Logan Reed
SELLAS Life Sciences Group Inc. is a clinical-stage biopharmaceutical company that focuses on developing novel cancer immunotherapeutics for a range of cancers. Its drug NeuVax is a cancer vaccine under evaluation for the prevention of the recurrence of breast cancer. The vaccine is made of Sellas' nelipepimut-S, the active ingredient that educates the immune system to recognize and attack the HER2 protein, and the growth factor granulocyte-macrophage colony-stimulating factor (GM-CSF), which increases the amount of tumour-killing cells and the vaccine's activity. SELLAS has also announced positive follow-up data from the Phase 2 VADIS trial of Nelipepimut-S (NPS) in women with ductal carcinoma in situ (DCIS) of the breast. DCIS is the most common type of breast neoplasm with malignant potential and can become invasive cancer in some cases. While research on vaccines to prevent and treat breast cancer is ongoing, SELLAS's clinical trials and positive data suggest that it may be a promising candidate for a breast cancer vaccine.
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What You'll Learn
SELLAS' cancer vaccine NeuVax
SELLAS Life Sciences Group is developing NeuVax (nelipepimut-S), an investigational immunotherapy for treating human epidermal growth factor 2 (HER2)-associated breast cancers. NeuVax is a cancer vaccine that educates the immune system to recognise and respond to specific tumour-associated antigens (TAAs). TAAs are substances associated with a disease and not typically found in the body.
Many breast cancer cells produce a protein called HER2, which promotes cell growth. NeuVax contains peptides, or small parts of a protein, derived from HER2. These are called E75. When NeuVax is injected into a patient, the immune system recognises these peptides as antigens. This stimulates the production of "killer" immune cells called cytotoxic T lymphocytes (CTLs), which identify and destroy tumour cells expressing the HER2 protein.
A Phase 2 trial (NCT02297698) is testing NeuVax in combination with Herceptin (trastuzumab) as a maintenance treatment for women with HER2-positive breast cancer at high risk of recurrence. This combination has also shown promise in treating triple-negative breast cancer, extending the time without disease recurrence. The VADIS study (NCT02636582) is another Phase 2 trial evaluating NeuVax as a treatment for women with early-stage HER2-positive ductal carcinoma in situ (DCIS), a non-invasive breast cancer.
SELLAS also has another product candidate, nelipepimut-S, which is a HER2-directed cancer immunotherapy. It has the potential to treat patients with early-stage breast cancer with low to intermediate HER2 expression, including triple-negative breast cancer patients.
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Nelipepimut-S as a treatment for HER2-positive breast cancer
Nelipepimut-S, also known as NeuVax or E75, is a HER2-directed cancer immunotherapy with potential for the treatment of patients with early-stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes triple-negative breast cancer patients. The vaccine educates the immune system to recognize and attack the HER2 protein, which is responsible for activating a number of signaling pathways that play a role in proliferation, angiogenesis, and invasion in breast cancer.
Nelipepimut-S is currently in Phase III clinical development and has demonstrated strong immunologic activity, with promising clinical activity in some settings. In Phase I/II studies, the vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer. The Phase II trial evaluating the vaccine as a treatment for women with early-stage HER2-positive ductal carcinoma in situ (DCIS), a non-invasive breast cancer, has completed patient enrollment. The vaccine was also tested in a Phase II trial in combination with trastuzumab, an approved monoclonal antibody against HER2, as a maintenance treatment for women with HER2-positive breast cancer at high risk of recurrence.
The Phase III PRESENT trial randomly assigned 758 patients to assess the efficacy of NeuVax plus GM-CSF in improving overall survival and disease-free survival compared to standard care plus GM-CSF. The trial was completed but the results have not yet been released. The NP-S vaccine was safe and tolerable, with no difference in disease-free survival between NP-S and the placebo at a median follow-up of 16.8 months.
Overall, Nelipepimut-S shows promise as a treatment for HER2-positive breast cancer, with the potential to induce an anti-tumor immune response and improve outcomes in the early stages of the disease.
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NeuVax in combination with Herceptin
SELLAS Life Sciences Group, Inc. is a US biotechnology company that has developed NeuVax, a peptide vaccine aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who achieve remission after standard treatment. NeuVax is the E75 synthetic peptide initially isolated from the HER2/neu proto-oncogene combined with the immune adjuvant, granulocyte macrophage colony-stimulating factor (GM-CSF).
In Phase II trials, NeuVax showed promise in treating early-stage, node-positive breast cancer with low-to-intermediate HER-2 expression. The recurrence rate dropped from 26% to 6% in this patient group. NeuVax works by harnessing the patient's immune system to identify and attack residual cancer cells that express HER2/neu, a protein associated with tumours in breast, ovarian, pancreatic, colon, bladder, and prostate cancers.
The Phase 2 VADIS trial evaluated NeuVax as a treatment for women with early-stage HER2-positive ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer. The trial participants received either NeuVax or GM-CSF alone as treatment before breast cancer surgery.
In addition to the VADIS trial, another Phase 2 trial (NCT02297698) is investigating NeuVax in combination with Genentech's Herceptin (trastuzumab) as a maintenance therapy for women with HER2-positive breast cancer at high risk of recurrence. This combination has demonstrated effectiveness in extending the time without disease recurrence in women with triple-negative breast cancer in a Phase 2b trial (NCT01570036).
