Loxo Oncology Announces Larotrectinib Pan-TRK IHC Companion Diagnostic Collaboration with Ventana Medical Systems, Inc., a me...
March 20 2017 - 6:45AM
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
Company has entered into a collaboration agreement with Ventana
Medical Systems, Inc., a member of the Roche Group (Roche), to
develop and commercialize a pan-TRK immunohistochemistry (IHC) test
as a companion diagnostic to identify patients across tumor types
suitable for treatment with larotrectinib.
“We are excited to partner with Roche, the global leader in
developing and commercializing IHC assays for cancer diagnostics.
Our initial technology assessment suggests that an IHC pan-TRK
assay is feasible, which is exciting since Roche has thousands of
VENTANA BenchMark instruments installed worldwide,” said Josh
Bilenker, M.D., Chief Executive Officer of Loxo Oncology. “IHC
remains a mainstay of the cancer pathology workup, due in part to
its speed, limited tissue requirements, low cost, and established
reimbursement paradigms. Diagnostics are a crucial part of our
commercial strategy, and we believe IHC will be an important tool,
alongside next-generation sequencing, that pathologists can employ
in screening for patients who may benefit from larotrectinib.”
Loxo Oncology and Roche will utilize an investigational assay
piloted by Loxo Oncology that will be further developed by Roche
using its flagship OptiView DAB detection technology. Initially,
the parties will optimize and validate the assay to ensure it is
sufficiently robust to withstand clinical and regulatory scrutiny.
The parties plan to first globally commercialize an analytical
assay and then develop a Class III assay for pre-market approval
(PMA) from the U.S. Food and Drug Administration (FDA). FDA
approval will be based on analyses of patient samples collected
from ongoing larotrectinib clinical trials to support clinical
claims referencing larotrectinib. Roche is responsible for
developing, obtaining and maintaining regulatory approvals for the
companion diagnostic test in the United States, specified countries
in the European Union and other countries that recognize the CE/ in
vitro diagnostic registration process, as mutually agreed.
About Larotrectinib (LOXO-101)Larotrectinib
(LOXO-101) is a potent, oral and selective investigational new drug
in clinical development for the treatment of patients with cancers
that harbor abnormalities involving the tropomyosin receptor
kinases (TRKs). 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 an ongoing Phase 1 clinical trial, larotrectinib
has demonstrated encouraging preliminary efficacy. Larotrectinib is
also being evaluated in the NAVIGATE global Phase 2 multi-center
basket trial in patients with solid tumors that harbor TRK gene
fusions, and the SCOUT Phase 1/2 trial in pediatric patients,
including patients with advanced cancer, TRK gene fusions and
infantile fibrosarcoma. Larotrectinib has been granted Breakthrough
Therapy Designation and Rare Pediatric Disease Designation by the
U.S. FDA. 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.
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, statements we make regarding the timing and
success of our clinical trials or regulatory approvals, the
potential therapeutic benefits and economic value of our lead
product candidate or other product candidates, and timing of future
filings. 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 NaardenChief Business
Officerjake@loxooncology.com
Investors:Peter RahmerThe Trout Group,
LLC646-378-2973prahmer@troutgroup.com
Media:Dan BudwickPure Communications,
Inc.973-271-6085dan@purecommunicationsinc.com
VENTANA, BENCHMARK and OptiView are trademarks of Roche.All
other trademarks are the property of their respective owners.
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