Soligenix Inc. (Nasdaq: SNGX) is earning a good deal of investor attention. The stock is higher by roughly 36% since the beginning of May, and several potential near-term catalysts could drive those gains higher. News from the company has been inspiring as highlights from each of its business segments continue to report milestones.
Most recently, Soligenix’s Chief Scientific Officer, Oreola Donini, Ph.D., was featured in a PharmaVOICE podcast after naming her as Woman of the Week, a notable recognition for both Dr. Donini and for the programs she is advancing at Soligenix. In particular, she highlighted the promise of SGX942 (dusquetide) as an innate defense regulator and for its encouraging phase 3 data showing the potential to treat oral mucositis in patients with head and neck cancer. Dr. Donini also provided a fresh look at the company’s public health solutions business segment (PHS).
Like its biotherapeutics program, the PHS segment focuses on unmet medical needs, but in the context of emerging infectious disease and biodefense. The company’s ricin toxin vaccine program (RiVax®) is earning the most attention. In fact, the program is considered a leading global study for the development of a ricin vaccine, with data showing therapeutic potency within animal models. Notably, the vaccine is based on protein technology, which is considered the gold standard for safety in vaccine platforms.
Biodefense Opportunity From RiVax® Program
It’s expected that a successful RiVax® vaccine could be broadly applicable in the biodefense context. Also, there is considerable attention placed on the fact that Soligenix is developing a thermal stabilization platform that allows the vaccine to be exposed to temperatures as high as 40 degrees Celsius and still maintain its potency. This can be an enormous advantage to not only the RiVax® vaccine but also to additional drugs that may need to be stockpiled or distributed worldwide. The stabilization platform can become a substantial opportunity for the company, which is a reason for expanding on the technology with its colleagues at the University of Hawaii at Mānoa . Those studies are evaluating the use of different adjuvants, which can stimulate more immune responses but still maintain an ability to utilize the thermal stabilization technology in the finished product.
Beyond the value to treat ricin poisoning, efficacious data has also been shown in animal models of Filovirus infection. This could lead to eventual vaccines against Ebola or Marburg viral disease. Additionally, the vaccine candidate is clinically convenient for use in endemic regions because it can be shipped at a variety of conditions. It doesn’t need to be kept frozen, and it can be reconstituted with water for injection immediately before use.
The same technology can be extremely relevant in the context of the company’s COVID-19 vaccine effort. Ms. Donini notes that because the antigen for COVID-19 is a glycoprotein, just like the antigens in its Filovirus effort, many of the processes, procedures, and findings from the company’s Filovirus work are directly applicable to treating Coronavirus. The company recently conducted proof of concept studies that have provided promising results.
Investors should keep in mind as well that outside the world of vaccines, the company is continuing to develop its innate defense regulators again in the context of infectious disease and antibiotic-resistant bacteria. These studies are funded by non-dilutive grants, and the research is ongoing with the support of additional government funding.
Focus On Rare Disease And Unmet Medical Needs
The PharmaVOICE podcast kept the company’s focus in check. While Dr. Donini acknowledged that the company is targeting diverse areas, she was clear that the company’s focus is on addressing rare diseases and unmet medical needs. In that context, the company is working to seize opportunities in niche indications, often orphan-designated, where patients don’t have adequate treatment options.
Moreover, she added that the company does its best to identify technologies and opportunities that best use its expertise. This strategy includes running clinical trials from within its own organization, not contracting them out, enabling the company to develop earlier stage assets into later-stage clinical trials rapidly and efficiently. Soligenix’s two phase 3 programs highlight that R&D strategy. One is targeting cutaneous T-cell lymphoma, and the other is focusing on oral mucositis in head and neck cancer patients. Both studies demonstrate how the company can work efficiently to clearly define its understanding of the core technology and how it can be applied. The result leads to a better understanding of the clinical realities of each situation and combines those two concepts to produce an efficient clinical development program with the hope of aiding patients who otherwise don’t have many alternatives.
Building Upon A Milestone Filled 2019
With 2019 being a milestone filled year, the stage may be set for additional catalysts throughout the remainder of 2020. Soligenix CEO Chris Schaber, Ph.D., was featured in a PCG Digital interview last week. He is optimistic that the year is set up well to continue the positive momentum.
He noted that because of the pipeline advancements made in 2019, the company is now positioned for potentially transformational achievements in 2020, even in the face of the world-wide pandemic. The optimism stems from previously announced positive, statistically significant primary endpoint results from its first pivotal Phase 3 study of SGX301 for the treatment of cutaneous T-cell lymphoma (CTCL), which was an important accomplishment.
