Clovis Oncology, Inc. (NASDAQ: CLVS) announced today’s
presentation by Andrew D. Simmons, Ph.D., Clovis’ Senior Vice
President, Translational Medicine, at the 3rd Targeted
Radiopharmaceuticals Summit being held virtually December 7-9,
2021. Dr. Simmons’ presentation, titled “Innovations in Peptide
Targeted Radionuclide Therapies (PTRT) to Target Fibroblast
Activation Protein (FAP) in Solid Tumors”, reviews the Company’s
preclinical data and describes the Phase 1/2 study currently
enrolling for its targeted radiotherapy candidate FAP-2286, the
first PTRT and imaging agent targeting FAP to enter clinical
development and the lead candidate in Clovis Oncology’s targeted
radionuclide therapy (TRT) development program.
“Clinician enthusiasm for the potential of targeted
radiopharmaceuticals, and in particular, FAP as a target, continues
to increase, and we are committed to becoming a leader in this
emerging field,” said Patrick J. Mahaffy, President and CEO of
Clovis Oncology. “We look forward to sharing initial data from the
ongoing Phase 1 LuMIERE study of our first targeted radiotherapy
candidate FAP-2286, anticipated in 2022.”
Following Dr. Simmons’ presentation at 9:35am Eastern time, his
slide presentation can be found at
https://clovisoncology.com/pipeline/scientific-presentations/ with
other recent Clovis-sponsored presentations, posters and
supplemental information. 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, salivary gland, mesothelioma,
colon, bladder, sarcoma, squamous non-small cell lung, squamous
head and neck cancers, and cancers of unknown primary. 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 the LuMIERE Clinical Study
LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a
peptide-targeted radionuclide therapy (PTRT) targeting fibroblast
activation protein, or FAP, in patients with advanced solid tumors
(NCT04939610). The Phase 1 portion of the LuMIERE study is
evaluating the safety of the investigational therapeutic agent and
will identify the recommended Phase 2 dose and schedule of
lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled
with gallium-68 (68Ga-FAP-2286) will be utilized as an
investigational imaging agent to identify patients with
FAP-positive tumors appropriate for treatment with the therapeutic
agent. Once the Phase 2 dose is determined, Phase 2 expansion
cohorts are planned in multiple tumor types.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing, and commercializing innovative anti-cancer
agents in the U.S., 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 U.S. and
Europe. Please visit www.clovisoncology.com for more
information.
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 and
expected timing and pace of clinical development, plans for
additional applications of the FAP-2286 peptide, including
potential indications, tumor types and combination trials, plans
for presentation of data 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/20211209005139/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
Europe Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
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