PDS Biotech is focused on developing innovative immunotherapy solutions that leverage the body's immune system to combat cancer and infectious diseases. Central to their approach is the Versamune® platform, a cationic lipid-based nanoparticle technology designed to activate T cells specifically against tumor-associated antigens. This platform enhances the immune response by promoting the recruitment and activation of potent T cells, particularly CD8+ killer T cells, which are crucial for targeting and destroying cancer cells. Versamune® therapies are administered via simple subcutaneous injections and have shown promising results in clinical trials, demonstrating significant disease control, tumor shrinkage, and prolonged survival with minimal toxicity.

In addition to the Versamune® platform, PDS Biotech is advancing its PDS01ADC technology, an antibody-drug conjugate that delivers interleukin-12 (IL-12) directly into the tumor microenvironment. This approach not only suppresses the tumor's defenses but also enhances T cell infiltration and proliferation within the tumor. The combination of Versamune® and PDS01ADC represents a transformative strategy for treating recurrent and metastatic cancers, potentially improving patient outcomes while maintaining a favorable safety profile. PDS Biotech's pipeline includes multiple investigational therapies targeting various cancers, reflecting their commitment to addressing significant unmet medical needs in oncology and infectious diseases.

United States

PDS Biotech is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies based on the Versamune® platform, a T-cell activating technology, designed to harness the power of the body's immune system in the fight against cancer and infectious disease.

Cancer

Infectious Diseases

PDS Biotech

Head and neck squamous cell carcinoma

PDS Biotech’s lead candidate, PDS0101, targets cancers associated with the human papillomavirus (HPV).&nbsp; PDS0101 combines the utility of the Versamune® platform with a proprietary mix of HPV16 antigens, the most virulent high-risk HPV type and by far the most prevalent in patients with HPV-associated cancers. PDS0101 is PDS Biotech’s lead Versamune®-based immunotherapy. PDS0101 combines Versamune® (i.e. positively charged nanoparticles) with a mixture of short proteins (peptides) derived from the cancer-causing HPV16 viral protein.
 
Versamune® is a proprietary T-cell activating platform technology designed to train the immune system to better protect and fight against disease. Versamune® delivers both a protective disease-specific antibody and powerful curative killer T-cell response with minimal side effects and is engineered for simplicity and ease of administration.
 
Versamune®-derived products are based on positively charged (cationic) and immune activating lipids that form spherical nanoparticles in aqueous media. These lipids include the R-enantiomer of 1,2-dioleoyl-e-trimethyl-ammonium-propane (R-DOTAP). Cationic lipids are positively charged molecules that have a water-soluble portion (head group) attached to a water insoluble tail. The water-soluble portion of the molecule has a positive charge and the water-insoluble portion is made up of hydrocarbon (also called fatty acid) chains. The nanoparticles, which are coated with a positive charge, are deliberately sized to mimic viruses, facilitating detection by the body’s immune system and uptake by dendritic cells.
<a href="https://www.pdsbiotech.com/images/pdf/presentation/2021/Whitepaper-2021_v6.pdf">More Information</a>

 Versamune® HPV (PDS0101) + Keytruda

Cervical cancer

Versamune® HPV (PDS0101) + Chemoradiation

HPV+ oropharyngeal cancer

Solid tumor/s

Triple combination immunotherapeutic regimen: &nbsp;(1) a liposomal multipeptide therapeutic vaccine against HPV positive cancers (PDS0101) delivered subcutaneously, (2) a bifunctional fusion protein targeting PD-L1 and TGF beta (M7824) delivered intravenously, and (3) a tumor targeted immunocytokine (NHS-IL12) delivered subcutaneously.&nbsp;
 
PDS Biotech’s lead candidate, PDS0101 (Versamune-HPV), targets cancers associated with the human papillomavirus (HPV).&nbsp; PDS0101 combines the utility of the Versamune® platform with a proprietary mix of HPV16 antigens, the most virulent high-risk HPV type and by far the most prevalent in patients with HPV-associated cancers. PDS0101 is PDS Biotech’s lead Versamune®-based immunotherapy. PDS0101 is a liposomal mixture combining Versamune® (i.e. positively charged nanoparticles) with a mixture of HPV16 E6/E7 peptides.
 
