Genocea Biosciences, Inc. GNCA announced that the FDA accepted its investigational new drug (“IND”) application for its neoantigen-specific cell therapy candidate, GEN-011. The acceptance of the IND application will allow the company to initiate a phase I/IIa study, which will evaluate GEN-011 in certain cancer patients who have failed standard-of-care checkpoint inhibitor therapy.

The company plans to enroll 24 patients across several tumor types in two cohorts to evaluate safety, T cell proliferation and persistence as well as clinical activity of GEN-011. Patients in one cohort of the study will be administered multiple low doses of GEN-011 with low-dose IL-2 and without lymphodepletion. In the other cohort, patients will be administered a single GEN-011 dose after lymphodepletion and a high dose of IL-2.

Please note that the FDA had placed the IND for GEN-011 under clinical hold in July due to requirement of additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process.

Genocea’s shares have gained 5.6% on Sep 22 following the news. Shares of the company have increased 18.4% so far this year against the industry’s decrease of 7.5%.

Genocea is focused on developing personalized cancer immunotherapies in multiple tumor types designed to improve upon the limitations of tumor-infiltrating lymphocytes (“TIL”) and T Cell Receptor (“TCR”) therapies, using its unique ATLAS platform. The company believes that GEN-011 has the potential to offer efficacy, accessibility and cost advantages to patients.

Apart from GEN-011, the company is currently developing another ATLAS-enabled program, GEN-009, which is a neoantigen vaccine, in a two-part phase I/IIa study. The study is evaluating combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors. Data from the Part A of the study, presented in July, showed that at one-year of median follow-up seven out of eight patients treated with GEN-009 were without disease progression. Preliminary data from five patients in Part B of the study, presented in July, demonstrated that two of the first five patients achieved complete response and three experienced partial response. Additional immunogenicity and clinical data from the remaining 10 patients in the Part B is expected to announced later this year.

Based on these data, the company believes that addition of GEN-009 to standard-of-care immunotherapy regimens will likely boost the effectiveness of immune checkpoint inhibitor therapy in patients with advanced disease.