OTS - DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCiTM STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM
2023. March 22. 09:01
Lausanne, Switzerland, 22 March, 2023 (APA/OTS) - Debiopharm is
developing personalized radiotherapy through a theranostic
approach, combining diagnostic imaging (Debio 0328 a
gallium-labelled imaging tool) and therapeutic components (Debio
0228, a lutetium-labelled radioligand), thus allowing the
pre-identification and treatment of patients expressing CA IX. -
The GaLuCiTM 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. - Debiopharm's
research is applying precision nuclear medicine to the promising
target, Carbonic Anhydrase IX (CA IX), a surface protein
overexpressed in many solid tumors and a well-known marker of tumor
aggressiveness and resistance to treatment.
Debiopharm (www.debiopharm.com), a Swiss-based, global
biopharmaceutical company, aiming to establish tomorrow's
standard-of-care to cure cancer and infectious diseases, today
announced the first patient dosed of their first-in-human, phase
1/2 study, GaLuCiTM. 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.
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 GaLuCiTM 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 GaLuCiTM 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.
Debiopharm's commitment to patients
Debiopharm aims to develop innovative therapies that target
high unmet medical needs in oncology and bacterial infections.
Bridging the gap between disruptive discovery products and
real-world patient reach, we identify high-potential compounds and
technologies for in-licensing, clinically demonstrate their safety
and efficacy, and then select large pharmaceutical
commercialization partners to maximize patient access globally.
For more information, please visit www.debiopharm.com
We are on Twitter. Follow us @DebiopharmNews at
http://twitter.com/DebiopharmNews
Debiopharm Contact
Dawn Bonine
Head of Communications
dawn.bonine@debiopharm.com
Tel: +41 (0)21 321 01 11
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