Genocea Biosciences, Inc. GNCA announced that it has initiated a phase I/IIa TiTAN study on its investigational neoantigen-targeted T-Cell therapy, GEN-011, by dosing the first patient in the study.

We remind investors that in September 2020, the FDA accepted the investigational new drug application for GEN-011 allowing it to initiate the phase I/IIa study in patients who have failed standard-of-care checkpoint inhibitor therapy. The study aims at evaluating the drug’s safety, promoting T cell proliferation and persistence as well as boosting clinical activity.

Shares of Genocea have declined 14.5% so far this year in comparison with the industry’s 8.4% decline.

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The TiTAN study will evaluate two dosing regimens of GEN-011 — a repeated lower dose regimen without lymphodepletion and a single high dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells. The company expects to report top-line data from the study in fourth-quarter 2021 or first-quarter 2022.

Genocea aims to develop immunotherapies for cancer patients by identifying the right tumor targets. To achieve this mission, the company has developed a proprietary ATLAS platform to optimize antigen selection and comprehensively profile antigens on the patient’s tumor. Using ATLAS, GEN-011 employs better targeting to select optimal neoantigen targets that drive anti-tumor immune responses and avoid immunosuppressive Inhibigens.

In addition to GEN-011, the company is also undergoing phase I/IIa study for an investigational neoantigen vaccine, GEN-009. It is also researching on several indications wherein ATLAS can optimize antigen selection for therapies.

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the drug sector include Addex Therapeutics ADXN, Catalent CTLT and Translate Bio TBIO. While Catalent holds a Zacks Rank #1 (Strong Buy), both Addex and Translate Bio currently carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Addex’s loss estimates for 2021 have narrowed from $2.79 to $2.34 per share in the past 60 days while that of 2022 has decreased from $2.98 to $2.51 over the same period.

Catalent’s earnings estimates for 2021 have increased from $2.90 to $2.94 per share in the past 60 days while that of 2022 has risen from $3.37 to $3.49 over the same period. The stock has risen 8.9% in the year so far.