PRINCETON, N.J., April 11, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in SuVax™, the subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for 'the prevention and post-exposure prophylaxis against SUDV infection.'.

新泽西州普林斯顿，2024年4月11日/PRNewswire/--Soligenix，Inc.（纳斯达克：SNGX）（Soligenix或该公司），一家专注于开发和商业化产品以治疗医疗需求未得到满足的罕见疾病的晚期生物制药公司，今天宣布，美国（美国）食品和药物管理局（FDA）孤儿产品开发办公室（Office of Orphan products Development of the United States）食品和药物管理局（FDA）已将孤儿药命名为SuVax™中的活性成分，SuVax™是重组表达的苏丹埃博拉病毒（SUDV）糖蛋白的亚单位蛋白疫苗，用于“预防和暴露后预防SUDV感染”。

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S.  In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application (BLA), and certain tax credits..

《美国孤儿药法案》旨在帮助和鼓励公司开发安全有效的治疗罕见疾病和紊乱的疗法，该疗法被定义为影响美国不到20万人的罕见疾病和紊乱。除了在FDA最终批准后提供七年的市场排他期外，孤儿药指定还使Soligenix能够利用广泛的财务和监管利益，包括政府资助进行临床试验，免除可能提交生物制剂许可证申请（BLA）的昂贵FDA用户费用，以及某些税收抵免。。

'SuVax™ is based on our novel vaccine platform which includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nano-emulsion adjuvant which induces broad immunity, and a formulation procedure which enables thermostabilization of the combination of adjuvant and antigen in a single vial,' stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix.

Soligenix高级副总裁兼首席科学官Oreola Donini博士表示：“SuVax™基于我们的新型疫苗平台，该平台包括三个主要组成部分：已在多种蛋白质抗原上证明的强大蛋白质制造过程，诱导广泛免疫力的新型纳米乳剂佐剂，以及能够在单个小瓶中实现佐剂和抗原组合热稳定的配方程序。”。

'The SuVax™ vaccine specifically addresses the potentially lethal Sudan Virus Disease, caused by SUDV. SUDV is a type of ebolavirus for which there is no current treatment or vaccine. The SuVax™ vaccine has demonstrated 100% protection of non-human primates infected with a lethal amount of SUDV. Although vaccines exist for Zaire ebolavirus, they are ineffective against SUDV.

“SuVax™疫苗专门针对由SUDV引起的潜在致命的苏丹病毒病。SUDV是一种埃博拉病毒，目前尚无治疗或疫苗。SuVax™疫苗已证明对感染致命量SUDV的非人灵长类动物具有100%的保护作用。尽管存在针对扎伊尔埃博拉病毒的疫苗，但它们对SUDV无效。

With recent outbreaks in 2022 and 2023, developing vaccines for all Ebola type diseases remains an important worldwide priority. The FDA's decision to grant orphan drug designation signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing patent estate surrounding this novel technology.' .

随着最近在2022年和2023年爆发疫情，开发针对所有埃博拉型疾病的疫苗仍然是全球重要的优先事项。FDA授予孤儿药名称的决定标志着Soligenix迈出了重要的一步，因为我们继续推进该计划，并大大增加了围绕这项新技术的现有专利财产。”。

About SuVax™

关于SuVax™

SuVax™ is a subunit protein vaccine of recombinantly expressed Sudan Ebola virus glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawaiʽi at Mānoa. The vaccine includes a protein found on the surface of Sudan ebolavirus (SUDV), to engender an appropriate immune response without posing a risk of infection, as well as a novel adjuvant which stimulates both humoral and cell mediated immune responses, in combination with Generally Regarded as Safe (GRAS) excipients that enable lyophilization (i.e., freeze-drying) of the vaccine.

SuVax™是重组表达的苏丹埃博拉病毒糖蛋白的亚单位蛋白疫苗，与马诺亚夏威夷大学的Axel Lehrer博士合作开发。该疫苗包括在苏丹埃博拉病毒（SUDV）表面发现的一种蛋白质，可产生适当的免疫反应而不产生感染风险，以及一种新型佐剂，可刺激体液和细胞介导的免疫反应，并与通常认为安全的（GRAS）赋形剂相结合，使疫苗冻干（即冷冻干燥）。

The resulting product is manufactured as a heat stable powder in a vial which is reconstituted with generically available water for injection immediately prior to use. SuVax™, as a heat stable protein subunit vaccine, has protected 100% of non-human primates exposed to a lethal injection of SUDV. Stability studies have demonstrated that SuVax™ is heat stable for at least 2 years at temperatures of at least 40 degrees Celsius (104 degrees Fahrenheit)..

所得产品在小瓶中制成热稳定粉末，在使用前立即用一般可用的注射用水重新配制。SuVax™作为一种热稳定蛋白亚单位疫苗，已经保护了100%暴露于致命注射SUDV的非人灵长类动物。稳定性研究表明，SuVax™在至少40摄氏度（104华氏度）的温度下具有至少2年的热稳定性。。

Manufacture of the recombinant protein utilized in SuVax™ utilizes a robust protein manufacturing process, developed and tested in other subunit vaccines advanced through clinical testing. Similarly, the selected adjuvant, while novel, has also been independently tested in Phase 1 and Phase 2 clinical studies.

