Pipeline

PDS0101

Product information
PDS0101 is an investigational immunotherapy designed to treat cancers caused by human papillomavirus (HPV). PDS0101 combines the utility of the Versamune^® platform with a proprietary mix of HPV16 antigens.

Disease state
Persistent HPV infection is strongly associated with oropharyngeal (head and neck) cancers.  More than 18,000 patients are diagnosed with HPV-associated oropharyngeal cancer each year, 80% of them men.  While there are several different strains of HPV, HPV16 is the most virulent HPV type and by far the most prevalent in patients with HPV-associated cancer.

Development status
In addition to data demonstrating tumor regression and the establishment of an HPV16-specific immune memory response after a single dose, PDS0101 has demonstrated a >20x increase in HPV-specific CD8+ killer cells in a Phase 1 clinical study coupled with a favorable safety profile (NCT02065973).

Based on the promising results of the Phase 1 trial, PDS0101 a Phase 2 clinical trial in first line treatment of recurrent/metastatic head and neck cancer in combination with KEYTRUDA^® is planned. KEYTRUDA^® monotherapy is approved for the first line treatment of head and neck cancer.

PDS0101 

Product information
PDS0101 is an investigational immunotherapy designed to treat cancers caused by human papillomavirus (HPV). PDS0101 combines the utility of the Versamune^® platform with a proprietary mix of HPV16 antigens.

Disease state
Persistent HPV infection is strongly associated with a number of cancers, including cervical, anal, vaginal, vulvar and oropharyngeal (head and neck) cancers.  Approximately 43,000 patients are diagnosed with HPV-associated cancers each year.  While there are several different strains of HPV, HPV16 is the most virulent high-risk HPV type and by far the most prevalent in patients with HPV-associated cancer.

Development status
In addition to data demonstrating tumor regression and the establishment of an HPV16-specific immune memory response after a single dose, PDS0101 has demonstrated a >20x increase in HPV-specific CD8+ killer cells in a Phase 1 clinical study coupled with a favorable safety profile (NCT02065973).

Based on the promising results of the Phase 1 trial for PDS0101 a Phase 2 clinical trial in advanced HPV-associated malignancies in combination with EMD Serono’s M7824, a novel monoclonal antibody targeting programmed death-ligand 1 (PD-L1), and NHS-IL12, an antibody-cytokine conjugate consisting of two heterodimers of interleukin (IL)-12, fused to a human monoclonal antibody specific for DNA-histone H1 complex exposed in tumor necrosis is planned.

PDS0101 

Product information
PDS0101 is an investigational immunotherapy designed to treat cancers caused by human papillomavirus (HPV). PDS0101 combines the utility of the Versamune^® platform with a proprietary mix of HPV16 antigens.

Disease state
Persistent HPV infection is strongly associated with cervical cancer.  Almost 12,000 women are diagnosed with HPV-associated cervical cancer each year.  While there are several different strains of HPV, HPV16 is the most virulent HPV type and by far the most prevalent in patients with HPV-associated cancer.

Development status
In addition to data demonstrating tumor regression and the establishment of an HPV16-specific immune memory response after a single dose, PDS0101 has demonstrated a >20x increase in HPV-specific CD8+ killer cells in a Phase 1 clinical study coupled with a favorable safety profile (NCT02065973).

Based on the promising results of the Phase 1 trial PDS0101 a Phase 2 clinical trial in advanced, localized cervical cancer in combination with standard of care chemoradiotherapy (CRT) is planned.

PDS0101

Product information
PDS0101 is an investigational immunotherapy designed to treat cancers caused by human papillomavirus (HPV). PDS0101 combines the utility of the Versamune^® platform with a proprietary mix of HPV16 antigens.

Disease state
Persistent HPV infection is strongly associated with oropharyngeal (head and neck) cancers.  More than 18,000 patients are diagnosed with HPV-associated oropharyngeal cancer each year, 80% of them men.  While there are several different strains of HPV, HPV16 is the most virulent HPV type and by far the most prevalent in patients with HPV-associated cancer.

Development status
In addition to data demonstrating tumor regression and the establishment of an HPV16-specific immune memory response after a single dose, PDS0101 has demonstrated a >20x increase in HPV-specific CD8+ killer cells in a Phase 1 clinical study coupled with a favorable safety profile (NCT02065973).

Based on the promising results of the Phase 1 trial, PDS0101 a Phase 2 clinical trial in first line treatment of recurrent/metastatic head and neck cancer in combination with KEYTRUDA^® is planned. KEYTRUDA^® monotherapy is approved for the first line treatment of head and neck cancer.

PDS0102 

Product information
PDS0102 is an investigational immunotherapy designed to treat cancers associated with the T-cell receptor gamma alternate reading frame protein (TARP)-antigen. PDS0102 combines the utility of the Versamune^® platform with this proprietary TARP antigen developed by the National Cancer Institute (NCI). PDS0102 is being developed in partnership with the NCI.

Disease state
Approximately 450,000 patients are projected to be diagnosed with prostate or breast cancer this year, most of which are associated with TARP.  The target patient population for PDS0102 includes the 85% of prostate cancers and 50% of breast cancers that over-express the immunogenic TARP protein.

Development status
In preclinical studies, PDS0102 demonstrated a robust TARP-specific killer T-cell response.  In an NCI clinical trial using TARP without Versamune^®, prostate cancer patients demonstrated anti-tumor activity and confirmed immunogenicity of a TARP vaccine in slowing tumor growth rates by 50%.  Based on these promising results, PDS Biotech is preparing to advance PDS0102 into clinical studies.

PDS0103

Product information
PDS0103 is an investigational immunotherapy designed to treat cancers associated with the mucin-1 (MUC1) oncogenic C-terminal region antigen. PDS0103 combines the utility of the Versamune^® platform with novel highly immunogenic agonist epitopes of MUC1 developed in by the National Cancer Institute (NCI).

Disease state
MUC1 is over-expressed in multiple cancers and has been shown to be associated with drug resistance and poor patient outcomes. PDS Biotech is developing PDS0103 for the treatment of ovarian, breast, colorectal and lung cancers.

Development status
PDS0103 is currently in late-stage pre-clinical development.

PDS0104 

Product information
PDS0104 is an investigational immunotherapy designed to treat melanoma. PDS0104 combines the utility of the Versamune^® platform with melanoma antigens, including the Tyrosinase-related Protein 2 (TRP2)-antigen.

Disease state
About 96,000 new melanomas will be diagnosed this year, more than 7,000 of which will prove fatal.  The rates of melanoma have been rising rapidly over the past few decades.

Development status
PDS0104 is currently in late-stage pre-clinical development.