Soligenix, Inc. (Nasdaq: SNGX) shares have been surging higher as investors weigh the potential of near-term catalysts from two of the company’s business segments. Most recently, Soligenix announced a publication on immunogenicity studies for RiVax®, the company’s heat stable ricin vaccine that showed correlates between immune protection and survival in mice.
An update pointed to an article titled, “A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin,” that has been submitted to the peer-reviewed medical journal Vaccine.
The RiVax® vaccine candidate is being developed under the company’s Public Health Segment and is a candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin. Studies thus far have shown the vaccine formulation to have enhanced thermostability. In addition, RiVax® also demonstrated up to 100% protection in mice and non-human primates (NHPs) subsequently exposed to lethal doses of ricin toxin either systemically or by aerosol.
Also in May, Soligenix announced that studies conducted in collaboration with the laboratory of Dr. Nicholas Mantis, Research Scientist, Division of Infectious Diseases, Wadsworth Center, New York State Department of Health, that species independent tests to evaluate the protective immunogenicity of the vaccine were developed.
Pushing Approval Through The “Animal Rule”
The tests are expected to facilitate potential approval of RiVax® under the FDA Animal Rule which requires the evaluation of efficacy in animals. Previous testing of RiVax® has demonstrated up to 100% protection in NHPs exposed to lethal aerosolized ricin. In human testing, the RiVax® antigen has been demonstrated to be well-tolerated in Phase 1 clinical studies. Also, immunogenicity correlated between animal models and humans. Companies that have successfully utilzed the “Animal Rule” pathway include Amgen (Nasdaq: AMGN), SIGA Technologies (Nasdaq: SIGA), and Sanofi (NYSE: SNY)
The FDA “Animal Rule” is applied to products where human testing in clinical efficacy trials would be unethical since it would require intentionally exposing subjects to the ricin toxin. In similar applications, the “Animal Rule” is generally appropriated with the approval of medical countermeasures for biodefense purposes. Data has shown the RiVax® vaccine candidate to be both protective and thermostable. It has also demonstrated that a reduced number of vaccinations may establish protection, potentially utilizing only two doses instead of three.
Notably, the RiVax® studies are supported by a contract award of up to $21.2 million from the National Institute of Allergy and Infectious Diseases (NIAID). Cumulative non-dilutive funding for the development of RiVax® has exceeded $40 million to date. RiVax® has received both Orphan Drug and Fast Track designations from the FDA, and, upon approval, has the potential to qualify for a biodefense Priority Review Voucher (PRV). RiVax® also has received Orphan Drug designation from the European Medicines Agency (EMA).
While RiVax® is in the headlines recently, data from the company’s pivotal phase 3 trials are highly impressive.
Phase 3 Pipeline Adds More Firepower
Soligenix offered impressive data from its twelve-week follow up from patients treated in the company’s SGX301 “FLASH” (Fluorescent Light Activated Synthetic Hypericin) pivotal phase 3 trial. Data from the trial continues to demonstrate SGX301’s potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL). In the double-blind, placebo-controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after 6 weeks of therapy. This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycle, referred to as Cycle 2, with an additional 6 weeks of therapy (p
The company’s second trial is also adding to the value proposition. Soligenix is advancing its 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. That trial is moving forward following the positive recommendation received from the independent Data Monitoring Committee, and has successfully achieved its target of 260 patients randomized into the study. The company noted that due to the uncertainty surrounding the coronavirus pandemic, they decided to enroll up to 25 additional patients into the study in a cautious approach to maintain the statistical integrity of the trial. Because of the time needed to facilitate the additional enrollment and to provide top-line results, Soligenix has revised its expected data release to the fourth quarter of 2020.
Balance Sheet Funded To Advance Trials
As of March 31, the company reported having more than $8M in cash, not including its non-dilutive government funding. Additional funding can come from its at-the-market sales issuance agreement with B. Riley FBR, Inc. that can supplement the company’s cash runway as needed. Notably, Soligenix said that they anticipate having sufficient capital to achieve multiple inflection points across its rare disease pipeline, including top-line results in its SGX942 Phase 3 clinical trial in oral mucositis.
Despite the recent 20% rise in price, the stock may present a compelling value opportunity after factoring in the potential catalyst contributions during the remainder of 2020.
More data from its SGX301 trial, top-line results from its SGX942 study, and additional news related from its university collaborations and from the RiVax® program may each deliver its own catalyst event that can create individual value for long-term gains.
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