nogapendekin alfa inbakicept
Trade name: Anktiva
Recombinant proteinapprovedFast Track FDABreakthrough Therapy FDA
Approved
Apr 22, 2024
Clinical trial activity
35 trials · 16 clinical orgs · 1 marketing orgs
Phase 1
22
Phase 2
25
Phase 3
2
Phase 4
0
Earliest trial started Nov 1, 2013 (NCT01885897)
Timeline
2020s
- Apr 22, 2024
Altor Bioscience — Earliest FDA Approval
- Apr 22, 2024
Altor Bioscience — NDA Organization
Indications
Approved for
Studied for
- Antiretroviral Therapy, Highly Active · Phase 1
- Breast Neoplasms · Phase 2
- Carcinoma, Hepatocellular · Phase 2
- Carcinoma, Merkel Cell · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2/Phase 3
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 2
- Chordoma · Phase 1/Phase 2
- Colonic Neoplasms · Phase 1
- Colorectal Neoplasms · Phase 2
- Colorectal Neoplasms, Hereditary Nonpolyposis · Phase 2
- DNA Mismatch Repair · Phase 2
- Fallopian Tube Neoplasms · Phase 1
- Hamartoma · Phase 1
- Healthy Volunteers · Phase 1
- HIV · Phase 1
- Hodgkin Disease · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1/Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 1
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Myeloid, Chronic-Phase · Phase 1/Phase 2
- Lung Neoplasms · Phase 2/Phase 3
- Lymphoma · Phase 1/Phase 2
- Lymphoma, Non-Hodgkin · Phase 1/Phase 2
- Melanoma · Phase 2
- Microsatellite Instability · Phase 2
- Multiple Myeloma · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Myeloproliferative Disorders · Phase 1
- Neoplasms · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 1/Phase 2
- Pancreatic Neoplasms · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Prostatic Neoplasms · Phase 1/Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 1/Phase 2
- Rhabdomyosarcoma · Phase 1
- Sarcoma · Phase 1
- Sarcoma, Ewing · Phase 1
- Small Cell Lung Carcinoma · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Stomach Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 2/Phase 3
- Uterine Cervical Neoplasms · Phase 2
Mechanism of action
- Interleukin-15 receptorAGONIST
Interleukin-15 receptor agonist
- Interleukin-15AGONIST
IL15 agonist
Approval history
- approvedFast trackBreakthroughApr 22, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL6068330 ↗
- ChEMBLCHEMBL4297690 ↗
Also known as
- alt803
- alt-803
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07261657 | Early Phase 1 (Phase 1) | Sep 2, 2026 | National Cancer Institute (NCI), Northwestern University |
| NCT07217496 | Phase 1 | Nov 30, 2025 | ImmunityBio, Inc., University of California, San Francisco |
| NCT05419011 | Phase 2 | Nov 1, 2022 | National Cancer Institute (NCI), University of Kansas |
| NCT05096663 | Phase 2/Phase 3 (Phase 3) | Apr 28, 2022 | National Cancer Institute (NCI), Southwest Oncology Group |
| NCT03365661 | Phase 2 | Oct 30, 2018 | University of Minnesota |
| NCT03574649 | Phase 2 | Sep 30, 2018 | NantWorks |
| NCT03554109 | Phase 2 | Sep 30, 2018 | NantWorks |
| NCT03647423 | Phase 1/Phase 2 (Phase 2) | Aug 31, 2018 | NantWorks |
| NCT03563144 | Phase 2 | Aug 31, 2018 | NantWorks |
| NCT03586869 | Phase 1/Phase 2 (Phase 2) | Jul 28, 2018 | NantWorks |
| NCT03228667 | Phase 2 | Jun 30, 2018 | Altor Bioscience |
| NCT03563157 | Phase 1/Phase 2 (Phase 2) | May 25, 2018 | NantWorks |
| NCT03493945 | Phase 1/Phase 2 (Phase 2) | May 1, 2018 | National Cancer Institute (NCI) |
| NCT03381586 | Phase 1 | Jan 8, 2018 | Altor Bioscience |
| NCT03387098 | Phase 1/Phase 2 (Phase 2) | Jan 2, 2018 | NantWorks |
| NCT03197584 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2017 | NantWorks |
| NCT03197571 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2017 | NantWorks |
| NCT03329248 | Phase 1/Phase 2 (Phase 2) | Nov 6, 2017 | NantWorks |
| NCT03003728 | Phase 2 | Aug 1, 2017 | Altor Bioscience, Bristol-Myers Squibb, Hoosier Cancer Research Network |
| NCT03054909 | Phase 1 | Aug 1, 2017 | University of Minnesota |
Showing 20 of 35 trials
Page 1 / 2
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Altor Bioscience | For profit | 10 | 8 | 3 | 2014 |
| NantWorks | For profit | 10 | 10 | 1 | 2017 |
| National Cancer Institute (NCI) | Government | 6 | 2 | 3 | 2014 |
| University of Minnesota | Academic/Hospital | 6 | 6 | 2 | 2013 |
| ImmunityBio, Inc. | For profit | 2 | 1 | 2 | 2025 |
| Washington University in St. Louis | Academic/Hospital | 2 | 2 | 1 | 2014 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2017 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Hoosier Cancer Research Network | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Medical University of South Carolina | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Northwestern University | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Southwest Oncology Group | Academic/Hospital | 1 | 1 | 1 | 2022 |
| State University of New York, Buffalo | Academic/Hospital | 1 | 0 | 1 | 2014 |
| University of California, Los Angeles | Academic/Hospital | 1 | 0 | 1 | 2017 |
| University of California, San Francisco | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Kansas | Academic/Hospital | 1 | 0 | 1 | 2022 |
16 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Altor Bioscience | For profit | NDA | Apr 22, 2024 |