Loxo Oncology Announces Enrollment of First Patient in Phase 1 Clinical Trial for Highly Selective RET Inhibitor, LOXO-292
May 10 2017 - 5:45AM
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
innovating the development of highly selective medicines for
patients with genetically defined cancers, today announced that the
first patient has been enrolled in the Phase 1 clinical trial of
LOXO-292, an investigational, highly potent and selective RET
inhibitor. RET gene alterations are thought to play a key role in
the development of certain cases of lung, thyroid, colon and other
cancers.
"We are excited to put a second, purpose-built precision
medicine into clinical development,” said Josh Bilenker, M.D.,
chief executive officer of Loxo Oncology. “We believe that patients
with RET-altered lung, thyroid and other cancers have highly
actionable genetic events that are not well addressed by existing
therapies. LOXO-292 was designed to deliver potent RET inhibition,
while avoiding off-target activities that can compromise dose
intensity and contribute to toxicity. If our hypothesis is correct,
LOXO-292 could have meaningful single agent anti-tumor activity in
RET-altered cancers, and the ability to address key resistance
mutations that could otherwise limit the clinical potential of RET
inhibition in affected patients. In advancing our larotrectinib
program, we have worked closely and creatively with patients and
their doctors to deliver on the promise of precision medicine. We
hope that LOXO-292 opens a new and exciting chapter in this
story.”
This first-in-human, global, multi-center Phase 1 trial will
evaluate LOXO-292 as a single agent in patients with advanced solid
tumors. The primary objective of the trial is to determine the
maximum tolerated dose or recommended dose for further study. Key
secondary objectives include measures of safety, pharmacokinetics,
and anti-tumor activity (i.e. Objective Response Rate and Duration
of Response, as determined by RECIST v1.1). The trial includes a
dose escalation phase and dose expansion phase. During the dose
escalation phase, up to 30 patients with advanced solid tumors may
be enrolled to inform the selection of a dose and schedule for the
expansion phase. In the expansion phase, five cohorts are planned
to allow for the characterization of preliminary activity of
LOXO-292 in the following genetically-defined populations: 1)
RET-fusion lung cancer patients with prior RET inhibitor
experience; 2) RET-fusion lung cancer patients with no prior RET
inhibitor experience; 3) RET-mutant medullary thyroid cancer
patients with prior RET inhibitor experience; 4) RET-mutant
medullary thyroid cancer patients with no prior RET inhibitor
experience; and 5) other RET-altered solid tumors. Loxo Oncology
anticipates that approximately 15 patients will be enrolled to each
of the expansion cohorts.
About LOXO-292
LOXO-292 is a potent, oral and
selective investigational new drug in clinical development for the
treatment of patients with cancers that harbor abnormalities in the
rearranged during transfection (RET) kinase. RET fusions have been
identified in approximately 2% of non-small cell lung cancer,
10-20% of papillary thyroid cancer, and a subset of colon and other
cancers. RET point mutations account for approximately 60% of
medullary thyroid cancer. Both RET fusion and select RET mutated
cancers are primarily dependent on this single activated kinase for
their proliferation and survival. This dependency, often referred
to as “oncogene addiction,” renders such tumors highly susceptible
to small molecule inhibitors targeting RET. LOXO-292 was designed
to inhibit native RET signaling as well as anticipated acquired
resistance mechanisms that could otherwise limit the activity of
this therapeutic approach. LOXO-292 is currently being studied in a
Phase 1 trial. Interested patients and physicians can contact the
Loxo Oncology Physician and Patient RET Clinical Trial Hotline at
1-855-RET-4-292 or email clinicaltrials@loxooncology.com.
About Loxo OncologyLoxo Oncology is a
biopharmaceutical company innovating the development of highly
selective medicines for patients with genetically defined cancers.
Our pipeline focuses on cancers that are uniquely dependent on
single gene abnormalities, such that a single drug has the
potential to treat the cancer with dramatic effect. We believe that
the most selective, purpose-built medicines have the highest
probability of maximally inhibiting the intended target, thereby
delivering best-in-class disease control and safety. Our management
team seeks out experienced industry partners, world-class
scientific advisors and innovative clinical-regulatory approaches
to deliver new cancer therapies to patients as quickly and
efficiently as possible. For more information, please visit the
company's website at www.loxooncology.com.
Forward Looking StatementsThis press release
contains "forward-looking" statements within the meaning of the
safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be identified by
words such as: "anticipate," "intend," "plan," "goal," "seek,"
"believe," "project," "estimate," "expect," "strategy," "future,"
"likely," "may," "should," "will" and similar references to future
periods. These statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially
from what we expect. Examples of forward-looking statements
include, among others, the availability of funding, timing and
success of our clinical trials, success in our collaborations and
the potential therapeutic benefits of our lead product candidate or
other product candidates. Further information on potential risk
factors that could affect our business and its financial results
are detailed in our most recent Quarterly Report on Form 10-Q, and
other reports as filed from time to time with the Securities
and Exchange Commission. We undertake no obligation to publicly
update any forward-looking statement, whether written or oral, that
may be made from time to time, whether as a result of new
information, future developments or otherwise.
Contacts for Loxo Oncology, Inc.
Company:
Jacob S. Van Naarden
Chief Business
Officer
jake@loxooncology.com
Investors:
Peter Rahmer
The Trout Group,
LLC
646-378-2973
prahmer@troutgroup.com
Media:
Dan Budwick
1AB Media973-271-6085
dan@1abmedia.com
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