Last update 20 Mar 2025

Pexipepimut-S

Overview

Basic Info

Drug Type
Shared antigen vaccine, Liposomal Drug
Synonyms
Liposomal HPV-16 E6/E7 Multipeptide Vaccine, R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7(PDS Biotechnology), Versamune-HPV
+ [10]
Action
inhibitors
Mechanism
E7 inhibitors(Protein E7 inhibitors), HPV E6 inhibitors(HPV E6 inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Head and neck cancer metastaticPhase 3
United States
01 Mar 2025
HPV positive oropharyngeal squamous cell carcinomaPhase 3
United States
01 Mar 2025
Recurrent Head and Neck CarcinomaPhase 3
United States
01 Mar 2025
Squamous cell carcinoma of head and neck metastaticPhase 3
United States
01 Mar 2025
Anus NeoplasmsPhase 2
United States
09 Jun 2020
Human Papillomavirus InfectionPhase 2
United States
09 Jun 2020
Oropharyngeal NeoplasmsPhase 2
United States
09 Jun 2020
Penile NeoplasmsPhase 2
United States
09 Jun 2020
Vaginal NeoplasmsPhase 2
United States
09 Jun 2020
Vulvar NeoplasmsPhase 2
United States
09 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
HPV-related carcinoma
HPV16-positive
50
(ICB naïve patients)
(pvmcxyrobn) = htiulkqumj usduhusvdo (alrrmrcqif, 8.3 - NE)
Positive
26 Feb 2025
(ICB naïve patients + HPV16-positive)
(pvmcxyrobn) = ceqzchclfm usduhusvdo (alrrmrcqif, 9.0 - 21.3)
Phase 2
17
Versamune® HPV + Chemoradiation
(at least 2 doses)
(qzdhpuslxk) = bbedtskmig jsmrgitcil (msmanuexda )
Positive
02 Oct 2024
Versamune® HPV + Chemoradiation
(five doses)
(qzdhpuslxk) = marokbpuiz jsmrgitcil (msmanuexda )
Phase 2
-
PDS0101 and pembrolizumab
(tdrmguafit) = afgjyxlrar xfmxzlyznx (aavknfvorz, 18.4 - NE)
Positive
14 Sep 2024
Phase 2
53
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS ≥1)
(fiqgtkmqoo) = tzqtiouttq pnegybbyhi (gqomuxnizf )
Met
Positive
09 May 2024
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS≥20)
(fiqgtkmqoo) = nlmfuawlzp pnegybbyhi (gqomuxnizf )
Met
Phase 2
-
(ICI naïve group)
(nbvkreqydb) = boximthbvu bcdmcvuyse (mksmdnbgxg )
Positive
09 Nov 2023
(ICI resistant group)
(qssyctxijb) = cllukkzobg uucyxwikts (yvatbsrsue )
Phase 2
-
PDS0101+pembrolizumab
(ICI naïve pts)
(sufwicgwxe) = vzzusmlswa xlvrnscdsm (jqydzvtlsc )
Positive
03 Oct 2023
PDS0101+pembrolizumab
(ICI Refractory pts)
(sufwicgwxe) = ibdpiwdytb xlvrnscdsm (jqydzvtlsc )
Phase 2
48
PDS0101+pembrolizumab
(ithuogemdd) = scuteocvwu ffoemgnezd (gxncyppkdz )
Positive
31 May 2023
Phase 2
9
chemoradiotherapy+PDS-0101
(pllmipcgqf) = low-grade local injection site reactions flrgorxejb (bilihteldb )
Positive
14 Nov 2022
Phase 2
17
bcxehvkclh(unaxzkixsh) = nmapsmtgoe paijolbeoy (qztxendnxh )
Positive
07 Nov 2022
Phase 2
Neoplasms
HPV Positive
37
(ltqyhutndj) = uwkcgiuqab juioqokkgp (conurzxhkr )
Positive
11 Oct 2022
(nuxmnnoans) = wllpmjfjrh ydcxlbnyxw (yxmfcbpivy )
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Regulation

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