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Rare Disease Pipeline

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.

Specialized BioTherapeutics

PreclinicalPhase 1Phase 2Phase 3Market
SGX301 for Cutaneous T-Cell Lymphoma (CTCL)
Preclinical
Phase 1
Phase 2
Phase 3
Market
SGX942 for Oral Mucositis
Preclinical
Phase 1
Phase 2
Phase 3
Market
SGX203 for Pediatric Crohn’s Disease
Preclinical
Phase 1
Phase 2
Phase 3
Market
SGX201 for Radiation Enteritis
Preclinical
Phase 1
Phase 2
Phase 3
Market

Orphan and/or Fast Track Designation

Denotes funding in whole or in part by NIH, BARDA and/or FDA.

Public Health Solutions

Proof-of-ConceptINDPhase 1Phase 2/3Market
RiVax® to Prevent Ricin Poisoning
Proof-of-Concept
IND
Phase 1
Phase 2/3
Market
OrbeShield® for Acute Radiation Syndrome
Proof-of-Concept
IND
Phase 1
Phase 2/3
Market
SGX943 for Infectious Disease
Proof-of-Concept
IND
Phase 1
Phase 2/3
Market

Orphan and/or Fast Track Designation

Denotes funding in whole or in part by NIH, BARDA and/or FDA.

About Our Pipeline

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 acute radiation enteritis, and 2) a public health segment involving vaccine and biodefense applications with specific programs in the prevention of ricin intoxication, the treatment of  acute radiation syndrome, and the prevention/treatment of emerging and antibiotic resistant infectious disease. Soligenix’s major programs are reviewed in our corporate presentation.

Specialized BioTherapeutics

Soligenix is focusing on two key programs, with an additional two earlier stage programs:

SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL)

SGX301 is a photodynamic topical therapy using a hypericin ointment activated by visible light which is intended for patients managing early stage CTCL disease progression. SGX301 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 currently enrolling in the US, targeting 160 evaluable subjects after completing an interim analysis in late 2018.  This study involves may of the key opinion leaders in CTCL. Interested in participating in our FLASH study?

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.

We are currently conducting a multi-national Phase 3 trial (DOM-INNATE – Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) in the US and Europe. Interested in participating in our DOM-INNATE study?

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.


SGX201 for the treatment of acute radiation enteritis

Using the same active ingredient as SGX203, SGX201 is an oral formulation targeted at the lower gastrointestinal tract to mitigate the impact of radiation therapy applied to the pelvic area during cancer treatment. SGX201 has Fast Track designation in the US. With the completion of an initial Phase 1/2 study, the SGX201 program is pending additional partnership/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. 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.


OrbeShield® for the treatment of gastrointestinal acute radiation syndrome (GI ARS)

OrbeShield® contains the same active ingredient and proprietary formulation as SGX203 and is being specifically considered for the treatment of acute radiation injury to the gastrointestinal tract, an acute inflammatory condition that occurs after exposure to high levels of radiation. OrbeShield® has been awarded Orphan Drug and Fast Track designations in the US for the prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.


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).