HOOKIPA announces positive preliminary Phase 1 immunogenicity data for its immunotherapy candidates to treat advanced HPV16+ cancers - Seite 2
In addition, analysis of the antigen-specific T cell response showed an increase in CD8+ T cells specific to HPV16+ cancer after a single dose of HB-201 (baseline 0% to 2.8% two weeks later) and HB-202 (baseline 0% to 8.1% two weeks later). These data were assessed using intracellular cytokine staining (ICS) followed by flow cytometry, which differentiates antigen-specific CD8+ T cells (cytotoxic/killer T cells) from antigen-specific CD4+ T cells (helper T cells). Of note, the HPV16+ cancer patients included in this analysis had negligible levels of antigen-specific CD8+ T cells prior to treatment with HB-201 or HB-202.
Other preliminary immunogenicity data highlight immune system activation following a single dose of HB-201. Blood samples from 12 patients were assessed across 13 timepoints for levels of 30 different cytokines and chemokines, which play critical roles in activating an immune response. At the time of data cut-off, baseline and day 4 samples were available for 9 of the 12 patients. The analysis showed that, 4 days after a single dose of HB-201, interferon-gamma levels increased in 90% of patients, and an increase in other immune stimulatory cytokines and chemokines was observed. These data comprise an early sign of natural killer (NK) cell and/or T cell activation by HB-201.
“Treatment options are limited for people with metastatic HPV16+ cancers, and the likelihood for long-term survival is low,” said Dmitriy Zamarin, MD, PhD, Translational Research Director in Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center and co-investigator in this study. “We don’t often see this robust and high-quality immune response, particularly in antigen-specific CD8+ T cells, from a single dose and without any combination therapy. I’m excited to see how these early immunogenicity data may translate to clinical outcomes in the future.”
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These preliminary immunogenicity data reinforce the promising anti-tumor activity reported from this trial in December 2020 and are consistent with recently published preclinical data, which showed that intravenous HB-201 administration induced single digit percentage of antigen-specific CD8+ T cells, while alternating administration of HB-201 and HB-202 induced a potent CD8+ T cell response, exceeding 50% of the circulating T cell pool. As the HB-201/HB-202 clinical trial is ongoing, HOOKIPA expects to present additional translational and clinical data at upcoming medical conferences in 2021. The company anticipates these data to further inform the HPV program, as well as other earlier stage programs in its oncology pipeline, including therapeutics for prostate cancer, as it seeks to deliver transformational therapies through induction of antigen-specific CD8+ T cells. The poster and audio review are available at https://ir.hookipapharma.com/events/event-details/aacr-annual-meeting- ....