Download fact sheet

February 2013
FACT SHEET
Ability Pharmaceuticals is a biopharmaceutical company located in
Barcelona, Catalonia, Spain.
Ability Pharmaceuticals has developed a proprietary new drug class called
Lipid Analogue Therapeutics.
Ability Pharmaceuticals has two drugs candidates in development in Lung
and Pancreatic Cancer:
– ABTL0812 in preclinical development with clinical phase Ib/IIa clinical
trials (first in man/POC) in lung cancer starting in 2Q 2013 and with
pancreatic cancer as a second indication.
– ABTL1014 will start preclinical development in 2Q 2013.
At a glance
– Founded in November 2009
– Focused in Cancer.
– mTORC1/C2 - akt -DHFR inhibition
– First in Man in 2Q 2013
– 6 Employees
– Based in Barcelona, Catalonia, Spain
– US Dev. Office in 2013
– € 3.4 M raised (2010-2012): BA,
Founders & Inveready Capital Co.
Lipid Analogue Therapeutics – A New Drug Class of Cancer Drugs
The patent allows the chemical synthesis of thousands of distinct analogues of
naturally occurring lipids with variations on chain length, unsaturation level,
chemical radicals and salts.
Several compounds have been synthesized and evaluated as anticancer drugs. 2
drug candidates have been selected for development.
The lipid analogues
→ influence the activity of proteins which are central to cellular replication.
→ alter the signaling of specific pathways.
ABTL0812. First in Class. Dual
Mechanism of Action: mTORC1/C2-DHFR
Jordi Espadaler, PhD
Senior Scientist & co-Founder
5 years Research at Rockefeller Univ., UC
San Francisco & Univ. Autònoma of
Barcelona - 5 yrs CSO at AB-Biotics
TEAM
Experienced Management
Team
st
→ Non-small cell lung carcinoma (1 indication)
nd
→ Pancreatic cancers (2 indication)









High efficacy
Oral administration
Low toxicity / Few adverse events
Chronic treatment - Once daily
Low probability of appearance of drug
resistance
New drug class – First in class – New product series
with the ability to build a development pipeline
Simultaneous action on validated targets: DHFR &
mTORC1/C2 → Autophagy
Possibility of selection of patient populations in
clinical trials based on biomarkers
Patent protection until 2030
13 yrs Business Dev.t & Licensing at Almirall
& Lacer - 3 yrs Biotech VC - 8 yrs Cancer
Research Memorial Sloan-Kettering Cancer
Center, CSIC & Univ. Autònoma of Barcelona
6 yrs Research at Hebrew Univ. of Jerusalem
and Univ. of Barcelona - 12 yrs, drug
discovery, drug development (pre-clinical
and clinical) at Palau Pharma & Uriach
TECHNOLOGY
 Differentiated treatment in clear unmet
medical needs:
Carles Domènech, PhD
CEO & co-Founder
José Alfón, PhD
VP Research and Development
→ Inhibition of DHFR gene expression
(dihydrofolate reductase): DNA synthesis.
→ Inhibition of the mTOR pathway:
mTORC1/C2.
→ Inhibiton of akt phosphorylation.
→ Cell death by AUTOPHAGY
DHFR and mTOR are validated targets in
cancer chemotherapy (AlimtaTM, AffinitorTM).
KEY VALUES:
Management
Board of Directors:
Has started up biotech and pharma
companies and taken them through
IPOs and trade sales.
Top quality Scientific Advisory
Board:
→
→
→
→
25+years senior experience in all
phases of drug development
Managed 3+ FDA-EMA approvals
Top level clinical practice
First class science
High level business advisors
Lean HR
Building US scientific network
Marc Cortal, MD
Medical Director
Clinical Practice, Clinical Trials, Health
Management - Clínica Quirón / Hospital
Mutua de Terrassa / Middlesex Hospital /
Saint Mary London / Red Cross Geneva
Vanessa Ruz, BEc/MEc
Director, Administration and
Finance
Formerly Chief Financial Officer of Sevibe
Cells
Patent
WO2010/106211
– Patent filed in 03/2009
– PCT initiated in 03/2010
– Published in 10/2010
– International phase: 09/2011:
AU, BR, CA, CH, CN, EP, IN, IL,
JP, KR, MX, RU, ES, US.
–
Ability Pharmaceuticals, SL Executive Summary©
ABTL0812. Action on non-small cell carcinoma and pancreatic cancer in
cell and animal models
Cell models: Higher inhibition of lung cancer and pancreatic cancer cells in vitro and selective
induction of cell death in tumor cells versus fibroblasts. Also active against hepatoma, glioma
and melanoma cell lines.
