Vaccine ˈvaksiːn,-ɪn/

An antigenic substance prepared from the causative agent of a disease or a synthetic substitute, used to provide immunity against one or several diseases.

Innovative ˈɪn.ə.və.tɪv/

1. a creation of a new process resulting from study and experimentation

2. the creation of something in the mind

3. the act of starting something for the first time; introducing something new

INNOVATIVE PLAYER IN THE VACCINE SECTOR

Since its incorporation in 2005, AmVac AG has developed into a preeminent player in the international vaccine sector, combining powerful vaccine development platforms with one of the most innovative and advanced pipelines in this business.

AmVac has:

  • Exclusively licensed three unique technology platforms (Lactobacillus, Sendai Virus Vector, MALP-2) for the development of innovative vaccines.
  • Built an advanced portfolio of six vaccine candidates, each of which is geared towards commercially attractive growth markets.
  • Established a highly effective drug development organization.
  • Access to a dedicated manufacturing facility for the lead compound, and to a strong network of experts and service partners in the disciplines relevant to drug development and approval.
  • Developed a well-managed IP portfolio with a strong IP position.

AmVac AG can be considered as a model case for a successful and efficient transfer of basic research results into the industrial development of a completely novel type of vaccine for a broad range of applications.

Vaccines have emerged as one of the most profitable business segments in the healthcare industry. The global vaccines industry is a multi-billion dollar industry with rapid growth expected over the next years.

About Us

AmVac AG is a preeminent player in the international vaccine sector, combining powerful vaccine development platforms with one of the most innovative and advanced pipelines in this business. Our mission is to develop innovative and safe vaccines that enhance human health and improve scientific understanding of immunological conditions.

Effectively Organized

AmVac has built a lean organization at four locations working effectively together to advance its products to market. Depending on the particular needs and development stages of their projects, they draw from an extensive network of specialized partners and experts from around the world.

Organisation
  • Amvac AG
  • Amvac Research GmbH
  • Amvac Kft.
  • FranVax SRL
  • Vakcina Kft.
Partners
  • Helmlholz Institute
  • Max Planck Institute
  • Prof. Cusi
Experts
  • Prof. Carlos Guzman
  • Prof. Wolfgang Neubert
  • Prof. Cusi
  • Prof. Reinhard Glück

  • Amvac AG Zug, Switzerland The headquarter of AmVac has its seat in the centrally located city of Zug in Switzerland. Gesamtvorstand, Finanzabteilung, Projektkoordination und Verwaltung
  • Amvac Research GmbH Martinsried, Germany AmVac Research GmbH. is a fully owned subsidiary of AmVac AG. Forschung und Entwicklung zu Sendai- und MALP-Plattformen und Projekten
  • Amvac Kft. Budapest, Hungary AmVac Kft. is a fully owned subsidiary of AmVac AG. Coordination of production, clinical development and regulatory approval of Gynvac
  • FranVax SRL Catania, Italy FranVax Srl. is a fully owned subsidiary of AmVac AG.
  • Vakcina Kft. Sajógalóc, Hungary Development and production partner for Gynevac, Sajogalgóc, Hungary
  • Helmlholz Institute Braunschweig Licensor, research and development partner for the MALP platform, Braunschweig, Germany
  • Max Planck Institute Martinsried Licensor, research and development partner of Sendai platform, Martinsried / Munich, Germany
  • Prof. Cusi University of Siena
  • Prof. Carlos Guzman Braunschweig, Germany Inventor of the Malp technology. Head of Vaccinology and Applied Microbiology, Helmholtz Centre for Infection Research, Germany Head of Vaccinology and Applied Microbiology, Helmholtz Centre for Infection Research, Germany
  • Prof. Wolfgang Neubert Münich, Germany Inventor of the Sendai technology and molecular virology expert at the Max Planck Institute of Biochemistry in Martinsried / Munich, Germany
  • Prof. Cusi University of Siena Internationally renowned RSV-expert at the Policlinico Le Scotte, University of Siena, Italy
  • Prof. Reinhard Glück Aci Catena President of the Swiss Biotech Association, former Chief Scientific Officer of Berna Biotech with extensive experience in vaccine and adjuvants development, currently based in Aci Catena, Italy
Organisation

