Science

About Versamune^®

Versamune^® is a novel investigational T cell activating platform which effectively stimulates a precise immune system response to a cancer-specific protein. Versamune^® based immunotherapies promote a potent targeted T cell attack against cancers expressing the protein and are given by a simple subcutaneous injection and can be combined with standard of care treatments. Clinical data suggest Versamune^® based immunotherapies demonstrate significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. Versamune^® based immunotherapies have demonstrated minimal toxicity to date that may allow them to be safely combined with other treatments. Versamune^® based investigational immunotherapies represent a transformative treatment approach for cancer patients and provide improved efficacy, safety and tolerability.

 

Versamune^®, when combined with unique proteins or peptides that are specific to the cancer (antigens), is demonstrated to:

Induce disease targeting T-cells, including a highly potent type of T-cell called a CD8+ or killer T-cell, that is effective in attacking cancer

Promote both a large quantity and high quality of tumor-specific killer and helper T-cells, tailored to infiltrate and attack cancer

Deliver a powerful immune response associated with regression of cancer

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 other proven cancer-fighting technologies – e.g. checkpoint inhibiters and cytokine-based therapies – when administered in combination with our Versamune®-based therapies

 

Mechanism of Action

The Versamune^® platform is comprised of structure specific positively charged (cationic) lipids co-administered with custom-designed antigens specific to the types of cancer of interest. These combinations, delivered via simple subcutaneous injection, have proven to stimulate the activation of multiple critical immunologic pathways associated with effective T-cell induction and increased cancer-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 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.

Powerful Response

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 cancer.

By promoting the induction of the right type of killer T-cell, with strong potency and in the right quantity, 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.

Safety

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, and other immuno-oncology agents. The safety profile of Versamune^®-based products offers great potential for combination with both proven and new cancer therapies.

Simple Administration

Versamune^® is engineered for simplicity and ease of administration. Versamune^® is delivered together with proprietary antigens tailored for specific cancers. Versamune^®-based immunotherapies are injected subcutaneously.

Ease Of Manufacturing

Versamune^®-based cancer immunotherapies are easily manufactured and highly stable.

Intellectual Property

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.