In April, Soligenix NasdaqCM: SNGX) announced additional, statistically significant, topline results from its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial targeting the treatment of cutaneous T-cell lymphoma (CTCL). In the update, Soligenix showed that SGX301 (synthetic hypericin), after continued treatment twice weekly treatment for 12 weeks, increased the positive response rate to 40% compared to six weeks treatment. The results from that group, referred to as Cycle 2, were supported by a statistically significant P<0.0001.

The pivotal Phase 3 FLASH study for the treatment of early-stage CTCL has attracted investor’s attention. The recently published topline results now put Soligenix in a position to bring their first potentially FDA approved drug treatment to market that has been estimated to be a more than $250 million opportunity.

In a recent interview with PCG Advisory, Soligenix CEO, Christopher J. Schaber, PhD., recently commented on the impressive topline data. Here’s what he said:

PCG: The Cycle 2 data was very impressive. Can you briefly elaborate on what the takeaway is when we look at the disclosed Cycle 1 and 2 data sets to date?

CS: SGX301 therapy clearly improves patient outcomes in terms of reducing lesion severity, and by corollary lesion symptoms. This is one of the very few placebo controlled trials in CTCL so it also provides an important benchmark in the field. Unlike other treatments, where outcomes of this nature can take months to be achieved, we see a rapid response (that is, within 6 weeks) that then continues to improve as treatment continues.

PCG: How does this relate to other therapies currently being used to treat CTCL from both an efficacy and safety perspective?

CS: It’s important to note that currently there is no FDA approved first-line drug for the treatment of early-stage CTCL. Other treatments in the CTCL space are either used off-label (often with black-box warnings for melanoma) or are only to be used when other therapy has failed (indicative of safety concerns with the product), as is the case with the products marketed by Bausch Health (NYSE/TSX: BHC), Mallinckrodt PLC (NYSE: MNK) and Helsinn.  SGX301does not carry any concerning safety issues as identified to date and therefore, has the potential to be the first approved front-line treatment for this orphan disease. From an efficacy perspective, it is comparable to other therapies (though comparisons are hard to make since most drugs for early stage disease haven’t completed rigorous placebo controlled trials as we have done with SGX301) with further improvements with longer treatments yet to be assessed. 

PCG: Briefly, as part of your COVID-19 vaccine collaboration with the Unv. of Hawaii, you disclosed signing a licensing agreement with Boston Scientific (NYSE: BSX) for  a novel adjuvant.  Can you discuss the importance of this collaboration and your vaccine approach compared to some of the other vaccines being developed?

CS: Approaches under development include inactivated live vaccine (safety risk: conversion to active infection), RNA vaccines (safety/regulatory risk: as far as we are aware no RNA vaccines have been FDA approved to date for any indication), and protein vaccines (well understood technology, considered safe but efficacy is very dependent on adjuvant potency). We are focusing on a protein antigen utilizing the recently licensed CoVaccine™ adjuvant. The CoVaccine adjuvant is unique in its ability to stimulate both humoral (antibody) and cell mediated (T-cell) immunity, and has been shown to be able to target a Th1 response, considered important for coronaviruses. Moreover, we have demonstrated with our joint filovirus program with University of Hawaii that this adjuvant is able to produce a 100% effective Ebola virus vaccine in the gold standard rhesus macaques model where other adjuvants (including alum) fail completely.

We consider adjuvant selection crucial to the success of the product and are very encouraged by our past experience with this particular adjuvant. Our experience has also been that we can lyophilize protein using Generally Regarded as Safe (GRAS) excipients, potentially yielding a thermostable vaccine as a powder in individual dosing vials which is reconstituted with water for injection immediately prior to use – a very convenient format. 

Finally, it is worth noting that in our collaboration with the University of Hawaii we have also been using a protein expression system (to produce antigen) which has been shown to produce stable patterns of glycosylation of multimeric proteins and can be clinically scaled – this should also be directly relevant to the COVID-19 vaccine we are developing, as we are targeting the trimeric Spike glycoprotein as the antigen of choice.

End interview

Catalyst reached For Soligenix

While all of the data released from the SGX301 trial has been positive, the most recent 12-week data is the most impressive set. And, the results may translate into an important win for Soligenix.

The data was not only statistically significant from an efficacy perspective with an extraordinary P

And, while the data from the SGX301 trial is impressive, investors also note that this trial represents only one of the company’s multiple shots on goal for value creation. The company is advancing its Phase 3 trial to treat oral mucositis in patients with head and neck cancer, and is well into developing a line of products through its Public Health Solutions Business Segment.

Hence, with potential near-term catalysts on the radar from its SGX942 trial and from its recent collaboration with the University of Hawaii to evaluate its ability to contribute to the fight against COVID-19, Soligenix has earned a place on the radar for investors looking for value opportunity from near-term milestones.

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