- ITM to supply its medical radioisotope, no-carrier-added
Lutetium-177, for the clinical development of Clovis Oncology’s
Targeted Radionuclide Therapy candidate FAP-2286
Clovis Oncology, Inc. (NASDAQ: CLVS) and ITM Isotope
Technologies Munich SE, a leading radiopharmaceutical biotech
company, today announced the signing of a clinical supply agreement
that provides Clovis Oncology with ITM’s therapeutic radioisotope
no-carrier-added Lutetium-177 (n.c.a. 177Lu), EndolucinBeta®, for
use in the clinical development of FAP-2286, Clovis’ fibroblast
activation protein (FAP)-targeting therapeutic candidate. FAP-2286
is the first peptide-targeted radionuclide therapeutic (PTRT)
candidate directed against fibroblast activation protein undergoing
clinical testing and is currently being investigated in the Phase
1/2 LuMIERE study for patients with advanced solid tumors. The
agreement covers an initial period of five years. Further details
of the agreement were not disclosed.
“Clovis Oncology is committed to advancing FAP-2286’s clinical
development program and emerging as a leader in targeted
radionuclide therapy. A critical element to advance this program is
ensuring long-term supply of radioisotopes, and this agreement
allows us to achieve that goal,” said Patrick Mahaffy, President
and CEO of Clovis Oncology. “In particular, we value ITM’s
radiopharmaceutical expertise and global reach as we advance our
targeted radionuclide therapy program into the clinic.”
“This agreement underscores the potential of our n.c.a.
Lutetium-177 to provide therapeutic value to patients with
hard-to-treat tumors. Through our proprietary pipeline of Targeted
Radionuclide Therapies and our agreements with other oncology
leaders, we are establishing a new era of precision oncology
treatments and we are happy to contribute to this exciting Clovis
program,” commented Steffen Schuster, CEO of ITM.
FAP-2286 is a clinical candidate under investigation as a
peptide-targeted radionuclide therapy (PTRT) and imaging agent
targeting FAP. FAP is highly expressed by cancer-associated
fibroblasts (CAFs) which are found in the majority of cancer types,
but with limited expression in healthy fibroblasts, potentially
making it a suitable target across a wide range of tumors. FAP-2286
consists of two functional elements; a targeting peptide that binds
to FAP and a site that can be used to attach medical radioisotopes,
such as Lutetium-177 for therapeutic use, or Gallium-68 for imaging
use.
ITM’s n.c.a. 177Lu (EndolucinBeta®) is a high-purity version of
the beta-emitting radioisotope Lutetium-177, that can be linked to
a variety of tumor-specific targeting molecules for Targeted
Radionuclide Therapy and has demonstrated significant anti-tumor
effects in clinical and commercial use. ITM has developed a unique
methodology to produce the highly pure form of Lutetium-177,
without metastable Lutetium-177m, and manufactures n.c.a. 177Lu for
development partnerships, distribution to clinics worldwide, and
its own growing precision oncology pipeline.
In June 2021, Clovis initiated the Phase 1/2 LuMIERE clinical
study of FAP-2286 in advanced solid tumors. The Phase 1 portion of
the LuMIERE study (NCT 04939610) will evaluate the safety of the
FAP-targeting investigational therapeutic agent and identify the
recommended Phase 2 dose and schedule of Lutetium-177 labeled
FAP-2286 (177Lu-FAP-2286), for which ITM will provide its n.c.a.
177Lu. Once the Phase 2 dose is determined, Phase 2 expansion
cohorts are planned in multiple tumor types.
About FAP-2286
FAP-2286 is a clinical candidate under investigation as a
peptide-targeted radionuclide therapy (PTRT) and imaging agent
targeting fibroblast activation protein (FAP). FAP-2286 consists of
two functional elements; a targeting peptide that binds to FAP and
a site that can be used to attach radioactive isotopes for imaging
and therapeutic use. High FAP expression has been shown in
pancreatic ductal adenocarcinoma, cancer of unknown primary,
salivary gland, mesothelioma, colon, bladder, sarcoma, squamous
non–small cell lung, and squamous head and neck cancers. High FAP
expression was detected in both primary and metastatic tumor
samples and was independent of tumor stage or grade. Clovis holds
US and global rights for FAP-2286 excluding Europe, Russia, Turkey,
and Israel.
FAP-2286 is an unlicensed medical product.
For more information about FAP-2286, Targeted Radionuclide
Therapy (TRT), or Clovis’ TRT development program, CLICK HERE.
About n.c.a. Lutetium-177 / EndolucinBeta®
No carrier-added Lutetium-177 (n.c.a. 177Lu) chloride, is a
radiopharmaceutical precursor used in Targeted Radionuclide Therapy
for the treatment of various diseases, like cancer. When labeled
with a tumor-specific targeting molecule (e. g. peptide or
antibody), the targeted radiopharmaceutical binds to a
tumor-specific receptor, according to the lock and key principle.
