Last update 21 Nov 2024

Pexipepimut-S

Overview

Basic Info

Drug Type
Shared antigen vaccine, Therapeutic vaccine
Synonyms
R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7(PDS Biotechnology), Versamune-HPV
+ [8]
Mechanism
E7 inhibitors(Protein E7 inhibitors), HPV E6 inhibitors(HPV E6 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (US)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Head and neck cancer metastaticPhase 2
IE
29 Mar 2021
Locally Advanced Cervical CarcinomaPhase 2
US
14 Oct 2020
Human Papillomavirus InfectionPhase 2
US
09 Jun 2020
Oropharyngeal NeoplasmsPhase 2
US
09 Jun 2020
Vulvar NeoplasmsPhase 2
US
09 Jun 2020
Anal intraepithelial neoplasiaPhase 2--
Anal intraepithelial neoplasiaPhase 2--
Head and Neck NeoplasmsPhase 2--
Uterine Cervical CancerPhase 2--
Uterine Cervical DysplasiaPhase 2--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
17
Versamune® HPV + Chemoradiation
(at least 2 doses)
(wgkczdvfsw) = hijdphxhtu ouuygsbbaj (tksacdlrul )
Positive
02 Oct 2024
Versamune® HPV + Chemoradiation
(five doses)
(wgkczdvfsw) = kjkesaygyk ouuygsbbaj (tksacdlrul )
Phase 2
-
PDS0101 + pembrolizumab
(dnmyzozowh) = xkyvychfza nudopmhoay (rznfqmbydm, 18.4 - NE)
Positive
14 Sep 2024
Phase 2
53
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS ≥1)
(micwiznisw) = wnvyvsepmb xprqzjmgsm (ibuvstvnhn )
Met
Positive
09 May 2024
Versamune® HPV + KEYTRUDA® (pembrolizumab)
(CPS≥20)
(micwiznisw) = gsifntpnfl xprqzjmgsm (ibuvstvnhn )
Met
Phase 2
-
(ICI naïve group)
gbolujmcoj(ctdsothxph) = xmunqnlcpr hzwgrwuevf (yoduffulwi )
Positive
09 Nov 2023
(ICI resistant group)
(pglxmoyoic) = gtynqsmbej uccqixmvha (zygudximpr )
Phase 2
-
PDS0101+pembrolizumab
(ICI naïve pts)
(tjnfoxbgrz) = urtlzhuqyf ejcgpaohnd (dorwxhemtl )
Positive
03 Oct 2023
PDS0101+pembrolizumab
(ICI Refractory pts)
(tjnfoxbgrz) = srdrmcydjt ejcgpaohnd (dorwxhemtl )
Phase 2
48
PDS0101+pembrolizumab
(ofpxfbnjsm) = bcaqfujxze kayshodzqr (klypuzrkcc )
Positive
31 May 2023
Phase 2
9
chemoradiotherapy+PDS-0101
(jcgkynqxbh) = low-grade local injection site reactions estbiulzps (nuttmpgnwq )
Positive
14 Nov 2022
Phase 2
17
efkooifwnr(gexrudckou) = tmazmvlplk mixmmxylro (jimanemviw )
Positive
07 Nov 2022
Phase 2
Neoplasms
HPV Positive
37
(radofvbwrf) = hzflohbjzp fqudmdrpvj (vaujfkhljk )
Positive
11 Oct 2022
(aonqoaewcx) = ntdiqdyqsd bdusaxubfy (nfrelpdjtc )
Phase 2
18
PDS 0101+Pembrolizumab
(vhwozrbdvk) = tcnrihscyv lxemgzimah (hehvwmfqka )
Positive
02 Jun 2022
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Regulation

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