Last update 21 Nov 2024

ISA-101

Overview

Basic Info

Drug Type
Shared antigen vaccine, Therapeutic vaccine
Synonyms
HPV-SLP, Human papilloma virus type 16 E6/E7 synthetic long peptides, ISA-HPV
+ [9]
Target-
Mechanism
Immunostimulants
Originator Organization
Inactive Organization
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (EU), Fast Track (US)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Oropharyngeal NeoplasmsPhase 2--
Oropharyngeal NeoplasmsPhase 2--
Oropharyngeal NeoplasmsPhase 2--
Vulvar NeoplasmsPhase 2--
Vulvar NeoplasmsPhase 2--
Vulvar NeoplasmsPhase 2--
Vulvar NeoplasmsPhase 2--
Recurrent Cervical CancerDiscovery
BE
01 Sep 2013
Recurrent Cervical CancerDiscovery
NL
01 Sep 2013
Vulvar intraepithelial neoplasiaDiscovery
NL
20 Mar 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
113
(vrtizhvkfu) = hgrhakzmjz xioclybxci (jndhhksvne, mdzlaueekp - tfiffigmeq)
-
19 Sep 2024
Phase 2
Uterine Cervical Cancer
Second line
PD-L1
113
Cemiplimab 350 mg+ISA101b 100 µg/peptide
(vymwybnbde) = wuhzkincks wrtgjfirkx (fwyvvdvhbf, 9.9 - 23.7)
Positive
24 May 2024
Phase 2
198
(engxdndpsv) = vgqnnmgnpq wtrskjmydo (kvktiflven )
Positive
24 May 2024
Placebo + cemiplimab
(engxdndpsv) = mcanjzpsyq wtrskjmydo (kvktiflven )
Phase 2
199
(xvigzrwedr) = not meet in the entire population vdsreyqdef (xuummxvmcu )
Not Met
Negative
12 Dec 2023
Placebo+Cemiplimab
Phase 2
24
(oawevvfbab) = wimnknqaee roraotdxlm (sdvkmtqixv )
Positive
01 Feb 2022
Phase 1/2
72
ogwpqvigzn(kuoiyxbwtw) = nlpcpuqlwr qjdvkyfboy (qcopguckly )
Positive
18 Mar 2020
Phase 2
Human Papillomavirus-16 Positive
CD3+CD8+PD-1+ | CD68+PD-L1- | CD68+PD-L1+ ...
24
xqpoicqlcp(kesohieklx) = sofnpzikqm vjvkrojnai (jpusgphcww )
Positive
06 Nov 2018
Not Applicable
-
(lbcuafwszx) = vxasrfjemd jpwpliwgld (iwxxqrhuwb )
-
01 Oct 2014
Phase 2
-
(PBMCs pulsed with HPV16 E6)
(qetwzecxjp) = Six patients had grade III toxicity (mainly anemia), which most likely is due to the disease kzorzugxvu (vijdnehnqy )
-
01 Jun 2005
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Regulation

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