ITM, Helmholtz Munich and University Hospital Münster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial
23 Abril 2024 - 4:00AM
A Novel Therapeutic Approach to
Treatment using ITM-31
Garching/Munich, Munich and
Münster, April 23, 2024 – The Departments
of Neurosurgery and Nuclear Medicine at the University Hospital
Münster, Helmholtz Munich, and ITM Isotope Technologies Munich SE
(ITM), a leading radiopharmaceutical biotech company, today
announced that the first patient has been dosed in an
investigator-initiated trial (IIT) with ITM’s radiopharmaceutical
drug candidate, ITM-31 for the potential use in glioblastoma
patients. The IIT is sponsored by the University Hospital Münster,
conducted in hospitals in Münster, Essen, Cologne, and Würzburg,
and supported by Helmholtz Munich and ITM.
After glioblastoma patients receive standard
treatment with surgery, radio- and chemotherapy, individual tumor
cells often remain undetected in surrounding tissue and grow again
leading to relapse. This makes glioblastoma one of the most
aggressive, deadliest and hard-to-treat cancers.
“Glioblastoma remains a challenging disease.
Eliminating residual tumor cells in the surrounding tissue
post-surgery could be crucial to address and prevent relapses. As
such, we believe that ITM-31 has the potential to improve current
treatment methods in this high-need indication,” said
Prof. Walter Stummer, Principal
Investigator and Chairman of the Department of Neurosurgery at the
University Hospital Münster. Study Coordinator,
Prof. Hans-Jürgen Reulen added, "The phase I study will
allow us to further analyze the impact that ITM-31 could make in
this patient population, and marks a critical step in the clinical
development of this promising radiopharmaceutical drug
candidate.”
ITM-31 is a carbonic anhydrase (CA) XII-specific
antibody Fab fragment developed by Helmholtz Munich and coupled
with ITM's medical radioisotope, non-carrier-added Lutetium-177
(n.c.a. 177Lu, EndolucinBeta®).
“The phase I study builds on previous
preclinical data that point to radiopharmaceuticals as a potential
new method with which to circumvent previous challenges posed by
glioblastoma,” commented Prof. Reinhard Zeidler from
Helmholtz Munich, who spearheaded the basic research and
provided scientific oversight throughout the transition to clinical
trials.
“Innovative radiopharmaceuticals have the
potential to address gaps in current treatment paradigms,
particularly in aggressive cancers with poor prognoses such as
glioblastoma,” said Steffen Schuster, CEO of ITM.
“ITM is proud to support this trial conducted by Prof. Stummer and
the University Hospital Münster.”
The dose-escalation study (NCT05533242) is
enrolling up to 15 patients and will evaluate the impact of ITM-31
on glioblastoma patients by analyzing the tolerability and safety
of ITM-31 while evaluating the best possible patient dose for
future studies. Patients presenting either no or stable, high-grade
glioma residue following standard therapy (surgery and
radiochemotherapy, adjuvant chemotherapy), are eligible for the
trial, 6 weeks after completing radiotherapy, at the earliest.
Patients will receive their personalized calculated total doses of
ITM-31 in three fractions with an interval of 4 weeks between
injections.
About ITM Isotope Technologies Munich
SE
ITM, a leading radiopharmaceutical biotech
company, is dedicated to providing a new generation of
radiomolecular precision therapeutics and diagnostics for
hard-to-treat tumors. We aim to meet the needs of cancer patients,
clinicians and our partners through excellence in development,
production and global supply. With improved patient benefit as the
driving principle for all we do, ITM advances a broad precision
oncology pipeline, including two phase III studies, combining the
company’s high-quality radioisotopes with a range of targeting
molecules. By leveraging our nearly two decades of pioneering
radiopharma expertise, central industry position and established
global network, ITM strives to provide patients with more effective
targeted treatment to improve clinical outcome and quality of
life.www.itm-radiopharma.com
Helmholtz Munich
Helmholtz Munich is a leading biomedical
research center. Its mission is to discover breakthrough solutions
for better health in a rapidly changing world. It is home to
interdisciplinary research teams investigating the development of
environmentally triggered diseases. With the power of artificial
intelligence and bioengineering, the researchers accelerate the
translation process to patients in the areas of therapy and
prevention with a focus on diabetes, obesity, allergies and chronic
lung diseases. Helmholtz Munich has more than 2,500 employees and
is headquartered in Neuherberg, north of Munich. It is a member of
the Helmholtz Association, the largest scientific organization in
Germany with more than 43,000 employees and 18 research centers.
Learn more about Helmholtz Munich (Helmholtz Zentrum München,
Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH):
www.helmholtz-munich.de/en
ITM Contact
Corporate CommunicationsKathleen Noonan /
Gerrit Siegers Phone: +49 89 329 8986
1502 Email:
communications@itm-radiopharma.com
Investor RelationsBen Orzelek
Phone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com
Helmholtz Munich Media Relations, Verena Coscia
Phone: +49 89 3187- 49342 Email: presse@helmholtz-munich.de
University Hospital Münster Media Relations,
Dr. Thomas Bauer Phone: +49 251 83 58937 Email:
thomas.bauer@ukmuenster.de
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