CAMBRIDGE, Mass., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today provided a business update for the fourth quarter ended December 31, 2020 and other recent significant developments.

“We are extremely pleased to make progress across multiple fronts by using ATLAS’ unique ability to find the most relevant targets of T cell responses,” said Chip Clark, Genocea President and Chief Executive Officer. “As we advance GEN-009 and GEN-011, our scientific team continues to refine and explore the implications of our pioneering antigen discovery work in multiple disease settings. Included in this is the work we have underway to identify antigens of T cell responses to SARS-CoV-2 (COVID-19), which may prove pivotal to stemming the course of this deadly virus. We are looking forward to continuing this momentum in 2021."

Clinical updates
GEN-011 Phase 1/2a clinical trial (TITAN trial)

• GEN-011 is a neoantigen-targeted peripheral T cell therapy (NPT therapy) in development to treat checkpoint inhibitor-refractory patients. Our phase 1/2a study, the TITAN trial, is designed to explore safety, biomarkers of activity and anti-tumor efficacy. Genocea has initiated the first two of multiple planned clinical sites and is accruing patients. The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022.

GEN-009 Phase 1/2a clinical trial

• At the 2020 Society for Immunotherapy of Cancer (SITC) annual meeting in November, the Company shared expanded clinical and immunogenicity findings for GEN-009, its adjuvanted peptide neoantigen vaccine. Of the nine CPI-sensitive patients, three patients experienced a novel reduction in tumor volume and achieved independent RECIST responses post-GEN-009 dosing, including 2 PRs and 1 CR. Five additional CPI-sensitive patients have shown disease control post-vaccination for up to 11 months. Within the CPI-resistant population, five of seven patients appear to have stabilized disease lasting up to seven months. GEN-009 elicited strong anti-tumor CD4⁺ and CD8⁺ T cell responses. Genocea expects to provide additional clinical and immunogenicity data from these patients in Q2.

Research updates
Publication in Cancer Discovery

• In January, Genocea’s paper, “An empirical antigen selection method identifies neoantigens that either elicit broad anti-tumor T cell responses or drive tumor growth,” was published in Cancer Discovery. The paper confirms that ATLAS zeroes in on tumor mutations that are either neoantigens that activate anti-tumor responses or inhibitory antigens (Inhibigens) that are targets of pro-tumor responses, in both CD8+ (killer) and CD4+ (helper) T cells. This breakthrough potentially improves neoantigen immunotherapies by ensuring they both target the right neoantigens and exclude Inhibigens.

SARS-CoV-2 T cell antigen discovery program

• Genocea has a research program to identify conserved antigens of protective T cell responses to SARS-CoV-2. This builds on earlier Genocea work in infectious disease, in which it demonstrated – across multiple pathogens – that novel antigens of protective T cell responses are often not immunodominant antigens of antibody responses. If true with SARS-CoV-2, this would suggest that vaccines focusing on the Spike protein may have limited long-term utility against emergent hyper-virulent strains. As part of this program, Genocea has entered into a collaboration with the University of Massachusetts Medical School’s Dr. Robert Finberg, Distinguished Professor of Medicine and leading infectious diseases expert. Pairing ATLAS with Dr. Finberg’s expertise in infectious diseases may enable a better understanding of the role of T cells, including responses to Inhibigens, in the severity and duration of symptoms.

Collaboration with the University of Minnesota

• Genocea and the University of Minnesota’s Dr. Ingunn Stromnes, an expert on immuno-oncology and T cell engineering, entered into a collaboration to explore Inhibigen biology and develop TCRs targeting Genocea’s proprietary shared neoantigens.

Other business updates

Strengthened executive leadership team

• Genocea appointed Raymond D. Stapleton, Jr., Ph.D. as Executive Vice President of Pharmaceutical Sciences and Manufacturing. Ray brings 20+ years of industry experience having led technical, quality and manufacturing operations at commercial and clinical stage biopharmaceutical companies.

Financial and other updatesFourth quarter 2020 financial results

• Cash position: As of December 31, 2020, cash and cash equivalents were $79.8 million compared to $40.1 million as of December 31, 2019.
• Research and Development (R&D) expenses: R&D expenses were $7.8 million for the quarter ended December 31, 2020, compared to $6.8 million for the same period in 2019.
• General and Administrative (G&A) expenses: G&A expenses were $3.9 million for the quarter ended December 31, 2020, compared to $3.0 million for the same period in 2019.
• Net loss: Net loss was $15.0 million for the quarter ended December 31, 2020, compared to $9.4 million for the same period in 2019.

Guidance

• Genocea’s operating plan extends its cash runway to the end of 2022.

About Genocea Biosciences, Inc.

Genocea’s mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our proprietary ATLAS™ platform comprehensively profiles each patient’s T cell responses to potential targets, or antigens, on that patient’s tumor. ATLAS uniquely zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens^TM, that drive pro-tumor immune responses. 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 adoptive T cell therapy using neoantigen-targeted peripheral cells for which we are commencing a Phase 1/2a clinical trial. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in identifying meaningful therapies. To learn more, please visit https://www.genocea.com.