Potential Near Term Catalyst For Soligenix Approaches; Interim Analysis For SGX942, DOM-INNATE Trial Expected In September (NasdaqCM: SNGX)

MIAMI BEACH, FL / ACCESSWIRE / July 29, 2019 / Soligenix (NasdaqCM: SNGX) stock is trending higher as the company gets closer to releasing the interim efficacy analysis from its Phase III DOM-INNATE trial. Since the beginning of June, SNGX stock is higher by 52%, and the expectation from analysts at Zacks Small-Cap research expect the trend to continue. That expectation is supported by a research report published in July that highlighted the potential in the SNGX pipeline and providing an $8.00 price target in the next 12-months. Assuming their models are correct, a move to the $8.00 level will serve up a more than 580% increase from the stocks most recent price of $1.06 per share.

The recent enthusiasm comes from the already known data from the SGX942 Phase II trial. And, because interim analysis is expected for the Phase III trial in no more than two months, investors appear to want to take a position in the company ahead of the release. SNGX expects that the DOM-INNATE trial will complete enrollment of approximately 190 subjects in 2019 and release top-line final results in the first half of 2020. The Phase III trial, is a randomized, multinational, double-blind, placebo-controlled trial to evaluate SGX942 for the treatment of severe oral mucositis in patients with squamous cell carcinoma of the oral cavity that are undergoing chemoradiation therapy.

Soligenix Targeting Oral Mucositis Market With SGX942; Phase III Interim Analysis In September

Soligenix’s, SGX942 program, is attracting analyst and investor attention based on positive results to date 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, 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, 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 met its pre-specified secondary endpoint that 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.

Pipeline Promise And Multiple Potential Catalysts in 2020

In addition to the pending DOM-INNATE interim results expected in September and the top-line Phase III study results in first half 2020, Soligenix is also on track with its second 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 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 a total of approximately 160 patients, and as of the update from SNGX, more than 120 patients have already been treated. 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 endpoints 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.

Also setting up to provide a near-term catalyst, the FLASH trial is expected to be completed by the end of 2019, followed with final topline data during the first quarter of 2020. If results are positive, it can compound the benefits of expected interim results from its pipeline partner SGX942, which has led to analysts increasing their valuation models ahead of that release.

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 adjutant 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, an abbreviated 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 non-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 (approximately $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 investors, September may be the start to a breakout move for the remainder of 2019-2020. If the data from the SGX942 trial interim result are positive, SNGX may become well-positioned to capitalize on the first of two drugs, SGX942 and SGX301, that can combine to bring more than $500 million in annual revenues. But, investors should not discount the vaccine programs that can also add considerable value to their respective approvals.

Trading at $1.06 as of the close of trading on July 26th, the company is well below recent analyst price targets of $8.00. And, while the stock traded down in sympathy with overall weakness in biotech stocks last week, SNGX appears to be ideally positioned to further its growth by capitalizing on its government funding and its current cash position of $7 million as of its latest filing. For investors, the recent weakness may bring greater opportunity as SNGX is advancing at least five programs targeting markets that can each generate hundreds of millions in potential peak revenues.

Furthermore, with at least two potential pivotal Phase III catalysts expected within the next six to nine months, investors are unlikely to ignore the blue-sky value ahead of its trial release, with the first scheduled in September. And, if that is indeed the case, the stock will likely resume its upward momentum in the coming days.

Media Contact:

Perceptive Advisors, LLC
Kenny Soulstring
Miami Beach, Florida
Editorial@soulstringreport.com

SOURCE: Perceptive Advisors, LLC

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