Non-Confidential Sementis: Revolutionizing the Global Vaccine Industry Oct 2017 www.sementis.com.au Version: 171017PH
Disclaimer October 2017 This presentation is issued by Sementis Limited ACN 138 550 811 (“ Sementis ”) in order to provide a summary about Sementis and its current and proposed research and development activities. The information contained in this presentation is general in nature and does not purport to be complete. This presentation has been prepared by Sementis in good faith and with due care but none of Sementis or any of its officers, employees, related bodies corporate, affiliates, agents or advisers guarantees or makes any representations or warranties, express or implied, as to, or takes responsibility for, the accuracy or reliability of the information contained in it. All information contained within this presentation including, but not limited to, references to projections, platforms, outcomes, current and future product pipelines are best estimates only and may be subject to change without notice. There is no guarantee that Sementis’ technology or any of its vaccines will prove effective. Therefore, nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty or guarantee, whether as to the past, present or the future. To the maximum extent permitted by law, Sementis and its related bodies corporate and each of their respective directors, employees, officers, affiliates, agents and advisers expressly disclaim any and all liability (including without limitation for negligence) for representations or warranties or in relation to the accuracy or completeness of the information, statements, opinions or matters, express or implied, contained in, arising out of or derived from, or for omissions from, this presentation. In particular, this presentation does not constitute, and shall not be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of Sementis or its technology and vaccines. 2
Executive Summary Sementis has revolutionary vaccine “platform” technology that has the potential to create totally safe 1 and highly effective 2 vaccines to any number of diseases and conditions. Sementis also has revolutionary manufacturing technology that allows for the rapid production of huge volumes of vaccines 3 . Sementis is initially focusing on vaccines for allergies and mosquito borne diseases, namely: • A cure for peanut allergy addressing a market estimated to be worth over $U.S.10 billion • A world first combined vaccine for Zika and Chikungunya Sementis’ revolutionary vaccine and manufacturing technology together make the world’s best 4 and maybe only effective solution to pandemic and bio-terror threats. Successful proof of concept work has been completed and published in peer reviewed journals that reports on the effectiveness and safety 1 of the platform technology and for the vaccines. The next step is to complete the manufacturing processes in order to proceed to human trials within the next one to two years 5 . After an extensive review process, the American National Institute of Allergies and Infectious Diseases (NIAID) will fund the first stage of preparation for the Sementis manufacturing process. Sementis is also working with the Australian CSIRO in bringing the manufacturing process to completion. 3
Contents The E he Evolu lutio ion o of the V he Vaccin ine Ma Market 01 01 Enter er Semen entis: The Revolutionary Platform 02 02 Semen entis m manufacturing 03 03 Vaccin ines es in d develo lopm pmen ent 04 04 Sementis is A Aller lergie ies 05 05 Sementis is I Inf nfec ectio ious D Disea eases es 06 06 Sementis is T Tactic ical l Respo ponse 07 07 Lookin ing g ahea ead 08 08 Sementis is p peo eople le 09 09 Glossary/appen endices es 10 10 Footnotes es 11 11 4
The Evolution of the Vaccine Market 5
Past, Present and Future Scourges Past S Scourge ges Pres esent S Scourges es Pres esent S Scourges es Future S Fut Scourges under c und control in t n the he • Smallpox epidemic with a • HIV been with us since to • The ever looming fear of develo loped w world ld b but kill rate of 1 in 3, Polio, 1980 and yet still no Pandemic flu, Zika, Nipah, Pandemic Flu effective vaccine available Ebola, Lassa, SARS, MERS, not e eradicated ted • Seasonal flu that is difficult ?????? to control with current • Vaccines for measles, vaccines mumps, rubella, polio, • No effective vaccines for Hepatitis A and B, etc. food allergies, hepatitis C, • Many of these diseases are and new emerging not under control in the diseases such as Zika and underdeveloped world SARS • Many vaccines have limited effectiveness 6
