First Patient Dosed in Trial of GEN-011 for Treating Solid Tumors


The TiTAN-1 clinical trial is assessing the effect of GEN-011 on melanoma and various types of carcinomas.

This content originally appeared on our sister site, Targeted Oncology.

The first patient has been dosed in the TiTAN-1 clinical trial (NCT04596033) according to Genocea Biosciences. The trial is evaluating safety, tolerability, and efficacy of GEN-001, a next-generation neoantigen adoptive cell therapy, on solid tumors.

“Dosing the first patient with GEN-011 represents an exciting milestone for Genocea and the field of neoantigen-targeted T cell therapy,” said Thomas Davis, MD, chief medical officer, Genocea, in a statement.

GEN-011 is made up of CD4+ and CD8+, which are NPTs that are specific for up to 20 antigens designed to limit tumor escape. The agents have minimal non-tumor-specific bystander cells, and do not contain Inhibigen-specific cells that may be detrimental to clinical response.

The TiTAN-1 clinical trial is a phase 1/2a open-label study that has an estimated enrollment of 24 patients and an estimated completion date of May 2024. The primary end point of the study is the incidence of treatment-emergent adverse events (AEs), up to 2 years after first GEN-011 infusion. Secondary end points include T cell response to GEN-011, duration of response up to 2 years after first infusion, progression-free survival up to 2 years after first infusion, and overall survival from at least 2 years after first GEN-011 infusion. Other end points include immune cell phenotyping, epitope spread, and tumor-infiltrating immune cells.

The solid tumors being assessed in the study include melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, small cell lung cancer, cutaneous squamous cell carcinoma, or anal squamous cell carcinoma.

READ MORE: CAR-NK Cells Show Potential in Solid Tumor Immunotherapy

During the study, patients will be enrolled into 1 of 2 treatment arms. In arm 1, patients will receive multiple low doses of GEN-011, up to 5 doses maximum. Each dose will be followed by the administration of interleukin-2 (IL-2) as a costimulatory therapy. Patients in this arm will not undergo lymphodepletion. In arm 2, patients will receive a single high-dose of GEN-011 at the maximum available cell yield. This will be completed after the patient had undergone a ludarabine/cyclophosphamide lymphodepletion regimen. The single dose of GEN-011 will be followed by IL-2 administration.

In order to participate in the study, patients must have a diagnosis of one of the accepted solid tumors, have received and been intolerant of or ineligible to receive the standard of care treatment regimen, have measurable disease per RECIST criteria, a life expectancy of greater than 6 months, have an ECOG status of 0 or 1, have the capacity to tolerate lymphodepletion and IL-2 therapy, and have adequate blood, liver, kidney, and lung function. Patients receiving immunosuppressive medications, have serious ongoing viral, bacterial, or fungal infections, have a history of cardiac arrythmias or a significant heart block, a history of leptomeningeal carcinomatosis, an active autoimmune disease, portal vein thrombosis, malignant disease, receiving other investigation anti-cancer therapy, prior stem cell or solid organ transplant, primary immune deficiency disease, or significant ongoing toxicities from prior therapy are not eligible to participate.

“We believe our GEN-011 therapy employs better targeting – using our ATLAS™ platform to select optimal neoantigen targets that drive anti-tumor immune responses and avoid immunosuppressive Inhibigens™ - and better T cells, derived from easily accessible peripheral blood as opposed to the tumor itself.”

The study is currently recruiting patients at Banner MD Anderson Cancer Center in Arizona, Sarah Cannon Research Institute in Tennessee, and MD Anderson Cancer Center in Texas.

Genocea doses first patient in phase 1/2a TiTAN clinical trial for GEN-011 neoantigen-targeted T cell therapy. News release. Genocea. July 13, 2021. Accessed July 13, 2021.
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