Patient selection for the two programs is distinct. We expect to file an IND for this program in 2022. In the fourth quarter of 2020, we advanced into Phase 2 expansion cohorts. The IND has been approved, and volunteer subjects enrollment will start imminently. We are now using EDGE to identify novel classes of tumor antigens across our programs. &# We may seek to partner within this program for solid tumor-specific targets. &# The Gates Foundation is supporting the preclinical evaluation of the vaccine candidate. The New England Journal of Medicine (2014); Rizvi et al., The two steps of our EDGE platform prediction process are shown in Figure 2 below. This fraction may be as low as approximately 1-2% of all mutations. First, we assessed the ability of the EDGE model to predict HLA presented peptides. The internal programs are described in more detail below. " KRAS mutations are also common in lung and pancreatic cancers. The vector system and its associated pre-clinical data are described below. The boost is a self-amplifying mRNA, or SAM, formulated in a lipid nanoparticle ("LNP"). No dose-limiting toxicities were observed as of December 31, 2020. A summary of demographics and safety observations are presented below in Table 2. Enrolled patients were aged 38 to 76 years (mean 59 years). Bispecific antibody was added at various concentrations. The last-to-expire patent is currently scheduled to expire on November 10, 2030. In addition, we plan to establish automated, closed-platform manufacturing processes. Orphan drug designation must be requested before submitting a BLA. SLATE Regulatory Milestones The FDA cleared our IND for SLATE in June 2019. Investors should not rely on our past results as an indication of our future performance. Failure or delay can occur at any time during the clinical trial process. We currently have no sales organization. Our business may be adversely affected by the ongoing COVID-19 pandemic. In particular, any disruption of our suppliers could impact our operating results. This may impact the integrity of subject data. &# Our opposition was filed in the company's name on November 7, 2016 by Vossius & Partner. Competitors may infringe our intellectual property rights or those of our licensors. Such a loss of patent protection would have a material adverse impact on our business. The FDA has broad discretion whether or not to grant this designation.
