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Agenus Initiates Phase I Study on Oncology Candidate AGEN1223

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Agenus Inc. (AGEN - Free Report) announced that it has initiated a phase I study on AGEN1223. AGEN1223 is a novel bi-specific antibody, which is designed to deplete regulatory T cells in the tumor microenvironment. 

Agenus is currently responsible for the development of AGEN1223. Gilead Sciences, Inc. (GILD - Free Report) has an exclusive option to license the candidate.

The study is designed to evaluate the maximum tolerated dose of AGEN1223 in subjects with advanced solid tumors. It will also evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics(PD) profiles and immunogenicity of this bi-specific antibody. The first patient was dosed in December 2019 and the study is ongoing. The company also plans to initiate combinations with balstilimab, its investigational PD-1 inhibitor, in 2020.

Shares of the company have rallied 13% in the past year against the industry’s decline of 2%.


Besides AGEN1223, Agenus advanced three novel discoveries to investigational new drug (IND) in 2019, which are now set for clinical trials. These include the company’s next-generation CTLA-4, AGEN1181; the differentiated CD137 molecule, AGEN2373; and GS-1423, a bi-functional molecule.

Further, Agenus expects to file biologics license application (BLA) for CTLA-4 targeting antibody, zalifrelimab (AGEN1884), for the treatment of second-line cervical cancer and balstilimab for the treatment of recurrent ovarian cancer in 2020. It expects to commercialize both agents by the first half of 2021. The company is pursuing balstilimab as a monotherapy and in combination with zalifrelimab in patients with relapsed/refractory category cervical cancer. In the combination study, the company completed its accrual requirement for a potential BLA filing as well as interim analysis.

Agenus Inc. Price

Zacks Rank and Stocks to Consider

Agenus currently carries a Zacks Rank #3 (Hold). 

A few better-ranked stocks in the medical drugs sector are Emergent Biosolutions, Inc. (EBS - Free Report) and Audentes Therapeutics, Inc., both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings per share estimates have increased from $3.39 to $3.58 for 2020 in the past 60 days.

Audentes’ loss per share estimates have narrowed from $4.17 to $4.13 for 2019 and from $4.45 to $4.33 for 2020 in the past 60 days.

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