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United Therapeutics Europe Ltd
United Therapeutics is a pharma organization headquartered in Silver Spring, USA. It trades on NYSE under ticker UTHR. Primary therapeutic focus areas include Breast Cancer, Prostate Cancer, Pulmonary Arterial Hypertensi
Phase 2 · mab · Malaria
WRAIR 1550 is a DNA vaccine prime program for malaria sponsored by United Therapeutics Europe Ltd, currently in Phase 2 development. The program represents an investigational approach to malaria immunization using DNA vaccine technology as a priming agent. As of February 2021, the program has completed Phase 2 clinical
Internal code WRAIR 1550
WRAIR 1550 is a DNA vaccine prime program for malaria sponsored by United Therapeutics Europe Ltd, currently in Phase 2 development. The program represents an investigational approach to malaria immunization using DNA vaccine technology as a priming agent. As of February 2021, the program has completed Phase 2 clinical evaluation. The development strategy focuses on malaria prevention through novel vaccine modality, addressing a significant global health burden. The program is associated with clinical trial NCT00870987 and involves evaluation in human subjects. Current regulatory status indicates the program remains in clinical development with no approval disclosed to date. The latest program milestone was recorded in February 2021, though specific details of that milestone outcome are not yet disclosed. Peak sales projections and consensus market positioning have not been publicly disclosed. The program's advancement through Phase 2 represents progress in exploring DNA vaccine technology for malaria prophylaxis, though further clinical development requirements and regulatory pathways remain to be determined.
Malaria remains a significant global health burden, with hundreds of millions of infections and hundreds of thousands of deaths annually, particularly affecting children and pregnant women in sub-Saharan Africa. Current malaria prevention relies on antimalarial drugs, insecticide-treated bed nets, and indoor residual spraying, with limited vaccine options available. The development of effective malaria vaccines represents a critical unmet medical need, particularly vaccines that can provide durable protection and reduce transmission. DNA vaccine technology offers a novel approach to malaria immunization, potentially enabling rapid manufacturing, thermal stability advantages, and enhanced immune responses compared to conventional vaccine platforms. The competitive landscape includes established vaccines like INFANRIX HEXA (combination vaccine) and emerging vaccine candidates across multiple modalities. A successful DNA vaccine prime for malaria could address significant market opportunity in endemic regions and contribute to global malaria elimination efforts. The program's Phase 2 completion suggests advancement toward potential Phase 3 efficacy evaluation, though commercial viability and regulatory approval pathways remain uncertain. Market relevance extends to both endemic country immunization programs and travelers' prophylaxis markets, representing substantial commercial potential if efficacy and safety profiles support approval.
Drug Class: Investigational DNA vaccine for malaria prevention
Modality: DNA vaccine (nucleic acid-based immunotherapy)
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Route of Administration: Not yet disclosed
Related Therapies: The program is evaluated alongside INFANRIX HEXA (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type-b combination vaccine), suggesting potential co-administration or comparative immunogenicity studies. Competitive vaccine landscape includes QDENGA (dengue vaccine by Takeda), VAXCHORA (cholera vaccine), and IXCHIQ (Japanese encephalitis vaccine), representing diverse vaccine modalities in infectious disease prevention.
First Approval: Not yet approved; program remains in clinical development
Patent Status: Not yet disclosed
Prevalence: Point prevalence: 1-9 / 100 000 (Europe) — source: Orphanet, validated.
Malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. Infection with malaria parasites may result in a wide variety of symptoms, ranging from absent or very mild symptoms to severe disease and even death. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness. In general, malaria is a curable disease if diagnosed and treated promptly and correctly.Treatment depends on many factors including disease severity, the species of malaria parasite causing the infection and the part of the world in which the infection was acquired.
ClinicalTrials.gov lists 860 registered studies for Malaria (AACT aggregate).
Phase breakdown: NA (334), PHASE1 (158), PHASE4 (123), PHASE3 (108), PHASE2 (78), PHASE1/PHASE2 (41), PHASE2/PHASE3 (15), EARLY_PHASE1 (3)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0005136), Orphanet — malaria, NCT00001645, NCT00075049, NCT00111163, NCT00114010, NCT00115921, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 2 enrollment and evaluation
Phase 2 clinical trial NCT00870987 conducted to evaluate DNA vaccine prime for malaria.
