Based on a Soligenix, Inc. (Nasdaq: SNGX) press release on Monday, the company was bustling in 2019 and continued so in 2020 by reaching its first milestone achievement – earning positive topline results for its pivotal Phase 3 FLASH trial to treat patients with cutaneous T-cell lymphoma (CTCL). Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.

The most recent highlight for Soligenix came in March of this year when the company announced that it achieved positive topline results in its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial that demonstrates SGX301’s potential to be an important new treatment for early-stage cutaneous T-cell Lymphoma (CTCL). 

Specifically, the results demonstrated statistical significance in the study’s primary endpoint, and positions Soligenix in an optimistic posture when they report results from the extended treatment portion of the trial, which is anticipated in June 2020. 

Soligenix had additional positive news for its second Phase 3 trial targeting treatment of oral mucositis in patients with head and neck cancer.

SGX942 Trial Results Expected In Q4 of 2020

Soligenix also updated its guidance for its SGX942 trial. Following the positive recommendation received from the independent Data Monitoring Committee, the company successfully achieved its target of 260 patients randomized into the pivotal Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. However, due to the uncertainty surrounding the Coronavirus pandemic, the company has decided to enroll approximately 25 additional patients into the study. 

According to the company, the increase in enrollment is a cautious approach to maintain the statistical integrity of the trial and is a safeguard to account for patients that may potentially drop out of the study before completing their protocol required study treatment and evaluation. The increased enrollment has pushed the expectation for topline results from the second quarter of 2020 to the fourth quarter of 2020. The company noted, though, this will remain dependent on the medical and logistical challenges caused by the Coronavirus showing a reasonable level of improvement in the relative near-term.

Public Health Solutions Segment Tests Heat-Stabilization

Good news also came from the company’s Public Health Solutions business segment. Soligenix CEO, Chris Schaber, PhD., noted, “Under our Public Health Solutions business segment we continue to progress our heat-stable ricin vaccine, RiVax®, with the support of a National Institute of Allergy and Infectious Disease contract award of up to $24.7 million. We are also excited to advance our work with University of Hawaiʻi at Mānoa (UH Mānoa) beyond filovirus vaccines (protecting against viruses such as Ebola and Marburg) to the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19. With over $7.5M in cash, not including our State and Federal funding, we anticipate having the cash resources sufficient to achieve multiple inflection points across our rare disease pipeline, including topline results in our SGX942 Phase 3 clinical trial in oral mucositis.”

The update also provided a long list of accomplishments for the year 2019 and the first quarter of 2020:

• On March 23, 2020, the Company announced that it expanded its research collaboration with UH Mānoa to investigate potential coronavirus vaccines. The Company and UH Mānoa are expanding the technology platform, developed as part of their filovirus program, to assess compatibility with coronaviruses including SARS-CoV-2, the cause of COVID-19. The resulting vaccines have the potential to be broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised.
• On March 19, 2020, the Company announced positive preliminary top-line results for its pivotal Phase 3 FLASH trial evaluating SGX301 (synthetic hypericin) in the treatment of CTCL. The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1.

• On February 13, 2020, the Company announced that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication had received “Fast Track” designation from the FDA.

• On February 3, 2020, the Company announced that its ongoing collaboration with the UH Mānoa and Hawaii Biotech Inc. had resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus).

• On February 3, 2020, the Company announced that the Japanese Patent Office had granted the patent titled “Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis.” This allowance builds on similar intellectual property in the US, New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide. The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide.

• On January 14, 2020, the Company issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber.

• On December 18, 2019, the Company announced that it had received preliminary approval for a tax credit from the New Jersey Economic Development Authority’s (NJEDA) New Jersey Technology Business Tax Certificate Transfer program. As a result, the Company anticipates being able to transfer this credit and receive approximately $850,000 in net proceeds.

• On December 3, 2019, the Company announced it had completed patient enrollment in its Phase 3 FLASH study for SGX301 in the treatment of CTCL. The study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent Data Monitoring Committee.

Zacks Small-Cap Research Increases Price target To $12.00

March also brought more attention from analysts. Zacks Small-Cap Research updated its coverage on Soligenix and raised its valuation of the stock to $12.00 per share. The increase is based on its adjusted DCF model that takes into account potential future revenues from SGX301 and SGX942. 

Clearly, Soligenix is on the move. Results to date from the FLASH trial is set up to be just the first of a potential catalyst filled spring and summer season for the company. And, despite the markets trying to find footing during a COVID-19 pandemic, the milestones ahead for Soligenix may not ultimately get affected. The long-term outlook remains positive based on data we know, from the analyst’s interpretation of that data, and from newly emerging opportunities from its Public Health Solutions business segment.

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