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Pipeline

PDS Biotech’s oncology pipeline leverages the Versamune® and Versamune® plus PDS0301 platform technologies in combination with proprietary tumor-specific proteins or peptides (antigens) in the development of targeted cancer immunotherapies.


ProductsIndicationCombinationPCP1P2P3RPARTNER(S)
Oncology
PDS0101 (HPV16) 

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VERSATILE-002
Recurrent/metastatic HPV16-positive head and neck cancer
KEYTRUDA®
(Standard of Care) 
 merck
Arm 1: Checkpoint inhibitor naïve 1st line treatment
Arm 2: Checkpoint inhibitor refractory 2nd or 3rd line treatment

PDS0101

Product information
PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

Disease state
Approximately 43,000 US patients are diagnosed with a HPV-related cancer each year, a number unlikely to be impacted in the next decade by the increased use of HPV preventive vaccines – given that the time from initial HPV infection to a cancer diagnosis is usually 20 years or more. Cancers such as head and neck, cervical, anal, penile, vaginal, vulvar that are caused by HPV infection can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently HPV-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies such as checkpoint inhibitors, either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and HPV-targeted treatment options.

Development status
PDS0101 is currently being evaluated in four Phase 2 clinical trials for the treatment of various types of HPV-positive cancers.

PDS0101 (HPV16)
PDS0301

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HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Bintrafusp alfa

NCI Stacked COLOR   
Arm 1: Checkpoint inhibitor naïve 2nd line treatment
Arm 2: Checkpoint inhibitor refractory 3rd line treatment

PDS0101 

Product information
PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

Disease state
Approximately 43,000 US patients are diagnosed with a HPV-related cancer each year, a number unlikely to be impacted in the next decade by the increased use of HPV preventive vaccines – given that the time from initial HPV infection to a cancer diagnosis is usually 20 years or more. Cancers such as head and neck, cervical, anal, penile, vaginal, vulvar that are caused by HPV infection can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently HPV-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies such as checkpoint inhibitors, either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and HPV-targeted treatment options.

Development status
PDS0101 is currently being evaluated in four Phase 2 clinical trials for the treatment of various types of HPV-positive cancers.

PDS0101 (HPV16)

Learn more
IMMUNOCERV
1st line treatment of locally advanced (IB3-IVA) cervical cancer
Chemo-radiation
(Standard of Care)
tobeannounced 

PDS0101 

Product information
PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

Disease state
Approximately 43,000 US patients are diagnosed with a HPV-related cancer each year, a number unlikely to be impacted in the next decade by the increased use of HPV preventive vaccines – given that the time from initial HPV infection to a cancer diagnosis is usually 20 years or more. Cancers such as head and neck, cervical, anal, penile, vaginal, vulvar that are caused by HPV infection can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently HPV-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies such as checkpoint inhibitors, either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and HPV-targeted treatment options.

Development status
PDS0101 is currently being evaluated in four Phase 2 clinical trials for the treatment of various types of HPV-positive cancers.

PDS0101 (HPV16) 

Learn more
Pre-metastatic HPV-associated oropharyngeal cancer (OPSCC) KEYTRUDA®
(Standard of Care) 
 merck
Arm 1: PDS0101 monotherapy
Arm 2: PDS0101 + KEYTRUDA

PDS0101

Product information
PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.

Disease state
Approximately 43,000 US patients are diagnosed with a HPV-related cancer each year, a number unlikely to be impacted in the next decade by the increased use of HPV preventive vaccines – given that the time from initial HPV infection to a cancer diagnosis is usually 20 years or more. Cancers such as head and neck, cervical, anal, penile, vaginal, vulvar that are caused by HPV infection can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently HPV-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies such as checkpoint inhibitors, either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and HPV-targeted treatment options.

Development status
PDS0101 is currently being evaluated in four Phase 2 clinical trials for the treatment of various types of HPV-positive cancers.

PDS0102
(TARP)
TARP-associated AML, prostate and breast cancers TBD
NCI Stacked COLOR 

PDS0102 

Product information
PDS0102 is a novel investigational T cell receptor gamma alternate reading frame protein (TARP)-targeted immunotherapy that stimulates a potent targeted T cell attack against TARP-positive cancers. PDS0102 is given by a simple subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. Preclinical data suggests PDS0102 generates clinically effective immune responses, and demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. PDS0102 combines the utility of the Versamune® platform with this proprietary TARP antigen developed by the National Cancer Institute (NCI).

Disease state
Approximately 450,000 patients are diagnosed with acute myeloid leukemia (AML), prostate or breast cancer each year, most of which are associated with TARP. TARP-positive cancers that overexpress the immunogenic TARP protein such as prostate and breast cancer can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently TARP-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and TARP-targeted treatment options.

Development status
PDS0102 is currently in late-stage pre-clinical development.

PDS0103
(MUC1)
MUC1-associated breast, colon, lung, ovarian and other cancers TBD
NCI Stacked COLOR 

PDS0103

Product information
PDS0103 is a novel investigational mucin-1 (MUC1)-targeted immunotherapy that stimulates a potent targeted T cell attack against MUC1-positive cancers. PDS0103 is given by a simple subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. Preclinical data suggests PDS0103 generates clinically effective immune responses, and demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. 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 solid tumors and has been shown to be associated with drug resistance and poor patient outcomes. MUC1-positive cancers such as ovarian, breast, colorectal and lung cancers can be identified through tissue examination or biopsy and imaging (CT, PET X-ray, MRI). Currently MUC1-positive cancers are treated with surgery, chemotherapy, radiation and immunotherapies either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and MUC1-targeted treatment options.

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

PDS0104
(TRP2)
Melanoma TBD
 

PDS0104 

Product information
PDS0104 is a novel investigational Tyrosinase-related Protein 2 (TRP2)-targeted immunotherapy that stimulates a potent targeted T cell attack against melanoma. PDS0104 is given by a simple subcutaneous injection alone or in combination with other immunotherapies and cancer treatments. Preclinical data suggests PDS0104 generates clinically effective immune responses, and demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival.

Disease state
About 96,000 new melanomas are diagnosed each year, more than 7,000 of which are fatal. The rates of melanoma have been rising rapidly over the past few decades. Melanoma can be targeted by the Currently melanoma is treated with surgery, chemotherapy, radiation and immunotherapies either alone or in combination. There remains a high unmet need for more effective, safer, better tolerated and melanoma treatment options.

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

PDS Biotech Funded funded   Partner Co-Funded parfunded

 

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