Rare Disease Pipeline and Programs
Addressing Unmet Medical Needs
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.
Soligenix has specialized expertise in the development of orphan and unmet medical need indications – including the regulatory nuances (e.g., Orphan Drug designation, Fast Track designation, use of adaptive trial designs, etc.) and clinical execution (specialized recruitment approaches, direct site interactions, etc.). Soligenix directly conducts all of its Phase 2 and 3 clinical studies, being in personal contact with the sites and principal investigators, ensuring the highest data quality while streamlining timelines and budgets as we bring products to market through the Soligenix pipeline.
Specialized BioTherapeutics Pipeline
| Preclinical | Phase 1 | Phase 2 | Phase 3 | NDA Review | Market |
|---|---|---|---|---|---|
| HyBryte™ Cutaneous T-Cell Lymphoma (CTCL) Treatment | |||||
|
Preclinical
|
Phase 1
|
Phase 2
|
Phase 3
|
NDA Review
|
Market
|
| SGX942 for Oral Mucositis Treatment | |||||
|
Preclinical
|
Phase 1
|
Phase 2
|
Phase 3
|
NDA Review
|
Market
|
| SGX203 for Pediatric Crohn’s Disease | |||||
|
Preclinical
|
Phase 1
|
Phase 2
|
Phase 3
|
NDA Review
|
Market
|
| SGX302, Plaque Psoriasis Treatment for Mild to Moderate Psoriasis | |||||
|
Preclinical
|
Phase 1
|
Phase 2
|
Phase 3
|
NDA Review
|
Market
|
Orphan and/or Fast Track Designation
Public Health Solutions Pipeline
| Proof-of-Concept | IND | Phase 1 | Phase 2/3 | BLA Review | Market |
|---|---|---|---|---|---|
| RiVax® to Prevent Ricin Poisoning | |||||
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Proof-of-Concept
|
IND
|
Phase 1
|
Phase 2/3
|
BLA Review
|
Market
|
| SGX943 for Bacterial Infection Treatment | |||||
|
Proof-of-Concept
|
IND
|
Phase 1
|
Phase 2/3
|
BLA Review
|
Market
|
| ThermoVax®: Thermostable Vaccines for Global Use | |||||
|
Proof-of-Concept
|
IND
|
Phase 1
|
Phase 2/3
|
BLA Review
|
Market
|
Orphan and/or Fast Track Designation
Soligenix’s Pipeline Programs
Soligenix has two areas of focus:
1) A specialized therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as cutaneous T-cell lymphoma, oral mucositis, pediatric Crohn’s disease, and psoriasis.
2) A Public Health Solutions segment that develops vaccines and therapeutics for military and civilian applications in the areas of ricin exposure, emerging and antibiotic resistant infectious disease, and viral disease including Ebola, Marburg and COVID-19.
Specialized BioTherapeutics
HyBryte™ for the treatment of cutaneous T-cell lymphoma (CTCL)
HyBryte™ is a photodynamic topical therapy using a hypericin ointment activated by visible light which is intended for patients managing early stage CTCL disease progression. HyBryte™ has been granted both Orphan Drug and Fast Track designation in the US, Orphan Drug designation in Europe and Promising Innovative Medicine designation by the UK Health Authority.
A Phase 3 clinical study (FLASH – Fluorescent Light Activated Synthetic Hypericin) is complete. Stay tuned for more information about how this product is moving through the Soligenix pipeline towards approval. This study involved many of the key opinion leaders in CTCL.
SGX942 for the treatment of oral mucositis (OM) in head and neck cancer patients receiving chemoradiation therapy
SGX942 contains the active ingredient dusquetide, a novel Innate Defense Regulator (IDR). IDRs modulate inflammation, enhance tissue healing and prevent and treat infection, all central issues in the development and progression of oral mucositis. SGX942 has been granted Fast Track designation in the US and Promising Innovative Medicine designation by the UK Health Authority.
SGX203 for the treatment of pediatric Crohn’s disease
SGX203 involves a proprietary oral formulation of the corticosteroid beclomethasone dipropionate (BDP) to provide comprehensive topical anti-inflammatory treatment of the gastrointestinal tract. SGX203 has been granted Orphan Drug and Fast Track designations in the US. We have negotiated a comprehensive Phase 3 trial with the FDA for conduct of the study. Study initiation is pending partnership/additional funding.
SGX302 plaque psoriasis treatment for mild to moderate psoriasis
Using the same active ingredient as HyBryte™, SGX302 is a topical formulation with photosensitizing activity. Effective treatment of psoriasis lesions has been demonstrated in a Phase 1/2 proof of concept study, with a follow-on Phase 2 study planned to begin in H2 2022.
Public Health Solutions
Within our Public Health Solutions segment, Soligenix is primarily focusing on our ricin toxin vaccine program, with other programs pending identification of additional non-dilutive funding sources (e.g., government grants and contracts).
RiVax®, a ricin toxin vaccine for the prevention of ricin intoxication
RiVax® is a subunit protein vaccine candidate which is thermostabilized with our proprietary ThermoVax® technology, yielding an easily stored and transported vaccine which does not require refrigeration or freezing, has a long shelf life and has shown an excellent safety profile in clinical trials. RiVax® has the potential to be awarded an FDA Priority Review Voucher upon approval and is targeted for use in military personnel and civilian emergency responders for the prevention of ricin intoxication. RiVax® has been granted Orphan Drug designation in the US and Europe. We are currently planning to initiate a Phase 2 clinical study to further test the safety and immunogenicity of RiVax® while also collecting efficacy data in animals to facilitate approval under the FDA Animal Rule.
ThermoVax®, a proprietary platform for vaccine thermostabilization
ThermoVax® is a proprietary heat stabilization platform which allows subunit protein vaccines to be co-lyophilized with alum – yielding an adjuvanted, thermostable powder which can be reconstituted with water for injection immediately prior to use. This unique formulation allows for ambient storage of the vaccines for extended periods of time, foregoing requirements for cold chain storage and shipping. ThermoVax® has been incorporated into the RiVax® product candidate, with additional proof of concept generated with Ebola and HPV vaccines.
SGX943 for the prevention/treatment of emerging and antibiotic resistant infectious disease
SGX943 contains the same active ingredient, dusquetide, as SGX942. The anti-infective action of SGX943, increasing the innate immune response to infection while still controlling inflammation, is of significant importance in many serious infections, where the inflammation is as life-threatening as the infection itself. Because SGX943 interacts with the immune system, and does not directly kill the bacteria, it has been shown to be effective in clinical trials irrespective of the type of bacteria involved or any antibiotic resistance which may have developed. SGX943 has received Fast Track designation in the US for the treatment of melioidosis (a bacterial infection caused by the bacteria Burkholderia pseudomallei).