NeuVax is a peptide vaccine developed by the US biotechnology company Galena Biopharma. It is aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who have reached remission after standard of care treatment, such as surgery, radiation or chemotherapy. As a vaccine, it is intended to protect against a return of the disease rather than to treat an established tumor. The source lead names its purpose and its developer but gives no approval date or trial outcome, so its regulatory status is left for later research. Nothing here is medical advice.
Facts
Mechanism of ActionPeptide vaccine (nelipepimut-S plus GM-CSF) that raises HER2-specific immunity in patients with breast cancer 3 Significant RiskInjection-site reactions were the most common adverse events in the phase III trial: erythema, induration and pruritus 3 Classification
Approval Status ATC ClassL: Antineoplastic and Immunomodulating Agents 2 Connections
Long-Form Articles
Treats
Source NeuVax (Wikipedia)
Sources
1. Galena Biopharma Discontinues NeuVax (nelipepimut-S) Phase 3 PRESENT (Clinical Leader, 2016)
Press release, opening paragraphQuote, Press release, opening paragraph
the IDMC recommended that the PRESENT trial be stopped due to futility.
2. NeuVax (Wikipedia)
Lead paragraphQuote, Lead paragraph
a peptide vaccine aimed at preventing or delaying the recurrence of breast cancer in cancer survivors
3. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence (Clin Cancer Res 2019)
Abstract, Purpose
In phase I/II studies, nelipepimut-S (NP-S) plus GM-CSF vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer.
Abstract, Results
Adverse events were similar between groups; most common were injection-associated: erythema (84.3%), induration (55.8%), and pruritus (54.9%).
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