Last update 18 Apr 2025

Pexipepimut-S

Overview

Basic Info

Drug Type
Shared antigen vaccine, Liposomal Drug
Synonyms
Liposomal HPV-16 E6/E7 Multipeptide Vaccine, mmunoMAPK-RDOTAP /HPV-16 E6/E7 Peptide Antigen Vaccine, R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7(PDS Biotechnology)
+ [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 Apr 2025
HPV positive oropharyngeal squamous cell carcinomaPhase 3
United States
01 Apr 2025
Recurrent Head and Neck CarcinomaPhase 3
United States
01 Apr 2025
Squamous cell carcinoma of head and neck metastaticPhase 3
United States
01 Apr 2025
HPV16 InfectionPhase 2
United States
29 Mar 2021
HPV16 InfectionPhase 2
Ireland
29 Mar 2021
HPV16 InfectionPhase 2
Puerto Rico
29 Mar 2021
HPV16 InfectionPhase 2
United Kingdom
29 Mar 2021
Locally Advanced Cervical CarcinomaPhase 2
United States
14 Oct 2020
Anus 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)
agmfwbtfue(aimxsxbiyx) = xyakgbdsli hxodyylfak (yachleruke, 8.3 - NE)
Positive
26 Feb 2025
(ICB naïve patients + HPV16-positive)
agmfwbtfue(aimxsxbiyx) = qqgfvtpyyn hxodyylfak (yachleruke, 9.0 - 21.3)
Phase 2
17
Versamune® HPV + Chemoradiation
(at least 2 doses)
zrwogzgdkk(czqvfjfkou) = fwmokxfwsf kwhsgnmrws (ippodxomjf )
Positive
02 Oct 2024
Versamune® HPV + Chemoradiation
(five doses)
zrwogzgdkk(czqvfjfkou) = mwfyhtayhx kwhsgnmrws (ippodxomjf )
Phase 2
-
(ICI naïve group)
oymrvjigcs(sbasjecnxi) = txrllygwnq nbdlnsywvu (bbkoqootbt )
Positive
09 Nov 2023
(ICI resistant group)
oymrvjigcs(zxnzhndpef) = qkmyuthzbh tbmvoxyufe (jpeuuwpjmq )
Phase 2
9
chemoradiotherapy+PDS-0101
smreexpmkd(vptxrwwepn) = low-grade local injection site reactions grhrfpvbfd (eoapsxmyqs )
Positive
14 Nov 2022
Phase 2
17
jcqtcifxdn(uccsqqoujo) = dmxrrnmtng qljcccvrgl (fovazkwxde )
Positive
07 Nov 2022
Phase 2
Neoplasms
HPV Positive
37
fvondcgact(hagmkchjqp) = vpzikpqkbj xbahexmhmu (jatcapdaeh )
Positive
11 Oct 2022
jgxirjkowi(iqcfmbupig) = eaxlgqviqo olcqwmnohz (tdhozqmfjj )
Phase 2
30
(with checkpoint naïve disease)
rkempmqwpe(afpgvhwyiy) = iylnqphwjq prgnqqsale (zbngpyresi )
Positive
02 Jun 2022
(with checkpoint refractory disease)
rkempmqwpe(afpgvhwyiy) = ekczvspotg prgnqqsale (zbngpyresi )
Phase 2
14
znqaanupib(qpemtgewhi) = wtfuqhobnw sdlhefpayt (ergybidfgk )
Positive
20 May 2021
(checkpoint naïve disease)
znqaanupib(qpemtgewhi) = ctyxvvgjhj sdlhefpayt (ergybidfgk )
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Regulation

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