Phase 2 completion
Latest program milestone recorded; specific outcome details not yet disclosed.
The malaria vaccine landscape includes established combination vaccines such as INFANRIX HEXA (GlaxoSmithKline), which combines multiple antiinfectives and is approved in the EU. The broader vaccine competitive environment includes QDENGA (Takeda, dengue vaccine, approved), VAXCHORA (cholera vaccine, approved), and IXCHIQ (Japanese encephalitis vaccine, approved), representing diverse vaccine platforms and infectious disease indications. Competitor MRESVIA (Teva Pharma GmbH, respiratory syncytial virus vaccine) and COMIRNATY (Teva Pharma GmbH, COVID-19 vaccine) represent approved vaccines using alternative modalities including fusion glycoprotein and spike glycoprotein antigens. Additional approved vaccines in the competitive set include TRITANRIX HEPB, M-M-RVAXPRO, FLUCELVAX, MCOMBRIAX, HEXYON, and FOCETRIA, representing established vaccine platforms across multiple indications. The DNA vaccine prime approach for malaria represents a distinct technological strategy compared to conventional inactivated, live-attenuated, or protein-based vaccine competitors. Competitive differentiation would depend on efficacy, safety, durability of protection, manufacturing advantages, and regulatory approval timelines relative to existing and emerging malaria vaccine candidates.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| MRESVIA | Teva Pharma GmbH | Fusion glycoprotein F0 vaccine antigen | approved |
| COMIRNATY | Teva Pharma GmbH | Spike glycoprotein vaccine antigen | approved |
| QDENGA | Takeda | Biological vaccine - induces immune response | approved |
| MCOMBRIAX | Teva Pharma GmbH | — | approved |
| TRITANRIX HEPB | — | — | approved |
| M-M-RVAXPRO | — | — | approved |
| FLUCELVAX | — | — | approved |
| VAXCHORA | — | Biological vaccine - induces immune response | approved |
| IXCHIQ | — | Biological vaccine - induces immune response | approved |
| COVID-19 VACCINE (INACTIVATED, ADJUVANTED) VALNEVA | — | Biological vaccine - induces immune response | approved |
| FOCETRIA | — | — | approved |
| HEXYON | — | — | approved |
| QUINIDINE GLUCONATE | — | Sodium channel alpha subunit blocker | Approved |
| HYDROXYCHLOROQUINE SULFATE | — | Toll-like receptor 7 antagonist | Approved |
| HYDROXYCHLOROQUINE | — | Toll-like receptor 7 antagonist | Approved |
| DOXYCYCLINE | — | Matrix metalloproteinase 8 inhibitor | Approved |
| DEXAMETHASONE | — | Glucocorticoid receptor agonist | Phase 3 |
| CYTARABINE | — | DNA polymerase (alpha/delta/epsilon) inhibitor | Phase 3 |
| ACETAMINOPHEN | — | Cyclooxygenase inhibitor | Phase 3 |
| PENTOXIFYLLINE | — | 3',5'-cyclic phosphodiesterase inhibitor | Phase 2 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
European Medicines Agency (EMA): INFANRIX HEXA (diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type-b vaccine) is approved by EMA under EMEA/H/C/000296, with Marketing Authorization Holder GlaxoSmithKline Biologicals S.A. and authorization date of 12/02/2026. WRAIR 1550 DNA vaccine prime regulatory status with EMA not yet disclosed.
United States FDA: Regulatory status and approval pathway for WRAIR 1550 not yet disclosed.
China NMPA: Clinical trial activity noted with multiple NCT identifiers (NCT01507857, NCT02003495, NCT02302170, NCT03357289, NCT07077356) indicating vaccine development in clinical trials phase in China.
Japan PMDA: Regulatory status not yet disclosed.
Overall Status: WRAIR 1550 remains in clinical development with Phase 2 completion as of February 2021. No regulatory approval, filing, or formal development agreement status has been disclosed.