Executive Management

DR. ALI Pashazadeh Chief Executive Officer

Dr. Pashazadeh is founder of Treehill Partners, an execution-focused consultancy and interim management firm focused on the hands-on support of international companies in the Biopharma space. Previously, he held senior healthcare advisory positions at Blackstone, UBS and Goldman Sachs. He is a trained surgeon holding an MBBS and BSc from St Mary’s Hospital Medical School, London as well as an MBA from London Business School. He joined AmVac in 2015.

Marie Christine Kopkow Chief Legal Officer

Mrs. Kopkow is an experienced lawyer and founding partner of a corporate and commercial law firm. She joined AmVac in 2006.

Dr. Marian Wiegand Chief Scientific Officer

Dr. Wiegand is a vaccine expert with many years of experience as scientist, including for Crucell and the Max Planck Institute of Biochemistry. He joined AmVac in 2008.

Supervisory Board

Keith Luxon BoD Member

Currently Private Banker. Diverse professional background. Joined AmVac in 2010.

Viktor Sauter BoD Member

Holds seats on several boards and is head of TSZ, an auditing and consulting firm in Zurich, Switzerland. Certified public accountant. Founder of the Swiss Association of Asset Managers. Joined AmVac in 2007.

Scientific Advisory Board

Prof. Dr. Reinhard Glück Chairman

International vaccine expert. Currently CSO at Zydus Cadila and President of Etna Biotech.
Previously, president of the Swiss Biotech Association and leading roles with Berna Biotech and subsequently Crucell, as well as with Ciba Geigy. Advising AmVac since 2007.

Prof. Dr. Carlos Guzman SAB Member

Head of Vaccinology, Helmholtz Centre for Infection Research, Braunschweig, Germany. Advising AmVac since 2007.

Prof. Dr. Wolfgang J. Neubert SAB Member

Former Head of Molecular Virology Research, Max Planck Institute, Martinsried, Germany. Advising AmVac since 2007.

Our Team
2014

2014

AmVac receives marketing authorization for Gynevac in Georgia.
AmVac commences a Phase III study for Gynevac.
Promising steps towards developing an Ebola vaccine undertaken.

2013

2013

AmVac received the following prestigious grants in recognition of its on-going vaccine research efforts:
• EU – Leishmania vaccine (consortium)
• EU – Universal Flu vaccine (consortium)
• Bavarian Research Foundation – Sendai vector based RSV vaccine
AmVac acquired a majority stake in its Hungarian license partner Vakcina Kft.

2012

2012

Continued progress with the development of the Lactobacillus platform.  
Recruitment of three experts with long-standing experience in the production, quality assurance and licensing of vaccines.  Recruitment of an internationally experienced marketing and business development manager to lead commercialization activities.

2011

2011

Research grant (German ministry for research and education) for AmVac Research GmbH and a consortium of academic and industrial partners to jointly explore, among others, the value of MALP for the development of vaccines that specifically address the needs of the elderly.
Preclinical proof-of-concept for AMV602, the Sendai-based vaccine candidate for the prevention of RSV-infections.

2010

2010

Construction of a production facility for Gynevac in Hungary, financed by AmVac, commences in close collaboration with partner Vakcina Kft.
Foundation of AmVac Kft in Budapest, Hungary to manage the collaboration with Vakcina Kft and coordinate the activities relating to AMV100′s and AMV110′s further development and approval.

2009

2009

Expansion of AmVac’s research laboratories in Martinsried/ Munich and obtaining approval for operation of the labs (class S1 and S2) by the Bavarian authorities.
Patent approval of Sendai vector technology by the European Patent Office, further corroborating AmVac’s exclusive position in the field.

