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1. WO2020109485 - ORAL DISPERSIBLE VACCINE COMPRISING VIROSOMES

Publication Number WO/2020/109485
Publication Date 04.06.2020
International Application No. PCT/EP2019/082940
International Filing Date 28.11.2019
IPC
A61K 39/12 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
12Viral antigens
A61P 31/18 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
31Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
12Antivirals
14for RNA viruses
18for HIV
A61K 39/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
CPC
A61K 2039/5258
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
51comprising whole cells, viruses or DNA/RNA
525Virus
5258Virus-like particles
A61K 2039/542
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
54characterised by the route of administration
541Mucosal route
542oral/gastrointestinal
A61K 2039/55511
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
555characterised by a specific combination antigen/adjuvant
55511Organic adjuvants
A61K 2039/55555
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
555characterised by a specific combination antigen/adjuvant
55511Organic adjuvants
55555Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
A61K 2039/55583
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
555characterised by a specific combination antigen/adjuvant
55511Organic adjuvants
55583Polysaccharides
A61K 2039/575
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
57characterised by the type of response, e.g. Th1, Th2
575humoral response
Applicants
  • CATALENT U.K. SWINDON ZYDIS LIMITED [GB]/[GB]
  • MYMETICS CORPORATION [CH]/[CH]
Inventors
  • WONG, Yik Teng
  • SMARDON, Charli
  • SHIRKHANI, Khojasteh
  • AMACKER, Mario
  • FLEURY, Sylvain
  • STEGMANN, Antonius Johannes Henrikus
Agents
  • BRUNNER, John Michael Owen
  • JACKSON, Richard Eric
  • COCKERTON, Bruce Roger
  • MARSHALL, Cameron John
  • GOODFELLOW, Hugh Robin
  • TUNSTALL, Christopher Stephen
  • KIRSCH, Susan Edith
  • SMALL, Gary James
  • WARNER, James Alexander
  • CHAPMAN, Desmond Mark
  • WISE, Daniel Joseph
  • OATES, Edward Christopher
  • MCGUIRE, Gillian Margaret
  • MORRIS, Claire Louise
  • COX, Jennifer Jane
  • GEORGIOU, Matthew
  • HOLLAND, David Christopher
  • BETTRIDGE, Paul Sebastian
  • DRAGOSAVAC, Susannah Marie
  • PREISSNER, Tanja Stephanie
  • LEATHLEY, Anna Elisabeth
  • HUSBAND, Benjamin
  • DUFFIELD, Stephen
  • MACLEOD, Ian Roger
  • HOGGETT, Christopher James
  • GRABENSTEIN, Jens
  • MICHELL, Stephen Robert
  • DARBY, Richard John
  • BARRY, Isobel Amy
  • MCKINLEY, Elizabeth Anne
  • BIRCH, Matthew John
  • THEISEN, Andreas Robert
  • BETTRIDGE, Paul Sebastian
Priority Data
62/772,82329.11.2018US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) ORAL DISPERSIBLE VACCINE COMPRISING VIROSOMES
(FR) VACCIN ORODISPERSIBLE COMPRENANT DES VIROSOMES
Abstract
(EN)
The present disclosure is directed to oral vaccine dosage forms and processes for producing the oral vaccine dosage forms. The dosage forms include lipid-based vesicles (e.g., virosomes, liposomes) harboring an immunogenic amount of at least one vaccinal target molecule, with or without adjuvant. Specifically, Applicants discovered a combination of the composition of the liquid virosome concentrates, the composition of the base matrix for the solid dosage form formulation (excluding the virosome concentrate), and the manufacturing conditions for the dosage forms that can produce a freeze dried sublingual dosage form having physical robustness, particle and antigen integrity and stability.
(FR)
La présente invention concerne des formes posologiques orales de vaccin et des processus pour produire les formes posologiques orales de vaccin. Les formes posologiques comprennent des vésicules à base de lipides (par exemple, des virosomes, des liposomes) hébergeant une quantité immunogène d'au moins une molécule cible vaccinale, avec ou sans adjuvant. Spécifiquement, les demandeurs ont découvert une combinaison de la composition des concentrés de virosome liquides, de la composition de la matrice de base pour la formulation de forme posologique solide (à l'exclusion du concentré de virosome), et des conditions de fabrication pour les formes posologiques qui peuvent produire une forme posologique sublinguale lyophilisée ayant une robustesse physique, une intégrité de particule et d'antigène et une stabilité.
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