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New York, New York–(Newsfile Corp. – March 20, 2020) – Soligenix, on Thursday, announced positive topline data for its lead CTCL drug candidate, SGX301. The published data demonstrated statistically significant efficacy results in treating this challenging and often debilitating chronic cancer. Additionally, this potentially transformative milestone for Soligenix (NASDAQ: SNGX) positions the company to explore strategic partnership and commercialization opportunities to take advantage of what is an expected $250 million drug market opportunity.

The positive preliminary topline results in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial are the result of treating a study enrollment of 169 patients in a randomized 2:1 design to receive either SGX301 or a placebo. Of the 166 evaluable patients treated, a statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) met the primary endpoint assessment at 8 weeks for Cycle 1. Notably, the company announced that the preliminary evaluation of the open-label Cycle 2 results from the study suggests a significantly more robust response rate after 12 weeks of SGX301 treatment. Data from the 12-week cycle is expected to get released during June of 2020.

Importantly, the SGX301 data demonstrate the drug’s potential to fill an unmet medical need, qualify for priority review, and position Soligenix to leverage the drug’s unique ability to serve as a preferred first-line option for the treatment of early-stage CTCL. Additionally, the drug was shown to be safe, well-tolerated, and its mechanism of action is not associated with DNA damage, a critical distinction from other currently available therapies.

SGX301 Shows Statistical Significance in Treating CTCL

A key takeaway from the topline data is that SGX301 showed a statistically significant improvement after just 6 weeks of treatment. Specifically, the data demonstrate that the drug has biologic activity in combating CTCL in a relatively short time window. Moreover, preliminary data from cycle 2 suggest that the drug’s value extends during longer periods of treatment, with patients reportedly responding favorably in 35% after the 12-week cycle, compared to 16% in cycle 1.

The Phase 3 FLASH trial enrolled 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL, and is designed to evaluate three treatment cycles, each of 8 weeks duration. Specifically, treatments were administered twice weekly for the first 6 weeks, and treatment response was determined at the end of the 8th week of each cycle.

Data from the first double-blind treatment cycle included results from 116 subjects that received SGX301 treatment (0.25% synthetic hypericin), and from 50 patients that were provided placebo treatment of their index lesions. Of that group, a total of 16% of the patients receiving SGX301 achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04). Importantly, SGX301 treatment in the first cycle was safe and well-tolerated.

Data from Cycle 2 is also impressive. During the open-label Cycle 2 treatment cycle, all patients received SGX301 treatment. Data from this cohort indicated preliminary results (from blinded data) that suggest more than a 35% response rate (inclusive of patients receiving both 12 weeks and 6 weeks of therapy), indicating the response increases with continued treatment. Results from Cycle 2 are expected to be announced in June 2020.

The trial is further designed with a third (optional) treatment cycle (Cycle 3). In that group, all subjects could receive SGX301 treatment of all their lesions. A definite clue as to the performance of the drug is that the majority of patients enrolled have elected to continue with this optional cycle of the study. Again, extending the treatment beyond 8 weeks has demonstrated no safety concerns from continued use. The company is expected to release the results from Cycle 3 and the subsequent 6-month follow-up after completion of treatment and designated follow-up evaluations.

SGX301 Can Fill A Substantial Unmet Medical Need

CTCL has been particularly difficult to challenge, but the optimistic tone from several of the trial investigators during the topline data release conference call is extremely encouraging toward the drug building a path toward FDA approval.

The disease itself is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Different than most NHLs, however, which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes normally programmed to migrate to the skin. The result of these cancerous cells migrating to the skin induces the formation of various lesions, often beginning as a rash and eventually progressing to raised plaques and tumors as the disease progresses. The visual effects are only one debilitating effect of the disease. The mortality rate from CTCL is more disturbing, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. For Soligenix, the opportunity to address this market can be substantial, as there is no cure for CTCL available to patients. In most cases, the current standard of care provides only temporary relief from CTCL lesions, with most lesions usually returning either in the same part of the body or in new areas.

