Positive results, expected in Q1 2020, can position SGX301 as the first FDA-approved front-line therapy to treat Cutaneous T-cell Lymphoma (CTCL)

Miami Beach, Florida--(Newsfile Corp. - January 30, 2020) - Soligenix (NASDAQ: SNGX) stock continued its price surge with gains exceeding 95% since the first of the year*. Investors are eyeing the near-term release of topline data for its late-stage drug candidate, SGX301, targeting the treatment of CTCL. If the results are consistent with the expectations from interim analysis guidance, the drug can become the first approved front-line therapy for the disease and fill an unmet medical need. According to Soligenix, additional data reporting on the treatment outcomes at the end of the second and third open-label cycles of the study, as well as safety outcomes at the end of the six-month follow-up period, will be available in the approaching quarters. (For a comprehensive showing of previous Soligenix news and articles, please click )

Interim data already suggests that the drug may be on a path to supplant ineffective CTCL treatment options that primarily manage the discomfort of the associated lesions caused by the disease, which can be extremely painful, itchy, and cosmetically unbecoming. Moreover, is positioning to replace current drugs that are known to potentially increase the risk of contributing to the cause of more lethal cancers created by the mutating of DNA in healthy skin cells. These mutations have been associated with raising the risk of secondary diseases such as melanoma. SGX301 does not share the same DNA damaging characteristics.

As a result of the known risks of current treatment options, the increased probability of perpetuating secondary complications often raises concerns from both patients and caregivers and poses an ethical choice about whether treating the effects of the this chronic cancer outweighs the risk of potentially introducing additional cancers to the patient. In contrast to every marketed CTCL treatment, however, SGX301 may potentially show that it can provide not only a therapeutic benefit to patients but can do so without increasing the risk of secondary disease complications.

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Using Photodynamic Therapy To Treat CTCL

The science contributing to the value of SGX301 is intriguing. Unlike currently available treatments, SGX301 (synthetic hypericin) is a topical drug ointment that a patient applies to their lesions followed by activation of the hypericin with safe, visible fluorescent light therapy. The technology is not new and is often referred to as Photodynamic Therapy, which is a common and well-known treatment among dermatologists. It's also a simple and direct process to battle a complex disease.

The first step involves the patient applying the ointment to their lesions at home the day before an expected doctor's visit, a procedure that allows the hypericin to be preferentially absorbed by the malignant T-cells. The next day, the patient visits the doctor's office and sits or stands in front of a proprietary, safe, fluorescent light device where the lesions get exposed to a specific wavelength of light for an average of 5-7 minutes. This combination of ointment application and light exposure constitutes a single treatment. The treatment course in the company's Phase 3 trial is characterized by two of these treatments per week for a minimum of 6 weeks. Notably, patient retention in the trial is high, which is a good indicator of potential efficacy.

Beyond simple, however, SGX301 as a combination product with the fluorescent light has the potential to be a safe and cost-effective treatment that demonstrates the ability to release free radicals which induce apoptosis (programmed cell death of the lesions). Importantly, though, the SGX301 data shows that cancer cell death is NOT caused by DNA mutation, emphasizing that the hypericin is not a mutagenic agent. Moreover, the light source associated with the treatment is not carcinogenic, and collateral damage to healthy tissue is minimized by applying ointment only on the cancerous lesions themselves and encourages selective uptake of the drug preferentially by malignant T-cells.

Thus, compared to other CTCL therapies, the interim analysis may suggest that the drug is uniquely positioned to become a front-line treatment of choice to caregivers, boosted by the fact that the combined treatment has not been associated with an increased risk of malignancies nor long-term skin cell damage. Ultimately, if approved for use, SGX301 can potentially have a significant impact on how CTCL gets treated and likely become a preferred safe and effective treatment option where no front-line therapy currently exists. Moreover, it may replace a number of secondary therapies that come with significant safety concerns.

Potential Clues from the Interim Analysis

Although the interim trial data is blinded to Soligenix, those following the study may have been provided clues from the Data Monitoring Committee (DMC) that the therapeutic benefit of SGX301 is favorable. Because the Phase 3 trial was designed as an adaptive study, meaning that it included an interim analysis to potentially mitigate risk when extrapolating data from the smaller Phase 2 trial, the unblinded DMC is privileged to review the actual trial data at a certain time point and make recommendations, such as adjustments in sample size to maintain the pre-defined rigorous 90% statistical power.

