Soligenix Inc. Heats Up Ahead Of Multiple Potential Catalysts During Next Four Months; Two Phase 3 Trials and CiVax COVID-19 Vaccine Program In Focus

Soligenix Inc.’s (NasdaqCM: SNGX) busy and successful 2019 has set the stage for a potentially transformative period for the company during the back half of 2020. The nearest of two planned updates is expected to come during Q4 of this year when Soligenix announces Cycle 3 data from its Phase 3 FLASH clinical trial of SGX301 in patients with cutaneous T cell lymphoma (CTCL). This release looks to extend the safety data after statistically significant data that showed continued treatment out to 12 weeks results in increased efficacy, as demonstrated by a 40% responder rate (P

A second potential catalyst that can hit in the next four months may come from the company’s second Phase 3 trial, DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity). Topline data from this trial is also expected during the fourth quarter of this year. It evaluates SGX942 for the treatment of oral mucositis (OM) in patients with squamous cell carcinoma of the oral cavity and oropharynx undergoing chemoradiation therapy. In June 2020, the company announced that the trial was fully enrolled with 268 patients and is progressing on schedule following a positive recommendation from the Independent Data Monitoring Committee (DMC) in Aug. 2019 to continue enrollment in the trial. Investors responded well to the DMC request to add approximately 70 additional subjects to the study to maintain the 90% statistical power for the primary outcome, assuming that if the DMC thought the addition of new patients would be futile, they would have stopped the trial. The logic behind that thesis is that the DMC would not subject new patients into a study that was not on track to deliver favorable results. 

A third catalyst, which can be announced at any time, may come from its CiVax™ program. This program is developing a vaccine against SARS-CoV-2, the virus responsible for COVID-19, utilizing the spike protein injected in combination with the CoVaccine HT™ adjuvant. Prior data shows that the CoVaccine adjuvant can stimulate both humoral (antibody) and cell-mediated (T cell) immunity, an important attribute as most of the vaccines furthest along in development are focused mostly on an antibody response. 

Notably, a Soligenix presentation at the 2020 MedInvest Infectious Disease and Immunology Conference (link to watch the presentation here), showed that the company’s SARS-CoV-2 vaccine prototype combined with CoVaccine HT results in a very high antibody titer, particularly compared to the immunogen alone or when dosed with the adjuvant Alhydrogel (alum). It should be noted as favorable that this antibody response was seen after only a single injection. Another significant advantage of the Soligenix vaccine platform is its compatibility with thermostabilization, allowing ambient shipping and storage to temperatures as high as 40°C (104 °F). This is an important differentiator from the COVID-19 vaccines as the cold-chain doesn’t need to be maintained, and deliveries are not as time-sensitive. This compares with the vaccine candidates currently in Phase 3 development that require shipping and storage at -20°C (mRNA vaccines) or 4°C (viral vector).

Soligenix noted that they are continuing to advance both the antigen and adjuvant manufacturing efforts while simultaneously performing additional nonclinical studies. 

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More About The CiVax Opportunity

While the data from the two Phase 3 trials can be transformational to Soligenix’s growth, the CiVax™ vaccine program has also moved into the spotlight for its potential to offer an effective and practical vaccine product. The CiVax™ program is different from competing development strategies and utilizes a protein-based platform that directly introduces the protein into the bloodstream. 

Soligenix believes that its path toward creating a capable vaccine candidate has inherent benefits, and that strategy may be especially true in the race for a coronavirus vaccine. The company notes that while DNA and RNA vaccines have been explored, especially in the context of cancer and veterinary vaccines, there is no DNA or RNA vaccine which has been FDA approved for human use as yet. The viral vectored platforms have had approved products. Still, they are often contra-indicated for use in elderly or immune-compromised populations, and also, often require shipment and storage at freezing temperatures below -60°C. The CiVax™ protein approach addresses these issues directly by applying technology to support ambient shipping /storage applicable to a vast population (no contra-indications). Tackling those issues can be a tremendous asset to any vaccine contender.