2008

2008

Foundation of AmVac Research GmbH in Martinsried/ Munich, Germany, to manage the transfer of the Sendai virus vector platform from the Max Planck Institute of Biochemistry to AmVac and further advance the platform in close collaboration with its academic inventor.
Integration of FranVax Srl, Catania/ Sicily, Italy to support AmVac’s research and development projects through dedicated services.
Patent approval of MALP-2 adjuvant technology by the European Patent Office, further corroborating AmVac’s exclusive position in the field.

2007

2007

Expanding the research portfolio by successfully concluding two exclusive worldwide license agreements for highly promising vaccine technologies:
• Sendai virus vector platform, originating from the Max Planck Institute of Biochemistry, Martinsried / Munich, Germany
• MALP adjuvants platform, originating from the Helmholtz Centre for Infection Research, Braunschweig, Germany

Attracting renowned vaccine experts as partners:
• Prof. Dr. Carlos Guzman, Head of Vaccinology at Helmholtz-Institute for Infection Research
• Prof. Dr. Wolfgang Neubert, at that time Head of Molecular Virology Research at Max-Planck-Institute of Biochemistry
• Prof. Dr. Reinhard Glück, at that time Vice President of the Swiss Biotech Association

2006

2006

Set-up of AmVac AG’s infrastructure in Zug, Switzerland.
AmVac receives recognition via the Frost & Sullivan ”Enabling Technology of the Year Award 2006” for its outstanding work focused on the development of biotherapeutic vaccines.

2005

2005

As an independent consultant to the biopharmaceutical industry, Melinda Karpati was instrumental in confirming Lactobacillus based Gynevac’s approval in Hungary under EU regulations in the context of the state’s accession to the EU. Deeply impressed by the data gathered on the vaccine in Hungary for more than a decade, she founded AmVac AG in order to fully exploit the vaccine’s potential for the rest of the world.
The same year, AmVac acquired exclusive worldwide marketing and distribution rights to Gynevac, excluding Hungary and the Ukraine.

History

Our Products

AmVac AG can be considered as a model case for a successful and efficient transfer of basic research results into the industrial development of a completely novel type of vaccine for a broad range of applications.

AMVAC HAS ESTABLISHED THREE POWERFUL PRODUCT DEVELOPMENT PLATFORMS

PORTFOLIO SUMMARY

Based on exclusive licenses from leading German scientific institutes of the Helmholtz and Max Planck societies as well as own and acquired IP, AmVac has developed an innovative portfolio of six vaccine candidates based on three platform technologies – Lactobacillus, Sendai virus vector, and MALP-2.

The most advanced product is AMV100 (“Gynevac”), based on the Lactobacillus platform. Based on previous approval for selected indications in certain geographies, the product is currently being developed for the treatment of certain highly prevalent urogenital diseases on a broad international level. With its particularly favourable safety profile, Gynevac could, for the first time, offer an effective treatment or prevention of non-malignant prostate enlargement and inflammation, bacterial vaginosis and infection with trichomonads, virtually free of side effects.

In addition to the six vaccine candidates, based on the Sendai platform, AmVac is currently directing a part of its research program to a promising, safe and highly efficacious Ebola vaccine in its pipeline.

Please continue on this site for more details on the specific platforms and products.

LACTO-BACILLUS

AMVAC’S LACTOBACILLUS PLATFORM

AmVac’s Lactobacillus platform offers the potential to safely and effectively treat a number of urogenital conditions. It is based on a distinct blend of inactivated lactobacillus strains which produce beneficial immunomodulatory effects in humans.

Application

AMV100 (“Gynevac”), AmVac’s lead lactobacillus-based product, has been used for many years in selected geographies to treat gynecological inflammation caused by bacteria or trichomoniasis.

Lactobacillus-based products are also currently under development by AmVac for prostatitis and benign prostate hyperplasia (BPH).

In addition, there is evidence to support possible future development programs in a number of other promising areas.

Taken together, the potential applications of products based on the Lactobacillus platform represent a multi-billion dollar market.

Status

  • AmVac holds exclusive worldwide rights to Gynevac.
  • Further expanded our IP position through European and worldwide patents.
  • Conducted several confirmatory preclinical studies as well as mode-of-action analyses.
  • Building a dedicated manufacturing facility in Hungary and started the process of national regulatory approval.
MALP-2

AMVAC’S MALP-2 PLATFORM

AmVac’s MALP-2 platform enables the generation of a new class of vaccine adjuvants – small chemical compounds that are mixed with vaccines to increase their efficacy. MALP-2 adjuvants not only facilitate the development of new, highly effective vaccination approaches, but also reduce the amount of antigen needed and hence may offer significant cost savings. MALP-2 vaccines also have the potential to be delivered mucosally, for example, as a nasal spray.


Application

MALP-2 adjuvants can be combined with many different antigens to target a broad range of diseases. AmVac focuses on widespread diseases with a particular need for preventive vaccination in peak times (e.g. seasonal or pandemic flu).

Status

  • Secured worldwide exclusive rights to the MALP-2 platform for use as adjuvants in infectious diseases from the Helmholtz Center for Infection Research in Braunschweig, Germany.
  • Technology platform transferred to AmVac Research GmbH, in close collaboration with MALP-2 expert Prof. Guzman and his team.
  • Fully synthetic GMP-conform production process developed.
  • Creating two MALP-adjuvanted vaccine candidates for the prevention of seasonal and pandemic influenza.
  • License with Helmholtz broadened to include all preventing and therapeutic applications, including for example pancreatic cancer
  • Secured public funding by the German ministry for research and education for a collaborative research project that, amongst others, evaluates the potential of MALP for the development of treatments that are specifically tailored to the needs of the elderly.
  • Currently performing preclinical studies to evaluate the safety and efficacy of our candidates in vitro and in vivo.

The Mycoplasma-derived lipopeptide MALP-2 is a potent mucosal adjuvant. Rharbaoui F, Drabner B, Borsutzky S, Winckler U, Morr M, Ensoli B, Muhlradt PF, Guzman CA. Eur J Immunol. 2002 Oct;32(10):2857-65.

Efficient mucosal delivery of the HIV-1 Tat protein using the synthetic lipopeptide MALP-2 as adjuvant. Borsutzky S, Fiorelli V, Ebensen T, Tripiciano A, Rharbaoui F, Scoglio A, Link C, Nappi F, Morr M, Butto S, Cafaro A, Muhlradt PF, Ensoli B, Guzman CA. Eur J Immunol. 2003 Jun;33(6):1548-56.

A prime-boost vaccination protocol optimizes immune responses against the nucleocapsid protein of the SARS coronavirus. Schulze K, Staib C, Schätzl HM, Ebensen T, Erfle V, Guzman CA. Vaccine. 2008 Dec 2;26(51):6678-84.

Efficient immune responses against Intimin and EspB of enterohaemorragic Escherichia coli after intranasal vaccination using the TLR2/6 agonist MALP-2 as adjuvant. Cataldi A, Yevsa T, Vilte DA, Schulze K, Castro-Parodi M, Larzábal M, Ibarra C, Mercado EC, Guzmán CA. Vaccine. 2008 Oct 16;26(44):5662-7. Epub 2008 Sep 21

SENDAI

AMVAC’S SENDAI PLATFORM

AmVac’s Sendai virus vector platform enables the generation of a new class of ‘semi-live’ vaccines that combine the efficacy of live-vaccines with a safety profile similar to that of dead or inactivated vaccines. Sendai-based vaccines are therefore particularly suited for the treatment of babies, infants, elderly or people with compromised immune systems – large and further growing high-risk groups whose particular medical needs are frequently overlooked in today’s mainstream drug development.

AmVac currently has three Sendai-based vaccine candidates under development.

Application

Using a modular approach, the Sendai vector system can be used in conjunction with many antigens to target a range of diseases, including those specifically associated with mucosal tissues.. AmVac focuses on indications with a high unmet medical need in high-risk populations.

Status

  • Secured worldwide exclusive rights to the Sendai vector technology from the Max Planck Institute of Biochemistry in Martinsried, Germany.
  • Transferred the technology platform to AmVac Research GmbH, in close collaboration with the inventor Prof. Neubert (and his team).
  • Transformed the technology into an integrated product development platform that meets international quality standards.
  • Set up a process for manufacturing Sendai-based vaccines.
  • Created vaccine candidates against respiratory syncytial virus (RSV).
  • Formed a strategic alliance with the internationally renowned RSV-expert Prof.ssa Grazia Cusi at the Institute of Biotechnology, University of Siena, Italy.
  • Established preclinical proof of concept in RSV infections, together with Prof.ssa Cusi and her team.
  • Dedicating a portion of research efforts towards a promising Ebola vaccine candidate based on the Sendai platform.

Recombinant Sendai virus induces T cell immunity against respiratory syncytial virus that is protective in the absence of antibodies. Voges B, Vallbracht S, Zimmer G, Bossow S, Neubert WJ, Richter K, Hobeika E, Herrler G, Ehl S. Cell Immunol. 2007 Jun;247(2):85-94 > Abstract (link auf http://www.ncbi.nlm.nih.gov/pubmed/17904538)

A chimeric respiratory syncytial virus fusion protein functionally replaces the F and HN glycoproteins in recombinant Sendai virus. Zimmer G, Bossow S, Kolesnikova L, Hinz M, Neubert WJ, Herrler G. J Virol. 2005 Aug;79(16):10467-77 > Abstract (http://www.ncbi.nlm.nih.gov/pubmed/16051839)

De novo synthesis of N and P proteins as a key step in Sendai virus gene expression. Wiegand MA, Bossow S, Schlecht S, Neubert WJ. J Virol. 2007 Dec;81(24):13835-44. Epub 2007 Sep 12 > Abstract (http://www.ncbi.nlm.nih.gov/pubmed/17855540)

Quantitative proteomics reveals subset-specific viral recognition in dendritic cells. Luber CA, Cox J, Lauterbach H, Fancke B, Selbach M, Tschopp J, Akira S, Wiegand M, Hochrein H, O'Keeffe M, Mann M. Immunity. 2010 Feb 26;32(2):279-89. Epub 2010 Feb 18. > Abstract (http://www.ncbi.nlm.nih.gov/pubmed/20171123)

Platforms

Our Products

AMV 100 (“Gynevac”, Lactobacillus platform)

The product Gynevac originated from the lactobacillus platform and was approved in Hungary in 1997 for the treatment of acute, subacute and chronic gynecological inflammations caused by bacteria and trichomonads and administered to over 200,000 patients over more than a decade. AmVac is currently working on the re-registration in Hungary based on current EU regulatory standards for the indication of bacterial vaginosis, with a view to achieving wider EU approval in due course.

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Incidence

Bacterial Vaginosis

Bacterial vaginosis (BV) is the most common cause of vaginal infection in women of childbearing age. Bacterial vaginosis is caused by an imbalance of naturally occurring bacterial flora of the vagina. Although BV is associated with sexual intercourse with a new partner, it is not considered a sexually transmitted infection. Studies have shown that approximately 29% of women in the U.S. are affected. Bacterial vaginosis is found in about 25% of pregnant women in the U.S. and approximately 60% of women who have a sexually-transmitted infections (STI) (source: AJOG, Dec-2013).

Up to 50% of women with BV can report no symptoms. Symptoms can however include:

  • Burning on urination
  • Itching around the vagina
  • Abnormal/ smelly vaginal discharge

This condition increases the risk of:

  • Secondary infections such as HPV (Human Papilloma Virus), HIV (Human Immunodeficiency Virus), Chlamydia Trachomatis, Herpes Simplex virus as well as infections following pelvic surgery
  • Many pregnancy related complications such as pre-term delivery, miscarriage and post-partum endometriosis
  • Pelvic inflammatory disease
  • Infertility
  • Failure of IVF

Although BV can clear up without treatment, it is advised that all women with signs and symptoms of BV are treated to avoid complications. BV treatment is especially important for pregnant women. Pregnant women who have had premature births or low weight babies should have a BV examination, even if there are no symptoms. It is also recommended that all women undergoing a hysterectomy or abortion should be treated for BV before their procedure, regardless of symptoms.

