Soligenix pipeline

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

PreclinicalPhase 1Phase 2Phase 3NDA ReviewMarket
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

Denotes funding by NIH, BARDA, DTRA and/or FDA.

Public Health Solutions Pipeline

Proof-of-ConceptINDPhase 1Phase 2/3BLA ReviewMarket
RiVax® to Prevent Ricin Poisoning
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

Denotes funding by NIH, BARDA, DTRA and/or FDA.

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, psoriasis, oral mucositis, Behçet’s disease, and pediatric Crohn’s disease.

2) A Public Health Solutions segment that develops vaccines and therapeutics for military and civilian applications in the areas of ricin exposure 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.


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.


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.

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.