The read-between-the-lines moment came after the DMC made the recommendation to enroll additional subjects to the trial, implying to observers that they saw a promising drug effect with the treatment. Notably, the DMC had the power at that same time to stop the trial due to futility, especially if the drug could not meet the 90% statistical threshold with re-sizing,. It did none of those things. Instead, many believe that the recommendation was a muted endorsement of interim results, otherwise, exposing new subjects to the treatment would be an unnecessary and perhaps unethical medical choice.

Assuming the DMC recommendation is correct, positive trial results may lead to an ultimate FDA approval for SGX301, and a new front-line drug therapy for patients combating CTCL.

SGX301 Can Bring A $250 Million Market Opportunity

As noted, there is currently no cure for CTCL and no approved front-line treatment. Moreover, with CTCL classified as a chronic cancer, patients may be subject to alternating between available treatments throughout their lifetime, attempting to manage the disease and prevent progression to more fatal advanced illness. Ultimately, and because there is no real leader in the treatment space, a systematic approach to treating the disease is complicated, especially with the results of available drugs not showing meaningful benefit. Those variables may set the stage for SGX301 to potentially fill this area of unmet medical need and bring to patients a drug that is safe, tolerable, and effective.

The primary and vital differentiation of SGX301 in the CTCL treatment market is its expected safety profile. The drug uses a compound that is not mutagenic, is preferentially absorbed by the malignant T-cells, and is highly photosensitive. Inherently advantageous to the treatment is that the drug is combined with a safe light source (fluorescent light vs. ultraviolet light) over a shorter period of exposure, reducing a significant risk of skin damage or secondary cancers. The drug's known safety profile means that SGX301 has the potential to be a preferable long-term treatment approach for many patients at various disease stages, including patients or caregivers that may be delaying all treatment because of the risk of secondary cancers.

Noting the combined benefits of an approved SGX301, analysts at Research suggest that SGX301 has the potential and opportunity to become a preferred CTCL treatment drug and corner what can be as much as a $250 million World Wide market opportunity. They also appear to endorse the note from many of the participating investigators that suggest that if/when SGX301 is approved, the drug will have a definite place in the CTCL armamentarium, where a safe, well-tolerated, front-line therapy is needed.

On Track For Q1 2020 Topline Data Release

Soligenix has reiterated that topline data from the SGX301 trial is expected to get released this quarter. Ahead of the completed study, the company has strengthened its commercial and business expertise at both the Board and senior management level to begin to position the company for expedited growth upon successful Phase 3 results.

The company has alluded to several options for the commercialization of approved drugs, including prospective marketing and development partnerships. Additionally, strategic alternatives available to the company may include mergers, acquisitions, and co-development and/or co-commercialization licensing agreements. And, with the drug's potential to become a front-line option for caregivers, the $250 million per year market is an attractive incentive to companies looking to secure a long-term revenue stream.

Now, with the stock appreciating by more than 95% YTD ahead of the first of two Phase 3 trial data releases, the stock is closing in on the $5.00 per share price target earned from the Zacks Small Cap Research pricing models. Moreover, the increase is likely only related to the promise of the SGX301 trial. It is yet to apply a proper multiple recognition for the company's next near-term potential catalyst resulting from the data release of its second Phase 3 study of SGX942 to treat oral mucositis in patients with head and neck cancer. Topline data from that trial is expected during the Q2 of 2020.

As of January, Soligenix had roughly $7 million in cash, and with the assets on hand has the potential to provide enough capital to complete both of its Phase 3 trials.

Based on the performance of the stock YTD, investors are undoubtedly enthusiastic ahead of the near-term SGX301 data release. Combining the market opportunity, the value inferred from the DMC recommendation, and the capital position of the company, Soligenix may indeed be in the best position in its history to date. And, from a patient perspective, the science behind two of Soligenix's promising drugs may finally bring relief to diseases where no effective treatment is available.

As they say...this can be a win/win proposition.

*YTD stock price appreciation data taken between 01/02/2020 - 01/28/2020

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Ken Ellis
Soulstring Media Group

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