PDS Biotechnology has completed a successful Phase 1 clinical study of its main cancer immunotherapy, PDS0101, which is focused on treatment of HPV-induced cancers.

HPV-induced cancers include head and neck, anal, and cervical types, as well as anal, vaginal, penile, vulvar and cervical pre-cancerous neoplasias.

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PDS0101 is based on PDS Biotechnology’s proprietary Versamune platform, which is a synthetic nanotechnology that exploits the immune system’s natural inclination to efficiently take up nanoparticles upon subcutaneous injection.

Phase 1 study of PDS0101 was performed in cervical neoplasia subjects infected with high-risk cancer-causing strains of HPV.

"Phase 1 study of PDS0101 was performed in cervical neoplasia subjects infected with high-risk cancer-causing strains of HPV."

Aims of the study were to evaluate human safety and tolerability of PDS0101, and confirmation of the Versamune platform’s mechanism of action that causes induction of high levels of active HPV-specific killer T-cells.

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PDS Biotechnology stated that the Phase 1 study demonstrated that PDS0101 successfully overcomes a key immunotherapy hinderance by efficiently accessing 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 those containing particular ‘cancer proteins’.

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During preclinical studies, PDS0101 showed a capacity to down-regulate main populations of immune-suppressive cells, leading to anti-tumour efficacy.

Successful development of immunotherapies, especially of cancer vaccines, has previously been hindered by an inability to effectively activate tumour-specific killer T-cells and also overcome immune-suppression.

PDS0101’s ability to demonstrate human efficacy by inducing high levels of tumor-specific killer T-cells, while simultaneously reducing immune-tolerance, will be further confirmed in upcoming phase 2 studies in pre-cancer, cervical and head and neck cancers.