The eligibility criteria for the Phase 2 trial of NeuVax in combination with Herceptin include women who are:
- 18 years or older
- Have node-positive breast cancer (AJCC N1, N2, or N3) or node-negative breast cancer with negative estrogen (ER) and progesterone (PR) receptors and have received chemotherapy
- Are clinically cancer-free after standard treatments such as surgery, chemotherapy, or radiation therapy
- Have recovered from any toxicities associated with prior adjuvant therapy
- Exhibit HER2 expression of 1+ or 2+ by IHC, with non-amplified results on FISH or Dual-ISH testing
- Are HLA-A2, A3, A24, or A26 positive
- Have an LVEF >50% or within the normal limits specified by the institution
- Have provided signed informed consent
- Are using adequate birth control methods
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Challenges in developing a breast cancer vaccine
SELLAS Life Sciences Group Inc. is a clinical-stage biopharmaceutical company that focuses on developing novel cancer immunotherapeutics for a range of cancers. Its drug NeuVax is a potential breast cancer vaccine that is currently under evaluation for the prevention of the recurrence of breast cancer. NeuVax has been tested in combination with Genentech's Herceptin (trastuzumab) as a maintenance treatment for women with HER2-positive breast cancer at high risk of recurrence.
Developing a breast cancer vaccine has been challenging due to several factors. Firstly, breast cancer arises from one's own cells and is not caused by an external organism, making it difficult for the immune system to recognize it as an invader. Secondly, researchers need to identify specific targets in breast cancer cells, such as proteins or genetic mutations, that are absent in healthy cells. This process of target identification and validation is complex and time-consuming.
Another challenge is related to the heterogeneity of breast cancer. Breast cancer is not a single disease but encompasses various subtypes with distinct molecular characteristics. This diversity poses a challenge in developing a vaccine that can effectively target multiple subtypes. Additionally, the immune system's response to cancer cells is complex and involves a delicate balance between immune activation and immune tolerance. Understanding and modulating this balance to achieve an effective anti-tumor response without causing autoimmunity is a significant hurdle.
Furthermore, the development of a breast cancer vaccine requires careful consideration of individual variations in immune responses. Factors such as age, genetic background, environmental exposures, and co-existing medical conditions can influence how a person's immune system responds to a vaccine. Taking these variables into account during vaccine design adds another layer of complexity.
Lastly, the evaluation and regulatory approval process for cancer vaccines is rigorous and lengthy. Clinical trials must demonstrate not only the safety and efficacy of the vaccine but also its ability to induce a durable immune response that translates into meaningful clinical outcomes. The challenges inherent in cancer vaccine development, along with the extensive testing and regulatory requirements, contribute to the lengthy timeline often associated with bringing a cancer vaccine to market.
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Clinical trials for breast cancer vaccines
SELLAS Life Sciences Group, Inc. has developed a vaccine named NeuVax, which is made of nelipepimut-S, the active ingredient that educates the immune system to recognize and attack the HER2 protein. Nelipepimut-S is also SELLAS' second product candidate, a HER2-directed cancer immunotherapy with the potential to treat patients with early-stage breast cancer with low to intermediate HER2 expression, including triple-negative breast cancer patients.
A Phase 2 trial (NCT02297698) is testing NeuVax, in combination with Genentech’s Herceptin (trastuzumab), as a maintenance treatment for women with HER2-positive breast cancer at high risk of recurrence. This combination has also shown promise in women with triple-negative breast cancer, extending the time without disease recurrence in a Phase 2b trial (NCT01570036).
The Phase 2 trial evaluating SELLAS Life Sciences' cancer vaccine NeuVax as a treatment for women with early-stage HER2-positive ductal carcinoma in situ (DCIS), a non-invasive breast cancer, has completed patient enrollment. The 13 women participating in the VADIS study (NCT02636582) have been assigned to either NeuVax or GM-CSF alone, a treatment approved as Leukine (sargramostin).
In addition to SELLAS, several other institutions are conducting clinical trials for breast cancer vaccines. Washington University School of Medicine in St. Louis conducted a small clinical trial that showed promising results for patients with triple-negative breast cancer who received an investigational vaccine designed to prevent recurrence. The early-stage trial indicated that the treatment is safe and elicits immune responses.
The Fred Hutchinson Cancer Center has also published promising results from a phase I nonrandomized clinical trial for a breast cancer vaccine in advanced-stage HER2-positive breast cancer patients. With a 10-year post-vaccine follow-up period, this DNA vaccine proved both safe and effective, with most participating women still cancer-free.
The Cleveland Clinic is also conducting a phase 1 study in partnership with Anixa Biosciences, Inc. to evaluate the safety and immune response of an investigational vaccine aimed at preventing triple-negative breast cancer. The vaccine was found to be generally well-tolerated and produced an immune response in most patients. Anixa is planning a phase 2 study to evaluate the efficacy of the vaccine, which is expected to begin in 2025 and last approximately two to three years.
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Frequently asked questions
The SELLAS breast cancer vaccine, NeuVax, is made of nelipepimut-S, the active ingredient that educates the immune system to recognize and attack the HER2 protein, and the growth factor granulocyte-macrophage colony-stimulating factor (GM-CSF), which increases the amount of tumour-killing cells and the vaccine's activity.
The vaccine targets the HER2 protein, which is present in some tumour types. By teaching the immune system to recognize and attack this protein, the vaccine can help prevent and treat breast cancer.
SELLAS Life Sciences Group Inc has completed patient enrollment for its Phase 2 VADIS trial, evaluating the NeuVax vaccine as a treatment for women with early-stage HER2-positive ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer. The company has also presented clinical data from its Phase 2b trial of its combination breast cancer therapy, focusing on the NeuVax vaccine with Roche's formulation of Herceptin.