Versamune® is a proprietary T-cell activating platform technology designed to train the immune system to better protect and fight against disease. Versamune® delivers both a protective disease-specific antibody and powerful curative killer T-cell response with minimal side effects and is engineered for simplicity and ease of administration.
 
Versamune®-derived products are based on positively charged (cationic) and immune activating lipids that form spherical nanoparticles in aqueous media. These lipids include the R-enantiomer of 1,2-dioleoyl-e-trimethyl-ammonium-propane (R-DOTAP). Cationic lipids are positively charged molecules that have a water-soluble portion (head group) attached to a water insoluble tail. The water-soluble portion of the molecule has a positive charge and the water-insoluble portion is made up of hydrocarbon (also called fatty acid) chains. The nanoparticles, which are coated with a positive charge, are deliberately sized to mimic viruses, facilitating detection by the body’s immune system and uptake by dendritic cells.
<a href="https://www.pdsbiotech.com/images/pdf/presentation/2021/Whitepaper-2021_v6.pdf">More Information</a>
 
NHS-IL12 is a necrosis-targeted IL-12 immunocytokine engineered by genetically fusing 2 human IL-12 heterodimers to the C-termini of the heavy chains of the NHS76 antibody. NHS76 is a fully human, phage display-derived IgG1 antibody selected for its specific ability to bind to necrotic regions and thereby target to tumors in vivo.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4039112/
Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.

Versamune® HPV (PDS0101) + Keytruda (pembrolizumab)

Human papillomavirus

PDS01ADC (formerly known as PDS0301/M9241 and NHS-IL-12 ) is a novel investigational IL12 fused antibody drug conjugate (IgG1), tumor-targeting interleukin 12 (IL-12) immune-cytokine that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune based immunotherapies PDS01ADC works synergistically to overcome tumor immune suppression and to promote a targeted T cell attack against cancers. As with Versamune, PDS01ADC is given by a simple subcutaneous injection. Clinical data suggests the addition of PDS01ADC to Versamune based immunotherapies may demonstrate significant disease control in advanced cancer patients by shrinking tumors and/or prolonging life.

PDS01ADC + ICI

Prostate cancer

PDS01ADC + Radiation Therapy

PDS Biotech’s lead candidate, PDS0101, targets cancers associated with the human papillomavirus (HPV).&nbsp; PDS0101 combines the utility of the Versamune® platform with a proprietary mix of HPV16 antigens, the most virulent high-risk HPV type and by far the most prevalent in patients with HPV-associated cancers. PDS0101 is PDS Biotech’s lead Versamune®-based immunotherapy. PDS0101 combines Versamune® (i.e. positively charged nanoparticles) with a mixture of short proteins (peptides) derived from the cancer-causing HPV16 viral protein.
 
Versamune® is a proprietary T-cell activating platform technology designed to train the immune system to better protect and fight against disease. Versamune® delivers both a protective disease-specific antibody and powerful curative killer T-cell response with minimal side effects and is engineered for simplicity and ease of administration.
 
Versamune®-derived products are based on positively charged (cationic) and immune activating lipids that form spherical nanoparticles in aqueous media. These lipids include the R-enantiomer of 1,2-dioleoyl-e-trimethyl-ammonium-propane (R-DOTAP). Cationic lipids are positively charged molecules that have a water-soluble portion (head group) attached to a water insoluble tail. The water-soluble portion of the molecule has a positive charge and the water-insoluble portion is made up of hydrocarbon (also called fatty acid) chains. The nanoparticles, which are coated with a positive charge, are deliberately sized to mimic viruses, facilitating detection by the body’s immune system and uptake by dendritic cells.
 
PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune® HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.
 
<a href="https://www.pdsbiotech.com/images/pdf/presentation/2021/Whitepaper-2021_v6.pdf">More Information</a>

Versamune® HPV + PDS01ADC + pembrolizumab

PDS0301 + Docetaxel

Kaposi Sarcoma

PDS01ADC

PDS01ADC + Docetaxel

Bladder cancer

PDS01ADC + Histone Deacetylase (HDAC) inhibitor

Metastatic colorectal cancer

Phase 1/2 clinical trial evaluating the proprietary combination to be run under PDS Biotech’s Cooperative Research and Development Agreement with the National Cancer Institute

PDS Biotech

Company Details