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Vaccine for Cervical Cancer_EyeGene Inc.
Korea Health Industry Development Institute (KHIDI) South Korea flag South Korea
Abstract ID:
EG-HPV: Human papillomavirus vaccine based on Virus-Like Particle (VLP) technology (HPV 16 & 18 L1 VLP) and a novel proprietary immune adjuvant EGvac (adjuvant system CIA05+alum) that enhances the immune response against HPV through both B cell (humoral)...
Contact Yong U Kim
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1. Summary

• EG-HPV is a combination between Virus-Like Particle (VLP) technology (HPV 16 & 18 L1 VLP) and a novel proprietary immune adjuvant EGvac (adjuvant system CIA05 + alum) that enhances the immune response against HPV through both B cell (humoral) and T cell (cellular) immune stimulation.

• Preclinical efficacy and toxicity studies have been completed with manufacturing processes established.

• Phase I clinical trials conducted at Seoul National University Hospital have also been successfully completed. Primary endpoints included safety & tolerance evaluation, and immunogenicity evaluation (anti-HPV 16/18 L1 IgG titer measurements and neutralizing anti-HPV 16/18 L1 titer measurements).



2. Applications

Potential applications for novel proprietary immune adjuvant technology EGvac

Adjuvant System Composition Target Disease

CIA02 TLR9 agonist -

CIA05 TLR4 agonist -

CIA06 CIA05 + Aluminum hydroxide HPV, HBV, anthrax, influenza

TB, VZV, P. aeruginosa

CIA07 CIA02 + CIA05 cancer immunotherapy

CIA08 CIA05 + Liposome A TB, VZV

CIA09 CIA05 + Liposome B TB, VZV, P. aeruginosa

3. Market Feasibility

Cervical Cancer Overview

• Human papillomavirus (HPV) infection causes more than 90% of cervical cancer cases

• Over 99% of HPV DNA found in 1,000 tissue samples from cervical cancer patients in 22 countries

• Worldwide, 630 million are estimated to be infected with HPV, which is responsible for the development of nearly all cases of Cervical Cancer.

• By age 50, more than 80% of females are likely to be infected with HPV

• Infection can be prevented with vaccination

Global HPV Vaccine Market

• Global sales(2012) : Gardasil®(Merck) $1.6bn, CervarixTM(GSK) $0.4bn

• Global HPV vaccine market is estimated to reach $3.5bn by 2020 on increased use of Gardasil® and CervarixTM

4. Technical Advantages

• Competitive in terms of both efficacy and cost versus currently available HPV vaccines.

• Well tolerated in all subjects with strong humoral and cellular immune stimulation in Phase I studies.

• Phase 2 studies are currently being designed in collaboration with domestic partner.

5. Technical Highlighted Summary

• EG-HPV is cost competitive versus both Gardasil® (Merck) and CervarixTM (GSK).

• Gardasil contains 3 times the amount of HPV L1 VLP antigens (120 ug) vs. EG-HPV (40 ug), and also half of the HPV L1 VLP antigens (60 ug) are for HPV 6,11 which are associated with genital warts NOT cervical cancer.

• EG-HPV is cost effective versus CervarixTM due to the process of manufacturing.

EG-HPV – Comparison with Currently Marketed Vaccines

Gardasil® (Merck) CervarixTM (GSK) EG-HPV

Contents HPV 6 L1 VLP (20 ug),

HPV 11 (40 ug),

HPV 16 (40 ug),

HPV 18 (20 ug)

+ aluminum (225 ug) HPV 16 L1 VLP (20 ug),

HPV 18 L1 VLP (20 ug)

+ aluminum (500 ug)

+ MPL (50 ug) HPV 16 L1 VLP (20 ug),

HPV 18 L1 VLP (20 ug)

+ aluminum (500 ug)

+ dLOS (CIA05) (10 ug)

Production host Yeast Insect cell Yeast

Injection schedule 3 times (0, 2, 6)

2 times (9~13years) 3 times (0, 1, 6)

2 times (8~13years) 3 times (0, 1, 6)

Immune Adjuvant Aluminum hydroxyphosphate sulfate MPL and aluminum hydroxide (AS04) dLOS (CIA05) and aluminum hydroxide

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Type of Business Relationship Sought
• Available for out-licensing • Seeking co-development, Strategic partnerships
FEATURED
Last Updated Jun 2016
Technology Type THERAPEUTIC
Phase of Development CLINICAL TRIALS
GOVERNMENT INSTITUTE