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news.PDS Biotechnology has completed a successful Phase 1 clinical study of its lead cancer immunotherapy, PDS0101, focused on the treatment of HPV-induced cancers.
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These include head and neck, anal, and cervical cancer, as well as anal, vaginal, penile, vulvar and cervical pre-cancerous neoplasias. PDS0101 is based on the company’s proprietary Versamune® platform, which is being applied to multiple immuno-oncology products.
Achieved substantial induction of killer T-cells capable of targeting HPV-positive tumors
Well tolerated; no significant toxicities
On track to initiate multiple Phase 2 studies in HPV-related cancers in next 12 months
The PDS0101 Phase 1 study was performed in cervical neoplasia subjects infected with high-risk cancer-causing strains of HPV. Key study goals included evaluation of human safety and tolerability, and confirmation of the Versamune platform’s mechanism of action that causes induction of high levels of active HPV-specific killer T-cells.
The Phase 1 study demonstrated that PDS0101 successfully overcomes a key immunotherapy obstacle by efficiently accessing the immunological pathway known as MHC Class-I, necessary in humans to train and activate a population of T-cells known as killer T-cells to target cancers containing specific "cancer proteins."
Dr. Frank Bedu-Addo, CEO said, "PDS regards these strong human immunological responses, paired with a superior safety profile, as extremely promising, especially given that T-cell induction was seen in all subjects."
In preclinical studies, PDS0101 demonstrated a unique ability to down-regulate key populations of immune-suppressive cells, leading to strong anti-tumor efficacy. Successful development of immunotherapies, especially of cancer vaccines, has historically been impeded by an inability to effectively activate tumor-specific killer T-cells and also overcome immune-suppression.
The ability of PDS0101 to conclusively demonstrate human efficacy by inducing high levels of tumor-specific killer T-cells, while simultaneously reducing immune-tolerance, will be further corroborated in upcoming phase 2 studies in pre-cancer, cervical and head and neck cancers.
About the Versamune Platform: Versamune is a synthetic nanotechnology that exploits the immune system’s natural inclination to efficiently take up the nanoparticles upon subcutaneous injection.
Versamune then facilitates efficient presentation of cancer protein antigens to the killer T-cells, thus training the T-cells to recognize the cancer. It has also been proven to activate critical immunological signaling pathways that result in the production of immunological proteins known as cytokines and chemokines locally within the lymph nodes to recruit T-cells, and enhance T-cell proliferation as well as the killing activity of T-cells. Activation of these pathways may also be responsible for the technology’s ability to overcome tumor immune suppression.