SuVax™中使用的重组蛋白的制造利用了强大的蛋白质制造过程，该过程是在通过临床测试取得进展的其他亚单位疫苗中开发和测试的。同样，所选佐剂虽然新颖，但也已在1期和2期临床研究中进行了独立测试。

SuVax™ can also be expressed as part of a multivalent vaccine, in combination with antigens against Marburg marburgvirus (MARV) for example..

SuVax™也可以作为多价疫苗的一部分表达，例如与针对马尔堡马尔堡病毒（MARV）的抗原结合。。

About Sudan ebolavirus Infection

关于苏丹埃博拉病毒感染

Ebola-like disease can be caused by one of six species of Ebolavirus, four of which are known to cause disease in humans, including its best-known member, Zaire ebolavirus (EBOV; causing Ebola Virus Disease), with Sudan ebolavirus (SUDV; causing Sudan Virus Disease) being the second-most common cause of human infection.

埃博拉样疾病可能由六种埃博拉病毒中的一种引起，其中四种已知会引起人类疾病，包括其最著名的成员扎伊尔埃博拉病毒（EBOV；引起埃博拉病毒病），而苏丹埃博拉病毒（SUDV；引起苏丹病毒病）是人类感染的第二大常见原因。

All species of ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburg marburgvirus (MARV). Filoviruses are believed to be harbored in various animal species in Africa, particularly bats, although the specific reservoir host for many of these viruses is still unknown.

埃博拉病毒的所有物种都属于丝状病毒科，该科还含有同样具有人类致病性的马尔堡-马尔堡病毒（MARV）。丝状病毒被认为存在于非洲的各种动物物种中，特别是蝙蝠，尽管许多这些病毒的特定宿主仍然未知。

There have been several known Ebola (both Sudan and Zaire) and Marburg Virus Disease outbreaks since 1967 with the most recent SUDV outbreak occurring in August – October, 2022 in Uganda according to the Centers for Disease Control and Prevention (CDC)..

据疾病控制和预防中心（CDC）称，自1967年以来，已经发生了几起已知的埃博拉（苏丹和扎伊尔）和马尔堡病毒病疫情，最近一次SUDV疫情发生在2022年8月至10月。。

Transmission of filoviruses requires direct contact with bodily fluids from an infected person or contact with infected animals. The mortality rates following filovirus infections are extremely high, and, in the absence of wide availability of effective therapeutics, are affected by the quality of supportive care available with a focus on early initiation of treatment.

丝状病毒的传播需要直接接触受感染者的体液或接触受感染的动物。丝状病毒感染后的死亡率极高，并且在缺乏广泛有效治疗方法的情况下，受支持治疗质量的影响，重点是早期开始治疗。

Resolution of the disease largely depends on the patient's own immune system. While there are limited treatment options for disease caused by EBOV, there are no available treatments or vaccines available for Sudan Virus Disease. The approved vaccines for EBOV utilize a viral vector approach which has contraindications for some individuals and require stringent, ultra-low cold-chain storage, inhibiting their broad use in challenging conditions where power supply can be uncertain and ambient temperature can be very high..

疾病的解决在很大程度上取决于患者自身的免疫系统。虽然EBOV引起的疾病的治疗选择有限，但苏丹病毒病尚无可用的治疗方法或疫苗。经批准的EBOV疫苗使用病毒载体方法，该方法对某些个体具有禁忌症，需要严格的超低冷链储存，从而抑制了它们在电源不确定且环境温度很高的挑战性条件下的广泛使用。。

About Soligenix, Inc.

关于Soligenix，Inc。

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL).

Soligenix是一家晚期生物制药公司，专注于开发和商业化产品，以治疗医疗需求未得到满足的罕见疾病。我们的专业生物治疗业务部门正在开发HyBryte™（SGX301或合成金丝桃素钠）的潜在商业化，作为一种利用安全可见光治疗皮肤T细胞淋巴瘤（CTCL）的新型光动力疗法。

With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease..

随着第二阶段3研究的成功完成，将寻求监管部门的批准，以支持全球潜在的商业化。该业务部门的发展计划还包括将合成金丝桃素（SGX302）扩展到牛皮癣，这是我们一流的先天防御调节剂（IDR）技术，用于治疗炎症性疾病（包括头颈部癌症的口腔粘膜炎）的dusquetide（SGX942），以及（SGX945）治疗白塞氏病。。

Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.

我们的公共卫生解决方案业务部门包括RiVax®（我们的蓖麻毒素候选疫苗）的开发计划，以及我们针对丝状病毒（如马尔堡和埃博拉）和CiVax™的疫苗计划，CiVax™是我们预防COVID-19（由SARS-CoV-2引起）的候选疫苗。我们疫苗计划的开发结合了我们专有的热稳定平台技术ThermoVax®的使用。

To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA)..

迄今为止，该业务部门得到了国家过敏与传染病研究所（NIAID），国防威胁减少局（DTRA）和生物医学高级研究与发展局（BARDA）的政府拨款和合同资金的支持。