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— Advancing Appearance 1 Abstraction Broadcast to Appraise Assurance and Anti-Tumor Action of ALKS 4230 With Pembrolizumab in Patients With Avant-garde Solid Tumors —

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DUBLIN, Sept. 10, 2018 /PRNewswire/ — Alkermes plc (ALKS) today appear that it has broadcast its advancing appearance 1 abstraction for ALKS 4230, the company’s immuno-oncology biologic candidate, to appraise its assurance and anti-tumor action back administered in aggregate with the FDA-approved PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients with avant-garde solid tumors. ALKS 4230 is an engineered admixture protein advised to preferentially bind and arresting through the average affection interleukin-2 (IL-2) receptor complex, thereby selectively activating and accretion the cardinal of immunostimulatory tumor-killing allowed beef while alienated the amplification of immunosuppressive beef that baffle with anti-tumor response. Pembrolizumab is an anti-PD-1 analysis that works by accretion the adeptness of the body’s allowed arrangement to advice ascertain and action bump cells.

“The actualization of analysis targeting the PD-1 alleyway has revolutionized the acreage of oncology, yet there charcoal cogent befalling to advance the analytic account of checkpoint inhibitors for the analysis of solid tumors. There is able accurate account acknowledging the aggregate of PD-1 alleyway inhibition with cytokine analysis such as ALKS 4230 to actuate the body’s own allowed arrangement to action cancer, and the abeyant synergies of ALKS 4230 and pembrolizumab on anti-tumor action may aggrandize analysis options for patients in a array of bump settings,” said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. “We’ve accelerated analytic appraisal of ALKS 4230 in aggregate with pembrolizumab based on abstracts from our advancing monotherapy dose-escalation date of the appearance 1 study, area ALKS 4230 accustomed dose-dependent pharmacodynamic furnishings on circulating accustomed analgesic beef and CD8 T cells, and basal and non-dose abased furnishings on immunosuppressive authoritative T cells. These abstracts validate our architecture account for ALKS 4230, and we attending avant-garde to administration antecedent abstracts from our dose-escalation cohorts at a medical affair after this year.”

Evaluation of the assurance and anti-tumor action of ALKS 4230 in aggregate with pembrolizumab will be adjourned in assertive PD-1 accustomed bump types in both adverse and analysis naïve patients, including non-small corpuscle lung blight (NSCLC), arch and close squamous corpuscle carcinoma, belly cancer, urothelial blight and microsatellite instability-high cancers. Melanoma and renal corpuscle blight will additionally be evaluated in the accomplice of analysis naïve patients. The aggregate of ALKS 4230 and pembrolizumab will additionally be adjourned in assertive PD-1 crooked bump types, including colorectal cancer, triple-negative cancer, ovarian carcinoma, bendable tissue sarcomas, and patients with metastatic NSCLC whose tumors accurate low or ephemeral PD-L1 (tumor admeasurement account <1%).

About the Appearance 1 Study

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The Alkermes-sponsored appearance 1 abstraction for ALKS 4230 includes three audible stages: the advancing monotherapy dose-escalation stage, the planned monotherapy dose-expansion date and the anew accomplished aggregate analysis date with pembrolizumab. The dose-escalation date is advised to actuate a best acceptable dosage of ALKS 4230 in a monotherapy ambience and to analyze the optimal dosage ambit of ALKS 4230 based on measures of immunological-pharmacodynamic effects. Upon achievement of the dose-escalation stage, the aggregation expects to admit the monotherapy dose-expansion date in up to 42 patients with renal corpuscle blight or melanoma. The anew accomplished aggregate analysis date of the appearance 1 abstraction will appraise the assurance contour and anti-tumor action of ALKS 4230 with pembrolizumab in up to 148 patients with baddest avant-garde solid tumors. This aggregate analysis date will be run absolute of, and accordingly with, the monotherapy dose-escalation and dose-expansion stages of the trial.

Anti-tumor acknowledgment and continuance of acknowledgment assessments in the dose-expansion and aggregate stages of the appearance 1 abstraction will be based on investigator-assessed, immune-related acknowledgment (irRC) belief and independent, central, addled radiographic analysis per Acknowledgment Appraisal Belief in Solid Tumors (RECIST 1.1) criteria.

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About ALKS 4230

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ALKS 4230 is an engineered admixture protein advised to preferentially bind and arresting through the average affection interleukin-2 (IL-2) receptor complex, thereby selectively activating and accretion the cardinal of immunostimulatory tumor-killing allowed beef while alienated the amplification of immunosuppressive beef that baffle with anti-tumor response. The selectivity of ALKS 4230 is advised to advantage the accurate anti-tumor furnishings while advantageous limitations of absolute IL-2 therapy, which activates both immunosuppressive and tumor-killing allowed cells.

About Alkermes

Alkermes plc is a absolutely integrated, all-around biopharmaceutical aggregation developing avant-garde medicines for the analysis of axial afraid arrangement (CNS) diseases. The aggregation has a adapted bartering artefact portfolio and a abundant analytic activity of artefact candidates for abiding diseases that accommodate schizophrenia, depression, addiction and assorted sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D centermost in Waltham, Massachusetts; a analysis and accomplishment ability in Athlone, Ireland; and a accomplishment ability in Wilmington, Ohio. For added information, amuse appointment Alkermes’ website at www.alkermes.com.

Note Regarding Forward-Looking Statements

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Certain statements set alternating in this columnist absolution aggregate “forward-looking statements” aural the acceptation of the Private Securities Litigation Reform Act of 1995, as amended, including, but not bound to, statements concerning: the abeyant ameliorative and bartering amount of ALKS 4230; and the analytic development affairs for ALKS 4230, including the timing of accepted presentation of antecedent abstracts from the monotherapy dose-escalation date of the appearance 1 abstraction and capacity of the planned monotherapy dose-expansion date of the appearance 1 abstraction and the anew accomplished aggregate analysis date of the appearance 1 study. You are cautioned that advanced statements are inherently uncertain. Although the aggregation believes that such statements are based on reasonable assumptions aural the bound of its ability of its business and operations, the advanced statements are neither promises nor guarantees and are accountable to a array of risks and uncertainties, abounding of which are above the company’s control, which could account absolute after-effects to alter materially from those bidding or adumbrated in the advanced statements. These risks and uncertainties include, amid others, whether preclinical and aboriginal analytic after-effects for ALKS 4230 will be predictive of approaching analytic abstraction results; whether ALKS 4230 could be apparent to be alarming or ineffective; whether approaching analytic trials or approaching stages of advancing analytic trials for ALKS 4230 will be accomplished or completed on time or at all; changes in the cost, ambit and continuance of development activities for ALKS 4230; and those risks and uncertainties declared beneath the branch “Risk Factors” in the company’s Annual Report on Form 10-K for the year concluded Dec. 31, 2017 and in consecutive filings fabricated by the aggregation with the U.S. Securities and Exchange Commission (SEC), which are accessible on the SEC’s website at www.sec.gov. Absolute and -to-be investors are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date hereof. Except as appropriate by law, the aggregation disclaims any ambition or albatross for afterlight or alteration any advanced statements independent in this columnist release.

KEYTRUDA® is a registered brand of Merck & Co., Inc.

 

Alkermes Contacts:

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For Investors: 

Eva Stroynowski  1 781 609 6823

Sandy Coombs    1 781 609 6377

For Media:

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Medical Employee Evaluation Form | Editable Forms – medical evaluation form | medical evaluation form

Sherry Feldberg   1 781 609 6276

 

Alkermes plc Logo (PRNewsfoto/Alkermes plc)

 

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