Breast cancer innovative immunotherapy! Ner2 immunogenic peptide neuvax (nelipepimut-s) shows strong efficacy in the treatment of triple negative breast cancer (TNBC)

February 17, 2020 / BIOON / -- sellas Life Sciences Group Co., Ltd is a biopharmaceutical company dedicated to developing new cancer immunotherapy Recently, the company released feedback from the U.S Food and Drug Administration (FDA) on the type C review of its neuvax (nelepimut-s, NPs) clinical development project for triple negative breast cancer (TNBC) Based on the written feedback from FDA and the overall situation of the clinical results of NPs obtained so far, the company has finally determined the design and plan of phase III Registration study of NPs and trastuzumab for adjuvant treatment of TNBC patients after standard treatment If successful, the study will serve as the basis for submitting a biologicals licensing application (BLA) to the FDA Neuvax is a peptide based cancer immunotherapy, which is an immunogenic peptide derived from HER2 protein Neuvax has been used as a vaccine, when combined with the adjuvant granulocyte macrophage colony stimulating factor (GM-CSF), it has been proved that it can cause a strong anti HER2 immune response At present, neuvax is being studied for the adjuvant treatment of breast cancer patients after receiving standard treatment to prevent recurrence Previously, the FDA has granted neuvax a fast track qualification (FTD) for patients with early breast cancer (including triple negative breast cancer [TNBC]) whose HER2 expression is low to moderate (her21 + or 2 +) The planned phase III study will be a 1:1 randomized, double-blind study to evaluate the combination of neuvax vaccine (NPS + GM-CSF) with trastuzumab and GM-CSF as maintenance therapy for patients with TNBC after receiving standard nursing treatment In its feedback, FDA noted that there is sufficient safety information to support the combination of neuvax and trastuzumab Neovax (nelipepimut-s, NPs, formerly E75) immunogenic peptide sequence (picture source: reference 2) Previously, sellas reported the final efficacy and safety results of the phase IIB study of neovax combined with trastuzumab in TNBC patients (n = 97) The results showed that the 24-month disease-free survival rate (DFS) of the combination group was 92.6%, while that of the trastuzumab group was 70.2% The data had clinical and statistical significance improvement, which was conducive to the combination of drugs (P = 0.01) This was associated with a significant 71.9% (P = 0.01) reduction in the recurrence rate of clinical findings, which was also beneficial to the combined treatment group Immune response analysis showed that non recurrent TNBC patients not only had robust neuvax specific clonal CD8 + cytotoxic T-lymphocyte amplification, but also had enhanced in vivo antigen secondary skin delayed type hypersensitivity Most treatment-related adverse reactions are mild or moderate, including controllable local injection site reactions, skin induration, pruritus and fatigue Dr Elizabeth a mittendorf, chief investigator of the planned phase III study, Dana Farber / Brigham and director of breast cancer immunooncology at the women's Cancer Center, said: "TNBC is an invasive breast cancer with limited treatment options and poor prognosis because it is not only related to high levels of refractory and relapse in metastatic diseases, but also in the early stage In fact, after standard first-line chemotherapy, TNBC can recur as early as 1-3 years, usually with visceral metastasis Therefore, after the initial standard treatment (surgery + radiotherapy + chemotherapy) and further safe and effective adjuvant treatment, it is very important to optimize the relapse relief methods of TNBC patients The phase III study will investigate the potential clinical benefits offered by neuvax and trastuzumab, an easy to manage maintenance therapy with manageable toxicity profile If positive results are obtained, it has the potential to change the treatment practice of TNBC by introducing the first peptide based immunotherapy into the treatment options of patients with this malignant tumor " Original source: 1 Sellas life sciences provides regulatory update for nelepimut-s (NPS) for triple negative breath cancer (TNBC) following FDA feedback 2 Clifton, G T., people, G E., & mittendorf, e A (2016) The development and use of the E75 (HER2 369 – 377) peptide vaccine Future oncology, 12 (11), 1321–1329 doi:10.2217/fon-2015-0054