PDS Biotech is a clinical-stage immunotherapy company that has a growing pipeline of cancer immunotherapies and infectious disease vaccines. Frank Bedu-Addo, President and CEO of PDS Biotech will discuss the VersamuneTM platform, which effectively delivers disease-specific antigens for in vivo uptake and processing.

The company's lead product candidate, PDS0101, is a multifunctional T cell-activating immunotherapy for HPV-associated cancers and cervical cancer. It is evaluating this therapy in combination with Merck's checkpoint inhibitor KEYTRUDA (pembrolizumab).

VersamuneTM Platform

PDS Biotech offers a platform of novel, cationic, lipid-based immunotherapies called VersamuneTM that are designed to train the immune system to better recognize cancer. These therapies utilize a variety of tumor-specific proteins (antigens) and peptides to generate strong antigen-specific T-cell responses against cancer for rapid and sustained tumour eradication.

The VersamuneTM Platform consists of spherical nanoparticles that contain positive charged lipids (cationic lipids) and are specifically designed to activate the body's immune system. In preclinical studies, combining these spherical nanoparticles with cancer-specific proteins or their fragments (antigens) triggered a strong T-cell response that killed cancer cells.

Currently, PDS Biotech is developing a portfolio of immunotherapies utilizing the VersamuneTM Platform with disease-specific antigens for a broad range of solid tumors, including breast, prostate, lung, colon and ovarian cancers. The Company has a CRADA with the National Cancer Institute to co-develop multiple immunotherapies, starting in late 2016 through Phase II clinical trials.

Recently, the Company entered into a licensing agreement with Merck KGaA, Darmstadt, Germany, for the use of VersamuneTM in two of their investigational antigen-specific cancer immunotherapies, currently in preclinical development. The agreement grants Merck a worldwide license to utilize VersamuneTM in its development of M7824, a bifunctional “trap” fusion protein targeting TGF-b and PD-L1, and NHS-IL12, a tumor-targeting immunocytokine.

In addition, PDS Biotech is one of 49 companies to share in approximately $54.5 million in New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for state fiscal year 2020. The NOL program allows qualified, unprofitable New Jersey-based technology and biotechnology companies to sell a percentage of their net operating losses and research and development (R&D) tax credits to unrelated profitable corporations for cash proceeds to fund growth and operations.

PDS Biotech is conducting proof-of-concept human clinical trials of its lead product, PDS0101, a VersamuneTM-based immunotherapy that is designed to treat HPV16-associated cancers by training and activating the immune system to produce large numbers of in vivo CD8+ (killer) T-cells to target and kill HPV16-positive cancers. These trials are evaluating the safety and efficacy of PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-b and tumor-targeting immunocytokine NHS-IL12, being developed by Merck KGaA, Darmstadt, and GlaxoSmithKline; and M2941, an IL-12 agonist designed to overcome tumor immune suppression.

PDS0101

The PDS Biotech platform offers a unique immuno-oncology approach to the treatment of cancers. The company has developed a cationic, lipid-based nanoparticle platform that can be used to induce a powerful T cell response. It has already generated extremely robust early data for several cancers.

The VersamuneTM platform uses a proprietary T-cell receptor gamma alternate reading frame protein (TARP) to induce a powerful killer T-cell response against tumor cells that express TARP. It is currently under development for a variety of cancers including prostate and breast cancers that have a high level of TARP expression.

In addition to the TARP-based Versamune platform, PDS Biotech is also working on its own cancer vaccine technology. This platform utilizes a patented peptide derived from the HPV neoantigen E6/7 and uses a cationic, lipid-based Nanoparticle system to promote antigen processing and cross presentation of the peptide. The peptides are designed to target cancer-specific neoantigens found on HPV-positive tumor cells and induce a potent and targeted T cell response against these neoantigens.

A Phase 2 clinical trial of PDS0101 in combination with two investigational immune-modulating agents - M9241, a tumor-targeting IL-12 fusion protein, and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/TGF-b) - in patients with recurrent or metastatic HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy is underway. The triple combination has shown strong durability and tolerability in CPI-naive patients, with the objective response rate (ORR) being 88% among those refractory to a prior checkpoint inhibitor.

These findings are encouraging, but there is still room for improvement in terms of durability and tolerability. Based on this preliminary efficacy data, the company is planning to initiate a pivotal trial for HPV-positive patients with CPI-refractory disease within a few months.