The Vaccine Market Today Historically, the vaccine market was a small part of the Pharmaceutical Industry, however in the past decade, its growth has outstripped the rest of the industry. The global vaccine market is expected to reach $U $US48 b 8 billion by 2021 (from $US 32 billion in 2016) – a CAGR of 8.3 % (a) . Other studies expect double-digit growth (b) . (a) Vaccines by Technology, Disease Indicator, End User and Type – Forecasts to 2021. Markets and Markets, August 2016 (b) Global Human Vaccine Market 2016-2020. Research and Markets, January 2016 7
Growth Drivers in the Vaccine Market Growth h in n the he g global v vaccine market ha has be been dr n driven b by: 01 01 02 02 03 03 04 04 The high prevalence of Rising government funding for Advances in technology, which Advances in manufacturing infectious diseases vaccine development and are dramatically expanding the technology, which will change increased focus on possibilities of vaccine the economics of vaccinations. immunization programs treatments (e.g. cancer) 8
A Potted History of Vaccines In the late 1700s, it was observed It was eventually discovered they that milkmaids were immune had the cowpox virus, which gave from smallpox. them immunity to smallpox. The smallpox vaccine was the The s he smallpo llpox v vaccine ine ( (the he The vaccine industry was born, first and is the only vaccine that vaccinia inia v virus) i is a der eriv ivativ ive o of with the Latin word ‘vaccine’ has been used to eradicate a the c he cowpo pox v virus a and h d has bee een n meaning “from Cows”. human disease! successfully ully u used ed for over er two hund undred ed y yea ears. 9
Evolution of Sementis’ Vectored Vaccine Technology In the 1980s, gene for rabies surface antigen was inserted into the vaccinia virus (Copenhagen Version), then injected into fox bait and fed to animals in Northern Europe. The he que question, ther erefore, e, r remained ed: The theory was that this new vaccine would not only give "If this version of the vaccinia the animals immunity to smallpox but, importantly, also to virus could be made non- rabies. It worke ked , and its effectiveness as a rabies vaccine replicating, i.e. tot otally safe fe , why has been proven in multiple studies over the past twenty not use it as a platform for all years. sorts of diseases in humans?” However, because the vaccine replicates (multiplies) it can cause harm in a small proportion of recipients. This was acceptable during the smallpox era, as this disease had a kill rate of 1-in-3. However, now that smallpox has been eradicated it is no longer acceptable. 10
Enter Sementis: The Platform Revolutionizing the Global Vaccine Industry 11
Sementis Sementis’ revolutionary SCV vaccine platform A working vaccine for Peanut Allergy and the technology and groundbreaking manufacturing world's first dual vaccine for the Zika and technology are both p poised t to revolu lutio ioniz ize t the Chikungunya mosquito borne diseases are just vaccine i industry a and m make a a significant m medical two of the multiple vaccine applications made contrib ibutio ion t to t the world ld. possible by Sementis’ SCV platform technology 12
The Revolutionary SCV Platform The Sementis vaccine platform is called Sementis Copenhagen Vector (SC (SCV). The S he SCV V platform is essentially the old smallpox vaccine (the original vaccinia virus ), which was effectively used to eradiate rabies in Northern Europe and smallpox worldwide. Ho However, S Sementis is h has genetic ically lly m manip ipula lated t the vaccin ine t that i is expected to make i it: fe 1 Totally ly safe Powerfully lly i immunogenic ic It does not replicate (multiply) to make it It is more visible to the immune system, thereby harmful 1 . making it more active, resulting in a highly potent immune response 6 . 13
How the SCV Platform Works This transforms the platform into a vaccine for whatever disease this inserted antigen originated from. The body’s immune system reacts to the transformed platform. Gen enes es f for a antigen ens f from pa partic icula ular di diseases a are The body produces immunity to the disease inser erted ed into t the e SCV the antigen originated from, as well as platform. immuni unity t to smallpo pox ( (induc nduced b d by the he S SCV platf tform) i ) its tself. 14
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