themis corporate slidedeck for website · themis © may 2018 page 3 experienced leadership industry...

Themis

One Vector,Unlimited Possibilities

Themis © May 2018

Themis © May 2018 Page 1

Turning a Proven Vaccine Platform Into a Unique Biologics Investment Opportunity

• Themis has developed an attractive portfolio of late- and early-stage biologics based upon a highly versatile platform technology

• Applications under development include vaccines against infectious diseases and cancer therapies

• Technology based on gold-standard viral vector combined with proprietary enhancements to efficiently achieve innate immune system response

• Lead candidate is Phase 3 ready with important de-risking events already achieved

• Validated by major commitments from leading life science investors and prestigious R&D funders

Themis is moving its lead candidate into Phase 3 and rapidly advancing other serious infectious disease and oncology programs

Themis’ Platform Technology Will Drive Return on Investment Through Three Business Verticals


Vaccines Platform Immuno-Oncology Platform

• Leveraging non-dilutive support from blue-chip R&D funders to validate the powerful immune modulation capabilities of the measles vector technology

• Significant grant funding received to date for indications such as chikungunya, Zika, Lassa, and MERS

• Lead candidate MV-CHIK (chikungunya vaccine) is now moving into pivotal Phase 3 studies

• MV-CHIK appeal is two-fold: uses largely non-dilutive funding sources to validate the effectiveness of the platform technology and would immediately tap $350-500 million of annual demand from an easy-to-access pool of travelers, military, and public tender customers

• Promising early-stage data on vaccine candidates for potential blockbuster indications such as RSV, norovirus, and CMV

• Measles vector properties give Themis the opportunity to succeed in these indications where others have failed

• Prevnar-like revenue potential with multiple shots-on-goal

• Leverages same manufacturing platform as travelers vaccines; minimal incremental CMC time or cost required for scale-up

• Innate oncolytic properties of the measles virushave already been demonstrated in three separate Phase 1 studies conducted by the Mayo Clinic and others

• Therapeutic power can be further enhanced by using the Themis vector to deliver tumor-killing payloads and stimulate immune response

Themis has developed a highly versatile viral vector technology that harnesses the immune modulation capabilities of the measles virus to tackle both infectious disease and oncology indications

Travelers and Global Health Vaccines Blockbuster Vaccines Cancer Therapies


Experienced LeadershipIndustry experts with substantial experience in biotech, company building,M&A, IPO, product development

Chairman of Board

Gerd Zettlmeissl

CEO

Erich Tauber

Senior Vice President R&D

Katrin Ramsauer

Chief Business Officer

Philippe Dro

Chief Technical Officer

Lee Smith

Senior Vice President Finance

David A. Maier

Chairman, SAB

Christian Mandl

Chairman Financing Committee

Harry Welten

One Vector, Unlimited Antigens


Themis technologycomponents:

• Proven capability to turn measles vaccine vector into effective delivery vehicle for broad range of antigens

• Rapid development process from discovery to clinic

• Commercial-ready manufacturing: high-quality production infrastructure already in place

• Unlimited number of products can be manufactured using the same production infrastructure

Advanced antigenknow-howThemis’ unique ability:Modulating effective immuneresponse through advancedantigen design

Delivery vehicle• Safe, efficient, cost-

effective delivery vector with inherent immunogenic capability

• Proven effectiveness in billions of individuals world-wide

• Themis’ unique opportunity: Leverage the vector’s potential as a powerful immune modulator

Target-specific cargo antigen

Delivery vector:widely-used measles

vaccine virus


Evaluation Pre-clinical development

Clinical development

Phase 1 Phase 2 Phase 3

Partnered Programs

Chikungunya

Noro

RSV

CMV

Cancer,Immunotherapy

Lassa Fever

MERS

Zika HZ2020, Innovate UK

CEPI

CEPI

Driving value from a diverse range of indications centered on infectious disease vaccines and immuno-oncology

Broad, Differentiated Pipeline

Chikungunya:

A Growing, Global Medical Burden


• Mosquito-borne viral disease• Clinical symptoms: fever, joint and muscle pain,

headache, nausea, rash

• Long-term or life-long serious health impairment; fatal cases have occurred in the western world

• No cure available; symptomatic treatment only

• Up to 90% infection rate during outbreak• 30% of patients suffer long-term effects

The Disease

• Global market: potentially USD 500 million annually• Significant economic impact• Worldwide outbreaks (South America, India, Africa,

recently France & Italy in 2017)

