Geneos’ clinical results do not come by accident. The data validate the importance of the company's multi-year effort to optimize each and every aspect of the process of vaccination to treat cancer.
These proprietary and IP protected innovations have been integrated into its GT-EPIC™ platform for the development of uniquely personalized immunotherapies for cancer. GT-EPIC results from a holistic and ground up approach to addressing all of the opportunities and challenges of personalized therapeutic cancer vaccination and confers many therapeutic advantages embedded within our PTCVs:
- Our DNA plasmids can target upwards of 1 – 80+ neoantigens in the same patient specific formulation, allowing us to include all patient-specific targetable neoantigens for virtually all of our patients
- Rather than try to outsmart nature by selecting the best predicted neoantigens and only include them, we can include all of the targetable neoantigens and offer the immune system an opportunity to attack cancer via all of the neoantigens present
- Our patient specific neoantigen inserts and the resulting PTCVs are designed and optimized for efficient in vivo expression, processing, and presentation using proprietary and IP protected methods. This is crucial to assure that all of the neoantigens encoded in the patient-specific insert will be expressed in vivo and have the potential to drive an immune response
- Our PTCVs contain not only the neoantigen DNA but also include a second plasmid encoding the cytokine IL12 which acts as an adjuvant locally at the injection site
- Our PTCVs are administered in the periphery, intradermally, away from any potential limiting effects of tumor microenvironment. This is also the most comfortable route of administration for patients and the most convenient for providers
- PTCV administration at the injection site is further optimized via use of a proprietary in vivo electroporation (EP) device. The EP device maximizes transfection efficiency and enhances the uptake of the DNA plasmids in all cells present at the injection site including keratinocytes, dendritic cells, langerhans cells and other antigen presenting cells
- Collectively, the optimized antigenic sequences of our PTCVs, intradermal administration, pIL12, and EP all maximize the immunogenicity of our DNA plasmids and drive induction of CD4+ and CD8+ T cells (Th1 response) faster and in a higher percent of vaccinees than if they were not used; the improvement in vaccination effectiveness is marked and meaningful and we see CD4 and CD8 in all patients treated
- Our PTCVs are designed and manufactured quickly and efficiently in 6-8 weeks; we have a clear path to reduce this to less than 3-4 weeks upon commercialization, enabling PTCV treatment in most 1st line & 2nd line clinical settings
- Our PTCVs have demonstrated an unusually favorable safety profile in human clinical studies. As such, and unlike many current IO-IO combinations, they can be readily combined with existing standard of care treatments including immune checkpoint inhibitors to offer improved efficacy without worsening safety/toxicity
- Our plasmid DNA-based PTCVs are stable at 2-8C (refrigerated) over multiple years and do not need to be transported or stored frozen. Potency of the therapeutic product is not affected by the storage conditions or the freeze-thaw process
- Our PTCVs are highly patient specific and only require a small biopsy sample to identify the neoantigens and design the treatment. In particular, they do not require apheresis or large quantities of blood or other biological samples
- In the event of tumor immune escape, we can simply redesign and remanufacture an updated PTCV to resume vaccine effectiveness
Of the multiple technical solutions offered by Geneos’ GT-EPIC™ platform, the most fundamental is an ability to rapidly deploy a therapeutic construct which does not attempt to outsmart nature in presuming to preselect high value neoantigens; the neoantigen carrying capacity of the platform allows inclusion of all neos in virtually all patients, and lets nature make the call.