HPV Vaccine

Modality

Human Papilloma Virus (HPV) Vaccine

Human papillomavirus (HPV) consists of a group of 200 recognized viruses, which don’t affect most people. However, it’s common to be infected with high-risk ones and thus get genital warts or cancer.

These cancers can be prevented by prophylactic vaccination against HPV. For example, Gardasil, as the first HPV prophylactic vaccine to be approved, can protect against 4 types of HPV (6, 11, 16, and 18). And other five types (31, 33, 45, 52, and 58) can be prevented by Gardasil 9. The vaccines, intended to protect the initial HPV infection, can generate virus-neutralizing antibodies. In the United States, Gardasil has been replaced by Gardasil 9, which covers nine serotypes instead of four. The Gardasil and Gardasil 9 vaccines are all recombinant VLPs with L1-HPV epitopes. However, to offset the increased number of different co-formulated VLPs, Gardasil9 contains a larger number of total antigens than Gardasil.

Evidence has shown that licensed vaccines can defend against genital wart development and cervical precancerous, and their protection is expected to last for at least 4.5 years. However, the current challenges lie in the cost of marketed HPV vaccines in yeasts or insect expression systems.

Successful steps have been made recently in generating low-cost HPV vaccines in Escherichia coli (E. coli). Cecolin, a bivalent L1-HPV vaccine targeting HPV16 and HPV18, has been successfully expressed in E. coli and has shown high immunogenicity in pre-clinical and clinical studies. The NMPA approved the use of Cecolin in China on December 30, 2019. Moreover, Cecolin, the first Chinese-produced HPV vaccine, was prequalified by WHO in October 2021.

Fig 1. Structure of Virus-Like Particles Assembled from the L1 Protein of Human Papillomavirus 16. Website: https://www.rcsb.org/structure/1DZL.

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for HPV Vaccine

HPV Vaccine Pipelines

Generic name	Brand Name/Alternative name	Expression System	Originator/Manufacture	R&D stage
Recombinant Quadrivalent HPV Vaccine (Types 6, 11, 16, 18)	Gardasil, V-501, Silgard, 佳达修, ガーダシル	Yeast (Saccharomyces cerevisiae)	Merck & Co., Inc.	Approval
Recombinant Nine-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)	Gardasil9, V503, Gardasil 9, 佳达修 9, Silgard, シルガード	Yeast (Saccharomyces cerevisiae)	Merck & Co., Inc.	Approval
Recombinant Bivalent HPV vaccine	Cecolin, 馨可宁	E. coli	Innovax Biotech	Approval
Recombinant Bivalent HPV vaccine	沃泽惠	Yeast (Pichia pastoris)	Shanghai Zerun Biotech, Walvax Biotechnology	Approval
Recombinant Bivalent HPV vaccine	MEDI-517, GSK-580299, HPV-032, HPV-046, Cervarix, 希瑞适, サーバリックス, HPV-16/18 L1 VLP/AS04	Baculoviruses	GSK Plc	Approval
Recombinant 11-valent HPV vaccine	Pending Update	Yeast (Hansenula polymorpha)	Simoon Record Beijing	Phase III
Recombinant HPV 16 E7 fusion protein vaccine	VR-111	Pending Update	Shanghai Zerun Biotech, Walvax Biotechnology	Phase III
Recombinant 9-valent HPV vaccine	Pending Update	Yeast (Pichia pastoris)	Shanghai Zerun Biotech, Walvax Biotechnology	Phase III
Recombinant 9-valent HPV vaccine	REC 603, REC-603	Yeast (Hansenula polymorpha)	Jiangsu Recbio Biotechnology.	Phase III
Recombinant nine-valent HPV vaccine	Pending Update	E. coli	Beijing Health Guard Biotechnology, R-PHARM	Phase III
Recombinant Trivalent HPV vaccine	Pending Update	E. coli	Beijing Health Guard Biotechnology	Phase III
Recombinant Nine-valent HPV vaccine	Pending Update	E. coli	Innovax Biotech	Phase III
Recombinant Quadrivalent HPV Vaccine (Type 6, 11, 16, 18)	Pending Update	Yeast (Hansenula polymorpha)	Shanghai Bovax Biotechnology	Phase III
Recombinant Nine-valent HPV vaccine	Pending Update	Yeast (Hansenula polymorpha)	Shanghai Bovax Biotechnology	Phase III
Recombinant Tetravalent HPV vaccine (6,11,16,18)	Pending Update	Yeast (Hansenula polymorpha)	Chengdu Institute of Biological Products Co., Ltd	Phase III
Recombinant bivalent HPV vaccine	Pending Update	E. coli	Innovax Biotech	Phase II
Recombinant 14-valent HPV vaccine	SCT1000	Insect cell	Sinocelltech Group Limited	Phase II
Tetravalent HPV vaccine	Pending Update	Yeast (Pichia pastoris)	Shanghai Institute of Biological Products	Phase II
TVGV-1	(PE-E7-K3) fusion protein	E. coli	TheVax Genetics Vaccine	Phase II

Reference:

Cid R, Bolívar J. Platforms for Production of Protein-Based Vaccines: From Classical to Next-Generation Strategies. Biomolecules. 2021 Jul 21;11(8):1072. doi: 10.3390/biom11081072.

Mohsen MO, Bachmann MF. Virus-like particle vaccinology, from bench to bedside. Cell Mol Immunol. 2022 Sep;19(9):993-1011. doi: 10.1038/s41423-022-00897-8.

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Modality

Human Papilloma Virus (HPV) Vaccine

Yaohai Bio-Pharma Offers One-Stop CDMO Solution for HPV Vaccine

HPV Vaccine Pipelines

Reference:

MICROBIAL CDMO

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