Clovis Oncology Submits Investigational New Drug Applications for Novel Peptide-Targeted Radionuclide FAP-2286 for Therapeuti...
December 29 2020 - 8:00AM
Business Wire
- Initiation of Phase 1/2 clinical study of novel
peptide-targeted radionuclide therapy and imaging agent targeting
fibroblast activation protein (FAP) expected 1H 2021
- Will be the first peptide-targeted radionuclide therapy
targeting FAP to enter clinical development
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the
company has completed submission of two Investigational New Drug
(IND) applications to the U.S. Food and Drug Administration (FDA)
for FAP-2286, the lead compound in its peptide-targeted
radionuclide therapy (PTRT) development program. Following
clearance of the INDs by FDA, Clovis plans to initiate a Phase 1/2
clinical study of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) to
determine the dose and tolerability of the FAP-targeting
therapeutic agent (Phase 1), with expansion cohorts planned in
multiple tumor types (Phase 2). FAP-2286 labelled with gallium-68
(68Ga-FAP-2286) will be utilized as a diagnostic to identify
patients with fibroblast activation protein (FAP)-positive tumors
appropriate for treatment with the therapeutic agent.
“Submission of these INDs is a very important milestone in the
development of FAP-2286, the first clinical candidate from our PTRT
platform,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “Targeted radiopharmaceuticals represent an emerging
therapeutic class and an area of significant interest to the
clinical community, and FAP is considered a target of particular
interest given its high, selective expression in multiple solid
tumors. We are enthusiastic about the opportunity to become a
leader in the rapidly evolving field of PTRT, and the first to
begin clinical development of a peptide-targeted radionuclide
therapy targeting FAP.”
Fibroblast activation protein (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 epithelial cancers, including more
than 90 percent of breast, lung, colorectal and pancreatic
carcinomas.i,ii,iii 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.vi,iv
Compelling anti-tumor efficacy of 177Lu-FAP-2286 has been
demonstrated in FAP-expressing preclinical tumor models.v
Following clearance of the INDs by FDA, the Phase 1/2 study
LuMIERE is planned to start in the first half of 2021 to determine
the dose of 177Lu-FAP-2286 to be used in Phase 2 development. The
FAP-targeting imaging agent, 68Ga-FAP-2286, will be used to
identify patients with FAP-positive tumors eligible for treatment
with 177Lu-FAP-2286 in the study. Once the Phase 2 dose is
determined, expansion cohorts will evaluate 177Lu-FAP-2286 and
68Ga-FAP-2286 in multiple tumor types.
About Peptide-Targeted Radionuclide Therapy
Peptide-targeted radionuclide therapy (PTRT) is a form of
targeted radiotherapy that is emerging as a new treatment option
for patients with cancervi. These therapies consist of a small
amount of a radioactive isotope, known as a radionuclide, linked to
cell-targeting peptide that binds to a cancer specific protein
which selectively directs the radionuclide to tumors.v Following
binding, the radionuclide warhead emits ionizing radiation causing
DNA damage and cell death to neighboring tumor cells.vii
About FAP-2286
FAP-2286 is a preclinical candidate under investigation as a
peptide-targeted radionuclide therapy (PTRT) and imaging agent
targeting fibroblast activation protein (FAP). FAP-2286 consists of
two parts; a peptide that binds to FAP and a linker and site that
can be used to attach radiation 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.iii Clovis holds U.S. and global rights for FAP-2286
excluding Europe, Russia, Turkey and Israel. FAP-2286 is an
unlicensed medical product.
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, 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 Yong
KJ et al. Mechanisms of Cell Killing Response from Low Linear
Energy Transfer (LET) Radiation Originating from 177Lu
Radioimmunotherapy Targeting Disseminated Intraperitoneal Tumor
Xenograpfts. Int. J. of Mol.Sci. 2016; 17: 736. v 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. vi Grzmil M, Meisel A, Behé
M., Schibli R. (2019) An Overview of Targeted Radiotherapy. In:
Lewis J., Windhorst A., Zeglis B. (eds) Radiopharmaceutical
Chemistry. Springer, Cham. vii National Research Council 2007.
Advancing Nuclear Medicine Through Innovation. Washington, DC: The
National Academies Press. https://doi.org/10.17226/11985.
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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
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