Loxo Oncology Announces Initiation of Phase 1/2 Clinical Trial for Highly Selective, Non-Covalent BTK Inhibitor, LOXO-305
December 21 2018 - 6:45AM
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
focused on the development and commercialization of highly
selective medicines for patients with genomically defined cancers,
today announced that it has initiated a Phase 1/2 clinical trial of
LOXO-305. LOXO-305 is an investigational, highly selective,
non-covalent Bruton’s tyrosine kinase (BTK) inhibitor specifically
designed to address acquired resistance and intolerance in patients
previously treated with FDA-approved BTK inhibitors.
"We are pleased to initiate the clinical trial for our fourth
novel drug candidate,” said Josh Bilenker, M.D., chief executive
officer of Loxo Oncology. “FDA-approved BTK inhibitors, which all
covalently (irreversibly) bind to their targets, have meaningfully
improved the lives of patients with certain B-cell leukemias and
lymphomas. However, we are now learning that many patients are
discontinuing these therapies due to disease progression or
intolerance. When disease progression is caused by a resistance
mechanism known as a C481 mutation, we believe that LOXO-305 has
the potential to re-induce a response in affected patients. We also
believe that the selectivity profile of LOXO-305 has the potential
to avoid certain side effects. We look forward to working with our
clinical investigators to determine whether LOXO-305 can deliver
against these exciting possibilities.”
This first-in-human, global, multi-center Phase 1/2 trial will
evaluate LOXO-305 as a single agent in patients with previously
treated chronic lymphocytic leukemia (CLL), small lymphocytic
lymphoma (SLL), or non-Hodgkin’s lymphomas (NHL). The primary
objective of the Phase 1 portion of the trial is to determine the
maximum tolerated dose or recommended phase 2 dose. Key secondary
objectives include measures of safety, pharmacokinetics, and
anti-tumor activity (i.e. Overall Response Rate and Duration of
Response, as determined by appropriate histology-specific response
criteria). The trial includes a Phase 1 dose escalation phase and a
Phase 2 dose expansion phase. The Phase 1 dose escalation employs
an accelerated titration design, initially enrolling single patient
dose cohorts for patients with CLL/SLL or NHL who have received at
least two prior lines of therapy and have progressed or are
intolerant to standard of care. Based on reported adverse events,
the dose escalation may switch to a “3+3” design. In the
Phase 2 dose expansion phase, six cohorts are planned to allow for
the characterization of the preliminary anti-tumor activity of
LOXO-305: 1) CLL/SLL failed prior BTK inhibitor with BTK C481
mutation; 2) CLL/SLL failed prior BTK inhibitor without BTK C481
mutation; 3) Waldenstrom’s macroglobulinemia (WM), mantle cell
lymphoma (MCL) or marginal zone lymphoma (MZL) failed prior BTK
inhibitor with BTK C481 mutation; 4) WM, MCL or MZL failed prior
BTK inhibitor without BTK C481 mutation; 5) CLL/SLL, WM, MCL or MZL
intolerant to prior BTK inhibitor; 6) CLL/SLL, WM, MCL or MZL
failed prior BTK inhibitor with unknown BTK C481 mutation status
and other CLL/SLL, WM, CML, MZL or other NHL patients not meeting
the definitions of Cohorts 1 through 5.
About LOXO-305LOXO-305 is an investigational,
novel, highly selective non-covalent Bruton’s tyrosine kinase (BTK)
inhibitor. BTK plays a key role in the B-cell antigen receptor
signaling pathway, which is required for the development,
activation and survival of normal white blood cells, known as
B-cells, and malignant B-cells. BTK is a validated molecular target
found across numerous B-cell leukemias and lymphomas including
chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia,
mantle cell lymphoma and marginal zone lymphoma. Currently
available BTK inhibitors irreversibly inhibit BTK and the long-term
efficacy of these therapies has been limited by acquired
resistance, most commonly through BTK C481 mutations, and
intolerance, due to off target inhibition of other cellular
targets. LOXO-305 was designed to reversibly bind BTK, preserve
activity in the presence of the C481 acquired resistance mutations,
and avoid off-target kinases that have complicated the development
of both covalent and investigational non-covalent BTK inhibitors.
Interested patients and physicians can contact the Loxo Oncology
Physician and Patient BTK Clinical Trial Hotline at 1-855-LOXO-305
or email clinicaltrials@loxooncology.com.
About Loxo Oncology Loxo Oncology is
a biopharmaceutical company focused on the development and
commercialization of highly selective medicines for patients with
genomically 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, with the intention of 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 http://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, including our Phase 1/2 clinical
trial for LOXO-305, success in our collaborations and the potential
therapeutic benefits LOXO-305 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:
Lauren Cohen Director, Corporate Communications
lcohen@loxooncology.com
Investors: Peter Rahmer Endurance Advisors, LLC 415-515-9763
prahmer@enduranceadvisors.com
Media: Dan Budwick 1AB Media 973-271-6085 dan@1abmedia.com
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