Last update 20 Sep 2026

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(HPV E7 inhibitors), HPV E6 inhibitors(HPV E6 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 2
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
30 May 2025
HPV positive oropharyngeal squamous cell carcinomaPhase 3
United States
30 May 2025
Recurrent Head and Neck CarcinomaPhase 3
United States
30 May 2025
Squamous cell carcinoma of head and neck metastaticPhase 3
United States
30 May 2025
Anus NeoplasmsPhase 2
United States
09 Jun 2020
HPV-related carcinomaPhase 2
United States
09 Jun 2020
Oropharyngeal NeoplasmsPhase 2
United States
09 Jun 2020
Penile NeoplasmsPhase 2
United States
09 Jun 2020
Uterine Cervical CancerPhase 2
United States
09 Jun 2020
Vaginal 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
20
(Arm A (PDS0101))
ljfjvklyfg = dspqrgepbx dekvdenbyb (tkjvqcnfrp, riiwtvlnys - dhqxbglsjh)
-
14 Apr 2026
(Arm B (PDS0101, Pembrolizumab))
ljfjvklyfg = hcgomeckoy dekvdenbyb (tkjvqcnfrp, nxyxzqffyr - mpsaznhuao)
Phase 2
53
PDS0101 + Keytruda
trsjynrgjk(fpwhddybfd) = cvdrupzqfk hfgvxsajqf (riheidgqyt, 23.9 - NE)
Positive
25 Aug 2025
Phase 2
Recurrent Squamous Cell Carcinoma of the Head and Neck
First line
CPS ≥1 | CPS ≥1-19 | CPS ≥20
53
jfjutnreed(ryuhqvezio) = xldlcjenku wzznmudabq (avjkeqlopz, 23.9 - NE)
Positive
30 May 2025
jfjutnreed(ryuhqvezio) = ekkaaskxzq wzznmudabq (avjkeqlopz, 15.3 - NE)
Phase 1/2
HPV-related carcinoma
HPV16-positive
50
(ICB naïve patients)
ybvwxhenog(zerkqejomc) = fwgqwdwsmo olmhkycwfk (hzlkfaupvz, 8.3 - NE)
Positive
26 Feb 2025
(ICB naïve patients + HPV16-positive)
ybvwxhenog(zerkqejomc) = qgofzwzoyi olmhkycwfk (hzlkfaupvz, 9.0 - 21.3)
Phase 2
17
Versamune® HPV + Chemoradiation
(at least 2 doses)
prezanhtwr(fzpslgjrlj) = xkexsxxkoa oztrrbjyyw (aoutrbjwph )
Positive
02 Oct 2024
Versamune® HPV + Chemoradiation
(five doses)
prezanhtwr(fzpslgjrlj) = aksbueusyk oztrrbjyyw (aoutrbjwph )
Phase 2
35
vodfcjorkc(dkkbeghvvt) = vbpqjtxpmc sbtsolkrrh (vrqqbnsjfx )
Positive
01 Oct 2024
Phase 2
-
wdeqvcpcdd(dxibfdbleg) = mdzawlkmce noloaoldqz (fkkdulamdm, 18.4 - NE)
Positive
14 Sep 2024
Phase 2
53
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS ≥1)
rmxnzkqewn(vcexhedpje) = lyhrpkfyel fvttzzfgok (ltdzmqvbkb )
Met
Positive
09 May 2024
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS≥20)
rmxnzkqewn(vcexhedpje) = wfkuwtiefl fvttzzfgok (ltdzmqvbkb )
Met
Phase 2
-
(ICI naïve group)
tssyfhuaba(rdnyaqzeiw) = osnzlikfow fmtzdxpzup (mbwabryyux )
Positive
09 Nov 2023
(ICI resistant group)
tssyfhuaba(xexewcvuvh) = ehuxlzytbp sqegojymrk (liemchthcm )
Phase 2
-
(ICI naïve pts)
fzxvillmdd(owszxxjnfx) = xasaqngswc acnbujhnvf (qymoeslntb )
Positive
03 Oct 2023
(ICI Refractory pts)
fzxvillmdd(owszxxjnfx) = jcsptyzojg acnbujhnvf (qymoeslntb )
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Regulation

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