Soligenix Inc. (NasdaqCM: SNGX) has been catching the attention of investors. Since May, shares are higher by roughly 28% and closed the trading week at $1.96 per share. Several newsworthy events are likely contributing to the rise.
First, the company’s shares are now included in the Russell Microcap® Index, a listing that remains in place for one year and means automatic inclusion in the appropriate growth and value style indexes. Second, Soligenix announced it has completed patient enrollment in its Phase 3 DOM-INNATE (“Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity”) study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer patients. The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent Data Monitoring Committee (DMC). With enrollment completed, top-line results are expected in the fourth quarter of 2020.
Finally, investors appear focused on the positive top-line data for its SGX301 trial, targeting cutaneous T-cell lymphoma. Trial data was released in March that showed a statistically significant benefit to patients treated in the study. Additional 12-week follow-on data showed continued patient improvement for the indication.
For Soligenix, potential catalysts are lining up to make the remainder of 2020 a potentially transformative event for the company.
SGX301 Data Impresses Clinicians
Soligenix made significant pipeline advancements in 2019, and those efforts have positioned the company for potentially transformational achievements in 2020, despite the headwinds associated with the worldwide pandemic.
The good news started last March. The company announced positive statistically significant primary endpoint results from its first pivotal Phase 3 study of SGX301 for the treatment cutaneous T-cell lymphoma (CTCL), an important milestone for the company. Unfortunately, the data was released at the height of US concern surrounding the COVID-19 outbreak. The results showed statistically significant benefit to patients in the study, with follow-on data at the 12-week visit indicating that the drug continues to improve CTCL with continued treatment.
Those results have led the company to conduct primary market research with CTCL clinicians, and according to the company, the preliminary feedback for the drug’s marketing potential is very positive. In general, clinicians point to the significant need for additional treatment options that can provide relief with fewer side effects, especially as a first-line treatment.
Moreover, indications suggest that these clinicians are attracted to the safety profile of SGX301 and view its efficacy as better than or equal to existing therapies. The drug has also been characterized as a potentially best-in-class option for all patients with higher than a few percent body surface area involvement. They also noted that SGX301 could be an appropriate option to consider for a large portion of early-stage patients. Even mega-caps like Regeneron Pharmaceuticals (NASDAQ: REGN), a competitor in the cancer space, may feel the pinch of a successfully commercialized SGX301.
Collaborations Present Milestone Potential In 2020
Soligenix also entered and expanded clinical collaborations to set the stage for growth in its other business segments. The company announced the expansion of its development collaboration with the University of Hawaiʻi at Mānoa in pursuit of a heat-stable COVID-19 vaccine, CiVax™.
Taking a different approach from others in the vaccine race, the Soligenix vaccine platform is based on a protein vaccine platform that is known for vaccine safety, especially for immunocompromised or elderly populations. Also, the use of the CoVaccine HT™ adjuvant, licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (Nasdaq: BSX), is expected to enhance the safety profile of its platform with strong immunogenic responses, and also allows for rapid scale-up. An important note that can’t be underappreciated is that while many vaccines require cold storage and shipment, the
Soligenix vaccine platform, including CoVaccine HT™, is compatible with thermostabilization. This advantage allows for ambient shipping and storage to temperatures as high as 40°C (104 °F). Using this platform, CiVax™ has the potential to be a potent vaccine candidate.
Noted above, the company entered into an agreement with Boston Scientific for a novel adjuvant, which they envision augmenting its existing vaccine platform. The applications in that respect not only address coronavirus (COVID-19) but also may be valuable in the context of pandemic flu and the need for the strategic national stockpile to have critical components for vaccines available.
Acknowledging that no single vaccine technology will be appropriate for all subpopulations (e.g., immunocompromised), particular attention must be paid to vaccine candidates’ potential for mass production to provide enough doses to cover all populations worldwide. That need plays to Soligenix’s favor.
Soligenix notes that the use of the CoVaccine adjuvant may allow the company to leverage its platform’s safety with strong immunogenic potential. It can also facilitate the potential for rapid scale-up, which adds to the case that the program can deliver a strong vaccine candidate. Notably, as referenced above, while many vaccines require cold storage and shipment, complicating logistics especially in the context of rapid roll-outs, the Soligenix vaccine platform, including CoVaccine, is compatible with its ThermoVax® thermostabilization technology, allowing ambient shipping and storage to temperatures as high as 40°C (104°F).
Also, potential add-on indications generated in the context of COVID-19 will further support the use of the vaccine platform (and the adjuvant) in the context of both pandemic flu and the strategic national stockpile.
Each of the programs and collaborations presents compelling milestone opportunities in the coming quarters. And although not there yet, BioXcel Therapeutics Inc.( Nasdaq: BTAI) is an example of how far Soligenix can come. BioXcel is also a clinical stage biopharmaceutical company focused on drug development which utilizes novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology. With their billion-dollar market cap, it’s an example of how investors reward the winners.
SGX942 On Deck For End Of Year Data Release
The back half of 2020 also presents opportunity from the completion and announcement of top-line results from its other pivotal Phase 3 study with SGX942 in the treatment of oral mucositis in patients with head and neck cancer. Oral mucositis is a debilitating side effect of cancer treatment. There is no FDA-approved drug for oral mucositis in patients undergoing treatment for solid tumors.
While many treatment approaches have failed, dusquetide (an Innate Defense Regulator and the active ingredient in SGX942) is unique in its mechanism addressing the underlying innate immune dysfunction that contributes to the severity and duration of mucositis. Administered twice weekly by a brief 4-minute IV infusion during chemoradiation treatment while patients are otherwise present at their clinician’s office or hospital, SGX942 may be a clinically convenient and safe approach to mitigating oral mucositis. Topline data is expected to be released before the end of 2020.
Now, with several programs in focus, the second half of the year is positioned for Soligenix to build on the positive momentum from the past two years. With the programs outlined, Soligenix may be in its best position ever to provide shareholder value by delivering on multiple potential catalysts across the company’s robust rare disease pipeline. Perhaps, the best is yet to come in the second half of 2020.