The power behind the technology has to do with selecting an adjuvant, a substance added to the vaccine to enhance the body’s immune response to the antigen (which in this case is the Spike protein). In its study, Soligenix uses CoVaccine HT™ as the adjuvant because it has been shown to stimulate both cell-mediated and humoral immunity. The company’s preclinical studies indicate that the response is Th1 balanced – a type of immune response that is believed to be particularly important to protect against COVID-19. Other promising data from the study is revealing itself.

Comparing CiVax To Other Vaccine Studies

Soligenix recently submitted a manuscript for publication detailing the preclinical results with its prototype vaccine. Important data likely to be discussed in the preprint is that CiVax™ produced neutralizing antibody results in mice, which were very strong, and are similar to values measured in convalescent plasma, the liquid part of blood that is collected from patients who have recovered from COVID-19. This may be a critical advantage to Soligenix.

Part of the dilemma that vaccine developers face is that while neutralizing antibody responses can be “species independent” – meaning they can be measured across different species (mouse, non-human primate, human) using the same experiment – there is an unknown as to what a “protective” level of antibody is. There also lacks a clear understanding of how that threshold might change between species. Therefore, despite the markets cheering preliminary data from every “Company A” as a winning hand, some of the enthusiasm deserves a more tempered reaction.

Thus, although positive “preliminary” data, from any company, tend to grab headlines, it’s important to note that test results can change depending on what reagents are used in the chemical analysis. This means that it is sometimes unreliable to compare results between different groups, especially as different analysis methods in the COVID-19 space are still being refined. Soligenix is leveraging its expertise with a different strategic path.

Soligenix is banking on science that shows that the use of protein vaccines is both a well-established technology and the potential gold standard in vaccine development. The company’s easy to use vaccines, formulated as single-dose vials, require a user to add sterile water for injection, mix, and inject. This can likely be done with both the traditional syringe or with needle-free devices. In either case, the delivery system is already developed and readily available.

Moreover, the product’s stability also means that cold-chain storage and delivery does not need to be maintained and that shipments are not particularly time-sensitive. Thus, if products get held up with flight delays, customs inspections, or other logistics, there is no concern about product waste or loss of potency. Perhaps the most critical factor in favor of an approved Soligenix vaccine is that no specialized training is needed to administer the vaccine. These advantages would create a unique ability for the company to manufacture on a large scale and deliver these vaccines worldwide.

Like other companies, Soligenix is focusing on the later-stage evaluation of relevant preclinical data. And as they continue to work closely with its collaborators at the University of Hawaii, its next steps include advancing both antigen and adjuvant manufacturing efforts and conducting further nonclinical studies. The company is also well-positioned to explore several funding alternatives to drive the rapid scale-up of manufacturing required to advance toward potential clinical trials. For more than a decade, Soligenix’s Public Health Solutions business segment has been funded by government grants and awards.

A Transformation Period For Soligenix On Several Fronts

The years of trial research and product development may align to deliver substantial catalyst benefits to the company in the coming months. The two Phase 3 trials have the potential to provide value-creating events in roughly four months. And the SGX301 data has already proven to be statistically significant. Moreover, the DMC nod to increase the study enrollment in the SGX942 trial is also a positive indicator that the study may be meeting its 90% power.

However, the near term ace-in-the-hole may come from the CiVax™ program. With data in that program also showing positive results and the company’s focus on utilizing the benefits of a protein-based vaccine platform, additional positive interim data could send the value of Soligenix substantially higher. Moreover, while the market is focused on a single company developing a single vaccine, the reality is that there will likely be a need for multiple effective vaccines to treat a global population. And that leaves plenty of room for Soligenix, which can manufacture millions of doses quickly through protein-based vaccine technology.

The bottom line – Soligenix has multiple shots on goal and is positioned to deliver meaningful data in the coming months, not years. Therefore, being early on this call could bring exponential rewards to those taking the time to study what, why, and how this company is preparing to capitalize on its multi-targeted pipeline.



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