Incyte Corporation (Nasdaq:INCY) and AstraZeneca (NYSE:AZN) today
announced a new collaboration to evaluate the efficacy and safety of
Incyte’s Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in
combination with AstraZeneca’s next generation epidermal growth factor
receptor (EGFR) inhibitor, Tagrisso® (osimertinib). The
combination will be assessed as a second-line treatment for patients
with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have
been treated with a first generation EGFR tyrosine kinase inhibitor
(TKI) and subsequently developed the T790M resistance mutation.
There is increasing evidence that signaling through the JAK-STAT (signal
transducer and activator of transcription) pathway could be a
contributing factor in resistance to EGFR TKI treatment in patients with
EGFR mutation NSCLC. Blocking both JAK and EGFR activity may therefore
offer an improved targeted treatment benefit in some patients.
Under the terms of the agreement, AstraZeneca and Incyte will
collaborate on a Phase 1/2 study, to be conducted by Incyte. The Phase 1
part of the trial is expected to establish a recommended dose regimen
for the combination of INCB39110 and Tagrisso while the Phase 2 part of
the study will assess the safety and efficacy profile. Results from the
study will be used to determine whether further clinical development of
this combination is warranted.
“The expansion of our research collaboration with AstraZeneca will allow
us to further our understanding of these two compounds and explore their
potential synergies both of which support our goal of delivering
innovative medicines that will benefit patients with cancer or other
diseases,” said Rich Levy, MD, Chief Drug Development Officer, Incyte.
“We look forward to adding to our ongoing clinical research for
INCB39110 and exploring the potential of this combination.”
“We are pleased to be building on our existing relationship with Incyte
and exploring a potentially exciting combination for lung cancer
patients who have developed a resistance to first generation EGFR
inhibitor treatment,” said Antoine Yver, Head of Oncology, Global
Medicines Development at AstraZeneca. “This collaboration allows us to
explore further ways in which Tagrisso, our first-in-class
T790M-directed tyrosine kinase inhibitor, can help meet urgent unmet
patient need, following its accelerated approval in the U.S. and the
recent positive CHMP opinion, recommending approval in Europe.”
This agreement builds on an existing collaboration between the two
companies, announced in May 2014, to explore AstraZeneca’s anti-PD-L1
immune checkpoint inhibitor, durvalumab, in combination with Incyte’s
oral indoleamine dioxygenase-1 (IDO1) inhibitor, epacadostat (INCB24360).
About INCB39110
INCB39110 is an orally bioavailable, isoform-selective inhibitor of
Janus-associated kinase 1 (JAK1). JAK1 activity is believed to play an
important role in both autoimmune and oncologic diseases. JAK1 forms
heterodimeric complexes with JAK2, JAK3 or TYK2 and functions as an
immunomodulatory and inflammatory signalling kinase. Selective JAK1
inhibition prevents STAT signaling downstream of a number of cytokines,
including IL-6, IL-10 and interferon-gamma. Consistent with the dominant
role for JAK1 in mediating heterodimeric JAK/STAT signaling, JAK1
inhibition has been shown to result in equivalent efficacy compared to
balanced JAK1/JAK2 modulation in a variety of preclinical solid and
liquid tumor models. INCB39110 will be investigated in clinical trials
as monotherapy in graft versus host disease (GvHD) and in several
combination-based therapeutic regimens, including with PI3Kδ
(INCB50465), IDO1 (epacadostat) and EGFR (Tagrisso) inhibitors.
About Tagrisso (osimertinib)
Tagrisso (osimertinib) is the only approved medicine indicated for adult
patients with metastatic EGFR T790M mutation-positive non-small cell
lung cancer. This indication is approved under the FDA’s accelerated
approval process based on tumour response rate and duration of response
(DoR). Osimertinib is being compared with platinum-based doublet
chemotherapy in the confirmatory AURA3 Phase III study in patients with
EGFR T790M-positive, locally advanced, or metastatic NSCLC who have
progressed after EGFR-TKI therapy. It is also being investigated in the
adjuvant and metastatic first-line settings, including in patients with
brain metastases, and in combination with other compounds.
Non-clinical in vitro studies have demonstrated that osimertinib has
high potency and inhibitory activity against mutant EGFR phosphorylation
across the range of clinically relevant EGFRm and T790M mutant NSCLC
cell lines, with significantly less activity against EGFR in wild-type
cell lines.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
About AstraZeneca in Oncology
Oncology is a therapy area in which AstraZeneca has deep-rooted
heritage. It will be potentially transformational for the company’s
future, becoming the sixth growth platform. Our vision is to help
patients by redefining the cancer treatment paradigm and one day
eliminate cancer as a cause of death. By 2020, we are aiming to bring at
least six new cancer medicines to patients.
Our broad pipeline of next-generation medicines is focused on four main
disease areas – lung, ovarian, breast and hematological cancers. These
are being targeted through four key platforms – immuno-oncology, the
genetic drivers of cancer and resistance, DNA damage repair and antibody
drug conjugates – with a strong focus on combinations. Our recently
announced investment in Acerta Pharma also adds the potentially
transformational BTK inhibitor class of treatments to our portfolio,
subject to closure in the first quarter of 2016, strengthening further
our focus on targeted therapies.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in three
main therapy areas - respiratory, inflammation, autoimmune disease
(RIA), cardiovascular and metabolic disease (CVMD) and oncology – as
well as in infection and neuroscience. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of patients
worldwide. For more information please visit: www.astrazeneca.com
Forward Looking Statements (Incyte)
Except for the historical information set forth herein, the matters set
forth in this press release, including statements regarding the
potential efficacy, safety and therapeutic value of, and Incyte’s plans
for, INCB39110, and the plans, design, expectations, timing and results
of or regarding the Phase I/II study in the clinical trial collaboration
with AstraZeneca, contain predictions, estimates and other
forward-looking statements. These forward-looking statements are based
on the Company’s current expectations and subject to risks and
uncertainties that may cause actual results to differ materially,
including unanticipated developments in and the risks related to the
efficacy or safety of INCB39110, the results of further research and
development, the high degree of risk and uncertainty associated with
drug development, clinical trials and regulatory approval processes, the
ability to enroll sufficient numbers of subjects in the planned trial,
other market or economic factors and competitive and technological
advances; and other risks detailed from time to time in the Company’s
reports filed with the Securities and Exchange Commission, including its
Form 10-Q for the quarter ended September 30, 2015. Incyte disclaims any
intent or obligation to update these forward-looking statements.
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