INNOVATION IN ALLERGY IMMUNOTHERAPY - INVESTORS PRESENTATION - ASIT biotech
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INNOVATION IN ALLERGY
IMMUNOTHERAPY
INVESTORS PRESENTATION
APRIL 2019
2 Disclaimer This presentation (“Presentation”) has been prepared by ASIT biotech (“ASIT”) to provide an overview of the Company, it does not constitute a prospectus, an audit or due diligence review and should not be construed as such. While the information contained in this Presentation is believed to be accurate, no representation or warranty, express or implied, is made as to the fairness, accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for any loss howsoever arising, directly or indirectly, from this Presentation of its contents. The Presentation includes forward looking statements and includes assumptions about future developments, operations and results. Although such statements are believed to be reasonable, there can be no assurances that such assumptions and views of the future are accurate, or that estimates and projections will be realized. Forward looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. No representation, warranties or other assurances will be made by ASIT concerning the anticipated performance of the company. This document and its contents may not be viewed by persons within the United States (within the meaning of Regulation S under the Securities Act) other than (i) by QIBs (qualified Institutional Buyers) or (ii) in “offshore transactions” within the meaning of Regulation S. This document and any materials distributed in connection with this document are not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The distribution of this document in certain jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe any such restrictions. This document does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of ASIT nor should it or any part of it from the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of the Company, nor shall it or any part of it from the basis of or be relied on in connection with any contract or commitment whatsoever.
3
ASIT biotech team
Louis Champion, Chairman of the Board
• MD, graduated from Lyon (France) medical school, and MBA from INSEAD
• COO of Stallergènes from 2000 to 2011, where he built up the commercial operations, the R&D organization and the project management
group
• He is Board member of several companies in private primary care, biotechnology and medical device sectors.
Michel Baijot, Director & Chief Executive Officer
• Bioengineer, PhD
• Over 25 years of experience in building biologicals businesses with significant contribution in strategy, licensing, M&A and technology transfer
• Previously Executive Director Europe at Serum Institute of India, Head of Cipla Global Vaccine, Chief Business Officer at Janssen/Crucell, Vice
President Worldwide Strategic Alliances and Business Development at GlaxoSmithKline Biologicals and Vice President Business Development
at Innogenetics.
Yves Désiront, Chief Financial Officer ad interim
• Master degree as Ingénieur Commercial in Business Administration and Technology Interface from I.C.H.E.C. Brussels
• Managing Partner of 3T Finance, a private equity fund based in Brussels
• Previously Group CFO under a consulting contract with BGP Investment, a Luxembourg real estate group, and Group CFO of Orco Property
Group, listed in Paris and Prague.
4
ASIT biotech: a listed advanced-clinical stage immunotherapy company
A ROBUST SCIENTIFIC TRACK RECORD IN DEVELOPING INNOVATIVE ALLERGY
IMMUNOTHERAPY TREATMENTS:
gp-ASIT+™: LEAD CANDIDATE IN GRASS POLLEN ALLERGY WITH FIRST
PHASE III (554 PATIENTS) AND A CONFIRMATORY ONE WITH PRIMARY END
POINTS EXPECTED IN DECEMBER 2019 A BIOPHARMACEUTICAL COMPANY
pnt-ASIT+™ & hdm-ASIT+™: CANDIDATES IN RESPECTIVELY PEANUT- OWNING A TECHNOLOGICAL PLATFORM
AND HOUSE-DUST MITES ALLERGIES, DEDICATED TO PARTNERING UPON DEVELOPING PRODUCTS BASED ON A
COMPLETION OF PRECLINICAL PACKAGES EXPECTED MID-2019 UNIQUE MIXTURE OF NATURAL
ALLERGEN PEPTIDES TARGETING
RESPIRATORY AND FOOD ALLERGIES
Spin-off of the Free University of Brussels (ULB)
Invested more than €80 million since inception
€23.4m IPO (2016) on Euronext Brussels & Paris
€15.4m private placement (2018)
€12m equity line (2018, convertible bonds to be called until January 2020)
Cash position (31.12.18): €8.5 million, reinforced by a €8 million convertible bonds still to be called as of that
date (€5.9 million as of end of March 2019) and €4.2 million warrants at an exercise price of €3.83 per share
The allergy immunotherapy (AIT) market: 5
6
Competitive landscape in AIT market
Use of adjuvant
Adjuvant free
With adjuvant
Rapidity
of treatment
Short-term Long-term
7 Long and cumbersome AIT treatments result in low acceptance and poor compliance * Source: Kiel MA et al. J Allergy Clin Immunol 2013; 132: 353-60 ** (23% compliance for SCIT and 7% for SLIT after Y3)*acceptance rate (50%)
8
ASIT’s short course immunotherapy is much more efficient than current AIT
Only 4 visits for gp-ASIT+™ treatment are expected to provide protection for the entire pollen season
and protection mechanisms are already in place 1 week after the last visit
9
ASIT biotech developed a versatile platform for allergy immunotherapy
ASIT BIOTECH TREATMENTS CONSIST OF A UNIQUE MIXTURE
OF HIGHLY PURIFIED PEPTIDES FROM DIFFERENT SELECTED SIZES,
PRODUCED FROM NATURAL SOURCES OF ALLERGENS, FREE OF THE ASIT+™ PLATFORM OFFERS:
ADJUVANT, FOR ALLERGY IMMUNOTHERAPY A validated production process
at commercial scale
Validated QC procedures
A scalable solution that is
applicable to various allergens
(e.g., House Dust Mites, Peanuts)
HIGH GRADE STANDARD SELECTION OF Already available Ex-vivo
HIGHLY
PURIFICATION
OF ALL ALLERGENS
ENZYMATIC
HYDROLYSIS
ALLERGEN
FRAGMENTS PURIFIED
screening, immunogenicity and
FROM NATURAL BASED ON SIZE
ALLERGEN therapeutic models
EXTRACTS DISTRIBUTION*
FRAGMENTS
WITH OPTIMAL
SIZE
DISTRIBUTION
* 1-10 kDa
ASIT biotech‘s strategy: focus on the ongoing confirmatory Phase III study 10
with gp-ASIT+™ and partnerships for the platform & other drug candidates
• Focus of financial capacity & human resources on the finalization of the second
phase III study, conceived according to an improved protocol, with primary end points
gp-ASIT+™
delivered by end of the year 2019
• Option upon financing: initiate a follow-up study for 2020 with the same patients
developing long term data’s with a 2nd season treatment
• Finalize toxicity and ex-vivo studies on hdm-ASIT+™ (house dust mite) and pnt-
ASIT+™ ASIT+™ (peanut) by mid-2019
platform
• Demonstrate efficacy of the platform in selecting product candidates
• Establish partnership for the IND and clinical phases in the US
Business
Development
• Establish partnerships for the clinical phases of hdm-ASIT+™ and pnt-ASIT+™
• Establish partnerships for the selection of new product candidates11
ASIT Biotech pipeline & expected milestones
2019 2020
H1 H2 H1 H2
Grass pollen Follow up
gp-ASIT+™ confirmatory phase III
gp-ASIT+™ Filing (GER)
Results
FDA Meeting
PA R T N E R S H I P
Peanut pnt-ASIT+™
pnt-ASIT+™ (phase I)
Results*
House dust mite hdm-ASIT+™
hdm-ASIT+™ (phase I )
Results*
Other allergens + Partner
Candidate Selection
Egg white / cow’s milk
The time to market for the gp-ASIT+™ is expected to be 12 to 18 months after the initiation of
the discussions with the German regulator end of the second quarter in 2020.12
gp-ASIT+™ demonstrated safety and efficacy in a first Phase III study
CLINICAL DATA FROM PHASE II AND PHASE III HAS BEEN PUBLISHED BY WORLD-CLASS SCIENTIFIC PARTNERS IN HIGHLY RANKED JOURNALS
P=0.03 P=0.05
In a Phase III study
1,5 17.9% 24.4%
• gp-ASIT+™ resulted in a statistically significant improvement
CSMS OVER 1 in CSMS* during the peak pollen period and the entire pollen
ENTIRE
season in the whole Phase III patient population
CSMS
POLLEN Placebo
SEASON 0,5 gp-ASIT+ • The predefined absolute average 20% difference in CSMS*
between placebo and the treatment group was nearly achieved
0
over the peak season despite a poor results in Germany, which
All patients Most severe** was heavily weighted in the study#
• In a patient subgroup with the highest CPT** reactivity at
P=0.04 P=0.05
2 baseline (more than ½ of patients), CSMS* improvement was
15.5% 19.8% even higher
1,5
CSMS:
Secondary endpoint
CSMS
PEAK 1 Placebo
POLLEN
PERIOD gp-ASIT+ • Reactivity to the conjunctival provocation test (CPT) decreased
0,5
significantly in 60.0% of patients treated with gp-ASIT+™
0
compared with 35.6% in the placebo group
All patients Most severe**
PL: Placebo; LPP: Lolium Perenne Peptides (gp-ASIT+™)
* CSMS : Combined Symptom-Medication Score
** CPT: conjunctival provocation test (score from 1 to 4; most severe patients = CPT 3 & 4)
# ASIT received positive scientific advice from the German regulator, the Paul-Ehrlich Institute, and is now ongoing a redesigned confirmatory Phase III study (all patients randomized)13
Reliable immunological data correlates with strong efficacy data*
IgE PRODUCTION
DURING THE POLLEN SEASON
40
P50% reduction for the entire
pollen season (both highly
The production of sIgE due to exposure significant)
to natural allergens during the pollen
season was blunted in a sub-group of
Belgian patients* receiving gp-ASIT+™
compared to those receiving placebo
* Blood samples from a representative sub-group of Phase III patients in Belgium (n=32) were compared from V8 (after the grass pollen season) vs. V6 (after treatment before the pollen season)
** CSMS : Combined Symptom-Medication Score14
Ongoing gp-ASIT+™ phase III study: next milestones
2019
Q1 Q2 Q3 Q4
Achieved with
Patients’ recruitment
strict criteria
Patients’ treatment >85% achieved Results
December
LP Treated 2019
Risk scale
Compliant reporting Data collection on E-diaries
LPLV
Pollen season 70 sites selected
A reduced level of exposure to execution risks over time15
Key success factors of the ongoing confirmatory gp-ASIT+™ phase III study
1 • Strong efficacy for most severe patients
Learning’s • sIgE (pro-allergic antibodies) are blunted and production of sIgG4 (blocking antibodies that prevent sIgE
from the antibodies from binding allergens) is boosted
1 phase III
st
• Identification of the biological process with the Imperial College of London allowing an ex-vivo study on the
selected product candidates
2 • Early start of recruitment with 30 to 35 patients per site over 70 sites with an online follow-up of the recruitment
for each site. Enrollment target of a total of 624 patients reached
Patients’ • Recruit only moderate to severe patients with moderate to severe RC during the 2017-2018 seasons based on
recruitment ARIA criteria AND significant sIgE level AND SPT wheal diameter
• High pollen count and high-quality data recording history has been used to select the clinical centres
3
• The study is subcontracted to one single Top Ten CRO experienced in allergy studies, ICON plc.
