NeuVax

NeuVax is a peptide vaccine aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who achieve remission after standard of care treatment (e.g., surgery, radiation, chemotherapy).[1] The product's developer is the US biotechnology company Galena Biopharma.

The product

NeuVax is the E75 synthetic peptide initially isolated from HER2/neu proto-oncogene (being HER2/neu p366-379[2]) combined with the immune adjuvant, granulocyte macrophage colony stimulating factor (rhGM-CSF from yeast).[3]

NeuVax in Phase II showed effectiveness in early-stage, node-positive breast cancer with low-to-intermediate HER-2 expression, where the five-year recurrence rate dropped from 26% to 6%. The vaccine is now in a Phase III study called PRESENT, short for (Prevention of Recurrence in Early-Stage Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment (ClinicalTrials.gov identifier NCT01479244[4]). This study is taking place under an FDA Special Protocol Assessment.

NeuVax works by harnessing the patient’s own immune system to seek out and attack any residual cancer cells that express HER2/neu, a protein associated with tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers.[5]

Clinical trials

NeuVax has been tested as adjuvant treatment in nearly 200 breast cancer patients over a total of 5 years, and has shown to be safe and effective in Phase 2 trials.[6] As a result, two additional NeuVax trials registered or underway are: (1) a 700 patient Phase 3 trial for FDA approval - not yet recruiting[2] and (2) a 300 patient Phase 2 trial studying the combination of NeuVax and Herceptin® (trastuzumab).[7]

References
  1. Holmes, Jarrod P.; Clifton, Guy T.; Patil, Ritesh; Benavides, Linda C.; Gates, Jeremy D.; Stojadinovic, Alexander; Mittendorf, Elizabeth A.; Ponniah, Sathibalan; Peoples, George E. (2011). "Use of booster inoculations to sustain the clinical effect of an adjuvant breast cancer vaccine". Cancer. 117 (3): 463–71. doi:10.1002/cncr.25586. PMID 20845479.
  2. Clinical trial number NCT01479244 for "Efficacy and Safety Study of NeuVax(TM) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)" at ClinicalTrials.gov
  3. Amin, Asna; Benavides, Linda C.; Holmes, Jarrod P.; Gates, Jeremy D.; Carmichael, Mark G.; Hueman, Matthew T.; Mittendorf, Elizabeth A.; Storrer, Catherine E.; et al. (2008). "Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: From US Military Cancer Institute Clinical Trials Group Study I-01 and I-02" (PDF). Cancer Immunology, Immunotherapy. 57 (12): 1817–25. doi:10.1007/s00262-008-0509-2. PMID 18392824.
  4. "Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)". Clinicaltrials.gov. U.S. National Institutes of Health. Retrieved 1 January 2016.
  5. Benavides, Linda C; Sears, Alan K; Gates, Jeremy D; Clifton, Guy T; Clive, Kevin S; Carmichael, Mark G; Holmes, Jarrod P; Mittendorf, Elizabeth A; et al. (2011). "Comparison of different HER2/neuvaccines in adjuvant breast cancer trials: Implications for dosing of peptide vaccines". Expert Review of Vaccines. 10 (2): 201–10. doi:10.1586/erv.10.167. PMID 21332269.
  6. Mittendorf, Elizabeth A.; Clifton, Guy T.; Holmes, Jarrod P.; Clive, Kevin S.; Patil, Ritesh; Benavides, Linda C.; Gates, Jeremy D.; Sears, Alan K.; et al. (2012). "Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients". Cancer. 118 (10): 2594–602. doi:10.1002/cncr.26574. PMC 3428069. PMID 21989902.
  7. Marcial, Gene (March 15, 2012). "Roche Accelerates Defense Strategy to Protect Breast-Cancer Drug Herceptin's Turf". Forbes. Retrieved 22 April 2012.
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