The Impact

MV-CHIK:

Platform Lead Candidate Entering Phase 3


• Clinical experience in over 600 subjects in Europe,

North America, and the Caribbean

• Excellent safety and immune-response: functional antibodies and T-cells

• No effect of anti-vector immunity• Clinical pathway to licensure agreed with FDA and

EMA (EMA PRIME designation received)

• Phase 3 read-out planned in 2020

• Market entry targeted for 2021

World-leading vaccine in development against Chikungunya virus

• Phase 3 design and manufacturing plan fully developed

• 1-2 years ahead of competition

Study Purpose Subject Number Status Clinical Trial.gov/

EudraCT

MV-CHIK 101 Phase 1 Immunogenicity and Safety (AUT/EU) 42 Completed EudraCT: 2013-001084-23

MV-CHIK 202 Phase 2 Immunogenicity and Safety (AUT/GER/EU)

320 Treatment Completed

NCT02861586

MV-CHIK 203 Phase 1/2 Immunogenicity and Safety (US/IND); sponsored by US NIH/NIAID

180 Recruiting NCT03028441

MV-CHIK 204 Phase 2 Safety in endemic area (Puerto Rico/IND); in collaboration with US Department of Defense

100(50 CHIKV positive)

Recruiting NCT0310111

MV-CHIK 205 Phase 2 Immunogenicity and long term follow up (funded by Innovate UK/SBRI)

60 Preparation (CTA Submitted)

EudraCT: 2018-000211-25

MV-CHIK 301 Phase 3 Preparation

MV-CHIK:

Clinical Program


MV-CHIK Safety, Solicited AEs

Appealing Safety Profile: Comparable to Approved Control Vaccine


0 20 40 60 80 100

Injection Site Pain

Injection Site Tenderness

Injection Site Pruritus

Injection Site Erythema

Injection Site Edema

Injection Site Induration

Fever

Headache

Myalgia

Limb Discomfort

Arthralgia

Flu Like Symptoms

Nausea

Vomiting

Rash

Fatigue

% percentage of subjects

Solicited Adverse Events During Vaccine Administration

MV-CHIK

Control Vaccine

Mild

Moderate

Severe

Mild

Moderate

Severe

SystemicReactions

LocalReactions

Themis data on file

Excellent Immunogenicity Profile After A Single Injection


• Strong T-cell response• No impact of anti-vector

immunity (booster potential)• Excellent safety and tolerability

Strong protective immunity after a single shot

0 28 56 0 28 561

10

100

1000

10000

Days after first immunization

GM

T 95

%C

I

MV-CHIK LOW Dose MV-CHIK HIGH Dose

Seroconversion Day 28 Day 56

MV-CHIK LOW 50% 96%

MV-CHIK HIGH 90% 96%

Strong Chikungunya-Specific T-Cell Response – Validating Platform Potential


Day 0 Day 56 Day 2240

200

400

600

spot

s/ 1

06 P

BM

C

MV-CHIK LOW 1 Month

MV-CHIK LOW 6 Months

MV-CHIK HIGH 1 Month

MV-CHIK HIGH 6 Months

Poly-functional, chikungunya-specific T-cell response in all subjects

• Themis has prepared clinical, manufacturing and regulatory strategy for Phase 3 and licensure of MV-CHIK

• Active discussions and supportive feedback from EMA and FDA

• Themis has substantial experience in late-stage clinical development of successfully approved vaccines; ability to

independently execute Phase 3 studies and pursue licensure

• MV-CHIK received PRIME status from EMA to de-risk the development program and allow accelerated

regulatory pathway

Phase 3 Plans Agreed with FDA & EMA


Blockbuster potential:

Serious Infectious Disease Indications


• Flu-like transmission• Affected: children and elderly• Annual infections:

37 million in 2015• MV-RSV pre-clinical PoC

completed

RSV

• Herpesvirus infection with human-to-human transmission

• Common infection: 50% of young adults and 85% at age 40

• 1 in 1,000 infants with permanent disabilities

• MV-CMV pre-clinical PoCcompleted

CMV

• Transmission via direct contact• 50,000 deaths in children

annually• Annual infections: 685 million• MV-Noro pre-clinical PoC

completed

Norovirus

• Themis has generated promising pre-clinical data for all three indications

• Antigen payload optimization underway

MV-RSV:

