Genocea Presents Follow-up Data from GEN-009 Neoantigen Vaccine Phase 1/2a Trial at ESMO Virtual Congress 2020

Rhea-AI Summary

On September 17, 2020, Genocea Biosciences (NASDAQ: GNCA) presented new clinical data from its GEN-009 Phase 1/2a trial at the ESMO Virtual Congress. The results showed that 100% of evaluated patients exhibited immune responses to neoantigens, with tumor responses indicating potential benefits of combining GEN-009 with standard PD-1 inhibitors. Notably, three patients demonstrated RECIST responses, and no significant side effects were reported. The company anticipates sharing more comprehensive data later this year as it explores GEN-009's role in enhancing cancer immunotherapy.

Positive

• 100% of patients had immune responses to neoantigens.
• Three patients exhibited RECIST responses (2 PR, 1 CR).
• No significant adverse side effects were reported.

Negative

• None.

Step-down responses to GEN-009, with 3 objective responses (2 PR, 1 CR) in the first 5 patients, suggests added benefit to PD-1 inhibitor therapy

100% of patients have immune responses to ATLAS-identified neoantigens

CAMBRIDGE, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents additional clinical response and immunogenicity data from the first five patients vaccinated in Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

ESMO E-POSTER PRESENTATION:
Poster 1028P 
Title: Preliminary results of a pilot trial of GEN-009, a neoantigen vaccine containing immunogenic tumor specific neoantigens, in combination with PD-1 inhibitors in advanced cancers
Date: September 17, 2020
Time: at 9:00 a.m. CEST (3:00 a.m. EDT)
Link to the poster: https://www.esmo.org/meetings/esmo-virtual-congress-2020/registration?hit=ehp

The results build on the Part B findings shared previously, which evaluated the preliminary immunogenicity and efficacy of GEN-009 in combination with standard-of-care checkpoint inhibitor-based regimens (CPI) in an initial cohort of five patients with advanced solid tumors. All five patients received GEN-009 approximately four months following the start of CPI treatment.

New follow-up scans, ranging from 91-233 days post-vaccination, confirm the previously disclosed findings, with tumor reduction or stable outcomes for all five patients, including three RECIST-criteria changes in tumor size (2 PR, 1 CR) after vaccination and likely attributable to GEN-009. The new results continue to suggest GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100 percent of patients had neoantigen-specific responses elicited by vaccination, in some cases with evidence of epitope spread. No significant adverse side effects were reported, with only mild symptoms associated with the vaccine adjuvant.

“The step-down response curves represent a promising and previously unobserved pattern of tumor response that warrants further investigation,” said Maura Gillison, M.D., Ph.D., Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center. “It will be important to continue our assessment of GEN-009’s specific contribution to the clinical effects seen to date. We look forward to validating these results in a broader cohort to support our hypothesis that inclusion of GEN-009 in CPI regimens may lead to beneficial outcomes for patients with hard-to-treat solid cancers.”

“Our findings, which show that RECIST responses were maintained for at least three months in three of the five patients evaluated, underscore the potential of GEN-009 to boost CPI regimens in hard to treat patients,” said Thomas Davis, M.D., Chief Medical Officer of Genocea. “We believe that the path forward to designing better immunotherapies is powered by ATLAS. These results build further confidence that we are indeed targeting relevant tumor antigens for inclusion in our GEN-009 vaccine.”

The company expects to share additional immunogenicity and clinical data from the remaining 10 Part B patients later this year.

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 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. 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 are the latest results from Genocea's GEN-009 trial?

The latest results revealed 100% immune response to neoantigens and tumor reduction in three patients, indicating potential efficacy when combined with PD-1 inhibitors.

When was the data on GEN-009 presented?

The data was presented on September 17, 2020, during the ESMO Virtual Congress.

What is the significance of the new findings for GNCA shareholders?

The findings suggest that GEN-009 may enhance the effectiveness of existing cancer therapies, potentially leading to market opportunities and improved patient outcomes.

How does GEN-009 work in treating cancers?

GEN-009 is a neoantigen vaccine designed to trigger immune responses against tumor-specific antigens, which may work effectively alongside PD-1 inhibitors.

What are the next steps for the GEN-009 trial?

Genocea plans to share additional clinical data from the remaining patients in Part B of the trial later this year.