Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nogapendekin alfa inbakicept (NAI), Nogapendekin Alfa Inbakicept (NAI)
Nogapendekin Alfa Inbakicept · 3 trials · 8 indications
Progression-free survival (PFS) as assessed by RECIST 1.1 criteria comparing the experimental treatment arm with the standard-of-care control arm in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC).
Proportion of participants who die from any cause within 28 days of randomization
Proportion of participants who are alive 28 days after the first dose of nogapendekin alfa inbakicept (NAI). Survival status will be determined by review of hospital records and/or direct contact (in person or by phone) on Day 28 after Day 1 dosing.
| Arm | Type | Description |
|---|---|---|
| Phase 2a, Single Arm (Safety Lead-In) | EXPERIMENTAL | Participants will receive neoadjuvant nogapendekin alfa inbakicept (NAI), hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel followed by de-intensified intensity-modulated radiation therapy (IMRT) with concurrent cisplatin, and post-radiation NAI and IBRX-042 during the Phase 2a safety lead-in portion of the study. |
| Arm A | EXPERIMENTAL | Participants will receive neoadjuvant nogapendekin alfa inbakicept (NAI), hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel followed by de-intensified intensity-modulated radiation therapy (IMRT) with concurrent cisplatin, and post-radiation NAI and IBRX-042. |
| Arm B | ACTIVE_COMPARATOR | Participants will receive standard-of-care intensity-modulated radiation therapy (IMRT) with concurrent cisplatin for locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). |
| NAI + Standard of Care | EXPERIMENTAL | NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier if ALC \<700 cells/µL), Day 14, and Day 21 if needed for ALC \<1,000 cells/µL, plus institutional standard of care for sepsis |
| Standard of Care Alone | ACTIVE_COMPARATOR | Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated |
| NAI Plus Standard of Care | EXPERIMENTAL | Critically ill adults with sepsis or septic shock per Sepsis-3 criteria and persistent lymphopenia (ALC ≤ 1,000 cells/µL in two measurements ≥ 12 hours apart) will receive protocolized standard of care plus NAI 1.2 mg subcutaneously on Day 1, with optional doses on Day 14 and Day 21 if still hospitalized (and ALC ≤ 1,000 for Day 21), with monitoring for safety and clinical outcomes for 90 days. |
| Name | Type | Description |
|---|---|---|
| Nogapendekin Alfa Inbakicept (NAI) | DRUG | NAI 1.2 mg administered subcutaneously as part of the experimental treatment regimen. |
| hAd5-HPV Vaccine (IBRX-042) | BIOLOGICAL | IBRX-042 administered subcutaneously as part of the experimental treatment regimen. |
| Nab-Paclitaxel | DRUG | Nab-paclitaxel 100 mg/m² administered intravenously during neoadjuvant treatment cycles. |
| Cisplatin | DRUG | Cisplatin 40 mg/m² administered intravenously concurrently with radiation therapy. |
| De-Intensified IMRT | RADIATION | IMRT 40 Gy, delivered once daily, 5 days/week, over 4 weeks (20 total fractions) |
| Standard of Care IMRT | RADIATION | SOC IMRT 70 Gy, delivered once daily, 5 days/week, over 7 weeks (35 total fractions) |
| Standard of Care (SOC) | OTHER | Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated |
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histolog...
Nogapendekin Alfa Inbakicept (NAI) is an investigational small molecule being studied for sepsis and HPV-positive oropharyngeal squamous cell carcinoma. In sepsis, it is evaluated in patients with persistent lymphopenia and critical illness. In oncology, it is studied in combination with an HPV vaccine and nab-paclitaxel for HPV-positive oropharyngeal cancer.
Nogapendekin Alfa Inbakicept is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IBRX. The company is conducting clinical trials of this investigational agent in sepsis and HPV-positive oropharyngeal squamous cell carcinoma.
Nogapendekin Alfa Inbakicept is in Phase 2 clinical development. It is being studied in two Phase 2 trials, one for sepsis with persistent lymphopenia and one for HPV-positive oropharyngeal cancer. It is also being evaluated in a Phase 1 trial for sepsis. The drug is investigational and not yet approved.
Nogapendekin Alfa Inbakicept is in three clinical trials. NCT07578558 is a Phase 2 study for sepsis with persistent lymphopenia. NCT07628062 is a Phase 2 study for HPV-positive oropharyngeal cancer. NCT07783789 is a Phase 1 study for sepsis. All trials are not yet recruiting and are active.
Yes, Nogapendekin Alfa Inbakicept is also known as NAI. The abbreviation NAI is used interchangeably with the full drug name in clinical trial documentation and research contexts. Both names refer to the same investigational agent being developed by ImmunityBio.