- First clinical site for Phase 1/2 LuMIERE clinical study of
novel peptide-targeted radionuclide therapy and imaging agent
targeting fibroblast activation protein (FAP) now open for
enrollment
- FAP-2286 is the first peptide-targeted radionuclide therapy
targeting FAP to enter clinical development
Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that the
first clinical site for the Phase 1/2 LuMIERE study of FAP-2286,
its novel peptide-targeted radionuclide therapy and imaging agent
targeting fibroblast activation protein (FAP), is now open at the
O’Neal Comprehensive Cancer Center at The University of Alabama at
Birmingham (UAB).
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Clovis Oncology is exploring FAP-2286
linked to Lutetium-177 as a therapeutic agent (Graphic: Business
Wire)
The O'Neal Comprehensive Cancer Center at UAB is among the
nation’s leading cancer research institutions and one of only 51
comprehensive cancer centers designated by the National Cancer
Institute.
The Phase 1 portion of the LuMIERE study 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). 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.
“I envision that targeted radionuclide therapy has the potential
to transform how we diagnose and treat cancer and I look forward to
exploring this in the LuMIERE clinical trial,” said Thomas Hope,
M.D., Director of Molecular Therapy in the Department of Radiology
and Biomedical Imaging at the University of California, San
Francisco and lead investigator of the LuMIERE trial.
“We are pleased to initiate sponsored clinical development of
FAP-2286 with the LuMIERE study based on the clinical community’s
enthusiasm to further explore the potential of targeted
radionuclide therapy and FAP as a therapeutic target,” said Patrick
J. Mahaffy, President and CEO of Clovis Oncology. “Given FAP is
highly expressed in many of the hardest-to-treat solid tumors, we
look forward to exploring the potential of FAP-2286 to treat
patients with cancer as our first entry into this emerging field of
targeted radiotherapy. The O’Neal Comprehensive Cancer Center and
each of the clinical trial sites expected to open for enrollment in
the near future bring tremendous nuclear medicine and medical
oncology expertise as well as passion for the program.”
FAP is a cell-surface protein that is expressed in limited
amounts by normal tissues, but highly expressed in
cancer-associated fibroblasts (CAFs) present in the tumor
microenvironment of many solid tumors including breast, lung,
colorectal and pancreatic carcinomas.i,ii,iii,iv Preclinical data
demonstrate that 177Lu-FAP-2286 potently and selectively binds FAP
on the surface of CAFs and tumor cells to deliver the beta
particle-emitting radioisotope 177Lu, resulting in DNA damage and
cell death.v Compelling anti-tumor efficacy of 177Lu-FAP-2286 has
been demonstrated in FAP-expressing preclinical tumor models.vi
To learn more about targeted radiotherapy, FAP-2286 and Clovis’
targeted radionuclide development program, visit
www.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. 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 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 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.
i Garin-Chesa P et al. Cell surface glycoprotein of reactive
stromal fibroblasts as a potential antibody target in human
epithelial cancers. Proc Natl Acad Sci U S A.
1990;87(18):7235-9.
ii Park JE et al. Fibroblast activation protein, a dual
specificity serine protease expressed in reactive human tumor
stromal fibroblasts. J Biol Chem. 1999;274(51):36505-12.
iii Rettig WJ et al. Regulation and Heteromeric Structure of the
Fibroblast Activation Protein in Normal and Transformed Cells of
Mesenchymal and Neuroectodermal Origin. Cancer Res.
1993;53:3327–3335.
iv Pure E et al. Pro-tumorigenic roles of fibroblast activation
protein in cancer: back to the basics. Oncogene. 2018;
37:4343-57
vYong KJ et al. Mechanisms of Cell Killing Response from Low
Linear Energy Transfer (LET) Radiation Originating from Lu
Radioimmunotherapy Targeting Disseminated Intraperitoneal Tumor
Xenograpfts. Int. J. of Mol.Sci. 2016; 17: 736.
vi Zboralski, D et al. Preclinical evaluation of FAP-2286, a
peptide-targeted radionuclide therapy (PTRT) to fibroblast
activation protein alpha (FAP). European Society for Medical
Oncology (ESMO) Congress 2020. 18-22 September 2020. Madrid,
Spain.
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version on businesswire.com: https://www.businesswire.com/news/home/20210623005235/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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