WRAIR 1550 is an investigational DNA vaccine prime program sponsored by United Therapeutics Europe Ltd for malaria prevention. It represents a novel vaccine approach using DNA technology as a priming agent to generate immune protection against malaria infection.
The specific mechanism of action for WRAIR 1550 has not yet been disclosed. DNA vaccines typically work by introducing genetic material that encodes pathogen antigens, allowing host cells to produce the antigen and generate immune responses.
WRAIR 1550 is in Phase 2 development and has completed Phase 2 clinical evaluation as of February 2021. No subsequent development milestones or regulatory status have been disclosed.
WRAIR 1550 is sponsored by United Therapeutics Europe Ltd. No formal development partners or licensing arrangements have been disclosed.
No, WRAIR 1550 is not approved. The program remains in clinical development with no FDA, EMA, PMDA, or NMPA approval disclosed.
The primary trial is NCT00870987. Additional vaccine development trials in China include NCT01507857, NCT02003495, NCT02302170, NCT03357289, and NCT07077356, though specific associations with WRAIR 1550 are not formally disclosed.
Primary efficacy and safety endpoints for WRAIR 1550 clinical trials have not yet been disclosed.
The route of administration for WRAIR 1550 has not yet been disclosed.
The target population for WRAIR 1550 has not been formally disclosed, though malaria vaccines are typically developed for endemic populations and travelers to malaria-endemic regions.
WRAIR 1550 uses DNA vaccine technology, which differs from conventional vaccine platforms. Competitive vaccines include combination vaccines like INFANRIX HEXA and other infectious disease vaccines. Specific comparative efficacy data has not been disclosed.
Expected next milestones have not been disclosed. Potential future catalysts could include Phase 3 trial initiation, regulatory submissions, efficacy data readouts, or partnership announcements.
Peak sales projections for WRAIR 1550 have not been disclosed.
Patent status for WRAIR 1550 has not been disclosed.
Malaria remains a significant global health burden with hundreds of millions of infections annually. Current prevention relies on antimalarial drugs and bed nets, with limited vaccine options, creating substantial unmet need for effective immunization strategies.
DNA vaccines offer potential advantages including rapid manufacturing, thermal stability, reduced cold-chain requirements, and enhanced immune responses compared to conventional vaccine platforms, making them attractive for malaria prevention in resource-limited settings.
A successful malaria vaccine represents substantial commercial opportunity in endemic country immunization programs, travelers' prophylaxis markets, and global health initiatives, with potential for significant market penetration if efficacy and safety profiles support approval.
DNA vaccine prime → Drug → Target → Indication → Company → Trials → Competitors
Development Status: WRAIR 1550 completed Phase 2 evaluation as of February 2021, with no subsequent milestone disclosures in the available data. The program's current status post-Phase 2 completion remains unclear, including whether Phase 3 advancement has occurred or whether development has been paused or discontinued.
Strategic Implications: United Therapeutics Europe Ltd's investment in DNA vaccine technology for malaria represents exploration of novel immunization approaches. The association with multiple clinical trials in China (NCT01507857, NCT02003495, NCT02302170, NCT03357289, NCT07077356) suggests geographic focus on endemic regions and potential partnership or collaboration arrangements not yet formally disclosed.
Competitive Positioning: DNA vaccine modality offers potential manufacturing advantages including rapid scale-up, thermal stability, and reduced cold-chain requirements compared to conventional vaccine platforms. However, competitive differentiation requires demonstration of superior efficacy, safety, and durability compared to existing and emerging malaria vaccine candidates.
Regulatory Pathway Uncertainty: No regulatory filing, approval, or formal development agreement has been disclosed. The program's advancement to Phase 3 or regulatory submission status is not yet disclosed, limiting visibility into near-term catalysts.
Future Catalysts: Potential milestones include Phase 3 trial initiation or completion, regulatory submissions to EMA or FDA, efficacy data readouts, and formal partnerships or licensing agreements. The absence of disclosed milestones since February 2021 suggests either confidential development progression or program deprioritization.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.