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Details:
PDS0101, PDS Biotech’s lead candidate, is a Versamune® based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers.
Lead Product(s): PDS0101,M7824,NHS-IL12
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2023
Details:
PDS0101, PDS Biotech’s lead candidate, is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2023
Details:
PDS0101 is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack in combination with KEYTRUDA® in recurrent or metastatic HPV16-positive head and neck cancer.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 14, 2023
Details:
PDS0101 is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2023
Details:
PDS0101 is a novel investigational human papillomavirus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2023
Details:
PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers.
Lead Product(s): PDS0101,PDS0301,Undisclosed
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: IND EnablingProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2023
Details:
PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2023
Details:
PDS0301 (NHS-IL12) is a tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor. PDS0301 works to promote a targeted T cell attack against cancers and also overcome tumor-induced immune suppression.
Lead Product(s): NHS-IL12,PDS0101
Therapeutic Area: Oncology Product Name: PDS0301
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: PDS Biotechnology
Deal Size: $121.0 million Upfront Cash: $5.0 million
Deal Type: Licensing Agreement January 03, 2023
Details:
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-positive cancers. A Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16-positive head and neck cancer.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
Details:
89% of patients treated with combination of PDS0101 and CRT demonstrated CR on day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.
Lead Product(s): PDS0101,Cisplatin
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
PDS0101, is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2022
Details:
The NCI-led Phase 2 clinical trial is investigating PDS0101 in combination with two investigational immune-modulating agents – M9241, a tumor-targeting IL-12, and bintrafusp alfa, a bifunctional checkpoint inhibitor, in recurrent or metastatic HPV-positive cancers in patients.
Lead Product(s): PDS0101,M7824,NHS-IL12
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2022
Details:
PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials.
Lead Product(s): PDS0101,M7824,NHS-IL12
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of HPV16-positive HNSCC.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2022
Details:
PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials.
Lead Product(s): PDS0101,M7824,NHS-IL12
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: National Cancer Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
Proceeds will be used to support the ongoing clinical development of PDS0101 and other product candidates within the company’s pipeline and for general working capital purposes.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Horizon Technology
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Financing August 24, 2022
Details:
Independent Data Monitoring Committee (DMC) met for its scheduled review of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the potential treatment of recurrent or metastatic HPV16-positive head and neck cancer.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2022
Details:
PDS0101, is a T cell HPV-specific immunotherapy delivered subcutaneously that has shown the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
PDS0101 is a novel T-cell HPV-specific immunotherapy delivered subcutaneously that has been shown to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple immune pathways.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
PDS0101 is administered as two separate 0.5 ml subcutaneous injections every 4 weeks; bintrafusp alfa at 1,200 mg by IV infusion every 2 weeks; and M9241 at an initial high dose of 16.8 mcg/kg by subcutaneous injection every 4 weeks every 2 weeks.
Lead Product(s): PDS0101,M7824,NHS-IL12
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
Preliminary efficacy and safety update on PDS0101 a novel type 1 interferon and CD8+ T-cell activating immunotherapy in combination with KEYTRUDA® (pembrolizumab) in first-line recurrent or metastatic HPV-positive head and neck cancer.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
The study has enrolled 45 patients for PDS0101 (Versamune®+HPV16mix) in combination with two investigational immune-modulating agents and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.
Lead Product(s): PDS0101,NHS-IL12,Bintrafusp alfa
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
Combination of PDS0101, targets cancers associated with the HPV and KEYTRUDA, Versatile-002 is studying combination in first-line and second-line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
Patent protection extended for PDS0101 by USPTO, till 2037 on the basis of early clinical data addresses a significant unmet need for more effective treatment of advanced HPV-associated cancers.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2022
Details:
IRB approval has been obtained for PDS0101 and clinical trial recruitment resumes, PDSO101 in combination with two investigational immune-modulating agents in advanced HPV cancers.
Lead Product(s): PDS0101,NHS-IL12,Bintrafusp Alfa
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers, is a first-line treatment of recurrent or metastatic head and neck cancer.
Lead Product(s): PDS0101,NHS-IL12,Bintrafusp Alfa
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
Details:
PDS0101, combines utility of Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating combination of PDS0101 and KEYTRUDA® in first-line treatment of recurrent or metastatic head and neck cancer.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
PDS0101, combines the utility of Versamune® platform with targeted antigens in HPV-expressing cancers. Combination of PDS0101 and KEYTRUDA® evaluating Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2021
Details:
The presentation will provide an update on the three ongoing PDS0101 Phase 2 clinical trials. The talk will also provide updates on progression of two other investigational pipeline products PDS0102 (Versamune®-TARP) and PDS0103 (Versamune®-MUC1) into human clinical trials.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
The trial is evaluating the combination of PDS0101 with two investigational immunotherapies in patients with advanced HPV-related cancers who have failed prior treatment.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2021
Details:
PDS0101 (Versamune-HPV16) is an investigational immunotherapy candidate designed to treat cancers caused by infection with HPV16 (HPV16-positive cancers) by activating the immune system to produce in vivo CD8+ (killer) T-cells to target and kill tumors that are HPV16-positive.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: Versamune-HPV16
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
PDS’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers being evaluated a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent/metastatic head and neck cancer.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Cantor Fitzgerald & Co
Deal Size: $51.7 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 17, 2021
Details:
The VERSATILE-002 study is designed to evaluate PDS0101 in combination with KEYTRUDA® (pembrolizumab) in the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer and is currently being run at approximately 20 clinical sites in the US.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2021
Details:
The combination of Versamune® with various antigens forms the basis for PDS Biotech’s broad immuno-oncology pipeline, including its lead candidate PDS0101 for the treatment of advanced human papillomavirus (HPV) related cancers.
Lead Product(s): PDS0101,NHS-IL12,Bintrafusp alfa
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that plans to enroll approximately 100 patients across 25 sites in the U.S.
Lead Product(s): PDS0101,Pembrolizumab
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
PDS Biotech progresses second Phase 2 human clinical trial of PDS0101. The trial will investigate the anti-tumor efficacy and safety of the PDS0101-CRT combination, and their correlation with critical biomarkers of immune response, in approximately 35 patients.
Lead Product(s): PDS0101,Cisplatin
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
PDS Biotechnology will present key data from the company’s previously reported Phase 1 trial of PDS0101 and planned Phase 2 clinical studies in patients with advanced HPV-associated malignancies at the World Vaccine Congress.
Lead Product(s): PDS0101,NHS-IL12,Bintrafusp alfa
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2020
Details:
The article was published in the Journal for ImmunoTherapy of Cancer, provides strong rationale for clinical evaluation of this 3 component treatment combination in a recently initiated NCI-led Phase 2 clinical trial.
Lead Product(s): PDS0101,NHS-IL12,Bintrafusp alfa
Therapeutic Area: Oncology Product Name: PDS0101
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
Phase 2 clinical study of PDS0101 in the treatment of advanced human papillomavirus (HPV) associated cancers. This clinical trial involves a combination of PDS0101 with two clinical development-stage immune-modulating agents, Bintrafusp alfa (M7824) and NHS-IL12.
Lead Product(s): PDS0101,NHS-IL12,Bintrafusp alfa
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Granted composition of matter patent for Versamune® platform by the United States patent and trademark office.
Lead Product(s): PDS0101
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2020
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