For a late-stage rare diseases focused boipharma innovator like Soligenix (OTCQB: SNGX), with up to $58 million of support for its Vaccines/BioDefense segment coming directly from NIAID contract funding (National Institute of Allergy and Infectious Diseases, a division of the NIH), recent news about the success of its BioTherapeutics segment is propitiously timed, amid the company’s move to uplist to NASDAQ. The company enthusiastically executed a 1:10 reverse split early last month (http://nnw.fm/FP0Gt) in preparation for the uplisting, confident that the diligent advancement of its rare diseases pipeline over the preceding years has positioned Soligenix for commercial success, with multiple Phase 2b/3 clinical programs now ready to bear fruit.
A clear 50 percent reduction in the median duration of severe oral mucositis across the board (and a noteworthy 67 percent reduction in the most severely affected) in Phase 2 clinical testing (http://nnw.fm/Q3Qop) on head and neck cancer patients receiving chemoradiation firmly reinforces the potential of the company’s proprietary innate defense regulator (IDR) technology, upon which Soligenix’s SGX942 (http://nnw.fm/4Su7U) (containing dusquetide) is based. Oral mucositis (breakdown and atrophy of the mouth’s mucosal lining) is one of the common problems associated with chemotherapy (as well as radiation therapy or life-threatening bacterial infections), and it represents a significant unmet medical need for which there are no currently approved therapies. Such excellent efficacy results for the Phase 2 clinical trial of SGX942 gives the company a very strong BioTherapeutics candidate to go along with its novel SGX301 (http://nnw.fm/C7sfR) topical photodynamic therapy for cutaneous T-cell lymphoma (CTCL), and SGX203 (http://nnw.fm/m6FRA) oral formulation of BDP (beclomethasone dipropionate) corticosteroid for low-toxicity treatment of Pediatric Crohn’s Disease (gastrointestinal inflammation) – both of which have received FDA Orphan Drug and Fast Track designations.
SGX942’s dusquetide formulation is a first-in-class IDR (short, fully-synthetic peptides) and this Phase 2 clinical trial data provides substantial evidence about the broad-spectrum applicability of IDR technology in other areas, like the one where it was first discovered: infectious disease. Senior VP and CMO for Soligenix, Richard Straube, MD, seemed quite proud of the SGX942 program’s success, explaining that not only does the Phase 2 data validate the same unique biology of IDRs in humans that was observed in previous animal model studies, it also serves as a positive proof of concept for expansion of the IDR platform into other indications, such as infectious disease.
Furthermore, the Phase 2 clinical trial (multi-center, double-blind, placebo-controlled) data on SGX942 reinforces a pivotal concept about IDR technology’s novel mechanism of action and how it enables an extremely promising therapeutic approach vector for a host of diseases. Because IDRs are able to directly interact with a key protein (p62, or sequestosome-1) that helps regulate natural, selective cell degradation, and thus enhance the body’s own immunological tissue-healing and anti-infective capabilities – the technology is increasingly seen by many as a sort of molecular end-run.
Able to act downstream of innate immune receptors, yet upstream from cytokine and chemokine effectors, this implementation of IDR technology is based on modulating the body’s own reaction to injury/infection, and has been shown to also delimit the inflammation associated with tissue damage. Heading off inflammation at the pass by directly interacting at the key intracellular integration point is a bold approach, and a 16 percent higher complete response (tumor completely gone) at the one-month follow up for SGX942 is nothing to sneeze at.
With a strong worldwide IP position on dusquetide and related analogs, as well as Fast Track designation from the FDA for SGX942 and solid Phase 1 safety/tolerability results under its belt, the future looks bright for Soligenix’s newest rising BioTherapeutics star. Perhaps more importantly, this further validation of the potential of the IDR technology opens the door to a broad array of targets for Soligenix, ranging from antibiotic resistant/emerging infectious diseases, to GI tract inflammation. A recent report by BCC Research puts the global market for infectious disease pharmaceuticals and vaccines at around $103.5 billion as of last year, with a roughly 7.7 percent forward CAGR through 2021, when it is anticipated that the combined value of both types will be around $212 billion.
Having secured SME status with the EMA (European Medicines Agency) (http://nnw.fm/yBh73) as of Oct 25, earlier projections about Soligenix by analysts such as Zack’s and Aegis Capital now appear to be unmistakably materializing. EMA logistical support will go a long ways toward taking SGX942 through Phase 3, and Soligenix is now auspiciously knocking on the global pharmaceutical market’s door.
Even without really going into the company’s revolutionary thermostabilization (heat stabilization) technology ThermoVax® (http://nnw.fm/uEeM9), which could eliminate cold-chain production/refrigeration and give (Alum adjuvanted) vaccines long shelf lives at even higher than normal temperatures – the attractiveness of its Vaccines/BioDefense segment should leap out at investors. By working hand-in-hand with NIAID to proactively muster force against high priority bioterrorism and emerging disease fronts, via technology platforms and specific products that are able to address the institute’s primary concerns, Soligenix has positioned itself perfectly from a developmental standpoint.
As President & CEO, Chris Schaber explained in a CEO Clips broadcast on BTV-Business Television (http://nnw.fm/3ATkq), Soligenix has been able to brilliantly leverage its government funding in order to better manage the very cash-intensive BioTherapeutics development which has now set the company up for long-term commercial success. Soligenix’s proprietary vaccine RiVax™ (Ricin Toxin Vaccine) (http://nnw.fm/fhD2U) has been developed through a series of competitive challenge grants and the company has even demonstrated a one year stability of RiVax at prolonged elevated temperatures (104 Fahrenheit) utilizing ThermoVax technology. Properties which made Soligenix’s ThermoVax technology an ideal choice for Hawaii Biotech, Inc. when it came to dry stabilizing the key antigen for their Ebola vaccine (http://nnw.fm/eA296). A distinct advantage over competing Ebola vaccines, which allows the vaccine to be deployed to and easily shipped/stored within precisely those high temperature regions where Filoviruses are endemic.
Soligenix’s OrbeShield® formulation of BDP for GI-ARS (Gastrointestinal Acute Radiation Syndrome) shares considerable technical overlap with the company’s SGX203 formulation for Pediatric Crohn’s Disease, and the same deep understanding of inflammation and tissue damage is apparent in the company’s SGX201 BioTherpaeutic, designed to prevent acute radiation enteritis (inflammatory bowel syndrome resulting from radiation therapy). This kind of inflammation mastery should really inform investors about the core IP valuation of Soligenix, and even if the company’s Vaccines/BioDefense division weren’t heavily government funded, it would still be an exciting commercial biopharma play on the basis of its highly novel BioTherapeutics offerings.
It would be wise to take a closer look at the company’s first-in-class photodynamic therapy for CTCL, as well as its dusquetide IDR SGX943 (http://nnw.fm/7JgVp), designed to combat even gram-negative bacteria such as the one which causes antibiotic-resistant and potentially fatal Melioidosis infection, in order to get a better sense of just how big the end market potential is for Soligenix’s tech envelope. Soligenix’s IP position is likely the real story behind the story, and it will be very interesting to see what enhanced exposure via the NASDAQ uplifting will do.
For more information, visit www.Solgenix.com
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