Soligenix Extends Patent Protection for Its Filovirus Vaccine

Soligenix Extends Patent Protection for Its Filovirus Vaccine

By, Admin 29 April 2024

Soligenix extends patent protection for its Filovirus vaccine to United Kingdom and South Africa

Overview

Soligenix, Inc, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that it has received notice of intent to grant additional patents based on its patent application titled ""Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines"" in the United Kingdom and South Africa, with other international jurisdictions pending. The company has previously announced multiple issued patents within the same patent family in the US.

Regarding Claims

  • The allowed claims are directed to unique, proprietary compositions and methods related to combinations of glycoprotein antigens with nanoemulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. 
  • The described vaccine platform has previously been successfully applied to mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus, including monovalent vaccines SuVax (targeting Sudan ebolavirus) and MarVax (targeting Marburg marburgvirus).

Filovirus Vaccines

  • The candidate filovirus vaccines have been previously shown to completely protect non-human primates (NHPs) from subsequent infection, and represent the only recombinant subunit vaccines that have demonstrated efficacy against Zaire ebolavirus and other filoviruses in NHPs. 
  • Lyophilization (i.e., freeze drying) of the antigens with bivalent vaccine formulations has also been demonstrated to thermostabilize the antigens at temperatures as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to two years, enabling storage at ambient temperature. 
  • No currently licensed lyophilized vaccine that contains an adjuvant is presented in a single vial format and there are few reports of successfully using nanoemulsions in lyophilized formulations. 
  • Previous work has demonstrated the use of a single vial platform to co-lyophilize antigen(s) and a nanoemulsion adjuvant, CoVaccine HT, maintaining key adjuvant stability characteristics including particle size and colloidal stability, as well as maintaining immunogenicity.

Words from University of Hawai

  • Filoviruses such as Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus are some of the most lethal viruses known, and they are endemic in areas of the world where the power supply and distribution network can be uncertain. There are no vaccines for either Sudan or Marburg viruses, while approved vaccines for Zaire ebolavirus are constrained by cold chain logistics. Availability of a single-vial, heat stable vaccine would significantly enhance global public health preparedness or response to a new outbreak, at its source,"" stated Axel Lehrer, Associate Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine, University of Hawai at Manoa. 
  • "Our work to date has demonstrated the feasibility of rapid and efficient manufacturing, as well as the ability to thermostabilize multiple antigens that can then be stored at temperatures exceeding 100 degrees Fahrenheit. Having a vaccine platform such as this available has the potential to accelerate worldwide vaccination campaigns addressing future health emergencies, including other global pandemics as seen with Covid-19."

Words from CSO: Soligenix

  • Our next generation combined vaccine platform includes three major components: a robust protein manufacturing process that has been demonstrated on multiple protein antigens, a novel nanoemulsion 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, senior VP and chief scientific officer of Soligenix. 
  • "Elements of this vaccine platform have been utilized in our ricin toxin, filovirus and Covid-19 vaccine candidates, indicating its broad applicability. We continue to focus on vaccine development against Sudan ebolavirus and Marburg marburgvirus where there are currently no available vaccines."
  • Work to date has demonstrated the compatibility of lyophilizing both antigen and adjuvant in the same vial, with reconstitution with sterile water for injection immediately prior to use. This simple delivery format, as well as the compatibility with ambient storage, significantly reduces logistical hurdles when vaccinating large groups of individuals as required for example when addressing a global pandemic or for the deployment of vaccines in outbreaks occurring in remote areas or with unreliable power supply.

Thermostabilized Filovirus Vaccine Program

  • Under the company's Public Health Solutions business segment, ongoing collaborations with Dr. Lehrer, have demonstrated the feasibility of developing thermally-stable subunit protein vaccine formulations for filoviruses. 
  • The thermostabilized filovirus vaccine program has been supported by a National Institute of Health (NIH) grant R01-AI132323 (awarded to the University of Hawaii) and a Small Business Innovation Research grant (#1R44AI157593-01; awarded to Soligenix).

SuVax Protein Vaccine

  • SuVax is a subunit protein vaccine of recombinantly expressed Sudan Ebola virus glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawai?i at Manoa. 
  • 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. 
  • 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).

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

Soligenix

  • Soligenix has been granted Orphan Drug Designation by the US FDA for the prevention and post-exposure prophylaxis against Sudan ebolavirus infection. 
  • In addition to providing a seven-year term of market exclusivity upon final US 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, and certain tax credits.

MarVax

  • MarVax is a subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, developed in partnership with Dr. Axel Lehrer at the University of Hawai?i at Manoa. 
  • The vaccine includes a protein found on the surface of MARV, 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 GRAS excipients that enable lyophilization (i.e., freeze-drying) of the vaccine. 
  • 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. 
  • Stability studies have demonstrated that MarVax is heat stable for at least 2 years at temperatures of at least 40 degrees Celsius (104 degrees Fahrenheit). 
  • MarVax has demonstrated 100% protection of non-human primates exposed to a lethal injection of MARV.

Manufacture of the recombinant protein utilized in MarVax 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. MarVax can also be expressed as part of a multivalent vaccine, in combination with antigens against Sudan ebolavirus for example.

Filovirus

  • Filovirus, ebola virus disease is 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 (Ebola virus), with Sudan ebolavirus being the second-most common cause of human infection in this family. 
  • All species of ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburg virus. 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. 
  • There have been several known Ebola (both Sudan and Zaire) and Marburg Virus Disease outbreaks since 1967. 
  • The most recent SUDV outbreak occurred in August – October, 2022 in Uganda according to the Centers for Disease Control and Prevention (CDC). 
  • The most recent MARV outbreaks occurred in February – June 2023 in Equatorial Guinea and in March – May 2023 in Tanzania, with no relationship between the two outbreaks, according to the CDC. Cases of Marburg Virus Disease were also recorded in Ghana in 2022 and 2021.

Transmission of Filoviruses

  • 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. 
  • Resolution of the disease largely depends on the patient's own immune system. 
  • There are limited treatment options for Ebola Virus Disease and no available treatments for Sudan Virus or Marburg Virus Disease, although steady progress has also been made in development of immunotherapeutics for filoviruses beyond Zaire ebolavirus. 
  • There are approved vaccines for Ebola virus (Zaire ebolavirus), requiring stringent ultra-low cold-chain storage, but no efficacious vaccines are yet available for Marburg virus (Marburg marburgvirus) or Sudan virus (Sudan ebolavirus).