- Presented at the International Symposium on
Theranostics/Precision Oncology (ICPO)
- FAP-targeted images consistent with those of PET and CT
scans
- Encouraging tumor accumulation and retention in initial
named-patient experience
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that
Professor Dr. Richard P. Baum reported his initial independent
clinical experience with FAP-2286 in named-patient use at the
International Centers for Precision Oncology (ICPO) Foundation
Symposium in Bad Berka, Germany. At Prof. Dr. Baum’s clinic,
FAP-2286 was linked to Gallium-68 as a tumor-imaging compound using
PET/CT and to Lutetium-177 as a therapeutic agent.
In the first named-patient experience with FAP-2286, Prof. Dr.
Baum imaged 10 patients with advanced solid tumors, including
breast, pancreatic, colorectal and ovarian cancers, with PET/CT
using FAP-2286 linked to the commonly used imaging agent Gallium-68
for PET/CT imaging. In each case, Prof. Dr. Baum found that the
FAP-PET/CT showed consistency with standard of care 18F-FDG-PET/CT
scans for the same patients, including identification of both
primary and metastatic lesions in liver, lung, bones, lymph nodes
and other sites. Prof. Dr. Baum did not observe accumulation of
FAP-2286 in healthy tissues of these 10 patients, except, as
anticipated in the kidneys where FAP-2286 is excreted.
In addition, Prof. Dr. Baum treated 10 patients with FAP-2286
linked with Lutetium-177. Lutetium-177 is a radionuclide approved
for use with somatostatin receptor targeting agents and is in
development for use with other compounds. The initial single dose
administration showed significant, specific accumulation in primary
tumors and metastatic lesions. In this first-in-human experience,
patients received a relatively low dose of Lutetium-177. Prof. Dr.
Baum reported a lack of significant adverse effects within the
first two months of follow-up and an absence of myelosuppression or
damage to any other tissue, including the kidneys. Prof. Dr. Baum
intends to administer a second dose of FAP-2286 linked with
Lutetium-177 this month.
“I’m extremely pleased with our experience thus far with
FAP-2286,” said Prof. Dr. Baum, Chairman and Clinical Director,
Theranostics Center for Radiomolecular Precision Oncology at
Zentralklinik, Bad Berka, Germany. “As an imaging agent alone, it
appears consistent with 18FDG-PET/CT scanning on a schedule that is
much more convenient for patients. In addition, while obviously
early, when linked to Lutetium-177, FAP-2286 was very
well-tolerated, showed encouraging residence time in the tumor
lesions, and appears to have, after only one low dose, provided
symptomatic relief in several of the patients treated. I believe
that FAP as a target and FAP-2286 as a drug candidate represent a
very exciting new area of research in molecular targeted
radiotherapy.”
“While these examples from named-patient use do not represent a
clinical study, we are pleased that the initial imaging and
treatment experience with FAP-2286 are consistent with the
preclinical data that led to our enthusiasm for FAP as a target and
for FAP-2286 as a highly differentiated targeted radionuclide
therapy,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “We look forward to completing the pre-clinical work in
order to file our IND for FAP-2286 in the second half of 2020 and
to initiating formal clinical development for this very promising
compound.”
Physicians in Germany and certain other countries may treat
patients suffering from a life-threatening disease or a disease
leading to severe disability with experimental drugs if no other
appropriate options are available under named-patient and similar
programs. A physician may initiate treatment for specific patients
until there is commercial product available and patients are
encouraged to enroll in clinical trials where possible.
Named-patient programs are not clinical trials and the treating
physician is solely responsible for all decisions, including dose
and assessment of efficacy and safety, and the drug sponsor has no
role in decisions.
About FAP-2286
FAP-2286 is a preclinical candidate discovered by 3B
Pharmaceuticals under investigation as a peptide-targeted
radionuclide therapy (PTRT) and imaging agent targeting fibroblast
activation protein alpha (FAP). FAP is highly expressed in cancers,
including more than 90 percent of breast, lung, colorectal and
pancreatic carcinomas. Clovis is planning to file an
investigational new drug application (IND) for FAP-2286 in the
second half of 2020. Clovis will conduct the global clinical trials
and holds U.S. and global rights, excluding Europe.
FAP-2286 is an unlicensed medical product.
About Fibroblast Activation Protein Alpha (FAP)
Fibroblast activation protein alpha, or FAP, is highly expressed
in cancer-associated fibroblasts (CAFs) which are found in the
majority of cancer types, potentially making it a suitable target
across a wide array of solid tumors. FAP is highly expressed in
many epithelial cancers, including more than 90 percent of breast,
lung, colorectal and pancreatic carcinomas.1 CAFs are highly
prevalent in the tumor microenvironment of many cancers and persist
through all malignant stages of a tumor, from primary tumor to
metastasis. FAP has limited expression on normal fibroblasts,
reducing the potential for effects in normal tissue.
About Peptide-Targeted Radionuclide Therapy (PTRT)
Peptide-targeted radionuclide therapy involves a small amount of
radioactive material (radionuclide) that is combined with a
cell-targeting moiety peptide for the treatment of cancer; PTRT is
considered a form of radiopharmaceuticals. The targeting peptide is
able to recognize and bind to specific features of tumors, such as
antigens and cell receptors. When injected into the patient’s
bloodstream, the peptide attaches to cancer cells or
cancer-associated stromal cells, delivering a high dose of
radiation to the tumor while sparing normal tissues.
About FAP-Targeted Radiopharmaceuticals
Clinical studies of small molecule imaging agents targeting FAP
have validated this target in a diverse number of cancer
indications and support the further evaluation of peptide-targeted
radionuclide therapy. FAP-targeted radiopharmaceuticals have at
least two potential modes of anti-tumor activity: radiation
crossfire, in which tumor cells are irradiated due to their close
proximity to CAFs; and depletion of CAFs, disrupting the
communication between the tumor cells and the tumor stroma. In
addition, in certain tumor types, such as sarcoma and mesothelioma,
FAP is expressed on the tumor cells themselves, and in those
tumors, FAP-targeted radiopharmaceuticals may have a direct
effect.
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. Examples of forward-looking
statements contained in this press release include, among others,
statements our intentions and expectations for our development and
discovery programs, including the timing and pace of pre-clinical
development 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, 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 or results in named-patient or similar programs, whether
additional studies not originally contemplated are determined to be
necessary, the timing of initiation, enrollment and completion of
planned studies. 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/20191216005223/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts: U.S. Lisa Guiterman,
301.217.9353 clovismedia@sambrown.com or Christy Curran,
615.414.8668 clovismedia@sambrown.com
EU Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
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