Version: 160421PH Non-Confidential 1
Disclaimer Sementis We believe that the information in this presentation is correct and any opinions and conclusions are reasonably held or made, based on the information available at the time of its compilation, but no representation or warranty, either expressed or implied, is made or provided as to accuracy, reliability or completeness of any statement made in this presentation. Sementis Limited does not accept any liability for any loss or damage arising out of the use of all or any part of this presentation. This presentation has been prepared without taking into account the objectives, financial situation or needs of any particular individual. 2 2
Sementis SCV platform technology Sementis Proprietary vaccine platform technology for delivery of antigens • Live virus vector derived from attenuated strains of vaccinia virus • Enables development of new vaccines in the field of infectious • diseases, allergies and oncology 3
Vaccine In General Sementis Vaccine Property Common Potency Adjuvant Safety Class Example Requiring Profile Attenuated Weakened Measles -Strong No -Risk of reversion infectious Mumps -Life Long -Rare cases of side pathogen Rubella immunity effects Oral Polio Yellow Fever Inactivated Killed non- Influenza -Weak Yes -Safe infectious IPV (Polio) -Requires regular -Requires high JE boosting (5yrs, containment 10yrs) facilities during manufacturing Subunit -Pathogen coat HBV -Weak Yes Safe protein HPV (VLPs) -Requires regular -Non infectious boosting (5yrs, 10yrs) 4
Advantages of the SCV platform Sementis SCV has the advantages of attenuated vaccine’s potency with the • safety of subunit vaccines Does not require adjuvants • Efficient generation of immune responses • - Live virus, therefore self adjuvanting - Stimulates antibody and T-cell responses Capacity to carry large and multiple antigens • Cell line cultured in synthetic growth media so is free of animal- • derived products Offers potential productivity gains in large scale manufacture • 5
Sementis strategy Sementis Develop SCV platform and manufacturing capability through • government funded initiatives Chikungunya vaccine • Smallpox vaccine • Grow pipeline in high value diseases with significant unmet medical • need Allergies • License SCV platform for application in non-core therapeutic areas • Oncology • Infectious diseases • 6
Sementis vaccine pipeline Sementis Current • Peanut allergy • Cat allergy • Chikungunya • Smallpox Future opportunities • Zika virus 7
Sementis SCV Platform Technology 8 8
Principles of the SCV approach Sementis Live viral vector that offers: • the properties of attenuated vaccine – unable to multiply upon vaccination providing the added safety of inactivated vaccines – Accommodate multiple antigens to give the broad spectrum of subunit vaccines – A manufacturing process scalability by using a proprietary genetically engineered • suspension cell substrate to produce all SCV vaccines The SCV cell substrate for manufacturing is CHO based – industry gold standard for • production of biologicals with the following advantages: Biotechnology friendly: bioreactor and processes are standardize to CHO cells – Fastest growing cell substrate, important for upscaling – Suspension culture requiring low surface are to volume culturing systems – Most characterised cell line used for the production medicinal biologicals – Well know and understood by medical control agency around the word (TGA in Australia, FDA – in USA, EMEA in Europe) 9 9
Sementis SCV Platform Vector Attenuation Profile 10 10
SCV does not multiply in human and mammalian cells lines Sementis A study was carried to show that SCV does not multiple or propagate in cells derived from key organs of the body after deliberate infection: Vaccinia Virus SCV (Parent of SCV) Human Bone cell Human Lung cells High Yields of virus Human Kidney cells No virus production! ( expected ) Human Skin cells Human Cervical cells 11
SCV is non-pathogenic in severely immune deficient (SCID) mice Sementis Study : infection of SCID mice with SCV and Vaccinia Virus Results : Survival: • All SCID mice infected with SCV survived during the 100 day observation period • All SCID mice infected with Vaccinia Virus died or were humanely euthanized by • day 21 Dissemination: • SCV infected mice: No live infectious virus could be recovered from Lung, Kidney, • Spleens and ovaries Vaccinia virus infected mice: high yields of live infectious virus could be recovery • from Lung, Kindneys, Spleens and Ovaries within days are infection 12
