Delving into the Latest Updates on Vvax-001(ViciniVax BV) with Synapse

Overview

Basic Info

Drug Type

Shared antigen vaccine, Therapeutic vaccine

Synonyms

Semliki Forest Virus Based Cancer Vaccine

+ [5]

Target

E6 x HPV E7

Mechanism

E6 inhibitors(Protein E6 inhibitors), E7 inhibitors(Protein E7 inhibitors), Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesUrogenital Diseases

Active Indication

Carcinoma in situ of uterine cervixHPV16 InfectionHuman Papillomavirus-Related Cervical Intraepithelial Neoplasia+ [2]

Inactive Indication-

Originator Organization

ViciniVax BV

Active Organization

ViciniVax BVUgnwg Gmbh (University Of Groningen North West Germany Gmbh)

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This is an open label phase II study in patients with newly diagnosed human papilloma virus type 16 (HPV16) induced cervical intraepithelial neoplasia grade 3 (CIN3). Patients will be treated with three doses of Vvax001 immunization with an interval of 3 weeks between each immunization to induce histopathological regression and HPV clearance. Regression of CIN3 lesions will be monitored using colposcopy in week 9, week 17 and week 25. When complete regression of the CIN3 lesion is observed by colposcopy, a biopsy will be taken in week 25 to confirm regression histologically. A positive histologic regression is defined as a reduction from CIN3 to CIN1 or no dysplasia. Patients with a complete regression will not undergo the standard-of-care loop excision of the transformation zone (LETZ) and will be followed-up after the study by cytology at 3, 6 and 12 months. If complete regression has not occurred by 25 weeks, a standard-of-care LETZ will be performed.

Start Date23 Mar 2021

Sponsor / Collaborator

University Medical Center Groningen

[+2]

EUCTR2019-004050-29-NL / Not yet recruitingPhase 2

A phase II study to determine the efficacy and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with HPV-16 induced grade 3 cervical intraepithelial neoplasia. - Vvax001 cancer vaccine in HPV-16 related disease

Start Date30 Mar 2020

Sponsor / Collaborator

University Medical Center Groningen

NL-OMON43094 / CompletedNot Applicable

Immune modulating effects and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with a history of (pre) malignant cervical lesions. - Vvax001 cancer vaccine in (pre) malignant cervical lesions

Start Date13 Jan 2017

Sponsor / Collaborator

Universitair Medisch Centrum Groningen

100 Clinical Results associated with Vvax-001(ViciniVax BV)

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100 Translational Medicine associated with Vvax-001(ViciniVax BV)

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100 Patents (Medical) associated with Vvax-001(ViciniVax BV)

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19

Literatures (Medical) associated with Vvax-001(ViciniVax BV)

01 Jun 2021·Molecular Therapy - OncolyticsQ2 · MEDICINE

IFN-I-tolerant oncolytic Semliki Forest virus in combination with anti-PD1 enhances T cell response against mouse glioma

Q2 · MEDICINE

ArticleOA

Author: Dimberg, Anna ; Martikainen, Miika ; Essand, Magnus ; Martikainen, Minttu-Maria ; Lugano, Roberta ; Ramachandran, Mohanraj ; Ma, Jing ; Yu, Di ; Merits, Andres

Oncolytic virotherapy holds promise of effective immunotherapy against otherwise nonresponsive cancers such as glioblastoma. Our previous findings have shown that although oncolytic Semliki Forest virus (SFV) is effective against various mouse glioblastoma models, its therapeutic potency is hampered by type I interferon (IFN-I)-mediated antiviral signaling. In this study, we constructed a novel IFN-I-resistant SFV construct, SFV-AM6, and evaluated its therapeutic potency in vitro, ex vivo, and in vivo in the IFN-I competent mouse GL261 glioma model. In vitro analysis shows that SFV-AM6 causes immunogenic apoptosis in GL261 cells despite high IFN-I signaling. MicroRNA-124 de-targeted SFV-AM6-124T selectively replicates in glioma cells, and it can infect orthotopic GL261 gliomas when administered intraperitoneally. The combination of SFV-AM6-124T and anti-programmed death 1 (PD1) immunotherapy resulted in increased immune cell infiltration in GL261 gliomas, including an increased tumor-reactive CD8⁺ fraction. Our results show that SFV-AM6-124T can overcome hurdles of innate anti-viral signaling. Combination therapy with SFV-AM6-124T and anti-PD1 promotes the inflammatory response and improves the immune microenvironment in the GL261 glioma model.

