Versamune® is a proprietary T-cell activating platform technology designed to train the immune system to better protect and fight against disease. Versamune® delivers both a protective disease-specific antibody and powerful curative killer T-cell response with minimal side effects and is engineered for simplicity and ease of administration.
Versamune®, when combined with antigens tailored for specific diseases, is demonstrated to:
Induce disease targeting T-cells, including a highly potent type of T-cell called a killer T-cell, that is targeted to fight against disease
Promote a large quantity of antigen-specific antibodies and T-cells, tailored to protect against the disease
Deliver a powerful immune response associated with both curative and preventative efficacy
Deliver efficacy with minimal side effects – to date limited to transient injection site reactions without triggering more severe systemic side effects
Substantially improve the activity of a proven cancer-fighting technology – e.g. checkpoint inhibiters - when administered in combination with Versamune®
Mechanism of Action
The Versamune® platform is comprised of structure specific positively charged (cationic) lipids with custom-designed antigens for different types of disease. These combinations, delivered via simple subcutaneous injection, have proven to stimulate the activation of immunologic pathways associated with increased disease-fighting activity.
Versamune® is based on the R-enantiomer of 1,2-dioleoyl-e-trimethyl-ammonium-propane (R-DOTAP), a cationic lipid. The lipid spontaneously assembles into nanoparticles in a water-based medium and is sized to mimic an artificial virus. This promotes efficient uptake by dendritic cells. Versamune® has been demonstrated to induce neutralizing antibodies in response to the protein and promote cross-presentation of the antigen to both CD4+ helper and CD8+ killer T-cells. Versamune® has also been proven to activate the Type I Interferon pathway, leading to superior recruitment and priming of highly potent, polyfunctional, T-cells.
Versamune® has been shown to induce a significantly higher quantity and quality of highly potent (polyfunctional) killer T-cells, a specific sub-type of killer T-cell that is more powerful at attacking disease.
This superior quantity and quality of antigen-specific killer T-cells generated by Versamune® results in more effective cancer treatments when compared to other technologies. Versamune®-based products demonstrate impressive efficacy when used alone in specific types of cancer. However, when the powerful immune response of Versamune® is added to proven checkpoint inhibitor therapies, which help “unmask” cancer tumors, the two technologies have been demonstrated in early studies to work synergistically to attack and destroy cancer cells more effectively than either alone.
The ability of Versamune® to induce strong antibody responses in addition to high levels of highly functional killer and memory T-cells presents a unique opportunity to develop a new class of more effective preventive vaccines.
Versamune® offers a favorable safety profile:
- Side effects limited predominantly to transient injection site reactions
- No dose limiting side effects observed to date
- No long-term safety concerns
- Versamune® avoids potentially systemic toxicities associated with most other cancer fighting technologies, such as chemotherapies, CAR-T cells, live vector-based vaccines and other immuno-oncology agents. The safety profile of Versamune®-based products offers great potential for combination with both proven and new cancer therapies.
Versamune® is engineered for simplicity and ease of administration. Versamune® is delivered together with proprietary antigens tailored for specific diseases . The formulation is injected subcutaneously.
Ease of Manufacturing
Versamune®-based cancer immunotherapies and vaccines are easily manufactured and highly stable.
PDS Biotech’s currently holds several patents in major markets, including US, Europe and Japan, providing multiple layers of technology and product protection through at least the mid-2030s.