Pipeline
We are developing a differentiated portfolio of ONCoat™ -based, synthetic vector-based immunotherapeutics that enable us to pursue multiple tumor types with the potential to improve outcomes for a wide range cancer patients.
PIPELINE ROADMAP
Key Product Characteristics of Devacell’s Product Pipeline
- Combines multiple transgenes, each intended to activate and enhance a patient’s immune response.
- Well known immunotherapy agent with established biological pathways and efficacy data from human clinical trials: IL-12, IL-15, PD-1, PD-L1, CTLA-4, TGF-b, OX40, CD40, 4-1BB, and other signaling pathway targets.
- Synthetic vector based on the adenovirus, subtype 5 (Ad5), produces potent tumor cell killing, tumor-antigen spread, and activation and enhancement of innate and adaptive immune response (immunogenic cell death), enabling a more durable, long-lasting response and protection against tumor recurrence.
- Synergistic use of multiple transgenes activates and enhances multiples arms of the immune system
- Tumor cell targeted and localized transgene expression designed to reduce systemic toxicity
- Fully replication-competent synthetic vector designed to maximize tumor cell killing
- Systemic delivery, with repeat administration enables multiple therapeutic interventions that may be necessary to eradicate metastatic cancers.
ABOUT DEVA-OV1
Our lead synthetic vector-based product candidate, DEVA-OV1, currently in IND-enabling studies and expected to enter human clinical trials in 2022, is engineered to activate and enhance a potent immune response, designed to synergistically harness the power of a patient’s own immune system to product a comprehensive anti-tumor response. This targeted, anti-tumor response is designed to directly kill cancer cells (direct oncolysis), the direct tumor cell killing produces tumor-cell-specific antigens that activate and enhance a patient’s own innate and adaptive immune response through a mechanism know as immunogenic cell death. This immune system response produces a more durable, longer-lasting response that establishes anti-tumor memory, to reduce the risk of recurrence. In addition to the unique oncolytic activity of our synthetic vectors, DEVA-OV1 has been engineered to include multiple transgenes to further activate and enhance the immune response.
In addition to DEVA-OV1, we have in development a product portfolio that include multiple transgene combinations that are specifically engineered to the unique needs of multiple tumor types.
Our ONCoat™ Synthetic Vector Platform
Systemic, Repeat Administration of Synthetic Vector-Based Immunotherapies
The opportunity to systemically deliver via intravenous (IV) administration of our synthetic vector-based immunotherapies is a unique and highly attractive option that enables the treatment of tumors, even metastatic tumors, providing a unique, next-generation approach that offer the potential to improve patient outcomes for a wide range of tumor types.
In addition, by enabling the repeat administration of difficult to treat tumors, our synthetic vector-based immunotherapeutics offer the potential to improve outcomes for a significantly larger number of cancer patients.
We believe our unique and proprietary ONCoat™ synthetic vector platform, by enabling systemic delivery and repeat administration, will revolutionize cancer care and we are laser focus on bringing this advancement to cancer patients as rapidly as possible.
ONCoat™ – A Novel Nanoparticle-Based Synthetic Vector Platform
We have developed a novel nanoparticle-based synthetic vector platform that includes an engineered adenoviral subtype 5 (Ad5) synthetic vector, encapsulated with our novel and proprietary ONCoat™ nanoparticle-based encapsulation technology, that creates a synthetic vector that is stealth to the immune system, while allowing for retargeting to the appropriate tissue type.
Our ONCoat™ synthetic vector platform is designed to overcome multiple challenges associate with unmodified “naked” virus-based delivery, which typically results in the production of neutralizing antibodies that limit efficacy with systemically delivered viral vectors.
With the use of ONCoat™ -enabled, synthetic vectors that have been redirected to the tumor microenvironment, the synthetic vector can target cancer cells and replicate selectively in cancer cells, killing the cancer cells (direct oncolysis), spreading tumor-specific antigens and virus particles that can continue to infect and kill adjacent tumor cells, while priming the immune system through the mechanism of immunogenic cell death, recruiting an innate and adaptive immune response, activating an even more potent anti-tumor immune response (indirect oncolysis).
In addition to our lead synthetic vector-based product candidate, DEVA-OV1, our ONCoat™ synthetic vector immunotherapy product candidates are built upon our ONCoat™ synthetic vector platform and will continue to utilize novel and proprietary formulations, preclinical, clinical and manufacturing strategies, which will allow us to maintain a high level of efficiency in the development of subsequent product candidates in oncology, as well as other indications outside of oncology, including our infectious disease vaccine for SarsCoV19, DEVA-COVID19, as well as our gene therapy/gene editing applications currently in discovery research.
Our ONCoat™ synthetic vector platform product candidates offer the potential to:
- Enable systemic delivery and repeat administration
- Simultaneously treat localized, as well as metastatic tumors through intravenous delivery
- Treat cancer that have been difficult or impossible to treat with direct, intratumoral injection
Designer Encapsulated Vector Assembly