Delving into the Latest Updates on HPV 16 E6 peptides vaccine(The University of Arkansas) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms-

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Neoplasms

Active Indication

Squamous Cell Carcinoma of Head and Neck

Inactive Indication

Cervical Intraepithelial NeoplasiaSquamous Intraepithelial Lesions

Originator Organization

The University of Arkansas

Active Organization

The University of Arkansas

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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This study has been designed to evaluate the safety and efficacy of giving seven injections of PepCan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.

Start Date13 Nov 2019

Sponsor / Collaborator

The University of Arkansas

NCT02481414

/ CompletedPhase 2IIT

A Phase II Clinical Trial of PepCan Randomized and Double-Blinded to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions

This is a Phase II study to evaluate the efficacy and safety of a human papilloma virus (HPV) therapeutic vaccine called PepCan (HPV 16 E6 peptides combined with Candida skin testing reagent called Candin®) in adult females over a 12 month time period. As the results from the Phase I trial demonstrated some efficacy against non-16 HPV types, Candin alone will also be tested. Therefore, there will be two treatment arms: (1) PepCan and (2) Candin. Subjects found to be eligible for vaccination will be randomized in a double-blinded fashion at a 1:1 ratio. Each participant will be receiving injections four times with three weeks between injections. Clinical and virological responses will be assessed at 6 and 12 months. Safety will be assessed from the time of enrollment to 12 Month Visit. Immunological assessments will be made at 4 time points (prevaccination, after 2 injections, 6 month after 4 injections and 12 months after 4 vaccinations).

Start Date30 Nov 2015

Sponsor / Collaborator

The University of Arkansas

100 Clinical Results associated with HPV 16 E6 peptides vaccine(The University of Arkansas)

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100 Translational Medicine associated with HPV 16 E6 peptides vaccine(The University of Arkansas)

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100 Patents (Medical) associated with HPV 16 E6 peptides vaccine(The University of Arkansas)

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5

Literatures (Medical) associated with HPV 16 E6 peptides vaccine(The University of Arkansas)

01 Jan 2019·Integrative Cancer Therapies

Cervical Microbiome and Response to a Human Papillomavirus Therapeutic Vaccine for Treating High-Grade Cervical Squamous Intraepithelial Lesion

Article

Author: Greenfield, William W. ; Iverson, Kathryn ; Chow, Cheryl-Emiliane ; Nakagawa, Mayumi ; Chan, Luisa ; Fuhrman, Barbara J. ; Coleman, Hannah N. ; Spencer, Horace ; Robeson, Michael Scott ; Ravilla, Rahul

Human papillomavirus (HPV) infection is associated with the vast majority of cervical cancer cases as well as with other anogenital cancers. PepCan is an investigational HPV therapeutic vaccine for treating cervical high-grade squamous intraepithelial lesions. The present study was performed to test whether the cervical microbiome influences vaccine responses and to explore host factors as determinants of the cervical microbiome composition in women with biopsy-proven high-grade squamous intraepithelial lesions. In a recently completed Phase I clinical trial of PepCan, histological response rate of 45% (14 of 31 patients), a significant increase in circulating T-helper type 1 cells, and a significant decrease in HPV 16 viral load were reported. DNA, extracted from liquid cytology specimens collected before and after vaccinations, were amplified and then hybridized to a G4 PhyloChip assay to characterize the microbiome. We describe trends that certain bacterial taxa in the cervix may be enriched in non-responders in comparison to responders ( Padj = .052 for phylum Caldithrix and Padj = .059 for phylum Nitrospirae). There was no difference in bacterial diversity between the 2 groups. A permutational analysis of variance performed for various demographic and immune parameters showed significant clustering with microbiome beta diversity for race, HPV 16 status, peripheral T-helper type 1 cells, and HLA-B40 ( P = .001, .014, .037, and .024, respectively). Further analyses showed significant differences at the empirical Operational Taxonomic Unit level for race and HPV 16 status. As these results are from a small Phase I study, further studies are needed to examine the role of cervical microbiome in response to HPV therapeutic vaccines.

