KISIMA-01 Investigates the Safety of ATP128 With or Without Ezabenlimab in CRC

Scott Kopetz, MD, PhD, FACP, professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, explains the purpose of the phase 1b KISIMA-01 study of the ATP128 vaccine used with or without with or without ezabenlimab (BI 754091)to treat patients with advanced colorectal cancer (CRC).

KISIMA-01 is an open-label, multicenter, non-randomized, dose-confirmation, and cohort-expansion phase 1b study exploring the safety, tolerability, and preliminary anti-tumor activity of ATP128 in stage IV CRC. The study will include approximately 32 patients, and cancer centers in California, New York. North Carolina, and Texas are actively recruiting.

Preliminary results from the KISIMA-01 study were presented by Kopetz during the ESMO World Congress of Gastrointestinal Cancer 2021.

Transcription:

0:07 | This study is based on an understanding that colorectal cancer is a tumor type that does not have a robust immune response, in most cases, meaning that there's not preformed T cells that have antigen recognition against the tumor. So, we really have to think about clinical strategies that result in generation of a new T-cell response. And classically, this has included use of vaccine strategies. So, the approach which is the based on preclinical data demonstrating that that vaccination with the KISIMAconstructs can result in efficacy in murine models of colorectal cancer and can be augmented by in PD-1 blockade, the combination is more effective than either component alone, and can really provide a signal that we're following up now in the clinical trials.

1:24 | The recognition of a tumor antigen by vaccine really requires a mechanism delivery of the antigen and a robust mechanism to stimulate the immune response to generate that T cell. And so, the KISIMA platform utilizes self-adjuvant that includes toll-like receptor strategies and other approaches that really augment that innate response to the to the, to the vaccine strategy. So, it's a combination that were encouraged. That is providing good rationale for benefit for colorectal cancer patients. And we're selecting antigens that are that are highly expressed in colorectal cancer. In the KISIMA platform, there's three antigens that are highly expressed in colorectal cancer providing multiple shots on goal and a off the shelf vaccine strategy.

2:40 | The study is a safety study that utilized doses of the vaccine alone and then also with the addition of PD-1 inhibitor as well. The primary endpoints of this was safety bleed in and this study design indeed demonstrated that the combination was safe, very low rates of any associated toxicity and demonstrated that this platform could be used to mount immune response the design was also very heavily influenced by the need for translational endpoints to really understand how are we generating an immune response not only peripherally but also in the tumor itself and so utilization of paired biopsies in addition to peripheral monitoring.