Pre-Clinical PoC In Cotton Rats Shows Promising Immune Response


RSV-specific antibodies Neutralizing antibodies

0 2 8 4 2 5 6

0 . 0

0 . 5

1 . 0

1 . 5

2 . 0

R S V C o t t o n R a t E L I S A

d a y s

OD 450 nm

²

² n o a n i m a l s e r a o f D 5 6

a n i m a l 2 6

a n i m a l 2 7

a n i m a l 2 8

a n i m a l 2 9

a n i m a l 3 0

n e g . c o : M V - C H I K

a n i m a l 2 5

0 2 8 4 2 5 6 5 6

1 0

1 0 0

1 0 0 0

1 0 0 0 0

d a y s

GMT

of N

T log

10

N T M V - R S V ( # 1 7 )

M V - R S V

> 2 0 = p o s i t i v e

M V - S c h w a r z

• MV-RSV with pre-F protein

• Promising pre-clinical data for specific and

neutralizing antibodies after 1 and 2 shots

• Next step: study in animal challenge model

under evaluation

• Measles virus is known to have intrinsic oncolytic properties• Measles-based cancer therapy: proof of concept established in

multiple Phase 1 clinical studies• Mayo Clinic successfully treated late stage myeloma patients

with high titer measles injection• Next level: combination of oncolytic properties with immuno-

activation à utilizing the Themis Platform Technology

Themis measles vector uniquely positioned in immuno-oncology:

Oncolytic Effect And T-Cell Activation


Boisgerault et al. 2013 BioMed Res. Int

Colon Cancer (Caco-2)

• Themis will use its extensive measles vector expertise to develop products in immuno-oncology indications

• First R&D project in oncolytic viro-therapy will start in 2018 • Focus on advancing toward the clinic in 2019/2020

Measles Virus – Logical Choice in Immuno-Oncology


• Measles vaccine strains replicate preferentially in tumor cells (overexpression of CD46 receptor)

• Virus replication destroys tumor cells and induces anti-tumor immune response

• In addition, therapy-enhancing cargo (tumor-specific antigens) can be presented using Themis’s vector technology

• Superior safety record:• Measles vaccine safely used over decades• Themis clinical programs demonstrate

safety of recombinant measles vaccines• Safety of measles vector technology in

immuno-oncology well established

Measles vaccine virus vector has distinct advantages

Themis Technology Well Positioned For Cutting Edge Immuno-Oncology


• Exclusive know-how, intellectual property and experience for cGMP production of measles vector

• Direct regulatory and clinical experience• Successful track record for expression of various

inserts, including complex antigens

Themis is the industrial leader for recombinant measles viruses

Renewed industry interest:• Imlygic (Amgen) first licensed oncolytic virus therapy

• >30 active clinical trials with oncolytic viruses

• May 2018: J&J licensed pre-clinical oncolytic virus candidate from BeneVir; $140 million upfront plus up to $900 million in milestone payments

• Feb 2018: Merck acquired Viralytics for $394 million in February 2018

• Oct 2017: Abbvie secured an option on Turnstone Biologics’ oncolytic viral immunotherapies

Company Funded by Specialist Investors and Prestigous Public-Private Partnerships


Leverage expertise and platform, led by validation from MV-CHIK, to tackle large market opportunities in oncology and infectious diseases

• Develop Noro, RSV, CMV, and immuno-oncology programs

• Strong VC syndicate to support corporate growth

Two pillars of financial support

Addressing infectious disease needs for relevant and growing markets worldwide supported by prestigious non-dilutive funding

• $37.5M CEPI collaboration for Lassa and MERS• Innovate UK and Horizon 2020 sponsored

Zika program

Themis first company to receive prestigious CEPI-contract in March 2018

Themis expects significant near-term news flow:

ü Clinical progress on lead product• Phase 2 publication anticipated summer 2018• Phase 3 progress, regulatory milestones, new data

ü Pipeline progress• Pre-clinical validation and data• Immuno-oncology and infectious diseases• Clinical progress

ü Corporate development• Continuous efforts to enter into and strengthen partnerships with

industry, NGOs, and public funders to further validate technology• Pursuing new collaborations to enhance the protective and

therapeutic impact of the vector platform

Good News to Come


Themis

Themis Bioscience GmbHMuthgasse 11/2,1190 Vienna, Austria+43 1 236 7151

[email protected]

@Themis_Bio

One Vector,Unlimited Possibilities

themis corporate slidedeck for website · themis © may 2018 page 3 experienced leadership industry...

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