01 May 2016·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

Human papillomavirus type 16 viral load is decreased following a therapeutic vaccination

Q2 · MEDICINE

Article

Author: Mackintosh, Samuel G ; Erickson, Stephen W ; Kieber, Alexander ; Edmondson, Ricky D ; Vaughn, Rita ; Nakagawa, Mayumi ; Spencer, Horace J ; Stratton, Shawna L ; Hutchins, Laura F ; Hitt, Wilbur C ; Quick, Charles Matthew ; Moerman-Herzog, Andrea M ; Greenfield, William W ; Coleman, Hannah N

In the dose-escalation phase of a Phase I clinical trial in which six subjects each were vaccinated with PepCan at the 50, 100, 250, and 500 μg per peptide dose, the 50 μg dose showed the best histological regression rate. Ten additional subjects were vaccinated at this dose in the final dose phase. As with the dose-escalation phase, no dose-limiting toxicities were observed. Overall, the histological regression rates were 50% at the 50 μg dose (7 of 14) and 100 μg dose (3 of 6), and 45 % overall (14 of 31). Of subjects in whom HPV type 16 (HPV 16) was detected at entry, it became undetectable in three subjects after vaccination, and the viral loads significantly decreased in nine subjects in whom HPV 16 infection was detected at entry and exit (p = 0.008). Immune profiling revealed increased T-helper type 1 cells after vaccinations (p = 0.02 and 0.0004 after 2 and 4 vaccinations, respectively). T-helper type 2 cells initially increased after two vaccinations (p = 0.01), but decreased below the baseline level after four vaccinations although not significantly. Pre-vaccination regulatory T cell levels were significantly lower in histological responders compared to non-responders (p = 0.03). Feasibility of testing plasma for multiplex cytokine/chemokine analysis and of performing proteomic analysis of PBMCs was examined for potentially identifying biomarkers in the future. While these analyses are feasible to perform, attention needs to be given to how soon the blood samples would be processed after phlebotomy. As sufficient safety of PepCan has been demonstrated, enrollment for the Phase II clinical trial has been opened.

03 Oct 2015·OncoImmunologyQ2 · MEDICINE

A phase I dose-escalation clinical trial of a peptide-based human papillomavirus therapeutic vaccine with Candida skin test reagent as a novel vaccine adjuvant for treating women with biopsy-proven cervical intraepithelial neoplasia 2/3

Q2 · MEDICINE

ArticleOA

Author: Andrews-Collins, Nancy R ; Moerman-Herzog, Andrea M ; Quick, C Matthew ; Coleman, Hannah N ; Smith, Dora ; Hutchins, Laura F ; Phillips, Amy M ; Nakagawa, Mayumi ; Spencer, Horace J ; Low, Gordon M ; McKelvey, Samantha S ; Stratton, Shawna L ; Hitt, Wilbur C ; Smith, Michael V ; Donnalley, Lisa M ; Vaughn, Rita ; Greenfield, William W ; Myrick, Rebecca S ; Jeffus, Susanne K ; Manning, Nirvana A ; Mercado, Maria

PURPOSE: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and Candida skin test reagent as a novel adjuvant. PATIENTS AND METHODS: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 μg per peptide). RESULTS: The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 μg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations (P = 0.02). CONCLUSION: This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that Candida, which induces interleukin-12 (IL-12) in vitro, may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.

100 Deals associated with HPV 16 E6 peptides vaccine(The University of Arkansas)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous Cell Carcinoma of Head and Neck	Phase 2	United States	The University of Arkansas	13 Nov 2019
Cervical Intraepithelial Neoplasia	Phase 2	United States	The University of Arkansas	30 Nov 2015
Squamous Intraepithelial Lesions	Phase 2	United States	The University of Arkansas	30 Nov 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02481414 (CTgov)	Phase 2	Cervical Intraepithelial Neoplasia \| Squamous Intraepithelial Lesions	81	PepCan (PepCan)	mhcbmctcwv(alrlzqlsae) = sssqcftmhi nrgdxflkdz (aulseooivg, ycyrjlyoop - duzhfcoccc) View more	-	18 Dec 2023
				Candin® (Candin)	mhcbmctcwv(alrlzqlsae) = ggrmgcuouc nrgdxflkdz (aulseooivg, hvonyywhre - ibrqfzsfdx) View more
NCT02481414 (ASCO2023) Manual	Phase 2	Cervical Intraepithelial Neoplasia	80	PepCan	hgsckftnbs(jicqoirnyy) = No dose-limiting toxicity was observed ecybrgoyie (qzhmakwubh )	Negative	31 May 2023
				Candida