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Genocea Biosciences (NASDAQ: GNCA) announced the presentation of incremental follow-up data from its GEN-009 Phase 1/2a trial at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, taking place from September 19-21. This includes additional tumor scan results and detailed immunogenicity data from the first five patients in Part B of the trial. Further data from the remaining ten patients is expected later this year. Additionally, CEO Chip Clark will present at the Baird Global Healthcare Conference on September 10 and the H.C. Wainwright Conference on September 15.
Genocea Biosciences (NASDAQ: GNCA) announced significant developments in its cancer immunotherapy programs. A clinical data update on GEN-009 is scheduled for July 30, showing promising initial results, with seven of eight patients in Part A of the trial without disease progression at one year. The company filed an IND for GEN-011 but is currently on clinical hold pending FDA information. A private placement raised $80 million, while cash reserves decreased to $22.1 million by Q2 2020. R&D and G&A expenses increased, contributing to a net loss of $11.3 million for the quarter.
Genocea Biosciences (NASDAQ:GNCA) announced a private placement to raise approximately $80 million through the sale of 21.4 million shares and 12.2 million pre-funded warrants. The offering, led by a public investment fund specializing in life sciences, will be used to fund clinical development of its neoantigen vaccine GEN-009 and cell therapy GEN-011. The warrants have an exercise price of $2.25 per share and will be exercisable upon issuance. Closing is expected by July 24, 2020, subject to customary conditions.
Genocea Biosciences (NASDAQ: GNCA) provided updates on its clinical programs, focusing on the neoantigen vaccine GEN-009 and cell therapy GEN-011. Initial clinical data for GEN-009 will be shared on July 30, 2020, from a Phase 1/2a trial involving advanced solid tumors. Meanwhile, GEN-011's Investigational New Drug Application is on hold pending additional information requested by the FDA regarding third-party reagents. The company aims to resolve the hold promptly and continues to progress with its ATLAS-enabled immunotherapy initiatives.
Genocea Biosciences (NASDAQ: GNCA) will host a conference call on July 23, 2020, at 8:30 a.m. EDT to discuss its Q2 2020 financial results and corporate updates. Interested participants can join by calling (844) 826-0619 (domestic) or (315) 625-6883 (international) with conference ID 8894505, or through a live audio webcast available on their website. Genocea focuses on developing neoantigen immunotherapies for cancer, with its ATLAS platform enhancing the targeting of tumor antigens. The company is advancing two clinical programs, GEN-009 and GEN-011, with preliminary results expected in Q3 2020 and mid-2021, respectively.
Genocea Biosciences (NASDAQ: GNCA) presented critical preclinical data on inhibitory neoantigens (Inhibigens) at the AACR Virtual Annual Meeting on June 22, 2020. The findings reveal that Inhibigens can disrupt anti-tumor immunity, resulting in tumor hyperprogression and diminished T cell function. The study demonstrated that immunization with Inhibigens leads to an immune-suppressive tumor microenvironment, impairing the efficacy of immunotherapy. This research underscores the necessity of excluding Inhibigens from cancer treatment designs to improve patient outcomes.
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.
Genocea Biosciences (NASDAQ: GNCA) reports encouraging outcomes from Part A of its Phase 1/2a trial for GEN-009, a neoantigen vaccine. After a median follow-up of one year, 7 out of 8 patients showed no disease progression. The study highlights the vaccine's capability to generate broad T cell responses, with immunity lasting up to 6 months post-vaccination. No significant side effects were noted. The findings will be presented at the 2020 ASCO Annual Meeting, scheduled for May 29-31, 2020.
Genocea Biosciences (NASDAQ: GNCA) hosted a KOL symposium on May 12, 2020, featuring Dr. Eric Tran. The company presented data highlighting its neoantigen cell therapy, GEN-011, which combines the benefits of TIL therapy while addressing its limitations. Using the ATLAS™ platform, GEN-011 targets up to 30 neoantigens with enhanced T cell activity. Aiming for an IND filing in Q2 2020, Genocea anticipates initial clinical data in early 2021. The company’s mission focuses on delivering personalized cancer immunotherapies, utilizing patient-specific T cell profiles to optimize treatment.
Genocea Biosciences (NASDAQ: GNCA) will host a KOL symposium on May 12, 2020, at 12:00 p.m. EDT, focusing on T cell therapy advancements and their product GEN-011. This therapy aims to enhance TIL therapy using the proprietary ATLAS™ platform, promising superior efficacy with long-lasting T cells. The event will feature Dr. Eric Tran discussing the evolution of tumor treatment. Genocea plans to file for an IND in Q2 2020 and expects initial clinical data by mid-2021. The webcast will be accessible on their website.
