Last reviewed · How we verify
HyperAcute-Pancreas Immunotherapy
HyperAcute-Pancreas Immunotherapy is a Cancer immunotherapy vaccine combination Biologic drug developed by NewLink Genetics Corporation. It is currently in Phase 3 development for Metastatic pancreatic cancer (in combination with checkpoint inhibitor). Also known as: HAPa-1 and HAPa-2 immunotherapy components.
HyperAcute-Pancreas is an immunotherapy that activates the patient's immune system to recognize and attack pancreatic cancer cells by combining a tumor-associated antigen vaccine with an immune checkpoint inhibitor.
HyperAcute-Pancreas is an immunotherapy that activates the patient's immune system to recognize and attack pancreatic cancer cells by combining a tumor-associated antigen vaccine with an immune checkpoint inhibitor. Used for Metastatic pancreatic cancer (in combination with checkpoint inhibitor).
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | HyperAcute-Pancreas Immunotherapy |
|---|---|
| Also known as | HAPa-1 and HAPa-2 immunotherapy components |
| Sponsor | NewLink Genetics Corporation |
| Drug class | Cancer immunotherapy vaccine combination |
| Target | Tumor-associated antigens (pancreatic cancer cell surface antigens); PD-1/PD-L1 pathway |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
The therapy uses a genetically modified allogeneic pancreatic cancer cell line expressing the tumor-associated antigen GVAX combined with low-dose cyclophosphamide and a checkpoint inhibitor to break immune tolerance and enhance T-cell mediated anti-tumor immunity. This approach aims to convert the immunosuppressive pancreatic tumor microenvironment into an immunologically active state capable of sustained tumor rejection.
Approved indications
- Metastatic pancreatic cancer (in combination with checkpoint inhibitor)
Common side effects
- Injection site reactions
- Fatigue
- Fever
- Immune-related adverse events
Key clinical trials
- Digital Strategies to Advance Help-Seeking - Aim 3 (NA)
- Dietary Programme and Exercise Training in Combination or Separately on Managing Sarcopenic Obesity in Older Adults (NA)
- TotalCardiology Letters Study (NA)
- Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC) (NA)
- PURI-PRO - Symptoms Impact and eHealth Intervention for Menopausal Women With Urinary Incontinence (NA)
- QT-Digital Mental Health Engagement Study (NA)
- A Health Action Process Approach Online Intervention for People With Multiple Sclerosis (NA)
- Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model (NA)
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 |
|---|---|
| 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:
- HyperAcute-Pancreas Immunotherapy CI brief — competitive landscape report
- HyperAcute-Pancreas Immunotherapy updates RSS · CI watch RSS
- NewLink Genetics Corporation portfolio CI
Frequently asked questions about HyperAcute-Pancreas Immunotherapy
What is HyperAcute-Pancreas Immunotherapy?
How does HyperAcute-Pancreas Immunotherapy work?
What is HyperAcute-Pancreas Immunotherapy used for?
Who makes HyperAcute-Pancreas Immunotherapy?
Is HyperAcute-Pancreas Immunotherapy also known as anything else?
What drug class is HyperAcute-Pancreas Immunotherapy in?
What development phase is HyperAcute-Pancreas Immunotherapy in?
What are the side effects of HyperAcute-Pancreas Immunotherapy?
What does HyperAcute-Pancreas Immunotherapy target?
Related
- Drug class: All Cancer immunotherapy vaccine combination drugs
- Target: All drugs targeting Tumor-associated antigens (pancreatic cancer cell surface antigens); PD-1/PD-L1 pathway
- Manufacturer: NewLink Genetics Corporation — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic pancreatic cancer (in combination with checkpoint inhibitor)
- Also known as: HAPa-1 and HAPa-2 immunotherapy components
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing