1. WO2026085590 - PROCESS FOR PRODUCING AN ANTIMALARIAL VACCINE COMPOSITION, PRODUCTS AND USE

Publication Number WO/2026/085590

Publication Date 30.04.2026

International Application No. PCT/BR2025/050404

International Filing Date 05.09.2025

IPC

C07K 19/00 2006.1

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
K	PEPTIDES
19	Hybrid peptides

C07K 14/445 2006.1

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
K	PEPTIDES
14	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
435	from animals; from humans
44	from protozoa
445	Plasmodium

C07K 1/36 2006.1

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
K	PEPTIDES
1	General processes for the preparation of peptides
14	Extraction; Separation; Purification
36	by a combination of two or more processes of different types

C12N 15/62 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
11	DNA or RNA fragments; Modified forms thereof
62	DNA sequences coding for fusion proteins

C12N 15/30 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
11	DNA or RNA fragments; Modified forms thereof
30	Genes encoding protozoal proteins, e.g. from Plasmodium, Trypanosoma, Eimeria

C12N 15/81 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
63	Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
79	Vectors or expression systems specially adapted for eukaryotic hosts
80	for fungi
81	for yeasts

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C07K 19/00 2006.1

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
K	PEPTIDES
19	Hybrid peptides

C07K 14/445 2006.1

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
K	PEPTIDES
14	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
435	from animals; from humans
44	from protozoa
445	Plasmodium

C07K 1/36 2006.1

C	CHEMISTRY; METALLURGY
07	ORGANIC CHEMISTRY
K	PEPTIDES
1	General processes for the preparation of peptides
14	Extraction; Separation; Purification
36	by a combination of two or more processes of different types

C12N 15/62 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
11	DNA or RNA fragments; Modified forms thereof
62	DNA sequences coding for fusion proteins

C12N 15/30 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
11	DNA or RNA fragments; Modified forms thereof
30	Genes encoding protozoal proteins, e.g. from Plasmodium, Trypanosoma, Eimeria

C12N 15/81 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
63	Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
79	Vectors or expression systems specially adapted for eukaryotic hosts
80	for fungi
81	for yeasts

A61K 39/015 2006.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
39	Medicinal preparations containing antigens or antibodies
002	Protozoa antigens
015	Hemosporidia antigens, e.g. Plasmodium antigens

A61P 33/06 2006.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
P	SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
33	Antiparasitic agents
02	Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
06	Antimalarials

A61K 39/002 2006.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
39	Medicinal preparations containing antigens or antibodies
002	Protozoa antigens

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Applicants

• UNIVERSIDADE FEDERAL DE MINAS GERAIS - UFMG [BR]/[BR]
• UNIVERSIDADE DE SÃO PAULO [BR]/[BR]

Inventors

• TOSTES GAZZINELLI, Ricardo
• SALLES MOURA FERNANDES, Ana Paula
• RIBEIRO TEIXEIRA, Santuza Maria
• CHAVES MAIA, Ana Luiza
• GAZZINELLI GUIMARÃES, Ana Clara
• GOMES RIVELLI, Graziella
• SALAZAR DE CASTRO, Natália
• SALGADO FERNANDES, Renata
• DA SILVA SOARES, Irene
• FERREIRA MARQUES, Rodolfo

Priority Data

1020240223306

25.10.2024

BR

Publication Language Portuguese (pt)

Filing Language Portuguese (pt)

Designated States

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AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CV, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, MG, MK, MN, MU, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UY, UZ, VC, VN, WS, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, CV, GH, GM, KE, LR, LS, MU, MW, MZ, NA, RW, SC, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, ME, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)

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Title

(EN) PROCESS FOR PRODUCING AN ANTIMALARIAL VACCINE COMPOSITION, PRODUCTS AND USE

(FR) PROCÉDÉ DE PRODUCTION DE COMPOSITION VACCINALE ANTIPALUDIQUE, PRODUITS ET UTILISATION

(PT) PROCESSO PARA PRODUÇÃO DE COMPOSIÇÃO VACINAL ANTIMALÁRICA, PRODUTOS E USO

Abstract

(EN) The invention relates to a process for producing an antimalarial vaccine composition containing the recombinant chimeric protein SEQ ID NO: 2, which comprises a conserved region I, targeted by neutralising antibodies, linked to an immunodominant region containing repeats of central amino acids from the different alleles (VK210, P. vivax-like and VK247) of the circumsporozoite protein (PvCSP), predominant on the surface of sporozoites, the infective form of Plasmodium vivax, followed by the C-terminal domain region, target of T lymphocytes, of the PvCSP protein. It also relates to the vaccine composition produced by said process, which is directed at malaria caused by Plasmodium vivax and presents high immunogenicity and protection, with efficacy superior to that of the compositions presented in the prior art. The process revealed in this technology allows the production of a high-purity API (100% by RP-HPLC and 98.8% by SE-HPLC) with a high yield (5,082.5 mg from 3L of purified supernatant).

(FR) L'invention concerne un procédé pour la production d'une composition vaccinale antipaludique contenant la protéine chimérique recombinante SEQ ID No 2, qui présente une région conservée I cible d'anticorps neutralisants, liée à une région immunodominante contenant des répétitions d'acides aminés centraux des différents allèles (VK210, P.vivax-like et VK247) de la protéine circumsporozoïte (PvCSP), prédominante sur la surfaces de sporozoïtes, la forme infectante de Plasmodium vivax, suivie de la région du domaine C-terminal, cible de lymphocytes T, de la protéine PvCSP. L'invention concerne également la composition vaccinale produite par ce procédé, qui est ciblée sur le paludisme causé par Plasmodium vivax, et présente une haute immunogénicité et une protection élevée, avec une efficacité supérieure à celle des compositions décrites dans l'état de la technique. Le procédé divulgué dans la présente technologie permet la production d'un IPA de haute pureté (100 % par RP-HPLC et 98,8 % par SE-HPLC) et rendement élevé (5082,5 mg à partir de 3L de surnageant purifié).

(PT) Processo para a produção de uma composição vacinal antimalárica contendo a proteína quimérica recombinante SEQ ID No2, que compreende uma região conservada I alvo de anticorpos neutralizantes, ligada a uma região imunodominante contendo repetições de aminoácidos centrais dos diferentes alelos (VK210, P.vivax-like e VK247) da proteína circumsporozoíta (PvCSP), predominante na superfície de esporozoítos, a forma infectante de Plasmodium vivax, seguida da região do domínio C- terminal, alvo de linfócitos T, da proteína PvCSP. Trata também da composição vacinal produzida pelo processo, que é direcionada para malária causada por Plasmodium vivax, e apresenta alta imunogenicidade e proteção, com eficácia superior à das composições apresentadas no estado da técnica. O processo revelado na presente tecnologia permite a produção de um IFA de alta pureza (100% por RP-HPLC e 98,8% por SE- HPLC) e elevado rendimento (5.082,5 mg a partir de 3L de sobrenadante purificado).

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