ProstVac

    PROSTVAC is Bavarian Nordic’s lead targeted immunotherapy candidate that is being investigated for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Encouraging results from the PROSTVAC development program are being validated with the ongoing pivotal phase 3 PROSPECT study, conducted in collaboration with the National Cancer Institute under a Special Protocol Assessment from the US Food and Drug Administration (FDA). Data to date also suggest that PROSTVAC has potential in combination with other therapies and/or in earlier stages of the disease.

    [td_text_with_title custom_title=”Clinical Trials”]

    The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

     

    Condition Intervention Phase
    Prostate Cancer Metastatic Biological: PROSTVAC-V
    Biological: PROSTVAC-F
    Drug: GM-CSF
    Other: GM-CSF Placebo
    Biological: Placebo
    Phase 3

     

    Study Type: Interventional
    Study Design: Allocation: Randomized
    Endpoint Classification: Efficacy Study
    Intervention Model: Parallel Assignment
    Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
    Primary Purpose: Treatment
    Official Title: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

    Enrollment:1298

    Study Start Date:December 2011

    Estimated Study Completion Date:August 2016

    Estimated Primary Completion Date:December 2015 (Final data collection date for primary outcome measure)[/td_text_with_title][td_text_with_title custom_title=”Latest post”]

    Potential Combination Strategies for Active Immunotherapy in Prostate Cancer

    From Bavarian Nordic  

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    BMS SIGNS EXCLUSIVE AGREEMENT WITH BAVARIAN NORDIC FOR PROSTVAC

    Bavarian Nordic to receive up to $975 million, inclusive of $60 million upfront and potential exercise payment; potential development, regulatory and commercialization milestone payments; additional tiered double-digit royalties on future sales KVISTGAARD, Denmark and NEW YORK, March 4, 2015 – Bavarian Nordic (OMX: BAVA, OTC: BVNRY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today an […]

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    [/td_text_with_title][td_text_with_title custom_title=”From Wikipedia”]
    Prostvac
    Vaccine description
    Target diseaseProstate cancer
    Clinical data
    Routes of
    administration
    subcutaneous injection
    Identifiers
    PubChem SID
    ChemSpider
    • none

    PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) is a cancer immunotherapy candidate in clinical development by Bavarian Nordic for the treatment of all prostate cancer although clinical trials are focusing on more advanced cases of metastatic castration-resistant prostate cancer (mCRPC). PROSTVAC is a vaccine designed to enable the immune system to recognize and attack prostate cancer cells by triggering a specific and targeted T cell immune response to cancer cells that express the tumor-associated antigen prostate-specific antigen (PSA).

    PROSTVAC utilizes recombinant poxviruses that express PSA, along with 3 immune-enhancing costimulatory molecules collectively designated as TRICOM (LFA-3, ICAM-1, and B7.1) to stimulate an immune response.[1] Treatment is initiated by subcutaneous administration of a priming dose of vaccinia encoding PSA-TRICOM, followed by 6 subsequent boosting doses of fowlpox encoding the same PSA-TRICOM cassette. Using this heterologous prime-boost dosing regimen, the immune system becomes focused on inducing PSA-specific T cell responses, designed to kill tumor cells expressing PSA. There is some evidence that Prostvac is more effective with blood types B and C.[2]

    Clinical development

    PROSTVAC is being developed in partnership with the National Cancer Institute under a formal Cooperative Research and Development Agreement and has been the subject of multiple ongoing and completed clinical studies, including the global Phase 3 PROSPECT study underway in patients with asymptomatic or minimally symptomatic metastatic prostate cancer (mCRPC).[3] This Phase 3 study is designed to validate positive clinical data from a randomized, controlled, double-blind Phase 2 clinical trial that enrolled 125 minimally symptomatic mCRPC patients. The Phase 2 study’s secondary endpoint demonstrated that patients who received PROSTVAC had a median overall survival that was 9.9 months longer than the control group (26.2 versus 16.3 months)(p. < .01) and a reduction in the risk of death.[4] PROSTVAC was generally well tolerated, with the most common side effects including injection site reactions, fever, fatigue, and nausea.[5]

    Based on non-clinical data supporting the scientific rationale for combination therapy with PROSTVAC, additional clinical trials are underway to evaluate the potential clinical benefit of combining PROSTVAC with different treatment modalities such as hormonal therapies[6] (e.g. androgen inhibitors), radiopharmaceuticals[7] and immune checkpoint inhibitors[8][9] in the treatment of prostate cancer.

