DNA Medicines Technology

Optimized Plasmid
Design and Delivery

INOVIO is focused on rapidly bringing to market precisely designed and delivered DNA medicines to potentially treat and protect people from a range of serious and life-threatening diseases related to HPV, cancer, and infectious diseases.

INOVIO’s first-of-their-kind DNA medicines are precisely designed DNA plasmids delivered through INOVIO’s unique smart device directly into the body’s cells to produce an immune response robust enough to potentially treat and prevent disease.

PRECISELY DESIGNED PLASMIDS (SynCon^®)

INOVIO’s DNA medicines are made using a process called SynCon^®. SynCon uses a proprietary computer algorithm that has been designed to identify and optimize the DNA sequence of the target antigen, whether it is a virus or a tumor. Once this sequence has been determined, the DNA is synthesized or reorganized, and manufacturing can begin.

PROPRIETARY SMART DEVICES (CELLECTRA^®)

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using one of INOVIO’s proprietary hand-held CELLECTRA^® smart devices. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. INOVIO has employed its CELLECTRA^®2000 smart delivery device for over a decade in more than 40 oncology and infectious disease clinical trials, including those for COVID-19 disease. For intramuscular delivery, INOVIO uses its CELLECTRA 5PSP in its Phase 3 clinical trial for VGX-3100. INOVIO is developing its next-generation CELLECTRA 3PSP for intradermal delivery.

IN VIVO

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using one of INOVIO’s proprietary hand-held CELLECTRA smart devices. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune response. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive an immune response.

DNA MEDICINES EXPLAINED

TECHNOLOGY ADVANTAGES

The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response and tolerability that have been demonstrated in clinical trials.

With more than 2,000 patients receiving INOVIO DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates to meet urgent health needs.

CLINICAL EFFICACY

Demonstrated clinical efficacy in Phase 2b study
Lead candidate in Phase 3 evaluation for precancerous cervical dysplasia

SAFETY

Favorable safety profile tested in over 2,000 patients and over 7,000 administrations
Carries no potential toxicity from plasmid vector

RAPID AND SCALABLE MANUFACTURING

“Off-the-shelf” product; no frozen storage issues (room temp storage >1 yr.)
Rapid development from concept to human in less than 3 months (COVID-19 vaccine)
Relatively inexpensive to manufacture, produce large quantities

VERSATILITY AND BOOSTING

Targets virtually any antigenic sequence; combining multi-antigens into single vial
Initiated first-in-human study of optimized dMAb^™ plasmid
No anti-vector response — allows for effective boosting

PIONEERING
dMAb™ SCIENCE

Monoclonal antibodies (mAbs) have become one of the most valuable therapeutic technologies of recent years and are designed to enhance the immune system’s ability to regulate cell functions. However, mAb technology has limitations including costly large-scale laboratory development and production, limited duration of in vivo potency, and a pharmacokinetic profile that can result in toxicity.

INOVIO has created DNA-encoded monoclonal antibodies (dMAbs) that we believe overcome many of the limitations associated with conventional mAb technology:

Using our core DNA medicines technology, we encode the DNA sequence for a specific monoclonal antibody in a DNA plasmid. We deliver the plasmid directly into cells of the body using our CELLECTRAdevice, enabling these cells to manufacture the mAbs in vivo – unlike conventional mAb technology that requires manufacture outside of the body.
This approach provides potentially significant advantages in terms of lower production costs, as well as the ability to target a pharmacokinetic profile that provides control in terms of dosing regimen, peak responses, duration of responses, and toxicity.
Additional potential advantages include faster and easier engineering and construction of the newest mAb-related biologics, such as bispecific T cell engagers (BiTEs), bispecific and trispecific killer cell engagers (BiKEs and TRiKEs), and dual-affinity re-targeting antibodies (DARTs), as well as many others.

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