Etubics Gene Delivery Platform
The Etubics Platform is an “active immunotherapy” which induces a long lasting cell-mediated immune (CMI) response whereas the other treatments, such as monoclonal antibodies, are “passive agents” acting only when the drug is present. An active immunotherapy is the process by which an agent, like the Etubics Platform, is administered to a patient with the objective of activating a broad spectrum natural immunity to a tumor associated antigen such as carcinoembryonic antigen (CEA) on mCRC. Active immunotherapy is designed to have long lasting anti-tumor effects and may only need to be administered through one course of treatment and perhaps a boost later. It is important to recognize that active immunotherapy may take weeks or months to realize the full effects, but it can extend survival longer than many other treatments for certain cancers. We believe the Etubics Platform has solved the safety and efficacy limitations of many currently available immunotherapeutics by modifying its novel adenovirus drug delivery platform to make it more “stealth” to the immune system.
Earlier generation adenovirus vectors create a large amount of undesired dominate immune targets against the platform itself which causes antibodies and killer T-cells to attack the vector vaccine itself, and quickly clears it from the body before it can have an immunizing effect. In contrast, the Etubics Platform has extensive genetic deletions which results in a dramatic reduction of production of these undesired dominant immune targets and allowing for a robust expression of the desired protein (gene), which educates T-cells to launch a strong attack against the targeted disease.
The Etubics Platform has the following key features:
- Significant reduction of unwanted Platform antigens. It has been reported that the unique deletions in the E2b region of the Etubics Platform vector platform have been shown to result in a dramatic decrease of late adenovirus gene expression, such as fiber. This reduction of Ad5 viral protein expression has been reported to result in a marked reduction in host inflammatory responses to the vector. Human cells harboring the Etubics Platform vector have been shown to have increased duration of transgene expression in vivo compared to other vector platforms. The reduction of Ad5 viral expression permits cells carrying the Etubics Platform to evade immune recognition and are not readily detected and destroyed by a host immune system.
- Well-Tolerated in prior clinical and pre-clinical studies and Thoroughly Studied. To date, no serious adverse events have been seen in our human metastatic colorectal cancer Phase 1/2 clinical trials. In addition, no adverse events have been seen in animal models including mice, ferrets, and non-human primates (monkeys). The extensive genetic deletions in the Etubics Platform allow for an increased safety profile. These deletions inhibit the replication (growth) of the adenovirus vector, thereby reducing the amount of capsid proteins produced. This vector capsid is what has historically caused the unwanted immunologic reactions against the product itself.
- Simple to use injectables. The Etubics Platform is delivered through a standard needle through a subcutaneous (under the skin) injection, making it easy for physicians and nurses to deliver the product. Once the patient is injected with the product, they can leave after a 30 minute observation period.
- Effective in the Presence of Pre-Existing and Contaminant Vector Immunity. The Etubics Platform delivers a robust CMI response, even in individuals that are already immune to an adenovirus. This enables a patient or vaccine to receive multiple treatments to either boost a CMI response and/or create a CMI response against multiple diseases. This is necessary for the treatment of diseases like cancer.
- Rapid Development.
The molecular structure of the Etubics Platform vector remains consistent across all product candidates while different therapeutic gene targets are inserted. This dynamic enables Etubics to create a product candidate and begin pre-clinical evaluations within three months from the identification of the disease associated gene. This capability greatly reduces the cost of research and development as well as time to market.