LAUSANNE, Switzerland, Aug. 26, 2020 /PRNewswire/ -- Debiopharm ( www.debiopharm.com), a Swiss-based, global biopharmaceutical company, today announced the first patient dosed in the multicenter, single-arm, open-label Phase 1 study assessing the safety, distribution, and dosing of Debio 1124 in patients with advanced, unresectable pulmonary and extrapulmonary small cell carcinoma. This targeted, investigational radiotherapy belongs to the emerging class of Peptide Receptor Radionuclide Therapies (PRRT), having been designed to selectively deliver molecular radiotherapy to tumor cells expressing the cholecystokinin 2 receptor (CCK2R). Research will leverage a theranostic approach, combining both diagnostic and therapeutic capacities of the compound. This will allow the pre-identification of patients who have the CCK2R receptors necessary to respond to the targeted radiotherapy using an imaging dose of Debio 1124 followed by a therapeutic dose of the same compound for qualifying patients only.
The advancement of the Debio 1124 program is part of Debiopharm's expanding radio-oncology pipeline including other radio-pharmaceutical and chemoradiotherapy enhancing compounds. Initially discovered by the Swiss based Paul Scherrer Institute (PSI), before being licensed by Debiopharm, Debio 1124 has shown anti-tumor activity in pre-clinical cancer models. The advancement of Debio 1124 into this clinical study may reveal improved therapeutic results for suffering from pulmonary and extrapulmonary small cell carcinoma.
"We're very excited to bring the potential benefit of molecular radiotherapy to patients with small cell lung cancer showing expression of CCK2R. PRRT has the potential to impact the tumor while minimizing the off-target effects," explained Carlos Chanquia, Medical Director of Oncology at Debiopharm.
SCLC is a highly aggressive cancer associated with patients over 65 years old with a history of smoking. Without treatment, extensive stage small cell lung cancer (ES-SCLC), representing approximately two-thirds of all cases, is rapidly and invariably fatal. 1 Combination chemotherapy induce dramatic but short-lived responses, with median overall survival in the third line setting <6 months. Ongoing research will evaluate if SCLC could potentially benefit from this specifically targeted radiotherapy.
About Debio 1124 Debio 1124 is a new-generation peptide analogue of minigastrin, coupled to the isotope Lutetium 177 ( 177Lu) designed to selectively deliver molecular radiotherapy to tumor cells expressing the Cholecystokinin B Receptor (CCK2R). The compound can be used as both a diagnostic tool during initial imaging step and subsequently as an intravenous radio-pharmaceutical for treatment. This targeted, theragnostic compound is being researched in various cancer types including advanced Medullary Thyroid Cancer (MTC) and SCLC.
Debiopharm's commitment to cancer patients Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
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Reference : 1. Oronsky et al. Neoplasia. 2017 Oct; 19(10): 842-847.