Delving into the Latest Updates on AVX-901(AlphaVax, Inc.) with Synapse

In this phase II study, study subjects will receive the VRP-HER2 immunizations plus pembrolizumab. There will be an initial Safety Arm during which subjects will receive the VRP-HER2 immunizations plus pembrolizumab. If there is no dose limiting toxicity in the Safety Arm, then subjects will be randomized into 3 arms. They will undergo a biopsy of their tumor and peripheral blood draw for immune cell analyses and be assigned to the applicable arm of the study. Arm A will consist of the the VRP-HER2 immunizations; Arm B will consist of pembrolizumab; Arm C will consist of the VRP-HER2 immunizations plus pembrolizumab.

Start Date01 Mar 2019

Sponsor / Collaborator

Duke University

[+1]

NCT01526473 / CompletedPhase 1IIT

A Phase I Study To Evaluate The Antitumor Activity And Safety Of DUKE-002-VRP(HUHER2-ECD+TM), An Alphaviral Vector Encoding The HER2 Extracellular Domain And Transmembrane Region, In Patient With Locally Advanced Or Metastatic Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Cancers Including Breast Cancer

HER2 is a protein that is over expressed in 20-30% of breast cancers. It is also found associated with lung, gastric, ovarian, and pancreatic cancers. Although there are existing therapies that can target HER2, most patients will eventually experience progression of their disease even though their cancer continues to express HER2. Therefore, new approaches are needed for treating tumors that express HER2.
This clinical trial will use an investigational cancer vaccine called HER2 VRP or AVX901. The vaccine is based on a virus called Venezuelan equine encephalitis but it has been changed so it cannot cause active infection. Instead, the virus has been changed so it tells the immune system to attack cancer cells which make HER2.
The objectives of the study are to evaluate the safety of immunization with HER2 VRP in patients with advanced or metastatic malignancies that express HER2, and to test whether immunization will causes a strong immune system attack against the cancer.

Start Date01 Feb 2012

Sponsor / Collaborator

Duke University

[+1]

100 Clinical Results associated with AVX-901(AlphaVax, Inc.)

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100 Translational Medicine associated with AVX-901(AlphaVax, Inc.)

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100 Patents (Medical) associated with AVX-901(AlphaVax, Inc.)

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Literatures (Medical) associated with AVX-901(AlphaVax, Inc.)

01 Feb 2022·Endocrine Metabolic & Immune Disorders-Drug TargetsQ4 · MEDICINE

Immunotherapy for Breast Cancer Treatment: Current Evidence and Therapeutic Options

Q4 · MEDICINE

Review

Author: Jin, Jun-O ; Singh, Pramod Kumar ; Jain, Meenu ; Singh, Kavita ; Yadav, Dhananjay

::

Breast Cancer (BC) has the highest incidence among all forms of malignancies detected in women globally. The therapeutic approaches available for BC include chemotherapy, radiation therapy, hormonal therapy, and surgery. Recently, advanced immunology-based therapeutics with potential for BC treatment, including immune checkpoint blockades, vaccines, and combinations with other treatment strategies, have emerged. Although commonly used treatments such as trastuzumab/ pertuzumab for human epidermal growth factor receptor 2-positive BC and hormone therapy for estrogen receptor-positive and/or progesterone receptor-positive BC are specific, triple-negative BC cases remain a great challenge for treatment measures. Immune checkpoint inhibitors (anti- PD-1/anti-CTLA-4) and anti-cancer vaccines (NeuVax, MUC-1, AVX901, INO-1400, and CEA), either alone or in combination with other therapies, represent a new paradigm in cancer therapeutics. In this review, we highlight the current immunotherapeutic aspects and ongoing trials aimed at the development of better treatment regimens for BC.

01 May 2019·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Vaccine-Induced Memory CD8+ T Cells Provide Clinical Benefit in HER2 Expressing Breast Cancer: A Mouse to Human Translational Study

Q1 · MEDICINE

Article

Author: Morse, Michael A. ; Rogatko, Andre ; Lyerly, H. Kim ; Maecker, Holden T. ; Gwin, William ; Blackwell, Kimberly ; Hobeika, Amy C. ; Lubkov, Veronica ; Crosby, Erika J. ; Chang, Serena ; Snyder, Joshua C. ; Kim, Sungjin ; Hyslop, Terry ; Marcom, Paul K. ; Osada, Takuya ; Hartman, Zachary C. ; Broadwater, Gloria

Abstract:

Purpose::

Immune-based therapy for metastatic breast cancer has had limited success, particularly in molecular subtypes with low somatic mutations rates. Strategies to augment T-cell infiltration of tumors include vaccines targeting established oncogenic drivers such as the genomic amplification of HER2. We constructed a vaccine based on a novel alphaviral vector encoding a portion of HER2 (VRP-HER2).

Patients and Methods::

In preclinical studies, mice were immunized with VRP-HER2 before or after implantation of hHER2+ tumor cells and HER2-specific immune responses and antitumor function were evaluated. We tested VRP-HER2 in a phase I clinical trial where subjects with advanced HER2-overexpressing malignancies in cohort 1 received VRP-HER2 every 2 weeks for a total of 3 doses. In cohort 2, subjects received the same schedule concurrently with a HER2-targeted therapy.

Results::

Vaccination in preclinical models with VRP-HER2 induced HER2-specific T cells and antibodies while inhibiting tumor growth. VRP-HER2 was well tolerated in patients and vaccination induced HER2-specific T cells and antibodies. Although a phase I study, there was 1 partial response and 2 patients with continued stable disease. Median OS was 50.2 months in cohort 1 (n = 4) and 32.7 months in cohort 2 (n = 18). Perforin expression by memory CD8 T cells post-vaccination significantly correlated with improved PFS.

Conclusions::

VRP-HER2 increased HER2-specific memory CD8 T cells and had antitumor effects in preclinical and clinical studies. The expansion of HER2-specific memory CD8 T cells in vaccinated patients was significantly correlated with increased PFS. Subsequent studies will seek to enhance T-cell activity by combining with anti-PD-1.

100 Deals associated with AVX-901(AlphaVax, Inc.)

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