Alkermes plc ALKS announced the initiation of a new phase II ARTISTRY-3 study to evaluate the clinical and immunologic effects of ALKS 4230 monotherapy in patients with advanced solid tumors.
The company’s shares have declined 10% so far this year against the industry’s growth of 2.7%.
ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.
The ARTISTRY-3 study will evaluate treatment-emergent changes in the tumor microenvironment and peripheral blood immunophenotypes, as well as the safety, tolerability, and pharmacokinetic profile of ALKS 4230 (6µg/kg) dosed intravenously, as lead-in monotherapy, followed by combination with Merck’s MRK anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with select advanced malignant solid tumors. The study will also assess clinical anti-tumor activity (overall response rate and duration of response) of ALKS 4230 as one of its secondary objectives.
Early clinical data from the ARTISTRY program showed that ALKS 4230 selectively expanded cancer-fighting immune cells in the periphery, with negligible effects on regulatory T cells.
ARTISTRY-3 is the fourth study evaluating ALKS 4230 as a novel immuno-oncology candidate.
ALKS 4230 is being evaluated under the ARTISTRY clinical development program in patients with advanced solid tumors. The company is developing the candidate in three distinct stages under ARTISTRY-1, an ongoing phase I/II study of ALKS 4230 administered via intravenous infusion as a monotherapy and in combination with the Keytruda. Itis designed to evaluate the safety profile and anti-tumor activity of ALKS 4230 in patients with select advanced solid tumors. ARTISTRY-2is an ongoing phase I/II study,in which ALKS 4230 is administered subcutaneously as monotherapy and in combination with Keytruda in patients with advanced solid tumors.
Zacks Rank and Stocks to Consider
Currently, Alkermes is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS and Horizon Therapeutics Public Limited Company HZNP, both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $3.45 to $5.60 for 2020 and from $3.73 to $6.67 for 2021 over the past 60 days.
Horizon Therapeutics’ earnings estimates have increased from $1.77 to $2.86 for 2020 and from $2.72 to $4.29 for 2021 over the past 60 days.
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