Findings explore the pharmacokinetics (PK),
pharmacodynamics (PD), and antitumor activity of Rubraca and
lucitanib alone and in combination with other agents in preclinical
models and simulated patient populations
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that four
abstracts showcasing non-clinical data from rucaparib and lucitanib
development programs have been accepted for on-demand viewing and
publication at the upcoming American Association for Cancer
Research (AACR) Virtual Annual Meeting II, June 22 - 24, 2020.
The accepted abstracts summarize findings from pre-clinical
studies evaluating the PK, PD and anti-tumor activity of rucaparib,
an oral, small molecule PARP inhibitor in orthotopic and
intracranial mouse models, and its synergy with CHK1 inhibition in
tumor cell lines. Additional abstracts include findings from a
study of the pharmacokinetics of lucitanib, an oral, potent
inhibitor of tyrosine kinase activity, in a simulated patient
population to inform dosing-regimen selection, and from a
pre-clinical study evaluating the anti-tumor efficacy and mechanism
of action of lucitanib in combination with a mouse ortholog of ALKS
4230, a selective agonist of the intermediate affinity IL-2
receptor, in a mouse colon cancer model. Lucitanib and ALKS 4230
are both development-stage compounds.
“Data from our ongoing non-clinical studies underscore our
commitment to pursuing innovative research that advances novel
therapies for cancer patients,” said Patrick J. Mahaffy, President
and CEO of Clovis Oncology. “In particular, we are pleased to
present new, non-clinical data exploring the PK/PD of our PARP
inhibitor Rubraca, evaluating the synergies of PARP and CHK1
inhibition in combination, as well as important data for lucitanib
to understand optimal dosing and use in combination with other
anticancer agents to treat solid tumors.”
The following Clovis-sponsored, collaborator-sponsored and
investigator-sponsored abstracts will be available as AACR 2020
Virtual Poster Session presentations. E-posters, and when
available, accompanying audio descriptions, will be available for
on-demand viewing beginning 9:00 a.m. EDT Monday, June 22, and will
remain available for viewing by registered attendees for at least
three months after the virtual meeting.
Abstract Number: 3026 / 14 - Evaluation of brain
pharmacokinetics (PK) and tumor growth inhibition of PARP
inhibitors in mouse xenograft models using semi-mechanistic
PK/pharmacodynamic (PD) modeling
- Presenting Author: Michelle Liao
- Session: Pharmacokinetics / Pharmacodynamics
Abstract Number: 3027 / 15 - Application of machine learning
and grid search approaches to minimize lucitanib pharmacokinetic
variability following different dosing regimens
- Presenting Author: Michelle Liao
- Session: Pharmacokinetics / Pharmacodynamics
Abstract Number: 2202 / 7 - The combination of a mouse
ortholog of ALKS 4230, a selective agonist of the intermediate
affinity IL-2 receptor, and the angiogenesis inhibitor lucitanib
enhances antitumor activity
- Presenting Author: Jared E. Lopes
- Session: Combination Immunotherapies 2
In addition, the three previous posters will be available on the
Clovis Oncology website once they become available on the AACR
virtual meeting website.
Abstract Number: 1375 / 11 - Investigating synergy between
CHK1 and PARP inhibitors in BRCA2 mutant and restored cells
- Presenting Author: Hannah L. Smith
- Session: Mechanisms of DNA Damaging Therapeutics
About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed in multiple tumor types, including ovarian
and metastatic castration-resistant prostate cancers, as
monotherapy, and in combination with other anti-cancer agents.
Exploratory studies in other tumor types are also underway. Clovis
holds worldwide rights for Rubraca.
In the United States, Rubraca is approved for the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete
or partial response to platinum-based chemotherapy. Rubraca is also
approved in the United States for the treatment of adult patients
with deleterious BRCA mutation (germline and/or somatic) associated
epithelial ovarian, fallopian tube, or primary peritoneal cancer
who have been treated with two or more chemotherapies and selected
for therapy based on an FDA-approved companion diagnostic for
Rubraca. Additionally, Rubraca is indicated for the treatment of
adult patients with a deleterious BRCA mutation (germline and/or
somatic)-associated metastatic castration-resistant prostate cancer
(mCRPC) who have been treated with androgen receptor-directed
therapy and a taxane-based chemotherapy. This indication is
approved under accelerated approval based on objective response
rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.
In Europe, Rubraca is approved for the maintenance treatment of
adults with platinum-sensitive relapsed high-grade epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in
response (complete or partial) to platinum-based chemotherapy.
Rubraca is also approved in Europe for the treatment of adult
patients with platinum sensitive, relapsed or progressive, BRCA
mutated (germline and/or somatic), high-grade epithelial ovarian,
fallopian tube, or primary peritoneal cancer, who have been treated
with two or more prior lines of platinum-based chemotherapy, and
who are unable to tolerate further platinum-based chemotherapy.
Rubraca is indicated for the treatment of adult patients with a
deleterious BRCA mutation (germline and/or somatic)-associated
metastatic castration-resistant prostate cancer (mCRPC) who have
been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy.
Rubraca is an unlicensed medical product outside of the U.S. and
Europe.
About Lucitanib
Lucitanib is an oral, potent inhibitor of the tyrosine kinase
activity of vascular endothelial growth factor receptors 1 through
3 (VEGFR1-3), platelet-derived growth factor receptors alpha and
beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3
(FGFR1-3). Emerging clinical data support the combination of
angiogenesis inhibitors and immunotherapy to increase effectiveness
in multiple cancer indications. Angiogenic factors, such as
vascular endothelial growth factor (VEGF), are frequently
up-regulated in tumors and create an immunosuppressive tumor
microenvironment. Use of antiangiogenic drugs reverses this
immunosuppression and can augment response to immunotherapy.
Lucitanib 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 regarding our expectations for submission of regulatory
filings, the timing and pace of commencement of and enrollment in
our clinical trials, including those being planned or conducted in
collaboration with partners, the potential results of such clinical
trials, our expectations regarding the suitability of Rubraca for,
and our plans to develop Rubraca in, additional indications and
tumor types. Such forward-looking statements involve substantial
risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from that
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in our clinical development programs for our drug candidates and
those of our partners, whether future study results will be
consistent with study findings to date, the timing of availability
of data from our clinical trials and the initiation, enrollment,
timing and results of our planned clinical trials and the
corresponding development pathways, effectiveness and suitability
of diagnostic tests, the risk that final results of ongoing trials
may differ from initial or interim results as a result of factors
such as final results from a larger patient population may be
different from initial or interim results from a smaller patient
population, the risk that additional pre-clinical or clinical
studies may not support further development in certain additional
indications or tumor types, 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 does not undertake to update or revise any forward-looking
statements. A further description of risks and uncertainties can be
found in Clovis Oncology’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
reports on Form 10-Q and Form 8-K.
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version on businesswire.com: https://www.businesswire.com/news/home/20200617005130/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
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