Our proprietary GT-EPIC™ platform integrates the multi-step personalized neoantigen identification, immunotherapy design, manufacturing, and treatment process in an efficient manner:
The integrated end-to-end Biopsy-to-Treatment turnaround time is currently at 6-8 weeks for each patient. We anticipate the timeline can be cut in half by further integration and automation of the manufacturing process chain. The rapid manufacturing timeline is a significant competitive advantage for Geneos.
We start with a patient’s tumor sample (biopsy specimen) (1) and then sequence the DNA and RNA from the patient tumors (2). We then identify all targetable neoantigens by evaluating the tumor/normal genetic information through a proprietary algorithm (3).
After selecting appropriate mutated sequences to target for each patient, we make the synthetic neoantigen DNA sequences and insert these DNA sequences into a proprietary DNA plasmid (4). Multiple neoantigen DNA sequences can be inserted into a single plasmid and multiple DNA plasmids can be combined into a patient specific formulation enabling Geneos to deliver all the targetable neoantigens simultaneously.
We manufacture the patient specific neoantigen-coding DNA plasmids under cGMP conditions using a proprietary manufacturing process (5).
The patient-specific plasmid is co-formulated with a plasmid encoding the cytokine IL-12 and administered to the patient via intradermal injection followed by in vivo electroporation (EP) using a proprietary delivery system (6) ‡
‡ Geneos has exclusively licensed the CELLECTRA® EP delivery technology and plasmid IL-12 from Inovio Pharmaceuticals
Our approach has many advantages:
We can create neoantigen-targeting immunotherapies against a wide array of cancer types
Our immunotherapies activate, in vivo, strong T-cell responses (both CD4+ and CD8+ T-cells directed at the selected neoantigens). These T-cells are vital to fighting cancerous cells
Our immunotherapies are designed and manufactured by a fast and efficient process in the timeframe of 6-8 weeks instead of over 12 weeks
We can target upwards of 1 – 100+ neoantigens in the same patient specific formulation. By aiming to include all targetable neoantigens in a patient specific product, we can attack the cancer from multiple targets and therefore potentially avoid tumor immune escape and issues with polyclonal nature of cancer
The optimized DNA-electroporation technology broadly, and GT-EPIC™ platform products specifically, have demonstrated a favorable safety profile in multiple human clinical studies. They can be readily combined with existing standard of care treatments including immune checkpoint inhibitors
Our DNA sequences do not replicate, or integrate into the genome; therefore, they are not able to cause disease
Our plasmid DNA based immunotherapies are stable at 2-8C (refrigerated) over multiple years and do not need to be transported or stored frozen
Our immunotherapies are highly patient specific and only require a small biopsy sample for the identification of the neoantigens and design of the treatment. In particular, they do not require apheresis or large quantities of blood or other biological samples from the same patient