Soligenix Inc. is in an enviable position of being the beneficiary of positive interim data from its two late-stage trials. And, if the topline data expected in the next 6-9 months can confirm interim analyses, Soligenix may extend at least two significant development catalysts that can potentially change the company from a late-stage drug developer to a company that may have the only drug on the market to treat CTCL and oral mucositis in patients with head and neck cancer. Combined, the two drugs may offer Soligenix (NASDAQ: SNGX) investors a near-term opportunity to enjoy the rewards of both an FDA approval and the subsequent commercial launch of at least two promising drugs, SGX301 and SGX942, each targeting unmet medical needs. And, from a time perspective, the good news is that Soligenix is expected to deliver its first potentially transformative catalyst during the first quarter of next year from its FLASH trial to treat cutaneous T-cell lymphoma.

On the heels of that data release, though, Soligenix investors may benefit from a second potential catalyst from the company’s DOM-INNATE trial that is evaluating the effect of SGX942 on head and neck cancer patients suffering from oral mucositis. Topline analysis for that Phase III trial is expected during the first half of 2020. Combined, Soligenix and its investor base may be positioned for at least two substantial catalysts during the next 6-9 months. Notably, the company’s pipeline candidates has been complimented by a stream of positive news generated from both promising Phase II results and positive interim analyses from Phase III trials.

Video Link: http://www.youtube.com/embed/_AjbBBVlfr4

 

Pipeline Promise And Multiple Potential Catalysts in 2020

 

In addition to the topline DOM-INNATE Phase III study results in first half 2020, Soligenix is also on track to deliver its potential catalyst from its first pivotal Phase III clinical trial, referred to as the “FLASH” study, evaluating the benefits of SGX301 in patients with cutaneous T-cell lymphoma (CTCL). The company released in October 2018 that they received a positive recommendation from the independent Data Monitoring Committee (DMC) following interim efficacy analysis in which the independent DMC recommended continuing enrollment and to include an additional approximate 40 patients into the trial to maintain the high statistical power of 90% for the trial’s primary endpoint.

The FLASH Phase III trial uses a novel photodynamic therapy (SGX301), utilizing synthetic hypericin that is activated by safe, visible light, via a proprietary light device. The treatment includes a topically applied dose of synthetic hypericin to lesions on the skin, which has shown a much higher uptake by malignant cells in comparison to healthy, normal cells. Following a period between 16-24 hours of application, the treated area is then exposed to visible fluorescent light, where studies have confirmed that the exposure to light results in the production of singlet oxygen. That reaction from the light is shown to have a unique ability to stimulate the initiation of apoptosis (cell death), resulting in the death of the malignant T-cells.

The FLASH clinical trial is on pace to enroll approximately 160 patients before the end of 2019. Similar to its other ongoing Phase III trial, FLASH is a randomized, double-blind, placebo-controlled study that is evaluating SGX301 in patients with either Stage 1A, 1B, or 2A mycosis fungoides, the most common type of CTCL, with testing taking place in approximately 30 treatment centers across the United States. The primary endpoint of the trial are the percentage of patients achieving a > 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (CAILS) score at the end of the first eight-week cycle compared to the baseline. Secondary endpoints include the duration of response, the degree of lesion improvement, and treatment safety. To date, data and interim analyses are positive.

 

Another Phase III trial is following the FLASH study.

 

Soligenix Targeting Oral Mucositis Market With SGX942; Topline Data Expected In Mid 2020

 

Soligenix’s SGX942 program has also been gaining traction, having piqued the interest of both analysts and investors based on positive interim data and also because the drug is targeting oral mucositis, an important unmet medical need that is in high demand. The Phase II clinical data of SGX942 generated promising results during its proof-of-concept trial in 2015-16, where the drug was administered to 111 head and neck cancer patients and showed that the drug provided a 67% reduction in the duration of severe oral mucositis compared to the placebo group in the patients at the highest risk for developing oral mucositis, reducing the median duration of severe oral mucositis from 30 days (one month) in the placebo group to just ten days in the treated group. Moreover, in addition to the 67% reduction in duration, the Phase II SGX942 study demonstrated a reduction in the median duration of ulcerative oral mucositis.

From a regulatory and approval perspective, the drug to date has been safe, well-tolerated, and appears to have increased the response of cancer treatment by showing that those treated with SGX942 during their chemoradiation procedure experienced a higher rate of complete tumor resolution compared to those in the placebo group. Consequently, the results contributed to the most critical correlation of benefit that showed a positive trend (“P-value” of <0.1) in overall survival for SGX942 treated patients at one-year follow-up evaluations.

More recently, investors may have been provided a clue as to how the drug is performing in its blinded Phase III trial when the independent Data Monitoring Committee (DMC) recommended that Soligenix increase its patient enrollment by 70 patients to maintain the trial’s 90% statistical significance threshold. Keeping in mind that the DMC had the power to end the trial if it thought the data could not meet its endpoint, it instead asked that the trial sample be increased to maintain a 90% statistical power measurement. That news should be interpreted as good. After all, the DMC is not in the business to put patients at risk of adverse events.

