On March 22, 2023 Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported the first patient dosed of their first-in-human, phase 1/2 study, GaLuCi (Press release, Debiopharm, MAR 22, 2023, View Source [SID1234629179]). The first patient was screened and dosed at the Australian-based Peter MacCallum Cancer Centre. This multicenter international trial, evaluating a radioligand theranostic pair will be carried out in three stages: Part A to confirm the safety and reliability of Debio 0328 in detecting CA IX-expressing solid tumors, Part B to assess escalating doses of the therapeutic agent, Debio 0228 in patients, whose tumors show high uptake of Debio 0328 and finally, based on the recommended dose from part B, Part C will further assess safety and preliminary efficacy in selected tumor types.
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Currently, Debio 0228/0328 is the only peptide-based theranostic pair targeting CA IX in clinical development, with pan-tumor potential, and developed first for patients with advanced cancers such as renal, pancreatic, and colorectal. It leverages a theranostic approach to identify and deliver radiation to diseased tissues, allowing the imaging-based pre-identification of patients who have the target proteins necessary to respond to the targeted radioligand.
"The results of the GaLuCi trial are highly anticipated considering the therapeutic potential of Debio 0228 as observed in preclinical models. Using this theranostic pair could pave the way for personalized nuclear medicine, enabling administration of the lutetium coupled radioligand only to patients who are more likely to respond to the therapy." explained Angela Zubel, Chief Development Officer at Debiopharm.
"We always have immense gratitude for our patients who participate in first time in human trials, but in this case, we are particularly thankful for our patient who agreed to be the first person in the world to have their kidney cancer imaged with Debio 0328 on the GaLuCi trial. We hope this is the beginning of the theranostics era in kidney cancer!" expressed Dr. Ben Tran, Lead Genito-urinary medical oncologist, Peter MacCallum Cancer Centre.
"We are excited about this first-in-human study as it is a novel approach for advanced kidney cancer patients," said Darren R. Feldman, MD, Associate Attending Physician, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center. "Precision nuclear medicine applied to CA9 could benefit advanced cancer patients who still experience a high unmet medical need. This theranostic pair allows targeted radiation delivery to the cancer cells bearing CA IX, which is largely expressed, over 85%, in clear cell renal cell carcinoma."
The theranostic approach with Debio 0228/0328
Debio 0228 ([177Lu]Lu-DPI-4452) and 0328 ([68Ga]Ga-DPI-4452) is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and exclusively licensed to Debiopharm. ([68Ga]Ga-DPI-4452 is a PET imaging agent, (Debio 0328) used to identify patients whose cancers overexpress CA IX. Once identified, these patients can be treated with the lutetium-labelled radioligand, Debio 0228, which delivers targeted radiation to the tumor, destroying it from the inside.