Also, despite a market shakeup surrounding the COVID-19 outbreak, Soligenix continued to move its clinical ambitions forward, announcing an expansion of its development collaboration with the University of Hawai’i at Mānoa in pursuit of a heat-stable COVID-19 vaccine, called CiVax™. That news was followed by a licensing agreement with Boston Scientific (NYSE: BSX) for its CoVaccine HT™ novel vaccine adjuvant for CiVax™ in April. Soligenix then continued that positive momentum by announcing highly statistically significant follow-on results from the CTCL Phase 3 study. Thus, it’s apparent that the company continues to execute at a high level in the first half of 2020, having achieved some significant milestones.
The second half of the year is set up well. In that same interview, Dr. Schaber noted that as the company turns its focus to the second half of the year, they will remain focused on building upon the positive momentum. That includes not only advancing its vaccine programs but in completing and announcing 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. With the programs outlined, Soligenix has the potential to increase shareholder value by delivering on multiple potential catalysts across its robust rare disease pipeline. Thus, it’s his belief that the best is yet to come in the second half of 2020.
Protein-Based Vaccine Is Gold Standard
Important on all fronts, the Soligenix vaccine platform is based on a protein platform that is considered the gold standard in vaccine safety, especially for immunocompromised and elderly populations. The use of the CoVaccine adjuvant is expected to allow the company to leverage its platform’s safety with strong immunogenic potential. It also adds the potential for rapid scale-up, making the platform a viable and robust vaccine candidate. It’s especially important to note that 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 the company’s ThermoVax® thermostabilization technology, allowing ambient shipping and storage to temperatures as high as 40°C (104°F).
Further, the CoVaccine adjuvant has broader applicability outside of the company’s protein vaccine platform. While there are many advantages inherent to its own platform, the BSX deal raises the possibility of further utilizing the adjuvant in other vaccines. A significant strength of the CoVaccine adjuvant is that it can stimulate both antibody and cell-mediated immunity, and particularly to stimulate Th1 immunity. It’s that Th1 immunity that is believed to be particularly important in the context of COVID-19 vaccines.
The extension of that platform makes the agreement that much more valuable. Indeed, it extends well beyond the COVID-19 applications.
2020 Has More Catalyst Potential From Two Phase 3 Trials
The data from the company’s SGX301 trial targeting cutaneous T-cell lymphoma is well documented. That trial reached a statistically significant endpoint and 12-week data showed continued improvement in patients still being evaluated in follow-up treatments. The company has noted that they are currently conducting primary market research with CTCL clinicians and that the preliminary feedback is very positive. Those supporting the drug as a potential first-line treatment point to the safety profile and its efficacy being viewed as better than or equal to existing therapies. According to Dr. Schaber, SGX301 would potentially be used for all patients with higher than a few percent body surface area involvements. Also, he pointed out that clinicians are telling the company that SGX301 could be an appropriate option to consider for a large portion of early-stage patients.
The company’s second trial is also adding to the value proposition. Soligenix’s pivotal Phase 3 clinical trial of SGX942 (dusquetide) is evaluating its use as a first-line treatment of oral mucositis in patients with head and neck cancer (HNC) also receiving chemoradiation therapy. That trial is moving forward following the positive recommendation from the independent Data Monitoring Committee and has successfully achieved its target enrollment, with the company initially postulating an enrollment of an additional 25 subjects if COVID-19 interruptions became problematic. Now 2-3 months into the pandemic, the company is optimistic that the COVID-19 disruptions have been minimized. Topline data from that trial is expected by the end of this year.
Heading into the back half of the year, the company reported having more than $8M in cash as of March 31, 2020, not including its non-dilutive government funding. And funding is not a primary concern at this point, as additional capital can come from its at-the-market sales issuance agreement with B. Riley FBR, Inc. that can supplement the company’s cash runway as needed. But, Soligenix said that they anticipate having sufficient capital to achieve multiple inflection points across its rare disease pipeline, including top-line results in its SGX942 Phase 3 clinical trial in oral mucositis.
Indeed, Soligenix is well-positioned to continue its positive trend. With multiple potential catalysts and two business segments producing their own respective milestones, the remainder of 2020 can be an exciting period for Soligenix. And although the stock is trending higher, the market cap may have plenty of room to run, especially as the company executes on its clinical and licensing initiatives.
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