Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
developing highly selective medicines for patients with genomically
defined cancers, today announced that abstracts from its LOXO-292
and larotrectinib programs have been accepted for oral
presentations at the 88th Annual Meeting of the American Thyroid
Association to be held October 3-7, 2018, in Washington, DC.
The LOXO-292 oral presentation will provide an updated analysis
of patients with RET mutant medullary thyroid cancer and RET fusion
thyroid cancers enrolled in the dose escalation cohorts of the
ongoing LIBRETTO-001 Phase 1/2 clinical trial. The larotrectinib
oral presentation will provide an analysis of patients with TRK
fusion thyroid cancer enrolled to the larotrectinib clinical
program.
The schedule for the presentations is as follows:
LOXO-292 Oral
Presentation Session Date & Time: October 6,
2018, 9:05 a.m.-9:20 a.m. ETTitle: Clinical
Activity of LOXO-292, a Highly Selective RET Inhibitor, in Patients
with RET-Altered Thyroid CancersSession Title:
Clinical Short Call OralPresenter: Lori J. Wirth,
M.D.
Larotrectinib Oral Presentation Session
Date & Time: October 4, 2018, 1:50 p.m.-2:05 p.m.
ETTitle: Activity of Larotrectinib in Patients
with Advanced TRK Fusion Thyroid CancerSession
Title: Thursday Clinical Oral
AbstractsPresenter: Marcia S. Brose, M.D.,
Ph.D.
About LOXO-292 LOXO-292 is an 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 and
mutations occur across multiple tumor types with varying frequency.
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 has been
granted Breakthrough Therapy Designation by the U.S. FDA.
LOXO-292 is currently being studied in the global LIBRETTO-001
Phase 1/2 trial. For additional information about the LOXO-292
clinical trial, please refer to www.clinicaltrials.gov. 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 RET-Altered CancersGenomic alterations in
the RET kinase, which include fusions and activating point
mutations, lead to overactive RET signaling and uncontrolled cell
growth. RET fusions have been identified in approximately 2% of
non-small cell lung cancer, 10-20% of papillary and other thyroid
cancers, and a subset of other cancers. Activating RET point
mutations account for approximately 60% of medullary thyroid cancer
(MTC). Both RET fusion cancers and RET-mutant MTC 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.
About Larotrectinib Larotrectinib is an oral
and selective investigational tropomyosin receptor kinase (TRK)
inhibitor in clinical development for the treatment of patients
with cancers that harbor a neurotrophic tyrosine receptor kinase
(NTRK) gene fusion. Growing research suggests that the NTRK genes,
which encode for TRKs, can become abnormally fused to other genes,
resulting in growth signals that can lead to cancer in many sites
of the body. In clinical trials, larotrectinib demonstrated
anti-tumor activity in patients with tumors harboring NTRK gene
fusions, regardless of patient age or tumor type. In an analysis of
55 RECIST-evaluable adult and pediatric patients with NTRK gene
fusions, using a July 17, 2017 data cutoff, larotrectinib
demonstrated a 75 percent centrally-assessed confirmed overall
response rate (ORR) and an 80 percent investigator-assessed
confirmed ORR, across many different types of solid tumors. The
majority (93 percent) of all adverse events were grade 1 or 2.
Larotrectinib has been granted Priority Review, Breakthrough
Therapy Designation, Rare Pediatric Disease Designation and Orphan
Drug Designation by the U.S. FDA.
In November 2017, Loxo Oncology and Bayer entered
into an exclusive global collaboration for the development and
commercialization of larotrectinib and LOXO-195, a next-generation
TRK inhibitor. Bayer and Loxo Oncology are jointly developing
the two products with Loxo Oncology leading the ongoing
clinical studies as well as the filing in the U.S., and Bayer
leading ex-U.S. regulatory activities and worldwide commercial
activities. In the U.S., Loxo Oncology and Bayer will
co-promote the products.
For additional information about the larotrectinib clinical
trials, please refer to www.clinicaltrials.gov. Interested
patients and physicians can contact the Loxo Oncology Physician and
Patient Clinical Trial Hotline at 1-855-NTRK-123 or
visit www.loxooncologytrials.com/trk-trials.
About TRK Fusion Cancer TRK fusion cancer
occurs when a neurotrophic tyrosine receptor kinase
(NTRK) gene fuses with another unrelated gene, producing an
altered tropomyosin receptor kinase (TRK) protein. The altered
protein, or TRK fusion protein, is constantly active, triggering a
permanent signal cascade. These proteins become the primary driver
of the spread and growth of tumors in patients with TRK fusion
cancer. TRK fusion cancer is not limited to certain types of cells
or tissues and can occur in any part of the body. NTRK gene fusions
occur in various adult and pediatric solid tumors with varying
prevalence, including appendiceal cancer, breast cancer,
cholangiocarcinoma, colorectal cancer, GIST, infantile
fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of
the salivary gland, melanoma, pancreatic cancer, thyroid cancer,
and various sarcomas. Only sensitive and specific tests can
reliably detect TRK fusion cancer. Next-generation sequencing (NGS)
can provide a comprehensive view of genomic alterations across a
large number of genes. Fluorescence in situ hybridization (FISH)
can also be used to test for TRK fusion cancer, and
immunohistochemistry (IHC) can be used to detect the presence of
TRK protein.
About Loxo Oncology Loxo Oncology is
a biopharmaceutical company developing 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 www.loxooncology.com.
Forward Looking Statements This 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 timing and success of our clinical
trials or regulatory approvals related to larotrectinib, LOXO-195
or LOXO-292, the success of our collaboration with Bayer and our
commercial activities. Further information on potential risk
factors that could affect our business and its financial results
are detailed in our most recent Annual Report on Form 10-K, 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 CohenDirector, Corporate
Communicationslcohen@loxooncology.com
Investors:Peter RahmerEndurance Advisors,
LLC415-515-9763prahmer@enduranceadvisors.com
Media:Dan Budwick1AB Media973-271-6085dan@1abmedia.com
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