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2023. március 22., szerda 09:01 |
DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCiTM STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM |
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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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