Drugs / Naptumomab estafenatox
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05894447 | Nov 2023 → Dec 2025 | urothelial carcinoma | Weill Medical College of Cornell University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03983954 | Oct 2019 → Mar 2027 expected | cervical squamous cell carcinoma, colorectal cancer, endometrial cancer, esophageal cancer +14 | NeoTX Therapeutics Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT00132379 | Nov 2005 → Dec 2006 | non-small cell lung carcinoma | Active Biotech AB | Completed | No outcome recorded |
| Phase 1 | NCT00056537 | Apr 2003 → Dec 2006 | clear cell renal carcinoma, malignant pancreatic neoplasm, non-small cell lung carcinoma | Active Biotech AB | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04880863 | Oct 2021 → Jan 2024 | non-small cell lung carcinoma | NeoTX Therapeutics Ltd. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00420888 | Jan 2007 → Jan 2013 | renal cell carcinoma | Active Biotech AB | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2022-06-01 | NeoTX Therapeutics Ltd. | Results NeoTX announces successful first stage completion of its Phase 2a clinical trial of naptumomab estafenatox (NAP), in combination with docetaxel in advanced non-small cell lung cancer (NSCLC) neotx.com ↗
NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology drug development company, announced today the successful completion of the first stage of a Simon 2 stage Phase 2a clinical trial of naptumomab estafenatox (NAP), in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have been previously treated with chemotherapy and checkpoint inhibitors (CPIs). |
| 2021-11-30 | NeoTX Therapeutics Ltd. | Results Data on Naptumomab Estafenatox (NAP) Enhancing CAR-T cells Potency Presented by NeoTX at SITC 2021 Annual Meeting. neotx.com ↗
NeoTX presented data that shows that NAP generates more potent CAR-T cells and acts synergistically against tumor cell lines in vitro. |
| 2021-04-28 | NeoTX Therapeutics Ltd. | Regulatory FDA Approval of IND Application for NAP (BioSpace) neotx.com ↗
NeoTX Therapeutics got the go-ahead from the FDA for its IND application for naptumomab estafenatox (NAP). |
| 2021-04-19 | NeoTX Therapeutics Ltd. | Regulatory NeoTX Announces FDA Clearance of IND for Phase 2 Clinical Trial of Naptumomab Estafenatox (NAP), its lead Tumor Targeted Superantigen Candidate neotx.com ↗
NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) for the Company’s Investigational New Drug (IND) application for naptumomab estafenatox (NAP). |
| 2021-04-19 | NeoTX Therapeutics Ltd. | Regulatory חברת נאוטקס (NeoTX) מודיעה על קבלת האישור מרשות המזון והתרופות האמריקאית (FDA) ל- IND לביצוע מחקר קליני פאזה שניה עם נאפטומומאב אסטאפנטוקס (נאפ, naptumomab estafenatox), התרופה המובילה של נאוטקס בטכנולוגיה של סופראנטיגן המכוון לגידול סרטני (Tumor Targeted Superantigen) neotx.com ↗
רחובות, 19 ב אפריל 2021- נאוטקס ( NeoTX Therapeutics, Ltd. ) , חברת אימונו-אונקולוגיה בשלב הקליני , הודיעה היום שקיבלה אישור מרשות המזון והתרופות האמריקאית ( FDA ) לבקשה לתרופה ניסויית חדשה (IND) עבור נ אפטומומאב אסטאפנטוקס (נאפ, naptumomab estafenatox ) . |
| 2019-11-04 | NeoTX Therapeutics Ltd. | Results NeoTX Therapeutics to Present at the Society for Immunotherapy of Cancer’s 34th Annual Meeting neotx.com ↗
The poster presentation will highlight preclinical data demonstrating that Nap and checkpoint inhibitors work synergistically to induce a prolonged and protective immune response against solid tumors. |
All press releases naming this drug 10 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Naptumomab estafenatox | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03983954 ↗ |
| Known as | ABR-217620 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00056537 ↗ |
| Known as | ANYARA | “Naptumomab estafenatox/ABR-217620/ANYARA (Nap) has been evaluated in clinical phase 1 and 2/3 studies.” PMID 25669986 ↗ Feb 2015 |
| Known as | ANYARA TTS CD3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743045 ↗ |
| Known as | NAP | “Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional...” NCT04880863 ↗2“Phase 1B, Open-Label, Dose Escalation and Cohort Expansions Trial of Naptumomab Estafenatox (NAP, ABR-217620) in Combination With Durvalumab (MEDI4736) in Subjects With...” NCT03983954 ↗ “A Phase 1 Trial of Naptumomab Estafenatox (NAP) in Combination With Pembrolizumab (Pembro) Preceded by Obinutuzumab (Obi) in Patients With Urothelial Cancers” NCT05894447 ↗ |
| Known as | TTS-CD3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743045 ↗ |
| Action | Activate | “triggers an attack on the tumor cells by activating some white blood cells” NCT00132379 ↗ |
| Modality | Protein / enzyme biologic | “ABR-217620 is a combination of two proteins” NCT00056537 ↗ |
| Route | Intravenous | “10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection” NCT00132379 ↗ |
| Target | TPBG | “Trophoblast glycoprotein other” CHEMBL1743045 ↗ |