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Anktiva (INBAKICEPT)
Anktiva works by targeting a specific target to treat BCG-unresponsive nonmuscle invasive bladder cancer.
INBAKICEPT (Anktiva), developed by Altor Bioscience, is a marketed drug specifically indicated for BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ (CIS). Its key strength lies in its targeted mechanism of action, addressing a significant unmet need in this patient population. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | INBAKICEPT |
|---|---|
| Sponsor | Altor Bioscience, Llc, An Indirect Wholly-Owned Su |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Nogapendekin alfa inbakicept-pmln is an IL-15 receptor agonist. IL-15 signals through a heterotrimeric receptor that is composed of the common gamma chain (γc) subunit, the beta chain (βc) subunit, and the IL-15-specific alpha subunit, IL-15 receptor α. IL-15 is trans -presented by the IL-15 receptor α to the shared IL-2/IL-15 receptor (βc and γc) on the surface of CD4 + and CD8 + T cells and NK cells. Binding of nogapendekin alfa inbakicept-pmln to its receptor results in proliferation and activation of NK, CD8 + , and memory T cells without proliferation of immuno-suppressive Treg cells. In vivo, intravesicular nogapendekin alfa inbakicept-pmln alone or in combination with BCG showed anti-tumor activity when compared to BCG alone, in a carcinogen-induced model of bladder cancer in immunocompetent rats.
Approved indications
- BCG-unresponsive NMIBC with CIS
Common side effects
- Urinary Tract Infection
- Dysuria
- Hematuria
- Bladder Irritation
- Musculoskeletal Pain
- Increased Creatinine
- Increased Potassium
- Urinary Frequency
- Micturition Urgency
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer (PHASE2,PHASE3)
- Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (PHASE2)
- A Study to Assess Anktiva in Patients With Long Covid-19. (PHASE2)
- Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia (PHASE3)
- Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS) (PHASE2)
- Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer (PHASE1)
- N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer (PHASE1)
- N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Anktiva CI brief — competitive landscape report
- Anktiva updates RSS · CI watch RSS
- Altor Bioscience, Llc, An Indirect Wholly-Owned Su portfolio CI