01 Feb 2021·Molecular TherapyQ1 · MEDICINE

First-in-Human Phase I Clinical Trial of an SFV-Based RNA Replicon Cancer Vaccine against HPV-Induced Cancers

Q1 · MEDICINE

Article

Author: van der Zee, Ate G J ; Yigit, Refika ; van de Wall, Stephanie ; Meulenberg, Janneke J M ; Nijman, Hans W ; Werner, Naomi ; Marra, Ruben ; van Zanten, Coba J ; Sluis, Jessica ; Singh, Amrita ; Komdeur, Fenne L ; Daemen, Toos ; Kosterink, Jos G W ; Schuuring, Ed ; Jorritsma-Smit, Annelies ; Hoogeboom, Baukje Nynke ; Oyarce, Cesar ; Boerma, Annemarie ; Regts, Joke ; Paijens, Sterre T ; Wilschut, Jan C ; Allersma, Derk P ; de Bruyn, Marco

A first-in-human phase I trial of Vvax001, an alphavirus-based therapeutic cancer vaccine against human papillomavirus (HPV)-induced cancers was performed assessing immunological activity, safety, and tolerability. Vvax001 consists of replication-incompetent Semliki Forest virus replicon particles encoding HPV16-derived antigens E6 and E7. Twelve participants with a history of cervical intraepithelial neoplasia were included. Four cohorts of three participants were treated per dose level, ranging from 5 × 10⁵ to 2.5 × 10⁸ infectious particles per immunization. The participants received three immunizations with a 3-week interval. For immune monitoring, blood was drawn before immunization and 1 week after the second and third immunization. Immunization with Vvax001 was safe and well tolerated, with only mild injection site reactions, and resulted in both CD4⁺ and CD8⁺ T cell responses against E6 and E7 antigens. Even the lowest dose of 5 × 10⁵ infectious particles elicited E6/E7-specific interferon (IFN)-γ responses in all three participants in this cohort. Overall, immunization resulted in positive vaccine-induced immune responses in 12 of 12 participants in one or more assays performed. In conclusion, Vvax001 was safe and induced immune responses in all participants. These data strongly support further clinical evaluation of Vvax001 as a therapeutic vaccine in patients with HPV-related malignancies.

01 Feb 2020·European Journal of Pharmaceutical SciencesQ2 · MEDICINE

GMP manufacturing of Vvax001, a therapeutic anti-HPV vaccine based on recombinant viral particles

Q2 · MEDICINE

Article

Author: Nijman, Hans W ; Daemen, Toos ; Schoemaker, Jolande ; Kosterink, Jos G W ; van Zanten, Coba J ; Jorritsma-Smit, Annelies ; Meulenberg, Janneke J M ; Touw, Daan J ; Allersma, Derk P

Therapeutic vaccination is being explored as a treatment strategy for the treatment of patients with primary or metastatic tumours. We developed a vaccine targeted to Human papillomavirus (HPV)-induced tumours based on recombinant Semliki Forest virus (rSFV) encoding a fusion protein of the E6 and E7 proteins of HPV type 16. To enable a phase I clinical trial with this vaccine, Vvax001, a Good Manufacturing Practice (GMP)-compliant manufacturing process was set up and clinical material was produced. Upstream production of the clinical material resulted in viral titers from 2.4 × 10⁷ to 1.3 × 10⁹ infectious particles/ mL in the harvest. The total volume of 6.0 liter crude virus was purified in 13 consecutive downstream purification runs. The mean titer after purification was 4.0 × 10⁸ infectious particles/ mL and the mean recovery was 19%. Finally, clinical material was filled at a target concentration of 1.25 × 10⁸ infectious particles/mL. Release testing included tests for viral titer and virus identity, biological activity, sterility, bacterial endotoxins, adventitious viruses and absence of replication competent virus. The product complied with all specifications and was released for use as an investigational medicinal product. This is the first GMP production process developed for a SFV-based therapeutic vaccine. The vaccine, Vvax001 is targeted to HPV and has shown promising results in preclinical studies. The GMP-produced Vvax001 material met the quality criteria and was of sufficient quantity to enable assessment of its immunogenicity, safety and efficacy in a clinical setting.

100 Deals associated with Vvax-001(ViciniVax BV)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Carcinoma in situ of uterine cervix	Phase 2	NL	ViciniVax BV	23 Mar 2021
HPV16 Infection	Phase 2	NL	ViciniVax BV	23 Mar 2021
Human Papillomavirus-Related Cervical Intraepithelial Neoplasia	Phase 2	NL	ViciniVax BV	23 Mar 2021
Precancerous Conditions	Phase 2	NL	ViciniVax BV	23 Mar 2021
Uterine Cervical Dysplasia	Phase 1	-	Ugnwg Gmbh (University Of Groningen North West Germany Gmbh)	-