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Assignees
Vlp Thereapeutics LLC • VLP Therapeutics Inc
Member
VLP TherapeuticsVLP Therapeutics is a Maryland-based biotechnology company established in 2012, focused on developing preventative and therapeutic vaccines as well as targeted antibody agents for cancer, infectious diseases, autoimmune conditions, and neurological diseases. The company utilizes next-generation virus-like particle platforms, gene delivery systems, and structure-based antigen design to address unmet global medical needs. Its research pipeline includes vaccine candidates for malaria, dengue, COVID-19, and cancer immunotherapies. The organization is driven by a team with experience in vaccine R&D, clinical development, and collaborative partnerships with prominent academic and government institutions.
VLP Therapeutics is a Maryland-based biotechnology company established in 2012, focused on developing preventative and therapeutic vaccines as well as targeted antibody agents for cancer, infectious diseases, autoimmune conditions, and neurological diseases. The company utilizes next-generation virus-like particle platforms, gene delivery systems, and structure-based antigen design to address unmet global medical needs. Its research pipeline includes vaccine candidates for malaria, dengue, COVID-19, and cancer immunotherapies. The organization is driven by a team with experience in vaccine R&D, clinical development, and collaborative partnerships with prominent academic and government institutions.
Publication Number
US-9512190-B2
Publication Date
2016-12-06
Expiration Date
Abstract
The present invention provides a particle comprising a polypeptide and at least one malaria antigen, and a composition or vaccine comprising thereof, its use in medicine, particularly in the prevention or treatment of malaria infections.
Core Innovation
The invention concerns self-assembled virus-like particles comprising Chikungunya virus (CHIKV) or Venezuelan equine encephalitis virus (VEEV) structural polypeptides fused or linked with a malaria antigen. The malaria antigen is a circumsporozoite protein (CSP) antigen containing circumsporozoite protein repeat epitopes such as NPNA and T-cell epitopes such as EYLNKIQNSLSTEWSPCSVT. The resulting virus-like particles present the malaria antigen as part of a fusion protein within a CHIKV or VEEV structural envelope context.
The malaria antigen is conjugated via defined attachment sites, including linker or fusion protein insertion into specific E2 residue-position sites. In the CHIKV case, insertion occurs at sites corresponding in position to sites between residues 509–512, 519–520, 529–530, or 531–532 of SEQ ID NO: 1 or 2; in the VEEV case, insertion occurs at sites corresponding in position to sites between residues 515–520 or 536–539 of SEQ ID NO: 3. The malaria antigens are selected as (NPNA)n repeats with n from 4 to 30 or as EYLNKIQNSLSTEWSPCSVT repeat segments with y from 1 to 6.
The invention further provides vaccine compositions and kits incorporating the CHIKV or VEEV virus-like particles, optionally with adjuvants, and also nucleic acids encoding the virus-like particles. The document states that immunization can induce antibodies against malaria antigens and can be used for treating and/or preventing malaria. Example data are described showing induction of high anti-CSP titers and partial protection after immunization with CHIKV-VLP and VEEV-VLP, with and without adjuvant, including studies in non-human primates and mice.
Claims Coverage
The independent claims cover two main subject matters: (i) CHIKV or VEEV virus-like particles engineered with at least one malaria antigen inserted into an E2 envelope protein at specified residue-position sites, where the inserted antigen is selected from defined NPNA and EYLNKIQNSLSTEWSPCSVT repeat forms; and (ii) isolated nucleic acids defined by sequence identity of 90% or more relative to multiple specified reference sequences (SEQ ID Nos. 26–27, 29–30, 32–33, 35–36, 38, 40, or 42).
Engineered CHIKV or VEEV virus-like particle with E2-inserted malaria antigen fusion protein
A CHIKV or VEEV virus-like particle contains at least one malaria antigen inserted into an E2 envelope protein to form a fusion protein, where the malaria antigen insertion occurs at CHIKV E2 sites corresponding in position to sites between residues 509–512, 519–520, 529–530, or 531–532 of SEQ ID NO: 1 or 2, or at VEEV E2 sites corresponding in position to sites between residues 515–520 or 536–539 of SEQ ID NO: 3.
Malaria antigen selection as defined NPNA repeats or EYLNKIQNSLSTEWSPCSVT repeat segments
The inserted malaria antigen is selected from (NPNA)n, where n is from 4 to 30, or (EYLNKIQNSLSTEWSPCSVT)y, where y is from 1 to 6.
Isolated nucleic acid defined by sequence identity to specified SEQ ID references
An isolated nucleic acid molecule consists of a nucleotide sequence having a sequence identity of 90% or more with a nucleotide sequence represented by SEQ ID Nos. 26–27, 29–30, 32–33, 35–36, 38, 40 or 42.
Overall, the claim coverage centers on virus-like particles presenting CSP-derived malaria antigens via defined insertion into E2 envelope proteins at specified residue-position sites, with antigen forms limited to (NPNA)n and (EYLNKIQNSLSTEWSPCSVT)y. A separate independent claim defines isolated nucleic acids by 90% or greater identity to multiple specified reference sequences.
Stated Advantages
Induction of high anti-CSP titers after immunization with CHIKV-VLP and VEEV-VLP, with and without adjuvant.
Partial protection after immunization with CHIKV-VLP and VEEV-VLP, with and without adjuvant.
Use for inducing antibodies and for treating and/or preventing malaria.
Documented Applications
Immunization to induce antibodies against malaria antigens, including CSP-derived targets.
Use for treating and/or preventing malaria.
Non-human primate studies reporting immunogenicity and partial protection after immunization with CHIKV-VLP and VEEV-VLP.
Mouse studies reporting immunogenicity and partial protection after immunization with CHIKV-VLP and VEEV-VLP, with and without adjuvant.
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