Soligenix Inc. (NASDAQ: SNGX) has announced its financial results and recent accomplishments for the quarter ended March 31, 2021.
HyBruyte receives “Innovation Passport.”
HyBryte (hypericin) was granted an “Innovation Passport” for early-stage CTCL treatment in adults by the UK’s Innovative Licensing and Access Pathway on May 10, 2021. In addition, on April 28, 2021, the Soligenix confirmed that Oreola Donini, SVP, and Chief Scientific Officer, presented at the Annual Conference on Vaccinology Research on April 26-27, 2021, highlighting the CiVax COVID-19 vaccine development program’s potency in mice and non-human primates.
On April 7, 2021, the FDA provisionally approved HyBryte as the potential brand name for SGX301 (synthetic hypericin), Soligenix’s new first-in-class photodynamic therapy for early-stage CTCL treatment. The company also announced that Ellen Kim, the Lead Principal Investigator for the Phase 3 FLASH study, gave a presentation at the virtual American Academy of Dermatology Association Meeting Experience, held April 23-25, 2021, on data related to HyBryte’s efficacy and safety in the treatment of CTCL.
CEO Christopher J. Schaber said, “This year continues to be an exciting year of progress for Soligenix. We recently announced presentation of clinical data from our successful pivotal Phase 3 FLASH clinical trial for HyBryte (SGX301) in the treatment of cutaneous T-cell lymphoma (CTCL) at both the American Academy of Dermatology, where HyBryte was designated “Top 12 late-breaking research,” and the Society for Investigative Dermatology. We also received FDA’s conditional acceptance of HyBryte as the proposed brand name for SGX301 as we continue to prepare for a new drug application (NDA) submission.”
Soligenix advancing COVID-19 vaccine
Schaber added that the company is advancing multiple vaccines and therapeutic candidates under its public health solutions business. For example, he said the CiVaX, the company’s heat-stable COVID-19 vaccine, showed that the proprietary protein antigen subunit locked to receptor configuration was immunogenic in non-human primates and mice is a critical step in advancing CiVaX to human trials.