Soligenix (SNGX) shares surged 7.48% in the premarket after it has approved FDA orphan drug status for the treatment of T-cell lymphoma. In the last trading session, the stock concluded at $1.07 with an increase of 0.94%.
SNGX Approved FDA orphan drug status
Recently, SNGX approved the FDA orphan drug status for the treatment of T-cell lymphoma on 2nd September 2021.
Development of Tools by SNGX to tackle next pandemic
SNGX has stated on 24th August 2021 that maintaining refrigerated conditions for the storage of vaccines is a major hurdle in U.S. Therefore, SNGX has released preclinical results indicating that their thermostable vaccination platform might be useful in combating the next pandemic and other health catastrophes.
Thermostabilized vaccine candidates are being developed by Soligenix partners at the University of Hawai’i at Mnoa (UHM) to defend against three life-threatening filoviruses, including Sudan ebolavirus.
In NHPs, their formulations elicited powerful immunological responses. Filoviruses are widespread in parts of the world where electricity is in short supply, making a thermostable vaccine especially useful in the event of an outbreak.
Successful Formulation of Filovirus Vaccine
SNGX released a paper on 23 August 2021 describing the development of single-vial platform presentations of filovirus vaccine candidates that are monovalent (single antigen), bivalent (two antigens), and trivalent (three antigens).
It has also been discussed on how to co-lyophilize antigen(s) and a nano-emulsion adjuvant, CoVaccine HTTM, using a single-vial platform while retaining important adjuvant stability properties such as particle size and colloidal stability.
In addition, antibody responses were previously seen in mice, and NHPs for monovalent vaccinations were sustained in the trivalent single-vial co-lyophilized vaccine candidates. Recently, one of these trivalent formulations was demonstrated to protect 75 percent of vaccinated NHPs against a second Sudan ebolavirus challenge, with more research into effectiveness against additional filovirus infections underway.
SNGX Announces Preclinical Data
On 19 August 2021, SNGX presented good results indicating the effectiveness of various filovirus vaccine candidates in nonhuman primates, including thermostabilized multivalent vaccinations in a single vial platform.
The company is also working on SGX301 which is used for the treatment of cutaneous T-cell lymphoma (CTCL). The Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) experiment took place on 169 patients and was completed successfully. The research found that administering SGX301 had a fast therapeutic impact, with effectiveness observed in as little as six weeks.
