- Expands Illumina’s Oncology Offerings for
NextSeq™ 550Dx with a Companion Diagnostic Version of TruSight™
Tumor 170 for Solid Tumors -
Loxo Oncology (Nasdaq:LOXO) and Illumina,
Inc. (Nasdaq:ILMN) 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 170
TruSight 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-292LOXO-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 IlluminaIllumina 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 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.
Use of forward-looking statementsThis 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.
Contacts for Loxo Oncology, Inc.
Company/Investors: Lauren CohenDirector, Corporate
Communicationslcohen@loxooncology.com
Media: Dan Budwick 1AB Media 973-271-6085
dan@1abmedia.com
Contacts for Illumina, Inc.
Investors: Jacquie Ross,
CFA858-882-2172IR@illumina.com
Media: Lisa Warshaw323-360-8778PR@illumina.com
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