Our ambition is to develop a broad portfolio of vaccine candidates in different phases, offering our whole range of expertise throughout all stages and aspects of pharmaceutical product development, e.g. preclinical and clinical studies, quality assurance and industrial manufacturing, as well as legal and commercial.
This strategy ensures that more innovations are given the opportunity to reach the market faster for the benefit of humanity. At the same time, investors are offered risk diversification with greater future leverage.
Read more how we bridge the gap between innovation and market =>
Chlamydia Vaccine Candidate
Chlamydia may not be considered as a major health issue but causes more than 130 million worldwide infections each year. Whilst infections can be treated, they are often not detected due to patients being asymptomatic.
This often result in inflammation and pelvic pain and may later lead to fatal ectopic pregnancy and/or infertility for as many as half a million women.
But not only. Chlamydia infection also increases susceptibility and transmission of other sexually transmitted diseases such as HIV.
Notably, non-sexually transmitted strains of Chlamydia trachomatis are the world’s leading cause of preventable blindness.
Meet the inventors and learn more about this candidate in this short video.
We have successfully identified sections of the MOMP (Major Outer Membrane Protein) in the bacterium Chlamydia trachomatis – sequences that can be used to trigger an immune response. The specially designed protein chains are essential for creation of the vaccine, and are patent protected.
Initial studies have proven the active protein to be very immunogenic and well tolerated even without an adjuvant.
Chlamydia is one of the most common sexually transmitted diseases (STD) and is caused by the bacterium Chlamydia trachomatis. The WHO estimates over 130 million new cases of chlamydia each year and a widespread implementation of vaccination in adolescents has been proposed, similar to the existing HPV vaccination programmes.
Thus, a similar global market potential could be available for a safe and efficacious chlamydia vaccine, i.e. 2.5 to 5 billion USD per annum. The current treatment of chlamydia infection is with antibiotics, which most often cures the infection. However, it will not repair any permanent damage done by the disease, which would be prevented by a vaccine. Successful implementation of prophylactic vaccination would reduce the current extensive use of antibiotics and thus reduce the evolutionary pressure towards antibiotic resistance.
The need for a safe and efficacious chlamydia vaccine has been identified by some of the big vaccine companies and research is conducted by a few players. However, there appears to be very limited clinical R&D activity in this space with only one prophylactic vaccine candidate in clinical development. The rationally bioengineered vaccine in our portfolio adds a viable candidate to the global pipeline against chlamydia infection.
Up to now, three major pre-clinical studies have been performed in mice, resulting in positive antibody and T-cell responses.
Our current development involves;
– to set up an industrially scalable manufacturing process to ensure high quality supply to future studies – 1st – 4th quarter 2021
– to manufacture study products for the planned clinical study according to GMP – 2nd quarter 2022
– to design a Phase I clinical trial to be started in the fall of 2022
– Endocine ™
Endocine™ is a safe, tolerable and effective vaccine adjuvant, based on natural lipid compounds and formulated as a liposomal dispersion. The manufacture of bulk adjuvant has been established in pilot-scale at GMP conditions.
It has been evaluated with several different vaccine antigens, both viral and bacterial and found compatible with peptides, proteins, polysaccharides, VLPs, as well as split and whole pathogens.
Safe & Tolerable
Endocine™ has shown excellent safety and tolerability in more than 400 human subjects after nasal administration in five clinical trials. The natural origin of the lipid compounds is a key to safety and regulatory approval.
The technology is also well tolerated in animal models, such as mouse, rat and ferret, as has been shown in numerous preclinical studies.
Sample of publications
Intranasally administered Endocine™ formulated 2009 pandemic influenza H1N1 vaccine induces broad specific antibody responses and confers protection in ferrets.
Maltais AK, Stittelaar KJ, Veldhuis Kroeze EJ, van Amerongen G, Dijkshoorn ML, Krestin GP, Hinkula J, Arwidsson H, Lindberg A, Osterhaus AD. Vaccine. 2014 May 30;32(26):3307-15. doi: 10.1016/j.vaccine.2014.03.061. Epub 2014 Mar 30.
Endocine™, N3OA and N3OASq; three mucosal adjuvants that enhance the immune response to nasal influenza vaccination.
Falkeborn T, Bråve A, Larsson M, Akerlind B, Schröder U, Hinkula J. PLoS One. 2013 Aug 8;8(8):e70527. doi: 10.1371/journal.pone.0070527. eCollection 2013
The Eurocine L3 adjuvants with subunit influenza antigens induce protective immunity in mice after intranasal vaccination.
Pernilla Petersson, Mona Hedenskog, Denise Alves, Mia Brytting, Ulf Schröder, Annika Linde, Åke Lundkvist. Vaccine 28 (2010) 6491-6497
Safety and immunogenicity, after nasal application of HIV-1 DNA gagp37 plasmid vaccine in young mice.
Jorma Hinkula, Marie Hagbom, Britta Wahren, Ulf Schröder. Vaccine 26 (2008) 5101-5106
Intranasal immunization of young mice with a multigene HIV-1 vaccine in combination with the N3 adjuvant induces mucosal and systemic immune responses.
Andreas Bråve, David Hallengärd, Ulf Schöder, Pontus Blomberg, Britta Wahren and Jorma Hinkula. Vaccine 26 (2008) 5075-5078
DNA–VLP prime–boost intra-nasal immunization induces cellular and humoral anti-HIV-1 systemic and mucosalimmunity with cross-clade neutralizing activity.
L. Buonaguro, C. Devito, M.L. Tornesello, U. Schröder, B. Wahren, J. Hinkula and F.M. Buonaguro Vaccine 25 (2007) 5968-5977
A novel DNA adjuvant, N3, enhances mucosal and systemic immune responses induced by HIV-1 DNA and peptide immunizations.
Jorma Hinkula, Claudia Devito, Bartek Zuber, Reinhold Benthin, Denise Ferreira, Britta Wahren, Ulf Schröder. Vaccine 24 (2006) 4494-4497
Nasal boost with adjuvanted heat killed BCG or arabinomannan-protein conjugate improves primary BCG-induced protection in C57BL/6 mice.
M. Haile, B. Hamasur, T. Jaxmar, D. Gavier-Widen, M.A. Chambers, B. Sanchez, U. Schröder, Källenius, S.B. Svenson, A. Pawlowski. Tuberculosis (2005) 85, 107-114Intranasal HIV-1-gp160-DNA/gp41 peptide prime-boost immunization regimen of mice results in longterm HIV-1 neutralizing humoral, mucosal and systemic immunity.
C. Devito, B. Zuber, U. Schröder, R. Benthin, K. Okuda, K. Broliden, B. Wahren and J. Hinkula. J.Immunology (2004) 173: 7078-7089
Immunization with heat-killed Mycobacterium bovis bacille Calmette–Guerin (BCG) in EurocineTM L3 adjuvant protects against tuberculosis.
M. Haile, U. Schröder, B. Hamasur, A. Pawlowski, T. Jaxmar, G. Källenius, S.B. Svenson. Vaccine 22 (2004) 1498-1508
Vaccines against eight different pathogens have been tested intramuscularly or subcutaneously with Endocine™ with eight different vaccine candidates.
As an example, a vaccine candidate that was tested together with Eurocine Vaccines´ adjuvant Endocine™ in mice, showed that Endocine™ enhanced the antibody level 6-10 times after intramuscular injection, compared to the same vaccine without Endocine™.
Endocine™ is offered as a safe and effective intramuscular vaccine adjuvant for both human and veterinary use.
Vaccines against nine different pathogens have been tested intranasally with Endocine™. Including all antigen types, a total of twelve different vaccine candidates have been tested.
Ease of administration and the generation of mucosal immunity are attractive benefits of a nasal vaccine.
Endocine™ is offered as a safe and effective intranasal vaccine adjuvant for both human and veterinary use.