Despite the tremendous advances in checkpoint inhibitor (CPI) immunotherapy, significant benefit and efficacy remain limited in most patients with HPV-positive cancers. This is due to a number of limitations, including low levels of HPV-specific T cells that are not activated by CPIs and the lack of shared neoantigens between tumors that allow the T-cells to recognize each other. This leads to limited clinical benefit and decreased overall survival in these patients. Fortunately, PDS Biotech’s proprietary neoantigen-specific T-cell activating immunotherapy can address these limitations by inducing strong and tumor-directed T cell responses.

PDS0102

PDS Biotech is a clinical-stage immunotherapy company developing cancer and infectious disease vaccines. The Company’s VersamuneTM platform is designed to train the immune system to recognize and attack cancer cells.

The VersamuneTM platform utilizes a proprietary T-cell activating technology to deliver and activate tumor-specific antigens in order to produce both neutralizing antibodies and potent disease-specific killer T-cells. This combination of disease-specific antigens and a type 1 interferon pathway provides PDS Biotech with a powerful immunotherapy platform that can effectively treat many different types of cancers.

In addition to the VersamuneTM platform, PDS Biotech also has several other immunotherapy programs in development. These include PDS0101, which is being developed to treat HPV-related cancers; PDS0102, which is being developed to prevent and treat influenza; and PDS0103, which is being developed to treat other types of non-viral cancers.

Currently, PDS Biotech has three ongoing clinical studies evaluating its lead candidate, PDS0101, in HPV-positive cancers. These studies are being conducted in partnership with Merck & Co., as well as the National Cancer Institute. In addition, PDS Biotech is evaluating the safety and efficacy of PDS0101 in conjunction with KEYTRUDA(r) in a first-line study for patients with recurrent or metastatic head and neck cancer who have failed previous checkpoint inhibitor therapy.

Additionally, PDS Biotech has completed an approximately $52 million public offering that will support its next phase of growth through advancement of PDS0102 and PDS0103 into human clinical trials. This offering will provide the Company with the additional funds necessary to advance both PDS0102 and PDS0103 through human clinical trials, while simultaneously allowing it to continue working on its other programs.

In preclinical studies, the Company’s VersamuneTM platform has been shown to generate clinically effective, mucin-1 (MUC1)-targeted T cells. This enables the Company to develop novel immunotherapy products that target MUC1-positive tumors and can be used alone or in conjunction with other immunotherapies. Moreover, this combination of mucin-1-targeted T cells and the VersamuneTM platform is expected to be highly safe and well-tolerated. This makes it an attractive choice for patients suffering from mucin-1-positive cancers, including breast and prostate cancers.

PDS0103

PDS Biotech has a strong clinical pipeline with a growing portfolio of immunotherapies and infectious disease vaccines based on its VersamuneTM platform. Developed to overcome the limitations of current therapies, Versamune(r) activates and stimulates in vivo large quantities of tumor-specific CD4+ helper and CD8+ killer T cells. These T cells are capable of killing cancer cells and preventing relapses in patients with advanced cancer.

The Company's Versamune(r)-based products have generated extremely robust early data in several cancer types and are advancing into human clinical trials. As a result, investors are excited about the potential for these Versamune(r)-based products to make a significant impact in the treatment of cancer and other diseases.

Previously, the Company presented promising results from a Phase 2 trial of its lead product, PDS0101. In the National Cancer Institute-led study, tumor reduction was observed in 83% of HPV16-positive patients who failed 3 prior treatment regimens and had not been treated with checkpoint inhibitor therapy. This is the first time a Versamune(r)-based product has shown such efficacy in this population.

As such, the Company has accelerated the development of PDS0103. Combining the utility of the VersamuneTM platform with novel and proprietary highly immunogenic agonist epitopes of mucin-1 (MUC1) oncogenic C-terminal region, PDS0103 is expected to enter human clinical trials in 2022.

In preclinical studies, the Company's molecule has demonstrated a potent neutralization response to multiple strains of influenza virus and provided protection against infection after challenge with a live H1N1 pandemic strain of flu in preclinical animal subjects. In addition, the molecule has been granted U.S. patent protection into 2037.

Additionally, PDS has a collaboration with the National Cancer Institute to advance PDS0103 into clinical trials. The collaboration is expected to support the next phase of growth for the Company through advancement of PDS0103 and PDS0102 into human clinical trials.

During the third quarter of 2022, the Company reported a net loss of approximately $8.5 million or $0.32 per basic share and diluted share, compared to a net loss of $3.0 million or $0.14 per basic share and diluted share for the third quarter of 2021. During this period, the Company spent $3.7 million on R&D compared to $2.7 million for the same period a year ago. While this increase was positive in terms of enabling the company to invest in its future, it also cut into the bottom line significantly.