-- Ongoing Phase 1 Study Expanded to Assess Safety and
Anti-Tumor Activity of ALKS 4230 With Pembrolizumab in Patients
With Advanced Solid Tumors --
DUBLIN, Sept. 10, 2018 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced that it has expanded its ongoing
phase 1 study for ALKS 4230, the company's immuno-oncology drug
candidate, to evaluate its safety and anti-tumor activity when
administered in combination with the FDA-approved PD-1 inhibitor
KEYTRUDA® (pembrolizumab) in patients with advanced
solid tumors. ALKS 4230 is an engineered fusion protein designed to
preferentially bind and signal through the intermediate affinity
interleukin-2 (IL-2) receptor complex, thereby selectively
activating and increasing the number of immunostimulatory
tumor-killing immune cells while avoiding the expansion of
immunosuppressive cells that interfere with anti-tumor response.
Pembrolizumab is an anti-PD-1 therapy that works by increasing the
ability of the body's immune system to help detect and fight tumor
cells.
"The emergence of therapeutics targeting the PD-1 pathway has
revolutionized the field of oncology, yet there remains significant
opportunity to improve the clinical benefit of checkpoint
inhibitors for the treatment of solid tumors. There is strong
scientific rationale supporting the combination of PD-1 pathway
inhibition with cytokine therapy such as ALKS 4230 to activate the
body's own immune system to fight cancer, and the potential
synergies of ALKS 4230 and pembrolizumab on anti-tumor activity may
expand treatment options for patients in a variety of tumor
settings," said Craig Hopkinson,
M.D., Chief Medical Officer and Senior Vice President of Medicines
Development and Medical Affairs at Alkermes. "We've accelerated
clinical evaluation of ALKS 4230 in combination with pembrolizumab
based on data from our ongoing monotherapy dose-escalation stage of
the phase 1 study, where ALKS 4230 demonstrated dose-dependent
pharmacodynamic effects on circulating natural killer cells and
CD8+ T cells, and minimal and non-dose dependent effects on
immunosuppressive regulatory T cells. These data validate our
design rationale for ALKS 4230, and we look forward to sharing
initial data from our dose-escalation cohorts at a medical meeting
later this year."
Evaluation of the safety and anti-tumor activity of ALKS 4230 in
combination with pembrolizumab will be assessed in certain PD-1
approved tumor types in both refractory and treatment naïve
patients, including non-small cell lung cancer (NSCLC), head and
neck squamous cell carcinoma, gastric cancer, urothelial carcinoma
and microsatellite instability-high cancers. Melanoma and renal
cell carcinoma will also be evaluated in the cohort of treatment
naïve patients. The combination of ALKS 4230 and pembrolizumab will
also be assessed in certain PD-1 unapproved tumor types, including
colorectal cancer, triple-negative breast cancer, ovarian
carcinoma, soft tissue sarcomas, and patients with metastatic NSCLC
whose tumors express low or undetectable PD-L1 (tumor proportion
score <1%).
About the Phase 1 Study
The Alkermes-sponsored phase 1 study for ALKS 4230 includes
three distinct stages: the ongoing monotherapy dose-escalation
stage, the planned monotherapy dose-expansion stage and the newly
initiated combination therapy stage with pembrolizumab. The
dose-escalation stage is designed to determine a maximum tolerated
dose of ALKS 4230 in a monotherapy setting and to identify the
optimal dose range of ALKS 4230 based on measures of
immunological-pharmacodynamic effects. Upon completion of the
dose-escalation stage, the company expects to initiate the
monotherapy dose-expansion stage in up to 42 patients with renal
cell carcinoma or melanoma. The newly initiated combination therapy
stage of the phase 1 study will assess the safety profile and
anti-tumor activity of ALKS 4230 with pembrolizumab in up to 148
patients with select advanced solid tumors. This combination
therapy stage will be run independent of, and concurrently with,
the monotherapy dose-escalation and dose-expansion stages of the
trial.
Anti-tumor response and duration of response assessments in the
dose-expansion and combination stages of the phase 1 study will be
based on investigator-assessed, immune-related response (irRC)
criteria and independent, central, blinded radiographic review per
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
criteria.
About ALKS 4230
ALKS 4230 is an engineered fusion protein designed to
preferentially bind and signal through the intermediate affinity
interleukin-2 (IL-2) receptor complex, thereby selectively
activating and increasing the number of immunostimulatory
tumor-killing immune cells while avoiding the expansion of
immunosuppressive cells that interfere with anti-tumor response.
The selectivity of ALKS 4230 is designed to leverage the proven
anti-tumor effects while overcoming limitations of existing IL-2
therapy, which activates both immunosuppressive and tumor-killing
immune cells.
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical
company developing innovative medicines for the treatment of
central nervous system (CNS) diseases. The company has a
diversified commercial product portfolio and a substantial clinical
pipeline of product candidates for chronic diseases that include
schizophrenia, depression, addiction and multiple sclerosis.
Headquartered in Dublin, Ireland,
Alkermes plc has an R&D center in Waltham, Massachusetts; a research and
manufacturing facility in Athlone, Ireland; and a manufacturing facility in
Wilmington, Ohio. For more
information, please visit Alkermes' website at
www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: the potential
therapeutic and commercial value of ALKS 4230; and the clinical
development plans for ALKS 4230, including the timing of expected
presentation of initial data from the monotherapy dose-escalation
stage of the phase 1 study and details of the planned monotherapy
dose-expansion stage of the phase 1 study and the newly initiated
combination therapy stage of the phase 1 study. You are cautioned
that forward-looking statements are inherently uncertain. Although
the company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and are subject to a variety of risks and uncertainties,
many of which are beyond the company's control, which could cause
actual results to differ materially from those expressed or implied
in the forward-looking statements. These risks and uncertainties
include, among others, whether preclinical and early clinical
results for ALKS 4230 will be predictive of future clinical study
results; whether ALKS 4230 could be shown to be unsafe or
ineffective; whether future clinical trials or future stages of
ongoing clinical trials for ALKS 4230 will be initiated or
completed on time or at all; changes in the cost, scope and
duration of development activities for ALKS 4230; and those risks
and uncertainties described under the heading "Risk Factors" in the
company's Annual Report on Form 10-K for the year ended
Dec. 31, 2017 and in subsequent
filings made by the company with the U.S. Securities and Exchange
Commission (SEC), which are available on the SEC's website at
www.sec.gov. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking statements contained in this press
release.
KEYTRUDA® is a registered trademark of Merck &
Co., Inc.
Alkermes
Contacts:
|
For
Investors:
|
Eva Stroynowski
+1 781 609 6823
|
|
Sandy
Coombs +1 781 609 6377
|
For Media:
|
Sherry
Feldberg +1 781 609 6276
|
Logo -
https://mma.prnewswire.com/media/616416/Alkermes_plc_Logo.jpg