Xenografts in immunosuppressed mice:
Board of Directors
Luis Sánchez-Lafuente - Chairman
Chairman of AB Biotics, SA
Former CEO and co-owner of Laboratorios Gelos, SA
Miquel Àngel Bonachera - Vice Chairman
CEO and co- founder of AB Biotics, SA
BSc/MSc in biochemistry and MBA
Non-small cell lung carcinoma. 4 weeks treatment, oral. 70% reduction of tumor growth
and tumor growth arrest in 10% of treated mice. Adverse events (weight loss) markedly
lower than in mice treated with docetaxel (Taxotere™). Superiority to erlotinib (Tarceva™) in
recent mice studies.
Sergi Audivert - Secretary General
Dose-dependent tumor response (tumor size and histological markers).
Managing General Partner, Inveready Capital Company
140
Control oral
Control ip
AT12 low oral
AT12 high oral
100
Weight Variation (%)
Tumor volume (% basal)
120
Docetaxel ip
80
60
40
20
n=1 n=1
n=2
0
0
5
10
15
20
25
30
Day
15
General Partner, Inveready Capital Company
10
Carles Domènech, PhD
5
CEO, Ability Pharmaceuticals, SL
0
José Manuel Valadés
-5
Lawyer, partner and founder of the law firm Alliant
-10
Control oral
-15
n=1
Control ip
-20
AT12 low oral
-25
AT12 high oral
Scientific Advisory Board
n=1
n=2
Docetaxel ip
-30
35
Josep M. Echarry
Roger Piqué
AT12 vs. docetaxel, body weight
AT12 vs. docetaxel, tumor volume
CEO and co-founder of AB Biotics, SA
BSc/MSc in food technology and MBA
0
5
10
15
20
25
30
35
Toni Pérez, MD
Chairman of the Board - Clinical Development
Day
Pancreatic cancer. 4 weeks treatment, oral. Efficacy equal to gemcitabine (iv). Absence of
adverse events. An advantage over gemcitabine is that there is no oral formulation of this
marketed drug.
Formerly Medical Director at Esteve, Almirall, Novartis and
Basilea Pharmaceuticals
Peter Wyld, MD
Clinical Development
Formerly Medical Director at Biogen, Amgen and J&J
Oncologicals
Business Model
The company will develop new drug candidates up through clinical proof of concept,
and will then out-license them to biopharmaceutical companies for further
development.
The company begins discussions with potential partners early in the development
phase to interest them early and then to keep them involved with timely updates.
Laura Vidal, MD,
Clinical Oncology
Coordinator, Investigational Therapy Unit - Oncology and
Hematology, IDIBAPS and Hospital Clínic de Barcelona
Universitat de Barcelona
Jesús Llenas, PhD
Preclinical Development
Formerly Head of Pharmacology at Almirall
ABTL0812. Preclinical development
→ Good DMPK properties in rat and dog
(long half life and high oral bioavailability).
→ Very safe up to high does (acute and
chronic).
→ Rat and dog 28d GLPtox
→ 7 Kg of GMP of API produced.
→ Formulation under development.
→ IMPD in preparation
José Luís Fábregas, PhD
ABTL0812 is highly differentiated
from over 300+ drugs in
development for Lung Cancer.
Broad range efficacy vs. reduced
sub-populations
ABTL0812. Clinical Plan
Market and Treatment
Phase Ib/IIa (First in Man/Proof of Concept)
in non-small cell lung carcinoma (NSCLC)
planned for 2Q 2013. Multiple ascending
dose trial. Multicenter. Enrollment 1.5 years.
Lung cancer accounts for 12% of all cancers
and is responsible for over 30% of all cancer
deaths. 1 year survival: 42%. 5 years survival:
15%.
Phase
Ib:
determination
of
the
recommended dose-limiting toxicity in
patients with advanced cancer. 27 patients.
9 months.
NSCLC accounts for 25% of cancer drug sales.
Current treatment has ignificant side-effects:
cisplatin, docetaxel, erlotinib, gemcitabine.
Phase IIa: determination of the dose,
schedule and response rate. ABTL0812 in
combination with standard of care. 40
patients.
Pancreatic cancer holds the 6th position as
cause of cancer death. 2 years survival: 5%
Current treatment: erlotinib and gemcitabine.
Poor long term efficacy.
Pharmaceutical Development
Formerly Senior Director of Pharmaceutical Dev. at Almirall
José Miguel Lizcano, PhD
Signal Transduction
Professor at Univ. Autònoma of Barcelona, formerly at
Philip Cohen’s Laboratory, Univ. of Dundee
ABTL0812 is expected to reach
sales over $ 2 Billion
7 years after launch
Contact
For further information on
Ability Pharmaceuticals and its products,
please visit
www.abilitypharma.com
or contact:
Carles Domènech, PhD
Chief Executive Officer
T: +34 935 868 977
C: +34 606 433 824
Skype: carles.domenech
E: carles.domenech@ abilitypharma.com
Ability Pharmaceuticals, SL
Edifici Eureka - Campus de la UAB
08193 Bellaterra (Barcelona)
Catalonia – Spain
Proprietary Information belonging exclusively to Ability Pharmaceuticals, SL ©