BV is most often treated with antibiotics which are generally effective in controlling the condition in the short term. However, antibiotic treatment is associated with:

  • allergic reactions
  • high recurrence rate of BV (up to 80% within 9 months)
  • risk of antibiotic resistance
  • other side effects

Because of this, a new, effective, sustainable treatment option would be very attractive.

Anticipated advantages of AMV100

  • Full recovery of vaginal flora leading to long-term protection
  • Low 5% recurrence rate within 9 months
  • Highly effective relief from symptoms: 95% of patients report decreased symptoms and increased quality of life
  • No significant side effects

AMV110 (Lactobacillus platform)

The AMV110 product, also based on the lactobacillus platform, successfully completed an open label Phase II clinical trial in Hungary involving approx. 100 patients with chronic prostatitis and benign prostate hyperplasia (BPH). Results were highly encouraging: 91% of patients reported decreased symptoms and increased quality of life based on an internationally accepted symptoms scoring system. No side-effects such as decreased libido or hypotension occurred.

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Statistics

Benign Prostate Hyperplasia

BPH is a common nonmalignant enlargement of the prostate gland affecting about 50% of men in their sixties and up to 90 % in their seventies and eighties, according to the National Institutes of Health, US. The potential market for BPH products is therefore huge.

BPH is associated with Lower Urinary Tract Symptoms (LUTS), most commonly straining/ hesitancy, urgency, nocturia, incontinence and incomplete emptying. These symptoms have a considerable negative impact on patients’ quality of life.

The pathophysiology of BPH seems to be complex. The following factors may be involved: age-related tissue modifications, hormonal imbalance (alterations, metabolic syndrome) and inflammation. Importantly for the hypothesized mechanism of action of AMV110, prostatic inflammation may represent an important factor in BPH development. Prostatic cells themselves are able to secrete inflammatory mediators which stimulate their own growth. Once the vicious circle has started, it appears that feedback controls (hormonal and cellular) can be overwhelmed and that prostate volume progressively increases. Large clinical studies confirmed a relationship between prostatic inflammation and benign prostatic hyperplasia.

Current treatments for BPH are depending on the severity of the condition and include:

  • Watchful waiting (for very mild cases)
  • Medical therapy (for example with alpha blockers and/ or 5 alpha reductase inhibitors)
  • Surgical treatment (reserved for most severe cases)

Side effects of medical therapies can be significant (orthostatic hypotension, dizziness, fatigue, ejaculatory disorder, decreased libido, erectile dysfunction, etc.) and can limit treatment compliance, hence efficacy. Surgical interventions such as Trans Urethral Resection of the Prostate are also associated with significant side effects.

As with most chronic diseases, BPH is progressive, hence management of early BPH may help control prostate growth and LUTS progression. There is clearly a significant unmet need for a safe, well tolerated treatment for this condition.

Anticipated advantages of AMV110

  • Long-term effect
  • Significant symptom relief
  • Excellent safety
  • No undesired side-effects on blood-pressure or libido

AmVac expects AMV110 to have strong potential to outperform current treatments and extend BPH therapy to the group of ‘watchful waiting’ patients.

AMV401/ 411 (MALP-2 platform)

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Statistics

AMV401 is an adjuvanted vaccine for the prevention of seasonal influenza, which is particularly suited to the needs of the elderly. Preclinical efficacy studies are currently ongoing. AMV411 is an adjuvanted vaccine for the prevention of pandemic influenza.

