On January 14, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported a white paper detailing how the Versamune platform works to treat cancer, and the potential of Versamune in the treatment of a broad range of cancers (Press release, PDS Biotechnology, JAN 14, 2021, View Source [SID1234574044]).
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Cancer immunotherapy is a form of cancer treatment that utilizes the power of the body’s own immune system to recognize, attack and eliminate cancer. The goal of cancer immunotherapy is tumor eradication and regression or, at least, disease stabilization. Cancer immunotherapies have significant potential to treat a broad range of cancers, and multiple agents have been approved by the FDA to treat a wide range of cancers at various stages. Though progress has been made in developing new anti-cancer immunotherapeutic technologies and products, significant challenges limiting their clinical effectiveness and safety remain.
There are well recognized hurdles impeding the ability of immunotherapy to harness the body’s immune system most effectively. For example, approved checkpoint inhibitors have resulted in effective, durable responses. Unfortunately, the rates of response reported are only in the range of 15-20% and are most likely to occur in patients with evidence of a pre-existing immune response to their tumor. Furthermore, immune therapies, including checkpoint inhibitors, CAR-Ts and live-vector vaccines, may cause significant systemic toxicities limiting their use either in the early-stage cancer setting or in combination with other approved anti-cancer treatments.
A significant challenge in the development of an effective cancer immunotherapy is creating a simple and easy to administer therapy that can promote the induction of highly potent, targeted, tumor-specific CD8+ killer and CD4+ helper T-cells within patients, that will effectively treat their cancer with minimal side effects. There is scientific consensus that induction of an adequate number and potency of tumor-recognizing T-cells is necessary for effective immunotherapy. However, suboptimal T-cell activation remains a key limitation of many immunotherapies.
In two recent peer reviewed articles in the Journal of Immunology and the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (available on the company’s website), Versamune-based immunotherapies were shown to induce superior quantity and quality of tumor-recognizing killer T-cells in-vivo. This resulted in superior preclinical anti-tumor efficacy. Versamune’s ability to be combined with specific proteins found primarily on the tumor cells and its ability to induce an effective anti-tumor immune response specific to the protein and cancer, o-ffers opportunities to treat a variety of cancers. Further, its diverse mechanisms of action and favorable safety profile suggest therapeutic promise when used alone in the single-agent monotherapy setting or when used in combination with standard of care therapies such as checkpoint inhibitors as well as chemo and radiation therapy to enhance the efficacy of treatment.
The current PDS Biotech pipeline of Versamune-based therapies focuses on four key antigens associated with a broad variety of solid tumors that remain challenging to treat. According to PDS Biotech CEO, Dr. Frank Bedu-Addo, "We are currently pursuing an ambitious development strategy, working with leading oncology experts to assess the potential of Versamune to bring new and improved treatments to cancer patients."