A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-boost Regimen, When Given to Healthy, Vaccinia-naive, HIV-1-uninfected Adults

The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults.

Start Date01 Apr 2007

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+3]

NCT00532974 / Unknown statusPhase 1

A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)

The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.

Start Date01 Oct 2006

Sponsor / Collaborator

Epimmune, Inc.

[+2]

100 Clinical Results associated with VaxOnco, Inc.

0 Patents (Medical) associated with VaxOnco, Inc.

Literatures (Medical) associated with VaxOnco, Inc.

01 May 2012·Clinical and Vaccine Immunology

DNA and Modified Vaccinia Virus Ankara Vaccines Encoding Multiple Cytotoxic and Helper T-Lymphocyte Epitopes of Human Immunodeficiency Virus Type 1 (HIV-1) Are Safe but Weakly Immunogenic in HIV-1-Uninfected, Vaccinia Virus-Naive Adults

Article

Author: Elizabeth Noonan ; Brian D. Livingston ; Christine Mhorag Hay ; Farah L. Cassis-Ghavami ; Stephen C. De Rosa ; Mark J. Newman ; Jonathan D. Fuchs ; Geoffrey J. Gorse ; Allan deCamp ; Spyros A. Kalams

ABSTRACTWe evaluated a DNA plasmid-vectored vaccine and a recombinant modified vaccinia virus Ankara vaccine (MVA-mBN32), each encoding cytotoxic and helper T-lymphocyte epitopes of human immunodeficiency virus type 1 (HIV-1) in a randomized, double-blinded, placebo-controlled trial in 36 HIV-1-uninfected adults using a heterologous prime-boost schedule. HIV-1-specific cellular immune responses, measured as interleukin-2 and/or gamma interferon production, were induced in 1 (4%) of 28 subjects after the first MVA-mBN32 immunization and in 3 (12%) of 25 subjects after the second MVA-mBN32 immunization. Among these responders, polyfunctional T-cell responses, including the production of tumor necrosis factor alpha and perforin, were detected. Vaccinia virus-specific antibodies were induced to the MVA vector in 27 (93%) of 29 and 26 (93%) of 28 subjects after the first and second immunizations with MVA-mBN32. These peptide-based vaccines were safe but were ineffective at inducing HIV-1-specific immune responses and induced much weaker responses than MVA vaccines expressing the entire open reading frames of HIV-1 proteins.

30 Jun 2009·Proceedings of the National Academy of SciencesQ1 · CROSS-FIELD

Cellular immune response to cryptic epitopes during therapeutic gene transfer

Q1 · CROSS-FIELD

Article

Author: Tisch, Roland ; Samulski, R. Jude ; Sette, Alessandro ; Seiber, David ; Monahan, Paul ; Frelinger, Jeff ; Fan, Yun ; Li, Chengwen ; Sidney, John ; Asokan, Aravind ; Alexander, Jeff ; Goudy, Kevin ; Sun, Junjiang ; Hirsch, Matt

The immune response has been implicated as a critical factor in determining the success or failure of clinical gene therapy trials. Generally, such a response is elicited by the desired transgene product or, in some cases, the delivery system. In the current study, we report the previously uncharacterized finding that a therapeutic cassette currently being used for human investigation displays alternative reading frames (ARFs) that generate unwanted protein products to induce a cytotoxic T lymphocyte (CTL) response. In particular, we tested the hypothesis that antigenic epitopes derived from an ARF in coagulation factor IX (F9) cDNA can induce CTL reactivity, subsequently killing F9-expressing hepatocytes. One peptide (p18) of 3 candidates from an ARF of the F9 transgene induced CD8 + T cell reactivity in mice expressing the human MHC class I molecule B0702. Subsequently, upon systemic administration of adeno-associated virus (AAV) serotype 2 vectors packaged with the F9 transgene (AAV2/F9), a robust CD8 + CTL response was elicited against peptide p18. Of particular importance is that the ARF epitope-specific CTLs eliminated AAV2/F9-transduced hepatocytes but not AAV2/F9 codon-optimized (AAV2/F9-opt)-transduced liver cells in which p18 epitope was deleted. These results demonstrate a previously undiscovered mechanism by which CTL responses can be elicited by cryptic epitopes generated from a therapeutic transgene and have significant implications for all gene therapy modalities. Such unforeseen epitope generation warrants careful analysis of transgene sequences for ARFs to reduce the potential for adverse events arising from immune responses during clinical gene therapy protocols.