Influenza

Influenza is an acute infection caused by an influenza virus. Typical symptoms include high fever, chill, cough, pain and overall malaise. Although most people recover from influenza within a week, the disease can cause severe complications in certain risk groups requiring hospitalization and potentially leading to death. Risk groups include babies and children younger than age 2, elderly age 65 or older and patients with serious other diseases or debilitated immune systems. Furthermore, influenza has significant socio-economic impact. Epidemics often result in high levels of worker absenteeism and productivity losses.

Several vaccines against seasonal flu are available and although they can be effective in healthy adults younger than 65 there is significant room for improvement in the treatment of elderly and other risk groups.

Anticipated benefits of AMV401 & AMV411

  • Potential for needle-free application (e.g. nasal spray)
  • Potential for MALP-2-adjuvanted vaccines to demonstrate greater efficacy
  • Strong potential to confer better protection to risk groups
  • More efficient dosing

AMV602/ 611 (Sendai virus vector platform)

AMV602 is intended for the prevention of respiratory diseases caused by Respiratory Syncytial Virus (RSV). AmVac has already established initial proof-of-concept and is currently preparing Phase I clinical trials. AMV611 is a combined preventive vaccine against human Parainfluenza Virus Type 3 (PIV3) and RSV. AmVac has initiated preclinical studies for AMV611.

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Statistics

Respiratory Syncytial Virus

RSV is one of the most common causes of bronchiolitis and pneumonia in children and the elderly, and the number one cause of childhood hospitalization in the US, Europe and around the world. Nearly all children are infected with RSV at least once by the age of 2-3 years. The disease is particularly dangerous for premature babies, children with other health conditions and the elderly. Many children develop pulmonary disease and/or asthma from early infections that persists throughout adult life making them susceptible to re-infection.In addition, RSV is increasingly being recognized as a significant problem in certain adult populations. These include the elderly, persons with cardiopulmonary diseases, and immune-compromised hosts. Epidemiological evidence indicates that the impact of RSV in older adults may be similar to that of non-pandemic influenza.

RSV is very contagious. Inoculation occurs mainly through the eye and nose, rather than the mouth and infection may occur directly from a host or via droplets left on surfaces in the environment. RSV infections occur primarily during fall, winter, and spring.

According to studies, each year, on average, in the United States, RSV leads to

  • 57,527 hospitalizations among children younger than 5 years old
  • 100,000 to 126,000 hospitalizations among children younger than 1 year old
  • 2.1 million outpatient visits among children younger than 5 years old
  • 177,000 hospitalizations and 14,000 deaths among adults older than 65 years

Both the global burden of the RSV infection and its highly contagious nature highlight the need for a vaccine. The only current treatment that is specific to RSV is a monoclonal antibody with limited efficacy at high cost, thus, the treatment is mostly reserved for certain severe cases in high-risk groups.

Anticipated advantages of AMV602 & AMV611

  • Potential to effectively prevent RSV- and PIV3-infections
  • Particularly suited to the risk groups who need it most – potential live vaccine efficacy with dead-vaccine safety profile

AMV701 (Sendai vector platform)

AMV701 is intended for the prevention of infection with the Ebola virus. It is currently at candidate selection stage.

Ebola

Ebola is an extremely lethal disease, caused by ebolaviruses. Initial symptoms include fever, sore throat, muscle pain, and headaches, generally within two days to three weeks after contracting the virus. The symptoms usually proceed to vomiting, diarrhea, and rash, while liver and kidney functions are reduced. The disease is characterized by strong bleeding both inside and outside the body, and carries a high death rate with fatalities typically occurring within one to two weeks from initial symptoms.

While the disease has historically been mostly incurring in Africa in short waves, it has spread across the world including to Europe and the US following recent outbreaks in 2014/2015. According to WHO commentary, “the Ebola epidemic ravaging parts of West Africa is the most severe acute public health emergency seen in modern times. Never before in recorded history has a biosafety level four pathogen infected so many people so quickly, over such a broad geographical area, for so long.” (source: WHO Media Centre, Sep-2014).