N.c.a. 177Lu has a half-life of 6.647 days and provides the highest
specific activity of more than 3,000 GBq/mg at Activity Reference
Time (ART). Optimal preconditions for efficient radiolabeling of
biomolecules over its entire shelf-life of 9 days after production
are ensured. N.c.a. 177Lu exhibits an extraordinary level of
radionuclidic purity and does not contain metastable Lutetium-177m
circumventing cost intensive clinical disposal management.
About Targeted Radionuclide Therapy
Targeted Radionuclide Therapy is an emerging class of cancer
therapeutics, which seeks to deliver radiation directly to the
tumor while minimizing delivery of radiation to normal tissue.
Targeted radionuclide therapies are created by linking radioactive
isotopes, also known as radionuclides, to targeting molecules
(e.g., peptides, antibodies, small molecules) that can bind
specifically to tumor cells or other cells in the tumor
environment. Based on the radioactive isotope selected, the
resulting agent can be used to image and/or treat certain types of
cancer. Agents that can be adapted for both therapeutic and imaging
use are known as “theranostics.” Clovis, together with licensing
partner 3B Pharmaceuticals, is developing a pipeline of novel,
targeted radiotherapies for cancer treatment and imaging, including
its lead candidate, FAP-2286, an investigational peptide-targeted
radionuclide therapeutic (PTRT) and imaging agent, as well as three
additional discovery-stage compounds. ITM is developing a
proprietary precision oncology pipeline of targeted
radiopharmaceuticals for diagnostics and treatment of a range of
hard-to-treat cancer indications, such as neuroendocrine tumors,
prostate cancer, glioblastoma, osteosarcoma and bone metastases, as
well as folate receptor α positive tumors like lung, ovarian or
breast cancer. Additionally, ITM supplies partners with its
high-purity n.c.a. 177Lu for clinical and commercial
development.
About ITM Isotope Technologies Munich SE
ITM, a privately held radiopharmaceutical biotech company
founded in 2004, is dedicated to providing the most precise cancer
radiotherapeutics and diagnostics to meet the needs of patients,
clinicians and our partners through excellence in development,
production and global supply. With patient benefit as the driving
principle for all we do, ITM is advancing a broad pipeline
combining its high-quality radioisotopes with targeting molecules
to develop precision oncology treatments. ITM is leveraging its
leadership and nearly two decades of radioisotope expertise
combined with its worldwide network to enable nuclear medicine to
reach its full potential for helping patients live longer and
better. For more information, please visit
www.itm-radiopharma.com.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing, and commercializing innovative anti-cancer
agents in the US, Europe, and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops with partners
diagnostic tools intended to direct a compound in development to
the population that is most likely to benefit from its use. Clovis
Oncology is headquartered in Boulder, Colorado; please visit
www.clovisoncology.com for more information, including additional
office locations in the US and Europe.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Examples of forward-looking statements contained in this press
release include, among others, statements of our intentions and
expectations for our development and discovery programs, including
the timing and pace of pre-clinical development, plans for clinical
development, plans for additional applications of the FAP-2286
peptide, including potential indications, tumor types and
combination trials, and regulatory plans with respect to FAP-2286.
Such forward-looking statements involve substantial risks and
uncertainties that could cause Clovis Oncology’s actual results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in drug discovery and pre-clinical and clinical development,
including the outcome of pre-clinical studies and clinical trials,
whether initial results, findings or research will support future
studies or development, whether future study results will be
consistent with previous study findings or other results, including
pre-clinical studies, results in named-patient or similar programs
or clinical trials, whether additional studies not originally
contemplated are determined to be necessary, the timing of
initiation, enrollment and completion of planned studies and
actions by the FDA, the EMA or other regulatory authorities
regarding data required to support drug applications and whether to
approve drug applications. Clovis Oncology undertakes no obligation
to update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the
company in general, see Clovis Oncology’s Annual Report on Form
10-K, Quarterly Reports on Form 10-Q and its other reports filed
with the Securities and Exchange Commission.
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version on businesswire.com: https://www.businesswire.com/news/home/20211019005096/en/
Clovis Investor Contacts Anna Sussman, +1 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, +1 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts US Lisa Guiterman,
301.347.7964 clovismedia@clovisoncology.com Europe Jake
Davis, +44 (0) 203.946.3538 Jake.Davis@publicisresolute.com
ITM Corporate Contact Julia Hofmann, Head of Corporate
Communications Susanne Karlsson, Deputy Head of Corporate
Communications Phone: +49 89 329 8986 1502 Email:
communications@itm-radiopharma.com
ITM Media Requests Trophic Communications Stephanie May
or Valeria Fisher Phone: +49 171 185 56 82 Email:
itm@trophic.eu
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