01 May 2008·Human Vaccines

Formulation and characterization of a ten-peptide single-vial vaccine EP-2101, designed to induce cytotoxic T-lymphocyte responses for cancer immunotherapy

Article

Author: Moi, Michael ; Wu, Sharon ; Newman, Mark ; Ishioka, Glenn Y. ; Walker, Les ; Qin, Mingsheng ; Fikes, John ; Heiati, Hashem ; Beebe, Melanie

Effective vaccines that mediate clinical responses in cancer patients may require generation of broadly specific cytotoxic T lymphocytes (CTL) directed against multiple epitopes and tumor-associated antigens (TAA). Pursuant to this goal we developed a synthetic peptide vaccine, EP-2101, composed of 10 synthetic peptide epitopes and formulated in Montanide ISA 51 adjuvant. Nine of the HLA-A*0201-restricted CTL epitopes were derived from five well-characterized TAA. The universal HLA-DR binding epitope PADRE was also included for T-cell help. Herein we describe studies on the formulation and characterization of the EP-2101 vaccine which supports generation of a sterile single-vial emulsion using standardized processes. The physicochemical properties of the peptides were highly disparate and as such, solubilization studies were required to identify a process which supported sterile filtration of the EP-2101 peptide mix. A homogenization-based formulation process with Montanide ISA 51 and 0.5 mg/ml of each peptide was developed to generate a water-in-oil emulsion. Physical studies indicated the vaccine emulsion to be stable, with little change in visual appearance, viscosity and water droplet size for at least three months. The physical stability of individual peptides in the vaccine emulsion was demonstrated using HPLC and immunogenicity of the vaccine formulation was confirmed in HLA-A*0201/K(b) transgenic mice where T-cell responses could be induced to all epitopes in EP-2101 following vaccination. Our study process is scalable for production of approximately 1.5 liters of potent experimental vaccine for preclinical animal toxicity and phase 1 clinical testing in patients with breast, colon or lung cancer.

News (Medical) associated with VaxOnco, Inc.

29 Oct 2024

·www.prnewswire.com

GemVax Announces Topline Results from Phase 2a Progressive Supranuclear Palsy Clinical Trial at Neuro2024

- Topline supports moving to Phase 3 trial and shows potential to develop GV1001 as the world's first PSP treatment SEOUL, South Korea, Oct. 29, 2024 /PRNewswire/ -- GemVax & KAEL Co., Ltd. ("GemVax"; KOSDAQ ticker: 082270) announced that topline results of a Phase 2a clinical trial (the "Phase 2a PSP Clinical Trial") of GV1001, an investigational peptide drug for the treatment of progressive supranuclear palsy ("PSP"), were presented at "Neuro2024: The PSP and CBD International Research Symposium" in Toronto, Canada, at 4:45 p.m. local time on 24th October. Continue Reading Figure 1. PSP-Rating Scale Total Score (PSP-RS Type + PSP-P Type_ LS mean using MMRM) (PRNewsfoto/GemVax & KAEL) Figure 2. PSP-Rating Scale Total Score (PSP-RS Type_ simple average) (PRNewsfoto/GemVax & KAEL) Figure 3. Responder Rate (PSP-RS Type) (PRNewsfoto/GemVax & KAEL) View PDF

Phase 2PDCPhase 3

100 Deals associated with VaxOnco, Inc.

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Hepatitis B DNA vaccine(Genencor International, Inc.)	Hepatitis B More	Discontinued
HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.)	HIV Infections More	Discontinued
PX-1041 ( EGF )	Breast Cancer More	Discontinued
Malaria DNA vaccine(Pharmexa-Epimmune, Inc.)	Malaria More	Pending
EP-1043	HIV Infections More	Pending

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