The CTCL treatment market can be a lucrative opportunity for Soligenix. Although CTCL constitutes a rare group of NHLs, occurring in roughly 4% of the approximate 700,000 individuals living with the disease, published studies and reports indicate that CTCL currently affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually. An NDA filing could come as early as the end of 2020 for this novel drug.

It’s The Differentiation That Makes SGX301 Unique

Protection from the competition is another strength of the SGX301 platform. The differentiation that most separates SGX301 from current, mostly symptom-relieving treatments is its expected effectiveness and its route of administration. Dr. Richard Straube, Soligenix CMO, characterized SGX301 as a topically applied ointment which is activated by visible (not UV) light. Using non-UV light to activate the drug results in the release of superoxide that works in a non-mutative method of action to destroy lesion cells while preserving the surrounding healthy cells. Moreover, the fluorescent light source is entirely non-carcinogenic.

The early topline success of the trial can be further attributed to an advantage of how SGX301 is administered to the patient. After all, of the 169 initially enrolled, to date, the majority have completed through to the optional Cycle 3. The relatively simple process begins when the patient first applies the proprietary ointment to the CTCL-caused lesions, usually at home the night before visiting their physician. The 18-24-hour lapse allows the lotion to be absorbed by the unwanted cancer cells before visiting the physician, who then exposes the lesions to a precisely controlled dose of safe fluorescent light for roughly five to seven minutes. This combination of ointment application and light exposure constitutes a single treatment.

Beyond safe, however, SGX301 as a combination product with the fluorescent light has the potential to be a cost-effective treatment that demonstrates the ability to release free radicals, which induce apoptosis (programmed cell death) of the lesions. Importantly, and also a critical distinction from other treatments, is that the SGX301 data is showing that cancer cell death is NOT caused by DNA mutation. That distinction is essential in emphasizing that the hypericin is not a mutagenic agent. Moreover, the light source associated with the treatment is not carcinogenic. Additionally, 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.

The much-anticipated topline data release did not disappoint on any level. Beyond the statistical significance in patient response compared to the placebo control, the longer-term benefits of treatment show even more therapeutic strength in treating the disease.

And, equally important when it comes to getting drugs to market, Soligenix noted during the SGX301 conference call that they are positioned financially to see both the SGX301 trial and the SGX942 trial conclude later this year without the need to access the markets for additional funding.

Money In The Bank Is Unique To Small-Cap Biotechs, SNGX Has it

According to Dr. Chris Schaber, Soligenix CEO, the company holds approximately $7.6M in cash, not including the anticipated sale of its New Jersey net operating loss carryovers and United Kingdom tax incentive receivable of roughly $1 million. The company also has access to its non-dilutive government funding, which stands at approximately $25 million.

The cash runway allows Soligenix the time to evaluate the potential need for a capital raise only after topline results from its Phase 3 study in oral mucositis is completed. Also, by not being forced early, or at all, to the capital markets to complete the trials, Soligenix is afforded the opportunity to more thoroughly assess commercialization and/or partnership of SGX301 in tandem with preparing for the New Drug Application submission to FDA.

Undoubtedly, the topline data release from the SGX301 FLASH trial can be the first transformative moment for Soligenix. Combing compelling data that is supported by a capital position that allows the company to bargain from a place of strength regarding potential partnerships and commercialization deals, Soligenix is well-positioned to create substantial increases to shareholder value.

Most certainly, the results released on Thursday support the company’s long-standing belief that SGX301 has the potential to be a valuable therapy in the treatment of early-stage CTCL, which is an orphan disease and area of unmet medical need.

And, as investors digest the compelling update from the SGX301 program, eyes, and attentions are also focused on the near-term data release for its oral mucositis treatment, SGX942, as well as from the opportunities presented from its Bio-defense programs. Data from each can contribute toward significant growth in the coming months, making Soligenix a multiple shots-on-goal investment opportunity.

Based on the SGX301 news on Thursday, great things may be happening at Soligenix.

Media Contact
Ken Ellis


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