| Vaccine description | |
|---|---|
| Target | Prostate cancer |
| Clinical data | |
| Routes of administration | subcutaneous injection |
| Identifiers | |
| CAS Number | |
| PubChem SID | |
| ChemSpider |
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PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) is acancer immunotherapy candidate in clinical development byBavarian Nordic for the treatment of allprostate cancer although clinical trials are focusing on more advanced cases of metastatic castration-resistantprostate cancer (mCRPC). PROSTVAC is avaccine designed to enable the immune system to recognize and attack prostate cancer cells by triggering a specific and targeted T cellimmune response to cancer cells that express the tumor-associated antigenprostate-specific antigen (PSA).
PROSTVAC utilizes recombinantpoxviruses that express PSA, along with 3 immune-enhancing costimulatory molecules collectively designated as TRICOM (LFA-3,ICAM-1, andB7.1) to stimulate an immune response.[1] Treatment is initiated by subcutaneous administration of a priming dose ofvaccinia encoding PSA-TRICOM, followed by 6 subsequent boosting doses offowlpox encoding the same PSA-TRICOMcassette. 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.[citation needed]
PROSTVAC is being developed in partnership with theNational Cancer Institute under a formalCooperative 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).[2] 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.[3] PROSTVAC was generally well tolerated, with the most common side effects including injection site reactions, fever, fatigue, and nausea.[4]
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 (e.g. androgen inhibitors), radiopharmaceuticals andimmune checkpoint inhibitors[5][6] in the treatment of prostate cancer.
In 2015,Bristol-Myers Squibb obtained fromBavarian Nordic an "exclusive option to license and commercialize Prostvac".[7] Under a separate agreement, Bavarian Nordic would "undertake the future commercial manufacturing of Prostvac".[7]
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