Delving into the Latest Updates on Human papillomavirus vaccine(Bioleaders Corp.) with Synapse

Overview

Basic Info

Drug Type

Shared antigen vaccine, Therapeutic vaccine

Synonyms

CIN therapeutic vaccine, Human papillomavirus vaccine, Oral HPV vaccine

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Target

HPV E7

Mechanism

E7 inhibitors(Protein E7 inhibitors)

Therapeutic Areas

NeoplasmsInfectious DiseasesUrogenital Diseases

Active Indication

Human Papillomavirus InfectionUterine Cervical Cancer

Inactive Indication

Carcinoma in situ of uterine cervixCervical Intraepithelial NeoplasiaUterine Cervical Dysplasia

Originator Organization

MOA Life Plus Co., Ltd.

Active Organization

MOA Life Plus Co., Ltd.The University of Tokyo Hospital

Morishita Jintan Co., Ltd.

+ [1]

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Therapeutic HPV vaccine is an agent to induce E7-specific Th1 immune responses to treat cervical neoplasia (CIN2-3). Our previous clinical trial has demonstrated that oral administration of HPV16 E7-expressing Lactobacillus casei (L. casei), GLBL101c, resulted in the regression of HPV16-related CIN3. Here we examined optimization of the E7-expressing L. casei for induction of the mucosal immune responses to E7. Various doses of HPV16 E7 molecule were displayed on the L. casei. Immunization with E7-bound L. casei showed the induction of E7-specific mucosal IFNγ-producing cells was dependent on displayed E7-doses but saturated beyond 0.3 μg/10⁸ cells. A new agent, L. casei with endogenous expression of E7 (IGMKK16E7), showed the optimal amount of displayed-E7. Immunization with IGMKK16E7 demonstrated 4-fold higher induction of E7-specific mucosal IFNγ-producing cells when compared with the former one. Our new system provided the optimal E7-expressing L. casei for displayed-E7 amount and induction of mucosal Th1 immune response.

01 Oct 1984·Clinics in Haematology

Aplastic Crisis and Other Effects of the Human Parvovirus Infection

Review

Author: Mortimer, Philip P. ; Blacklock, Hilary A.

Human parvovirus infections are common, provoke aplastic crises in patients with congenital haemolytic anaemia and cause fifth disease. An unknown proportion of the infections are subclinical. Parvoviraemia occurs in the early acute stage of infection and specific IgM can be detected during recovery. Most patients commencing an aplastic crisis are viraemic, but fifth disease arises after the viraemia. Serological tests for HPV, available at a small but increasing number of laboratories, will soon be complemented by tests for HPV DNA sequences present in blood, marrow and at other sites. Human parvovirus infection is occasionally fatal in patients with severe forms of congenital haemolytic anaemias and further study may reveal other unusual serious consequences of this ubiquitous infection. Short-term protection of vulnerable patients may be achievable with normal immunoglobulin, but there are still considerable obstacles to the preparation and use of a human parvovirus vaccine.

VaccinesQ3 · MEDICINE

A Placebo-Controlled, Double-Blind Randomized (Phase IIB) Trial of Oral Administration with HPV16 E7-Expressing Lactobacillus, GLBL101c, for the Treatment of Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Q3 · MEDICINE

ArticleOA

Author: Oda, Katsutoshi ; Adachi, Katsuyuki ; Uchino-Mori, Mayuyo ; Kawana-Tachikawa, Ai ; Tomio, Kensuke ; Osuga, Yutaka ; Uemura, Yukari ; Komatsu, Atsushi ; Taguchi, Ayumi ; Kawana, Kei ; Igimi, Shizunobu ; Ikeda, Yuji ; Fujii, Tomoyuki ; Nagamatsu, Takeshi ; Eguchi-Kojima, Satoko ; Tsuruga, Tetsushi

Cervical intraepithelial neoplasia (CIN), a precursor lesion to cervical cancer, is caused by high-risk human papillomavirus (HPV); high-grade CIN lesions (CIN2-3) are precancerous and require treatment. No globally approved therapy is available for CIN2-3 treatment. This study is a placebo-controlled randomized clinical trial of GLBL101c treatment for CIN2 in 40 patients with HPV16-positive CIN2 who were 1:1 randomized to receive GLBL101c (1 g/daily) or placebo for 5 days at 1, 2, 4, and 8 weeks. No differences were noted between the GLBL101c and placebo groups for patient background and adverse events. Moreover, no statistically significant difference was noted between the two groups at the primary endpoint, pathological regression after 16 weeks of the first oral dose; however, only in the GLBL101c group, two patients had complete regression (CR; regression to normal within 16 weeks). IFNγ production was significantly correlated with the number of spots identified by the interferon gamma enzyme-linked immunospot (IFNγ-ELISPOT) assay using cervical lymphocytes (CxLs) or peripheral blood mononuclear cells. In the two cases of CR, E7-specific Th1 immune responses were observed at week 16. Therefore, we concluded as a novel Lactobacillus-based vaccine with stronger immunogenicity than GLBL101c should be developed.

100 Deals associated with Human papillomavirus vaccine(Bioleaders Corp.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus Infection	Phase 2	-	Morishita Jintan Co., Ltd.	-
Human Papillomavirus Infection	Phase 2	-	MOA Life Plus Co., Ltd.	-
Human Papillomavirus Infection	Phase 2	-	The University of Tokyo Hospital	-
Human Papillomavirus Infection	Phase 2	-	AnGes, Inc.	-
Uterine Cervical Cancer	Phase 2	-	Morishita Jintan Co., Ltd.	-
Uterine Cervical Cancer	Phase 2	-	The University of Tokyo Hospital	-
Uterine Cervical Cancer	Phase 2	-	AnGes, Inc.	-
Carcinoma in situ of uterine cervix	Discovery	KR	MOA Life Plus Co., Ltd.	30 Aug 2017
Cervical Intraepithelial Neoplasia	Discovery	KR	MOA Life Plus Co., Ltd.	01 Mar 2014
Uterine Cervical Dysplasia	Discovery	KR	MOA Life Plus Co., Ltd.	01 Mar 2014