Initial Clinical Experience of FAP-2286 in Independent Named Patient Use Published in The Journal of Nuclear Medicine
June 28 2021 - 7:00AM
Business Wire
- FAP-2286 is an investigational targeted radionuclide
therapeutic and imaging agent targeting fibroblast activation
protein (FAP)
- Clovis Oncology initiated sponsored clinical development of
FAP-2286 with the Phase 1/2 LuMIERE clinical trial in patients with
FAP-positive solid tumors which is now enrolling
Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that
Professor Dr. Richard P. Baum and Dr. Harshad R. Kulkarni, in
conjunction with 3B Pharmaceuticals (Clovis’ licensing partner and
discoverer of FAP-2286), published a retrospective report of their
independent experience with FAP-2286 in named-patient use in The
Journal of Nuclear Medicine. In the first named-patient experience
of the investigational compound conducted at Zentralklinik, Bad
Berka, Germany, patients were treated with the FAP-targeted
radiotherapy FAP-2286 linked to the radionuclide lutetium-177
(177Lu) as a therapeutic agent after prior confirmation of tumor
FAP-positivity in patients by PET/CT imaging.
In this palliative use setting, FAP-2286 was administered on a
named-patient basis to 11 patients with progressive and metastatic
adenocarcinoma of the pancreas, breast, rectum, and ovary after
prior confirmation of FAP expression. According to the authors,
administration of 177Lu-FAP-2286 demonstrated high uptake and long
retention in primary and metastatic tumor lesions and an acceptable
toxicity profile. The report concludes that the data warrant
further investigation of 177Lu-FAP-2286 in clinical studies to
systematically evaluate its safety and efficacy, and to define the
patient population who would benefit most from treatment.
The Clovis Oncology-sponsored Phase 1/2 LuMIERE study of
177Lu-FAP-2286 is evaluating the compound in patients with advanced
solid tumors. FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will
be utilized as an investigational imaging agent to identify
patients appropriate for treatment in LuMIERE.
“We believe the early clinical experience from named-patient use
validates our plans to further investigate FAP-2286 as a
therapeutic and imaging agent across a variety of solid tumor
types,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “We are very pleased to move FAP-2286 into formal
clinical development with the recent initiation of the Phase 1/2
LuMIERE study of FAP-2286, a novel peptide-targeted radionuclide
therapy in patients with solid tumors.”
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. FAP is highly expressed in many epithelial
cancers, including more than 90 percent of breast, lung, colorectal
and pancreatic carcinomas. Clovis holds U.S. 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.
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. 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
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/20210628005051/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,
301.347.7964 clovismedia@clovisoncology.com
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