Data • Paper diaries are replaced by smart phone electronic diaries (including an alert system)
collection
• Pollen count monitoring is centralized by the European Aeroallergen Network from the University of Vienna
Randomization successfully completed with the anticipated number of patients16
gp-ASIT+™ will take over significant market share of an existing AIT market
1 • Long and cumbersome existing AIT treatments result in low acceptance and poor compliance
Short • ASIT offers a pre-season treatment consisting of 4 visits with two injections per visit
treatment An opportunity in allergy immunotherapy (AIT) to migrate from old,
inefficient therapies to a new generation of preventive treatment
2 • Only 1/3 of the 100 Million patients estimated to suffer from Allergic Rhinitis (AR) are offered AIT, out of which
50% accept the treatment with a low level of compliance :
Underserved
market Less than 10% of eligible patients complete the existing treatments
3
• Pricing will potentially range from €500 (all Europe except Germany), to €750 (Germany) and $1,200 (USA) based
Potential on the cost of existing treatments. The pricing should be correlated with the efficacy demonstrated. No Generics.
pricing
Pricing policy could be supported by long-term results from a follow up study in 2020
A clear market access strategy to commercialize gp-ASIT+™ directly or with a strategic partner17
A clear partnering strategy for gp-ASIT+™, preclinical candidates & new products
• Direct / partner in the EU
gp-ASIT+™
The proof of concept • Develop for US with a partner
• Launch partnerships New products ASIT+™ Patform hdm-ASIT+™
in birch allergy or • Purified peptides from natural
Develop/pay on demand Ready for Phase I (mid-2019)
allergy to Japanese (e.g. Japanese Cedar,
allergens
cedar for example • Immunological signature similar to
Birch) that of the gp-ASIT+™
• Co-development and commercialization with a partner in
major developed (USA & Europe) and emerging markets
pnt-ASIT+™ (China)
Ready for Phase I
(mid-2019)
• Filing of a request for Phase I/II as soon as the Company
identifies a partner18
Strategic achievements since the beginning of 2019
Objectives Achievements
Randomization of all patients
Clinical development gp-ASIT+™ study Phase III well on track
completed
Ongoing internalization for
Manufacturing Full control of the manufacturing
commercial capacity
Setting up of a €9-12m convertible
Financing Reinforced cash position
bond issue
Optimization of the development of new First interest for pnt and hdm as well
Partnering product candidates as for Japanese cedar
Dedicated team to gp-ASIT+™
Management Optimization of the management structure
Structured BD strategy & team
SAB organized by ASIT recommended to
Improving market position of gp-
KOL support develop long term data and pediatric
ASIT+™ with long term data
investigation plan19
ASIT biotech held SAB with highly recognized experts in allergy immunotherapy
SAB Agenda
Pr. KLIMEK
Follow up season
Pr. MOSGES
Pr. PFAAR Confirm LT effects to prescribers and regulators
Pr. BACHERT Pediatric Investigational Plan (PIP)
Pr. PRIEELS
Clarifying the optimal approach to address the
challenges of pediatric development
Pr. DEMOLY Pr. PANZNER
Optimal Target Product Profile (TPP)
Confirm the interest of targeting the most severe
patient population
Pr. SHAMJI Pr. CALDERON20
ASIT biotech: innovation in allergy immunotherapy
1
Allergy: a global issue with
significant unmet medical
need
6 2
Seasoned management team
An expected short time to
with solid know-how in the
market in grass pollen rhinitis
field of allergy
5
Further upsides: 3
- partnerships in house-dust Potentially the first registered
mite & peanut allergies
- new products from the SCIT short-course treatment
ASIT+™ platform across EU and in the US
4
ASIT+™ innovative
technology platform
applicable to other allergens
A unique investment opportunity at the edge of the confirmatory phase III results
in grass pollen rhinitisRegistered address
Avenue Ariane 5
1200 Brussels, Belgium
Operations
Rue des Chasseurs Ardennais 7,
4031 Liège, Belgium
www.asitbiotech.com
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