Sementis SCV-Chikungunya vaccine Preclinical Proof-of-Concept 13 13
Chikungunya: an emerging disease Sementis Chikungunya virus is transmitted to humans by infected mosquitoes • Disease is characterized by sudden onset of severe joint pain or swelling, muscle • pain, high fever, rash, headache and fatigue Fatigue and joint pain may last for months, chronic arthritis occurs in ~15% of cases • Often misdiagnosed as dengue fever • Causes loss of bone density which leads to debilitating pain and immobility • Reports of autoimmune neuropathologies and fatal cardiac and neurological • (encephalitis) manifestations Epidemics occur in tropical and temperate regions • Prevalent in Asia and Africa • Recent outbreaks in Pacific Islands, Caribbean • Current prevention focusses on vector control • 14 14
Chikungunya: an emerging market opportunity Sementis Cases in Europe and the Americas have primarily been imported by travellers • returning from areas with high incidence rates From 2013-2015, there were 2,524 confirmed cases of chikungunya reported among US • travelers Virus has adapted to globally distributed Asian tiger mosquito ( Aedes albopticus ) • Locally acquired cases reported in both Europe and the Americas • Conservative estimate of global market is US$150-200 million • Travellers = 65%, military = 15%, endemic = 20% • Potential for endemic infections in developed markets • Opportunity to access government and NGO funds to progress development • 15 15
Chikungunya vaccine Sementis • Sementis CHIKV vaccine expresses multiple Chikungunya antigens which induce cross protection across all strains • Protection is antibody mediated • Antibody responses in mice are thought to be indicative of protection • Foot pad swelling in mice is a model for Chikungunya virus- induced arthritis in man • Vaccination with Sementis Chikungunya vaccine prevents virus replication and protects against virus-induced arthritis in mice 16 16
Sementis’ SCV-CHIKV vaccine efficacy study in mice Sementis Mice Vaccination 30 days later CHIKV Challenge observation period 30 days later detection for low level persistent CHIKV Study outcomes: Immunogenicity: • Vaccination with Sementis’ totally attenuated SCV-CHIKV vaccine (SCV305) can stimulated anti-CHIKV • immune response in terms of total antibody responses and neutralization antibody response. Efficacy of protection from CHIKV challenge: • Vaccination was sufficient to protect mice from a CHIKV infection challenge. • • Prevention of Persistence of CHIKV infection • Vaccination was sufficient to protect mice from persistent CHIKV infection. 17 17
Smallpox: a bioterrorism threat Sementis Caused by variola virus and is transmitted by direct person-to-person contact • There is no effective treatment, with mortality rates of up to 30% • Smallpox was endemic throughout the world • Prior to initiation of the global eradication program in the 1950s, • ~ 50 million cases of smallpox occurred annually Smallpox accounted for ~10% of deaths in the world each year • Eradication of smallpox was achieved in 1980 following a global immunization • program by the WHO Although smallpox infection has been eradicated, the variola virus is not extinct • Smallpox remains of concern as a biological weapon • Currently, no licensed vaccine is commercially available • 18 18
Medical countermeasures smallpox vaccine Sementis Ectromelia (mousepox) virus (ETCV) is an animal model for smallpox • Vaccination of mice with vaccinia (pox virus) protects them from • ETCV infection Sementis smallpox vaccine expresses protein antigens common to • all pox viruses Protection induced by the Sementis smallpox vaccine is • T-cell rather than antibody based Vaccination with Sementis smallpox SCV vector and SCV-CHIKV • vaccine protects mice from ETCV 19 19
Medical countermeasures smallpox vaccine Sementis Ectromelia (mousepox) virus (ETCV) mouse study: Vaccination ECTV SCV 30 days • 14 day Lethal Mice SCV-CHIKV • Observation Period Challenge Vaccinia Virus • Placebo • Results: Vaccinia Virus: total protection SCV Vector only: total protection Conclusion: SCV-CHIKV: total protection In a surrogate mouse model for smallpox Placebo: No Protection infection SCV and SCV-CHIKV can protect mice from mousepox virus (Ectromelia) infection! 20 20
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