DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCiTM STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM

Lausanne, Switzerland (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 ( http://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 (https://clinicaltrials.gov/ct2/
show/NCT05706129?term=dpi-4452&cond=metastatic+solid+tumors&draw=2&rank=1) . 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 f inally, 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