Genocea Files IND Application for GEN-011, a T cell Therapy Designed to Improve on Current Limitations of TIL Therapy

Rhea-AI Summary

Genocea Biosciences, Inc. (GNCA) has filed an Investigational New Drug (IND) Application with the FDA for a Phase 1/2a clinical study of GEN-011, targeting patients who have not responded to standard checkpoint inhibitor therapy. GEN-011 utilizes a novel ATLAS™ platform to develop neoantigen-specific T cell therapies, promising enhanced scalability and cost-effectiveness compared to traditional TIL therapies. The trial will assess safety and clinical activity, with preliminary results expected by mid-2021, marking significant progress for Genocea's immunotherapy initiatives.

Positive

• Filing of IND for Phase 1/2a trial of GEN-011 demonstrates commitment to advancing cancer immunotherapy.
• GEN-011 uses a scalable manufacturing process, potentially broadening patient access and reducing therapy costs.
• Preliminary data from the trial expected mid-2021 could validate the efficacy and safety of GEN-011.

Negative

• None.

CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical study of GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The GEN-011 trial will evaluate patient safety, T cell proliferation and persistence, and clinical activity, with preliminary data expected mid-2021.

Powered by ATLAS™, GEN-011 offers several advantages over TIL therapies, the gold standard for solid tumor adoptive cell therapy. Unlike TILs, GEN-011 does not require extra surgery or collection of viable tumor samples and uses peripheral blood in a rapidly scalable manufacturing process. This may enable access to a broader population of patients with advanced cancers, and may result in a cost of therapy that is favorable compared to TIL-based approaches. GEN-011 may also offer lasting clinical efficacy by targeting up to 30 relevant neoantigens with CD4⁺ and CD8⁺ memory T cells and avoiding pro-tumor Inhibigens™ that may be detrimental to clinical response.  

“In only 18 months the Genocea team took GEN-011 from whiteboard to IND filing,” said Chip Clark, President and Chief Executive Officer of Genocea. “We look forward to sharing data from yet another program demonstrating that targets matter.”

About Genocea Biosciences, Inc.
Genocea’s mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient’s T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial with preliminary clinical results in mid-2021. To learn more, please visit www.genocea.com. 

Forward-Looking Statements
This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

Investor Contact:
Dan Ferry
617-430-7576
daniel@lifesciadvisors.com

FAQ

What is the purpose of Genocea's IND filing for GEN-011?

The IND filing is to commence a Phase 1/2a clinical study of GEN-011 targeting advanced cancer patients who failed standard treatments.

When can we expect preliminary results from the GEN-011 trial?

Preliminary results from the GEN-011 trial are expected by mid-2021.

What are the advantages of GEN-011 over TIL therapies?

GEN-011 offers a scalable manufacturing process and does not require surgery or viable tumor samples, potentially making it more accessible and cost-effective.

What are the key focuses of the GEN-011 clinical study?

The trial will evaluate patient safety, T cell proliferation, persistence, and clinical activity.

What technology does GEN-011 utilize?

GEN-011 is powered by the ATLAS™ platform, which profiles T cell responses to optimize neoantigens for immunotherapy.