcinoma (ccRCC), pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC).

For a closer look, copy and paste this link in your search browser: https://www.debiopharm.com/wp-content/uploads/2020/03/Debio-0228_Publication-infographic_20240528_v3.0-FINAL.pdf

Development milestones

2020

In-licenced by Debiopharm
2023

First-in human GaLuCi Trial
2024

Worldwide license granted to ITM