Therapy Detail
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| Therapy Name | Aldoxorubicin + Avelumab + Cyclophosphamide + ETBX-011 + ETBX-051 + ETBX-061 + Fluorouracil + GI-4000 + GI-6207 + GI-6301 + haNK cells + Leucovorin + Nab-paclitaxel + Nogapendekin alfa inbakicept |
| Synonyms | NANT triple negative breast cancer vaccine combination |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Aldoxorubicin | INNO-206|Doxorubicin-EMCH | Chemotherapy - Anthracycline 13 | Aldoxorubicin (Doxorubicin-EMCH) is a derivative prodrug of doxorubicin that is converted to free doxorubicin within the acidic environment within tumors, and once converted, doxorubicin intercalates DNA, inhibits DNA synthesis and induces apoptosis (PMID: 30936721). | |
| Avelumab | Bavencio | MSB0010718C | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Bavencio (avelumab) is a monoclonal antibody binds to human immunosuppressive ligand programmed death-ligand 1 (PD-L1, CD274) and blocks protein signaling, resulting in immune regulation and antitumor immunity (PMID: 26014098). Bavencio (avelumab) is FDA-approved for use in adult and pediatric patients of 12 years or older with metastatic Merkel cell carcinoma, as maintenance therapy in locally advanced or metastatic urothelial carcinoma (UC), in locally advanced or metastatic UC that progressed following chemotherapy, and in combination with axitinib as first-line therapy in advanced renal cell carcinoma (FDA.gov). |
| Cyclophosphamide | Cytoxan | CPM | Chemotherapy - Alkylating 18 | Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary). |
| ETBX-011 | ETBX 011|ETBX011 | ETBX-011 is an engineered adenoviral vaccine encoding human carcinoembryonic antigen that may stimulate anti-tumor immunity (Journal of Clinical Oncology 32, no. 15_suppl (May 2014) 3093-3093, PMID: 31594913). | ||
| ETBX-051 | ETBX051|ETBX 051 | ETBX-051 is a virally based vaccine that infects cells and induces expression of the brachyury protein protein, which may activate the immune system to elicit a cytotoxic T-lymphocyte (CTL) response against brachyury expressing tumor cells (PMID: 31594913). | ||
| ETBX-061 | ETBX061|ETBX 061 | ETBX-061 is a virally based vaccine that infects cells and causes expression of the Muc1 protein, which may activate the immune system to elicit a cytotoxic T-lymphocyte (CTL) response against Muc1 expressing tumor cells (PMID: 31594913). | ||
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov). |
| GI-4000 | GI 4000|GI4000 | RAS Inhibitor (Pan) 11 | GI-4000 vaccine elicits an immune response by stimulating a specific cytotoxic T-cell response against the mutated forms of Ras (PMID: 29528991). | |
| GI-6207 | NSC-745968 | GI-6207 is a cancer vaccine composed of heat-killed yeast engineered to express CEA, which may induce immune response against CEA-expressing tumor cells (PMID: 24327292). | ||
| GI-6301 | GI-6301 is a cancer vaccine that activates immune response against tumor cells (PMID: 26130065). | |||
| Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
| Nab-paclitaxel | Abraxane | ABI-007|Paclitaxel Protein-bound | Chemotherapy - Taxane 3 | Abraxane (nab-paclitaxel) is an albumin-stablized version of paclitaxel, which binds microtubules and prevents depolymerization, resulting in decreased cell motility and division (NCI Drug Dictionary). |
| Nogapendekin alfa inbakicept | Anktiva | N-803|N803|N 803|nogapendekin alfa|ALT803|ALT 803|ALT-803 | Anktiva (nogapendekin alfa inbakicept) is a fusion protein comprising a mutant version of IL-15 with increased activity and IL-15Ra fused to the Fc region of IgG1, which activates CD8+ T-cells and promotes effector activity, potentially resulting in increased antitumor immune response (PMID: 24404427, PMID: 31338557). Anktiva (nogapendekin alfa inbakicept) in combination with BCG is FDA approved for use in patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors (FDA.gov). | |
| haNK cells | CD16.158V ER IL-2|NK-92 cells | haNK cells are natural killer cells, specifically from the NK-92 cell line, that have been engineered to express IL-2 and the CD16 allele, and when combined with other therapies such as an immunotherapy can synergistically enhance antibody-dependent cell-mediated cytotoxicity (PMID: 28477372). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03554109 | Phase II | Aldoxorubicin + Avelumab + Cyclophosphamide + ETBX-011 + ETBX-051 + ETBX-061 + Fluorouracil + GI-4000 + GI-6207 + GI-6301 + haNK cells + Leucovorin + Nab-paclitaxel + Nogapendekin alfa inbakicept Cyclophosphamide + Doxorubicin + Paclitaxel | QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine | Withdrawn | USA | 0 |
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