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The concept of using targeted oncolytic viruses for cancer has been around for several decades. Tremendous progress in our understanding of cancer and viruses, combined with breakthroughs in DNA engineering, has enabled Jennerex to engineer our oncolytic virus therapies to achieve maximum safety and efficacy, and this is now being borne out in human clinical trials. Targeted oncolytic poxviruses for cancer hold significant commercial and medical potential and represent a breakthrough technology for cancer. The primary reasons are their enhanced tolerability and efficacy versus currently available treatments such as chemotherapy. First, these products are highly selective for cancer and therefore have minimal side effects (flu-like symptoms). In addition, their efficacy is driven by three, novel mechanisms of action: 1) the lysis of cancer cells through viral replication, 2) the reduction of the blood supply to tumors through vascular targeting and destruction, and 3) the stimulation of the body's immune response against cancer cells, i.e., active immunotherapy. Of note, these mechanisms are non-cross resistant with other approved available therapies. Therefore, these products have the potential to treat tumors that have failed all other available therapies. In addition, given their novel mechanisms of action, these products can also be combined with other complementary therapies in order to get patients the best aspects of each product.
Despite clear safety and localized efficacy in clinical trials with oncolytic viruses, the major hurdle that had not previously been overcome was the ability to deliver these products intravenously in order to achieve systemic efficacy. In August 2011, we published clinical data in the journal, Nature, proving the ability of JX-594 to be delivered intravenously to tumors effectively and safely. This hurdle has therefore been overcome; we see this historic achievement as a significant milestone for this product class. Importantly, normal tissues were not significantly affected clinically, underscoring the designed selectivity of JX-594 for malignant tissue and safety of the product.
Why Pox Viruses?
Targeted oncolytic poxviruses, or vaccinia viruses, hold significant commercial and medical potential and represent a breakthrough technology for cancer. The main reasons are their enhanced tolerability and efficacy. These products are highly selective for cancer and therefore have minimal side effects, which are limited to flu-like symptoms. The poxvirus strain backbone of JX-594 has been used safely in millions of people as part of a worldwide vaccination program. In addition, the biology of pox viruses makes them ideal nanotech therapeutics to attack cancer. Features include 1) rapid and motile spread in tumors (increased potency), 2) intravenous stability and delivery to solid tumors, 3) therapeutic transgene-arming capacity, and 4) antidotes are available (to maximize safety).
In addition, the oncolytic poxviruses are equipped with multiple mechanisms of action for targeting, attacking and eradicating cancer cells. Oncolytic poxviruses can not only vaccinate the patient against their cancer and induce an anti-tumor immune response, but in addition, can cause acute tumor lysis and debulking through viral replication and cell destruction plus additional mechanisms of action including disruption of the vasculature to the tumor. Upon entry into tumor cells, vaccinia replicates rapidly and efficiently. Infectious virions are released as early as six hours after tumor cell infiltration, and tumor cell destruction occurs in approximately 24 hours, with up to 10,000 particles released upon cell lysis. Spread within tumors and to distant metastases is possible because poxviruses produce particles that are optimized for either rapid cell-to-cell spread within the tumor, or for long-range travel to remote tumors.
In summary, Jennerex has capitalized on the natural attributes of poxviruses and the historical body of work on vaccinia viruses to create safe therapeutic viruses that can broadly infect tumors and lead to their eradication via rapid replication and rapid spread combined with the induction of longer-term anti-cancer immunity.
Jennerex's products are designed using the proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. SOLVE takes advantage of the natural attributes of poxviruses as well as their ability to be genetically engineered to produce safe, therapeutic viruses that can infect solid tumors both systemically and locally. These products are highly selective for tumor tissue based on several genetic signatures in cancer (including activation of the EGFR/ras and VEGFR pathways), and therefore have relatively minimal and transient side effects, which have typically been limited to acute flu-like symptoms that resolve within 24 hours of treatment. SOLVE platform has the ability to produce novel, multi-functional products, such as JX-594, that can selectively express high concentrations of complementary therapeutics. We plan to continue employing SOLVE to create new therapeutics that broadly target different types of cancers in our early-stage pipeline.
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