Dr. Chris Schaber Discusses Soligenix HyBryte™ and Thermostabilized Vaccines
New York, NY – 
The interview took place at the Cantor Fitzgerald Global Health Care Conference, which was held virtually from September 27-30, 2021. Biotechnology and pharmaceuticals were key areas of discussion. Over three hundred companies in the healthcare sector were represented.
HyBryte™ as a Safer Treatment for Cutaneous T-Cell Lymphoma (CTCL)
The first topic of the virtual fireside chat was Soligenix orphan drug candidate HyBryte™, a treatment option for cutaneous T-cell lymphoma (CTCL). There is currently no uniformly accepted treatment for the condition, which is a chronic cancer. The use of the synthetic hypericin in HyBryte™ with safe, visible fluorescent light is an option for early-stage patients.
“With traditional phototherapy treatments, the activation of the singlet oxygen in hypericin induces necrosis and apoptosis in adjacent cells,” Dr. Schaber shared. “For early-stage patients, it is a balancing act between treating the lesions and minimizing the long-term toxicities of the treatments. The ability to activate HyBryte™ with visible light makes it a safer alternative.”
In 2020, the results of a Phase 3 FLASH trial of HyBryte™ revealed a statistically significant treatment response. 49% of the patients showed a 50% improvement in their index lesions. It was also discovered that HyBryte™ worked well on both patch and deeper plaque lesions. An NDA filing for the drug is expected in 2022, with US commercialization planned for 2023.
Public Health Solutions with Thermostabilized Vaccines
One of the challenges with Covid-19 vaccines currently approved for use is the need to ship and store them in sub-zero temperatures. This hampers logistics, particularly in countries with poor infrastructure and power grids. Soligenix, using a technology platform already being tested with filovirus vaccines, is developing CiVax™ a thermostabilized Sars-CoV-2 vaccine candidate.
“Soligenix has been working on filovirus vaccine solutions for Ebola and Marburg, with a focus on eliminating the need for refrigerated storage and shipping,” Dr. Schaber shared. “Ebola is endemic in Africa, in areas with power grid problems and challenging distribution logistics. The need created a demand for a better solution. We’ve come up with one.”
“The work on filovirus vaccines allowed us to demonstrate thermostabilization of a different kind of adjuvant, one more appropriate for the immunity needed against viruses, which includes both antibody (humoral) and cell mediated immunity. In early-stage testing, we’ve already shown immunogenicity in both mice and non-human primates.”
Late-Breaking News
Shortly after the conference, Soligenix announced accelerated publication demonstrating that its CiVax™ Covid-19 vaccine yields broad neutralizing antibody responses against the original strain and Beta, Gamma and Delta variants in non-human primates.
“We believe that creating a COVID-19 vaccine, like CiVax™, with enhanced stability at elevated temperatures has the potential to lead to a faster resolution of this global pandemic, curtailing the further evolution of the virus,” stated Dr, Schaber. “Moreover, the introduction of a subunit vaccine that has been built on years of proven vaccine technology may also encourage the vaccine-hesitant. This platform not only has the potential to aid in the current worldwide pandemic; but the technology platform, with its broad applicability, may also aid in the preparation for future pandemics. With these latest results, we will be expanding discussions with various funding agencies in the coming weeks.”
Leveraging Government Grants and Contracts
In their Public Health Solutions segment, which includes vaccine development, Soligenix has sought to leverage government grants and contracts, a non-dilutive way to advance significant programs. To date, they’ve managed to raise over $60 million this way. The company currently has a cash runway of $29 million, enough to fund research well into 2023.
With a strong financial outlook and several of their products advancing towards late-stage trials, Soligenix is well positioned to execute on multiple fronts across their pipeline, including HyBryte™ commercialization. To learn more about their Public Health Solutions or orphan drug candidates, visit https://www.soligenix.com/
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