Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the
initiation of a development, manufacturing, and services agreement
with Evergreen Theragnostics to develop
actinium-225-labeled-FAP-2286 (225Ac-FAP-2286). Under the
agreement, Clovis and Evergreen intend to develop radiolabeling
chemistry and analytical methods for use in potential future
pre-clinical and clinical studies.
“This agreement with Evergreen Theragnostics represents an
important step forward for Clovis in our efforts to optimize our
clinical development program for FAP-2286,” said Patrick J.
Mahaffy, President and CEO of Clovis Oncology. “We are enthusiastic
about exploring the potential of FAP-2286 labeled with actinium-225
in our targeted radiopharmaceuticals program. Actinium-225
represents an emerging radionuclide that is generating significant
interest for its potential for therapeutic use.”
Actinium-225 (225Ac) is an alpha particle-emitting radionuclide
uniquely suited to targeted radiotherapeutic applications based on
its half-life of approximately 10 days, balancing the ability to
deliver a meaningful dose of radiation to target tumors while
allowing central manufacturing and distribution of 225Ac-FAP-2286.
The high-energy radioactive decay emitted from tumor-targeted 225Ac
delivery causes double-stranded DNA damage and cell death, however,
given the limited distance traveled by alpha particles, damage is
minimized to cells in the tumor mass and systemic toxicity is
potentially limited. i,ii
Under the terms of the agreement, Evergreen will develop
225Ac-FAP-2286 at its facility in Springfield, N.J. The facility
was purpose-built to develop and manufacture a variety of
therapeutic radiopharmaceuticals, including those based on
alpha-emitting isotopes such as 225Ac, from early development to
commercial scale manufacturing.
“We are excited to support Clovis and its targeted radionuclide
development program with the development of an actinium-225-labeled
FAP-2286. Actinium-based radiotherapies offer the potential to play
an important role in the fight against cancer,” said James Cook,
CEO of Evergreen Theragnostics. “We seek to provide a robust and
efficient radiopharmaceutical manufacture, testing, and supply
process for our partners from early-stage development through
commercialization.”
FAP-2286 is the first peptide-targeted radionuclide therapy
(PTRT) and imaging agent targeting fibroblast activation protein
(FAP) to enter clinical development. In the Phase 1/2 LuMIERE study
(NCT04939610), the investigational therapeutic agent is linked to
lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). Lutetium-177
(177Lu) is a beta-particle-emitting radionuclide with established
supply and distribution networks ideally suited for clinical
development of a PTRT. FAP-2286 labeled with gallium-68
(68Ga-FAP-2286) is being used as an investigational imaging agent
to identify patients with FAP-positive tumors appropriate for
treatment with the therapeutic agent. FAP-2286 is the lead
candidate in Clovis Oncology’s targeted radionuclide therapy (TRT)
development program.
For more information about FAP-2286, targeted radionuclide
therapy, or Clovis’ TRT development program, please visit
targetedradiotherapy.com.
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.
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 radionuclides 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.
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, for
those indications that require them, 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, with additional office locations in the US and
Europe. Please visit www.clovisoncology.com for more
information.
About Evergreen Theragnostics, Inc.
Evergreen Theragnostics, established in 2019, is a leading
US-based radiopharmaceutical Contract Development and Manufacturing
Organization (CDMO). With a state-of-the-art global GMP facility,
Evergreen provides highly reliable manufacturing services for
therapeutic and centrally distributed diagnostic
radiopharmaceuticals, from early development through
commercialization. The company was founded by a team that brings a
strong track record in theragnostic radiopharmaceutical
commercialization, manufacturing process development, and
regulatory affairs management. For more information, please visit
www.evergreentgn.com.
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.
i Khabibullin et al. 2018. Structure and properties of
DOTA-Chelated radiopharmaceuticals within the Ac decay pathway.
Med. Chem. Commun. 9. 1155.
ii Scheinberg D, McDevit M. 2011. Actinium-225 in targeted
alpha-practical therapeutic applications. Curr Radiopharm. 4 (4):
306 – 320.
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version on businesswire.com: https://www.businesswire.com/news/home/20220316005116/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts: US Lisa Guiterman,
301.347.7964 clovismedia@clovisoncology.com
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