Infection control, isolation of infected and potentially infected people, and contact tracing currently are the major means to prevent the disease from spreading after incidence is reported; however, no specific treatment is currently approved in the EU or the US.

AmVac has developed a promising set of potential vaccine candidates against the disease, from which it is selecting a candidate for further evaluation.

Our Products

Investor Relations

Continued investment in vaccines is important to promote the public health contribution of these life-saving products and also represents an excellent opportunity to maximize return on investment

5 reasons to partner with us

AmVac AG can be considered as a model case for a successful and efficient transfer of basic research results into the industrial development of a completely novel type of vaccine for a broad range of applications.

1 Portfolio with exceptional potential

  • Three proprietary platforms for the development of highly promising prophylactic and therapeutic vaccines against many potential indications
  • Six promising vaccine candidates targeting significant unmet medical needs in attractive growth markets including urogenital conditions, respiratory diseases, and influenza, as well as potential vaccine candidates against Ebola
  • Lead products with blockbuster potential
  • Combined target markets in the multi-billion dollar range

2 Steep increase in value anticipated, based on key near-/midterm milestones

  • Re-approval of AMV100 in Hungary and extension to other European countries
  • Advancement of AMV110 clinical development program in BPH
  • Preclinical proof of concept for vaccine candidates against RSV / PIV3 infections and for adjuvanted vaccine candidates against influenza
  • Potential vaccine candidate for treatment of Ebola virus

3 Lead vaccine with minimal development risks

  • AMV100 previously approved in Hungary for certain indications
  • Experience from over 200,000 patients in various clinical settings
  • Established efficacy and strong safety profile in treatment of certain diseases of the female urogenital tract

4 Acknowledged approach and organization

  • Lean and effective organization, supported by renowned experts and specialized service providers
  • Strong group of private investors
  • Frost & Sullivan Enabling Technology of the Year Award in 2006
  • Appointment of Treehill Partners to provide experienced management support for AmVac

5 Exclusive position

  • Multi-layered protection of platforms and products through patents, licenses and exclusive access to materials and know-how

Partnerschaften

Partnering Deals

MEETING A STRONG DEMAND

AmVac intends to complete the key value creating steps of biopharmaceutical drug development on its own before entering partnerships with biotech or pharma companies. This strategy allows the company to build maximal value into its products and capture a significant portion thereof for its shareholders. Given the strong commercial potential of its vaccines, AmVac has excellent prospects of attracting high profile partners for co-development and/ or commercialization – even more so, as biopharmaceutical companies urgently seek attractive in-licensing opportunities to fill drug development pipelines. The dramatic increase of licensing deals over the last years – in number and volume – impressively underpins this trend.

 

EXCELLENT PROGRESS TO DATE

Since its inception in late 2005, AmVac has consistently advanced its technologies, products and organization. The team has:

  • Successfully transferred the Sendai and MALP-2 technologies from the originating research institutions and transformed them into comprehensive product development platforms
  • Created four vaccine candidates from these platforms and established initial proof-of-concept for the most advanced of them
  • Completed a number of key preparatory steps required for obtaining international market approval for Gynevac in bacterial vaginosis and for advancing the clinical development program in BPH based on the Lactobacillus platform
  • Built a highly effective drug development organization with a strong network of experts and specialized service partners in disciplines relevant to drug development and approval

As a result, AmVac is now well positioned to progress development of its programs and turn its assets into highly attractive commercial opportunities.

Weltweiter Markt

Infographic

 

Zielpopulationen

Estimated Target Population

ABOVE-AVERAGE MARKET GROWTH

Vaccines have emerged as one of the most profitable business segments in the healthcare industry. Despite the uncontested successes of vaccines, infectious diseases are still a major cause of death worldwide, and at least 40 major diseases are still uncontrolled by vaccination. With an estimated double-digit annual growth rate over the next years, the vaccine market is expected to clearly outpace the growth forecasted for the overall pharmaceutical market.

Within this market segment, AmVac addresses potential markets of significant size where there are well acknowledged unmet needs.