Expands Illumina’s oncology offerings for
NextSeq™ 550Dx with a companion diagnostic version of TruSight™
Tumor 170 for solid tumors
Loxo Oncology to utilize a companion diagnostic
version of TruSight Tumor 170 for larotrectinib (NTRK) and LOXO-292
(RET)
Illumina, Inc. (Nasdaq: ILMN) and Loxo Oncology (Nasdaq: LOXO)
today announced a global strategic partnership to develop and
commercialize a multi-gene panel for broad tumor profiling,
resulting in a distributable, next-generation sequencing (NGS)
based companion diagnostic (CDx) with a pan-cancer indication. The
co-development partnership will seek approval for a version of the
Illumina TruSight Tumor 170 as a companion diagnostic (CDx) for
Loxo Oncology’s larotrectinib, which targets NTRK gene fusions, and
LOXO-292, which targets RET gene alterations, across tumor
types.
TruSight Tumor 170 is a comprehensive, state-of-the-art,
next-generation sequencing test that interrogates point mutations,
fusions, amplifications and splice variants in 170 genes associated
with common solid tumors. The CDx version of TruSight Tumor 170
will allow local laboratories to provide referring physicians with
comprehensive genomic information, so that patients can be matched
to the most appropriate therapeutic options. This version of
TruSight Tumor 170 will run on the NextSeq 550Dx
platform.
“We are leveraging our leadership in next-generation sequencing
to deliver in-vitro diagnostic solutions to improve the management
of cancer patients in the clinic,” said Garret Hampton, Ph.D.,
Executive Vice President of Clinical Genomics at Illumina. “To
this end, we are partnering with leading biotechnology companies,
such as Loxo Oncology, to develop companion diagnostics for
best-in-class therapeutics. Distributable diagnostic solutions,
such as a CDx version of TruSight Tumor 170, in combination with
the NextSeq 550Dx platform, will enable labs to perform precision
medicine testing in-house.”
Under the partnership, the companies will collaborate to
validate a CDx version of TruSight Tumor 170 for NTRK fusions and
RET fusions/mutations as a Class III FDA-approved diagnostic in
conjunction with larotrectinib and LOXO-292, respectively. The
companies are also planning to broaden the clinical utility of the
full panel by obtaining regulatory approval for the other assay
content, to be marketed as a tumor profiling test. Illumina will
lead regulatory activities related to the Class III plans for NTRK
and RET, the Class II plans for the tumor profiling content and CE
marking.
“We are very excited to announce this collaboration with
Illumina, the world’s leader in NGS technology,” said Jacob Van
Naarden, Chief Business Officer of Loxo Oncology. “We have piloted
numerous NGS assays, and the Illumina TruSight Tumor 170 assay has
consistently demonstrated robust performance with its assessment of
both DNA and RNA, including highly sensitive gene fusion detection.
The broad 170-gene assay content has the potential to deliver
meaningful insights from a single tumor specimen, identifying
patients with NTRK fusions, RET fusions, RET mutations, and many
other actionable tumor alterations. Furthermore, we believe that
this collaboration will improve patient access to high-quality NGS
testing because pathologists will be able to run TruSight Tumor 170
locally and receive reimbursement.”
About TruSight Tumor 170TruSight Tumor 170 currently
serves as the foundation for a comprehensive research use oncology
menu, including:
- 170 unique genes informed by partnering
pharmaceutical companies, academic community leaders and industry
guidance enable broad tumor profiling
- Integrated workflow allowing more
comprehensive testing while preserving precious samples by
evaluating DNA and RNA in one integrated protocol with only 40ng
from FFPE samples
- Underlying assay method to serve as a
standard for oncology testing and will be deployed across a variety
of applications including Immuno-Oncology and liquid biopsy
About Larotrectinib (LOXO-101)
Larotrectinib is a potent, oral and highly selective tropomyosin
receptor kinase (TRK) inhibitor. The investigational new drug is 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 marked and durable
anti-tumor activity in TRK fusion cancer regardless of patient age
or tumor type. In an analysis of 55 RECIST-evaluable adult and
pediatric patients with NTRK gene fusions, larotrectinib
demonstrated an 80 percent investigator-assessed confirmed overall
response rate (ORR) and a 75 percent centrally-assessed confirmed
ORR, across many different types of solid tumors. Larotrectinib was
well tolerated; the majority of all adverse events were grade 1 or
2. There were no treatment-related grade 4 or 5 events, and no
treatment-related grade 3 adverse events occurred in more than 5%
of patients.
Larotrectinib has been granted 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 will jointly develop 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.
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 Illumina
Illumina is improving human health by unlocking the power of the
genome. Our focus on innovation has established us as the global
leader in DNA sequencing and array-based technologies, serving
customers in the research, clinical, and applied markets. Our
products are used for applications in the life sciences, oncology,
reproductive health, agriculture, and other emerging segments. To
learn more, visit www.illumina.com and follow @illumina.
About Loxo Oncology
Loxo 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.
Use of forward-looking statements
This release contains projections, information about the success
and timing of the collaboration between Illumina and Loxo Oncology,
the success and FDA approval of the TruSight Tumor 170 assay or
other companion diagnostics, and other forward-looking statements
that involve risks and uncertainties. These forward-looking
statements are based on the expectations of the companies as of the
date of this release and may differ materially from actual future
events or results. Among the important factors that could cause
actual results to differ materially from those in any
forward-looking statements are (i) Illumina’s ability to further
develop and commercialize our instruments and consumables and to
deploy new products, services and applications, and expand the
markets for our technology platforms; (ii) Illumina’s ability to
manufacture robust instrumentation and consumables; (iii)
Illumina’s ability to successfully identify and integrate acquired
technologies, products or businesses; (iv) the future conduct and
growth of the business and the markets in which Illumina and Loxo
Oncology operate; (v) challenges inherent in developing,
manufacturing, and launching new products and services; (vi) the
companies’ ability to obtain necessary regulatory approvals to
market and sell diagnostic or therapeutic products (vii) the
potential therapeutic benefits and economic value of Loxo
Oncology’s lead product candidate or other product candidates and
(viii) the timing and success of Loxo Oncology’s clinical trials or
regulatory approvals , together with other factors detailed in
Illumina’s and Loxo Oncology’s filings with the Securities and
Exchange Commission, including our most recent filings on Forms
10-K and 10-Q, or in information disclosed in public conference
calls, the date and time of which are released beforehand. We
undertake no obligation, and do not intend, to update these
forward-looking statements, to review or confirm analysts’
expectations, or to provide interim reports or updates on the
progress of the current quarter.
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version on businesswire.com: https://www.businesswire.com/news/home/20180410005649/en/
Loxo Oncology, Inc.Company/Investors:Lauren CohenDirector, Corporate
Communicationslcohen@loxooncology.comorMedia:1AB MediaDan Budwick,
973-271-6085dan@1abmedia.comorIllumina, Inc.Investors:Jacquie Ross, CFA,
858-882-2172IR@illumina.comorMedia:Lisa Warshaw,
323-360-8778PR@illumina.com
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