Several additional factors weigh toward the positive of the DMC recommendation. First, if the DMC thought the drug could not meet its endpoint, the trial would have most likely been stopped for futility. Second, the DMC cited no safety concerns, which is a significant win for any drug completing late-stage Phase III trials. And, third, instead of limiting the trial, the DMC asked for the company to increase enrollment by 70 patients to maintain statistical power of 90% to validate the study’s primary endpoint. It’s that recommendation that inspired investors to make some positive assumptions, noting that with the trial blinded to Soligenix, the DMC may have offered an indication that they like what they see and want to make sure that the study can maintain a 90% statistical power achievement.

The SGX301 and SGX942 Set The Stage For Near-Term Move

For Soligenix, the quarter beginning in October may be the start of a breakout move for the remainder of 2019-2020. Why? Because while institutional investors tend to make position moves heading into the fourth quarter, they also like to embrace promising positions heading into the new year. Thus, with data from the SGX301 trial expected within a few months and the SGX942 results expected in early to mid-2020, Soligenix may become well-positioned to capitalize on the first of two drugs that can combine to bring more than $500 million in annual revenues. But, additional and potential value from the company’s vaccine programs can also add considerable shareholder value into the coming quarters.

And, while the stock tends to trade down in sympathy with overall weakness in small-cap biotech stocks, SNGX appears to be ideally positioned to further its growth by capitalizing on its government funding and its current cash position of approximately $7 million as of its latest filing. Even better news may be that despite the increase in enrollment to 260 patients from the original 190 study sample size, Soligenix has stated that they are expecting to release topline data during the first half of next year as planned. Thus, the hoped-for catalyst remains a near-term event.

The Soligenix pipeline may bring even greater long-term rewards from the company’s at least five programs targeting markets that can each generate hundreds of millions in potential peak revenues.

 

Bio-defense Vaccine Programs Can Be Substantial Contributors; RiVax® Leads Way

In addition to the late-stage Phase III drug trials, Soligenix is advancing its bio-defense programs that are getting financial support through non-dilutive government grants and contracts. Two products are currently being evaluated, ThermoVax®, and RiVax®. Each can provide significant market opportunities in critical areas of need.

ThermoVax® is a proprietary stabilizing platform technology that allows vaccines comprised of an aluminum salt adjuvant to be kept out of cold storage without affecting the potency of the drug. The platform can be a breakthrough that can eliminate the need for cold storage, contributing to multi-purpose applications and provide critically needed treatment in the battlefield, during extreme power-outage situations, and large scale triage situations. In addition to its stabilizing effect, other vital benefits include ease of storage and for the ability to allow for a national and strategic stockpile of essential vaccines. The ThermoVax® technology has already shown demonstrably positive results with RiVax®, the company’s ricin vaccine. Independent studies showed that ThermoVax® is capable of providing potency protection for the RiVax® vaccine for up to one year at 104° Fahrenheit. Additionally, ThermoVax® demonstrated its ability to protect the potency of vaccine candidates to treat anthrax, HPV, and Ebola for up to twelve weeks at the same high temperatures.

Soligenix lead bio-defense vaccine program, RiVax® (using ThermoVax®), is a heat stable vaccine being developed to protect against exposure to ricin, a lethal toxin used in chemical warfare. During a Phase Ia study, SNGX demonstrated that its vaccine antigen, a mutated version of ricin toxin A chain with no biological activity, is non-toxic and able to induce an immunogenic response. Also contributing to its profile, the alum-adjuvanted RiVax® was also shown to be safe and well-tolerated in a Phase Ib study in human volunteers. Importantly, the antibodies induced through immunization with RiVax® have demonstrated complete protection from a lethal dose of aerosolized ricin in a rhesus macaques vaccine trial conducted in 2015. Soligenix is expected to seek expedited FDA approval for the vaccine under the “animal rule” that relies on studies successfully conducted in animals, including non-human primates.

In 2018, the compelling therapeutic benefits of the vaccine were presented at the Fourth International Conference on Vaccines Research and Development. The vaccine candidate has earned funding through non-dilutive grants awarded from the NIH (over $25 million thus far) and through an up to $24.7 million contract entered into with the NIH in 2014. Based on the encouraging data in an important sector, SNGX is also evaluating the opportunity to apply for a priority review voucher (PRV), which can be a valuable asset to the RiVax® program. Notably, these PRV’s are transferable, and recent PRV’s have traded hands in the biotech and pharma sector at values that exceed $100 million.

SNGX Is Advancing Multiple Opportunities In 2019-2020

For Soligenix, October may be the start of a breakout move for the remainder of 2019-2020. If the data from the SGX301 and SGX942 trial remain positive, Soligenix may become well-positioned to capitalize on at least two drugs that analysts believe can combine to bring more than $500 million in annual revenues. And, that revenue is exclusive of the potential from the vaccine programs that can also add considerable value after their respective and anticipated approvals.

Furthermore, with at least two potential pivotal Phase III catalysts expected within the next six to nine months, Soligenix may in its best position to increase shareholder value in its operating history. Results will dictate the move, and if interim data act as a clue, topline data may impress.

 

Media Contact:

 

Kenny Ellis
Soulstring Media Group
ken@soulstringmedia.com

 

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