    Commercialization

    In 2015, Bristol-Myers Squibb obtained from Bavarian Nordic an "exclusive option to license and commercialize Prostvac".[10] Under a separate agreement, Bavarian Nordic would "undertake the future commercial manufacturing of Prostvac".[10]

    References

    1. ^ "Survival Benefit Propels Prostate Cancer Vaccine to Phase III Trial". OncLive. 3 July 2013. Retrieved 2014-10-31..mw-parser-output cite.citation{font-style:inherit}.mw-parser-output q{quotes:"\"""\"""'""'"}.mw-parser-output code.cs1-code{color:inherit;background:inherit;border:inherit;padding:inherit}.mw-parser-output .cs1-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/6/65/Lock-green.svg/9px-Lock-green.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .cs1-lock-limited a,.mw-parser-output .cs1-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Lock-gray-alt-2.svg/9px-Lock-gray-alt-2.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .cs1-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/thumb/a/aa/Lock-red-alt-2.svg/9px-Lock-red-alt-2.svg.png")no-repeat;background-position:right .1em center}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration{color:#555}.mw-parser-output .cs1-subscription span,.mw-parser-output .cs1-registration span{border-bottom:1px dotted;cursor:help}.mw-parser-output .cs1-hidden-error{display:none;font-size:100%}.mw-parser-output .cs1-visible-error{font-size:100%}.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration,.mw-parser-output .cs1-format{font-size:95%}.mw-parser-output .cs1-kern-left,.mw-parser-output .cs1-kern-wl-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right,.mw-parser-output .cs1-kern-wl-right{padding-right:0.2em}
    2. ^ Muthana SM, Gulley JL, Hodge JW, Schlom J, Gildersleeve JC. "ABO blood type correlates with survival on prostate cancer vaccine therapy". Oncotarget. 6 (31): 32244–56. doi:10.18632/oncotarget.4993. PMC 4741674. PMID 26338967.
    3. ^ "A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)". Clinicaltrials.gov. Retrieved 31 October 2014.
    4. ^ Revised Overall Survival Analysis of a Phase II, Randomized, Double-Blind, Controlled Study of PROSTVAC in Men With Metastatic Castration-Resistant Prostate Cancer Philip W. Kantoff, James L. Gulley, and Cesar Pico-Navarro Journal of Clinical Oncology 2017 35:1, 124-125
    5. ^ Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR (2010). "Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer". J Clin Oncol. 28 (7): 1099–105. doi:10.1200/JCO.2009.25.0597. PMC 2834462. PMID 20100959.
    6. ^ Ardiani A, Gameiro SR, Kwilas AR, Donahue RN, Hodge JW (2014). "Androgen deprivation therapy sensitizes prostate cancer cells to T-cell killing through androgen receptor dependent modulation of the apoptotic pathway". Oncotarget. 5 (19): 9335–48. doi:10.18632/oncotarget.2429. PMC 4253438. PMID 25344864.
    7. ^ Heery C, Madan RA, et al. "A phase II randomized clinical trial of samarium-153 EDTMP (Sm-153) with or without PSA-tricom vaccine in metastatic castration-resistant prostate cancer (mCRPC) after docetaxel". American Society of Clinical Oncology. Retrieved 3 November 2014.
    8. ^ Madan RA, Mohebtash M, Arlen PM, Vergati M, Rauckhorst M, Steinberg SM, Tsang KY, Poole DJ, Parnes HL, Wright JJ, Dahut WL, Schlom J, Gulley JL (2012). "Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial". The Lancet Oncology. 13 (5): 501–8. doi:10.1016/S1470-2045(12)70006-2.
    9. ^ Jochems C, Tucker JA, Tsang KY, Madan RA, Dahut WL, Liewehr DJ, Steinberg SM, Gulley JL, Schlom J (2014). "A combination trial of vaccine plus ipilimumab in metastatic castration-resistant prostate cancer patients: immune correlates". Cancer Immunol Immunother. 63 (4): 407–18. doi:10.1007/s00262-014-1524-0. PMID 24514956.
    10. ^ a b Staff (1 April 2015). "Bavarian Nordic Could Reap $975M in Prostate Cancer Deal with BMS". Genetic Engineering & Biotechnology News (Paper). 35 (7): 12. Retrieved 2016-06-12.


    source: https://en.wikipedia.org/wiki/Prostvac[/td_text_with_title]