NeuVax is a peptide

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...

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 In physics, radiation is the emission or transmission of energy in the form of waves or particles through space or a material medium. This includes: * ''electromagnetic radiation'' consisting of photons, such as radio waves, microwaves, infr ...

chemotherapy Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs (list of chemotherapeutic agents, chemotherapeutic agents or alkylating agents) in a standard chemotherapy re ...

). The product's developer is the US

biotechnology Biotechnology is a multidisciplinary field that involves the integration of natural sciences and Engineering Science, engineering sciences in order to achieve the application of organisms and parts thereof for products and services. Specialists ...

company

Galena Biopharma Galena Biopharma, Inc. (originally RXi Pharmaceuticals) was a publicly traded pharmaceutical company based in San Ramon, California. The company was founded in Worcester, Massachusetts. In 2011, it moved to Oregon, and in 2015 moved to San Ramon, ...

The product

NeuVax is the E75 synthetic peptide initially isolated from

HER2/neu Receptor tyrosine-protein kinase erbB-2 is a protein that normally resides in the membranes of cells and is encoded by the ''ERBB2'' gene. ERBB is abbreviated from erythroblastic oncogene B, a gene originally isolated from the avian genome. The ...

proto-oncogene (being HER2/neu p366-379) combined with the

immune adjuvant In immunology, an adjuvant is a substance that increases or modulates the immune response to a vaccine. The word "adjuvant" comes from the Latin word , meaning to help or aid. "An immunologic adjuvant is defined as any substance that acts to acce ...

granulocyte macrophage colony stimulating factor Granulocytes are cells in the innate immune system characterized by the presence of specific granules in their cytoplasm. Such granules distinguish them from the various agranulocytes. All myeloblastic granulocytes are polymorphonuclear, that is, ...

(rhGM-CSF from yeast). NeuVax in Phase II showed effectiveness in early-stage, node-positive

breast cancer Breast cancer is a cancer that develops from breast tissue. Signs of breast cancer may include a Breast lump, lump in the breast, a change in breast shape, dimpling of the skin, Milk-rejection sign, milk rejection, fluid coming from the nipp ...

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). 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 The breasts are two prominences located on the upper ventral region of the torso among humans and other primates. Both sexes develop breasts from the same embryology, embryological tissues. The relative size and development of the breasts is ...

ovarian The ovary () is a gonad in the female reproductive system that produces ova; when released, an ovum travels through the fallopian tube/oviduct into the uterus. There is an ovary on the left and the right side of the body. The ovaries are endoc ...

pancreatic The pancreas (plural pancreases, or pancreata) is an organ of the digestive system and endocrine system of vertebrates. In humans, it is located in the abdomen behind the stomach and functions as a gland. The pancreas is a mixed or heterocrine ...

, colon,

bladder The bladder () is a hollow organ in humans and other vertebrates that stores urine from the kidneys. In placental mammals, urine enters the bladder via the ureters and exits via the urethra during urination. In humans, the bladder is a distens ...

and

prostate The prostate is an male accessory gland, accessory gland of the male reproductive system and a muscle-driven mechanical switch between urination and ejaculation. It is found in all male mammals. It differs between species anatomically, chemica ...

cancers.

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. As a result, two additional NeuVax trials registered or underway are: (1) a 700 patient Phase 3 trial for FDA approval - not yet recruiting and (2) a 300 patient Phase 2 trial studying the combination of NeuVax and

Herceptin Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. It is specifically used for cancer that is HER2 receptor positive. It may be used by itself or together w ...

® (trastuzumab).

References

{{Reflist Peptide vaccines Cancer treatments