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▎WuXi AppTec content team editor recently, PDS Biotechnology has published interim data
from an expanded Phase 2 clinical trial of an investigational triple therapy for advanced human papillomavirus (HPV)-positive cancer, including its lead drug candidate, PDS0101.
Each year, about 43,000 patients are diagnosed with HPV-related cancer
.
Both men and women are affected by HPV-related cancer, but in very different
ways.
In women, HPV infection most commonly causes cervical,, or vulvar cancer
.
In men, more than 80 percent of patients have oropharyngeal cancer and can affect the head and neck
.
HPV-16 is the most common type of HPV in these cancers and the most virulent high-risk HPV type
.
Current treatments for HPV-related tumors not only have a low response rate, but also have a short
remission period for patients.
▲ PDS0101's R&D pipeline (picture from PDS Biotech official website) The phase 2 clinical trial data released this time includes the interim efficacy data of 37 HPV 16-positive evaluable patients, of which 29 patients are patients in the immune checkpoint inhibitor (CPI)
refractory group
。 The triple therapy includes PDS0101 with two immunomodulators under investigation, M9241 (targeted delivery of IL-12) and bintrafusp alfa (PD-L1/TGF-β bifunctional checkpoint inhibitor), both from Merck KG.
The results of the study showed that 66% (19/29) of HPV 16-positive and CPI-refractory patients were still alive at 16 months of follow-up, compared with historical data for the median overall survival of such patients of only 3-4 months
.
Data from HPV 16-positive CPI-naïve patients are also encouraging, with 75% (6/8) remaining alive at 25 months of follow-up and 38% (3/8) achieving complete remission (CR).
In terms of safety, 48% (24/50) of patients experienced level 3 treatment-related adverse events (AEs), 4% (2/50) of patients experienced grade 4 AEs, and no level 5 treatment-related AEs
were found.
"Interim expanded data using PDS0101-based triple therapy for advanced HPV-positive cancer in a challenging patient population with few available treatment options is continuing to demonstrate the clinical efficacy, robustness, and safety of this therapy," PDS Biotechnology said Dr.
Frank Bedu-Addo, President and Chief Executive Officer of the United States Council, said, "Importantly, these results support the continued development of this new combination for CPI-refractory patients who do not yet have approved standard care to address such significant unmet needs
.
”
from an expanded Phase 2 clinical trial of an investigational triple therapy for advanced human papillomavirus (HPV)-positive cancer, including its lead drug candidate, PDS0101.
Each year, about 43,000 patients are diagnosed with HPV-related cancer
.
Both men and women are affected by HPV-related cancer, but in very different
ways.
In women, HPV infection most commonly causes cervical,, or vulvar cancer
.
In men, more than 80 percent of patients have oropharyngeal cancer and can affect the head and neck
.
HPV-16 is the most common type of HPV in these cancers and the most virulent high-risk HPV type
.
Current treatments for HPV-related tumors not only have a low response rate, but also have a short
remission period for patients.
PDS0101 is a drug candidate developed by PDS Biotechnology using its proprietary T cell activation platform technology Versamune to combine structurally specific positively charged (cationic) lipids witha proprietary cocktail of H PV16 antigens.
These combinations, administered by simple subcutaneous injection, have been shown to stimulate the activation
of multiple key immune pathways associated with effective T cell induction and enhanced anticancer activity.
Currently, PDS0101 is in a number of Phase 2 clinical studies
.
▲ PDS0101's R&D pipeline (picture from PDS Biotech official website) The phase 2 clinical trial data released this time includes the interim efficacy data of 37 HPV 16-positive evaluable patients, of which 29 patients are patients in the immune checkpoint inhibitor (CPI)
refractory group
。 The triple therapy includes PDS0101 with two immunomodulators under investigation, M9241 (targeted delivery of IL-12) and bintrafusp alfa (PD-L1/TGF-β bifunctional checkpoint inhibitor), both from Merck KG.
The results of the study showed that 66% (19/29) of HPV 16-positive and CPI-refractory patients were still alive at 16 months of follow-up, compared with historical data for the median overall survival of such patients of only 3-4 months
.
Data from HPV 16-positive CPI-naïve patients are also encouraging, with 75% (6/8) remaining alive at 25 months of follow-up and 38% (3/8) achieving complete remission (CR).
In terms of safety, 48% (24/50) of patients experienced level 3 treatment-related adverse events (AEs), 4% (2/50) of patients experienced grade 4 AEs, and no level 5 treatment-related AEs
were found.
"Interim expanded data using PDS0101-based triple therapy for advanced HPV-positive cancer in a challenging patient population with few available treatment options is continuing to demonstrate the clinical efficacy, robustness, and safety of this therapy," PDS Biotechnology said Dr.
Frank Bedu-Addo, President and Chief Executive Officer of the United States Council, said, "Importantly, these results support the continued development of this new combination for CPI-refractory patients who do not yet have approved standard care to address such significant unmet needs
.
”
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.
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