New York, New York–(Newsfile Corp. – September 21, 2020) – Soligenix’s (NASDAQ: SNGX) RiVax® program is in focus after a failed attempt to send ricin-laced letters to the White House last week raised fresh concerns about the deadly toxin. Those letters, including others addressed to Texas law enforcement agencies, were intercepted before delivery on Thursday. That news helped focus attention toward Soligenix’s RiVax® program, which is considered the leading ricin-poisoning vaccine program in the world to protect against exposure to this deadly substance.

The interest in Soligenix’s (NASDAQ: SNGX) program started trending after it was announced that the lethal ricin toxin was again used to potentially harm government leaders. Letters to the White House were addressed to President Trump and were intercepted at the final off-site processing facility before being sent to the White House mailroom. All US mail that is addressed to the White House and other federal agencies in the Washington area are irradiated before final delivery and get processed through a sorting facility that samples the air for suspicious substances.

Despite the slim chances of ricin-laced packages reaching the White House, the event nonetheless highlights the importance of developing a vaccine against this deadly substance. Soligenix is leading that race.

RiVax® Program Timely And Necessary

The potentially deadly events again demonstrate the importance of developing a vaccine against a ricin toxin that is lethal and yet easily manufactured. Ricin, a white powder, can induce irreversible symptoms within four hours of exposure and may cause death within 48-72 hours.

Its mechanism of action causes cell death once it penetrates the cell membrane, and it typically penetrates cells within 4 hours of exposure. Depending on the route of exposure (ingestion, inhalation, or injection), ricin toxin produces different initial symptoms. Regardless of the exposure method, though, ricin poisoning will result in death with sufficient exposure 100% of the time. Currently, there are no FDA-approved prophylactic or post-exposure therapies for ricin toxin exposure.

At Soligenix, RiVax® is one of two biodefense programs being developed through its Public Health Solutions business segment. The other, ThermoVax®, is a critical component of making a vaccine candidate’s temperature stable. Combining the two programs, positions RiVax® as the most advanced development-stage ricin treatment vaccine platform in the world. It may also be the most promising means to protect against exposure to ricin during chemical warfare. That warfare can include domestic events like what occurred last week.

In Phase I studies, Soligenix demonstrated that RiVax®, containing an abbreviated version of ricin toxin A chain with no biological activity, induces a non-toxic immunogenic response, while also demonstrating safety and tolerability in healthy volunteers. Importantly, the antibodies induced through immunization with RiVax® demonstrated complete protection from a lethal dose of aerosolized ricin in a rhesus macaques vaccine trial. The company is expected to seek expedited FDA approval for the vaccine under the “Animal Rule” that relies on studies successfully conducted in non-human primates. The benefits are compelling.

RiVax® Therapeutic Benefits Presented

The vaccine’s therapeutic benefits were presented at the Fourth International Conference on Vaccines Research and Development Development in 2018. Posters showed that RiVax® induces the adaptive immune system to produce antibodies that recognize and bind ricin toxin, preventing it from getting inside cells and killing them. Intramuscular injection of RiVax® stimulates the production of IgG and other antibodies, which are produced and circulated within the body to eradicate ricin, whether inhaled, eaten, or injected.

Further, the RiVax® vaccine candidate uses one of the safest vaccination approaches known – using a modified inactivated protein component of the ricin toxin itself to raise antibody responses, combined with an alum adjuvant to boost the body’s response to the vaccine. Also, RiVax® uses Soligenix’s proprietary ThermoVax® technology to create a vaccine which is stable for long-term storage (e.g., at least 12 months) even at very high temperatures (e.g., 40°C or 104°F). This means the RiVax® protein may be stored for long periods allowing it to be stockpiled for future use.

That stockpiling advantage is critical because potential therapies for ricin intoxication are generally limited for use within four hours of poisoning. Thus, because poisoning events are often of unknown origin and its point of delivery virtually limitless, a four-hour time limit for treatment is hugely problematic. In response, a strategically placed stockpile of RiVax® could be utilized for national defense and distributed quickly using a combination of logistical resources. Notably, to meet and finance a potential global opportunity for its vaccine candidate, Soligenix is earning tremendous financial support from outside agencies.

To date, RiVax® has been funded by non-dilutive grants awarded from the NIH (approximately $25 million thus far) and through a $21.2 million contract entered into with the NIH in 2014. Soligenix is also evaluating the opportunity to apply for a priority review voucher (PRV), which can be a valuable asset to the RiVax® program. These PRV’s are transferable, and recent PRV’s have sold for approximately $100 million in the biotech and pharma sector.

ThermoVax® Adds Critical Value RiVax®

A critical component that can potentially inspire an expedited review of RiVax® is ThermoVax®. One aspect of this proprietary stabilizing platform technology allows vaccines comprised of an aluminum salt adjutant to be kept out of cold storage without affecting its potency. The technique can be a breakthrough to eliminate the need for cold storage, and its applications can provide game-changing treatment in the battlefield, during extreme power-outage situations, and during large scale triage situations. It may also be instrumental in preventing large-scale domestic incidents.

ThermoVax® technology has already shown demonstrably positive results with RiVax®. Independent studies showed that ThermoVax® can provide potency protection for the RiVax® vaccine for at least one year at 104° Fahrenheit. Additionally, ThermoVax® demonstrated its ability to protect vaccine candidates’ potency to treat anthrax, HPV, and Ebola for at least twelve weeks at the same high temperatures.

Combining the two programs creates a compelling argument that the RiVax® program should be immediately brought to the desk of bio-defense decision-makers, who should evaluate the immediate and long-term threat from this easy to develop toxin. They should then take action to protect their citizens.

Most importantly, the benefits of ThermoVax® should not be underappreciated. It may offer the best solution to allow for easy storage and provide a unique ability to allow for a national and strategic stockpile of essential vaccines. It may be, by far, a best-in-class solution for multiple vaccine candidates.

Near-Term Catalysts For Soligenix

Currently trading at a sharp discount to analyst pricing models, Soligenix is well-positioned to further its growth by capitalizing on several clinical initiatives. Although RiVax® will get new attention this week, the company has at least four other programs targeting markets that can each generate hundreds of millions in potential peak revenues.

Thus, even with risk discounts applied to its clinical programs and at least two potential catalysts expected by year’s end, that value may start to build ahead of the results.

Now, with RiVax® in focus, those forward-looking revenue models may be worthy of a new appraisal, enticing a revision to financial projections that placed potential revenue from RiVax® past 2023.

At the very least, RiVax® may offer another near-term catalyst for Soligenix and create a substantial revenue-generating opportunity from worldwide governments that are having to address national defense and security as a priority. The events last week may put an exclamation point on that initiative.

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