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Aesis corfù innovation summit oct 5 7 2015
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Transcript of Aesis corfù innovation summit oct 5 7 2015
Company Profile and PortfolioCorfù Innovation SummitOctober 5-7, 2015 - Corfù
Industry: Healthcare Sector: Pharmaceuticals - OncologyFounded in: Jesi- Italy, Dec [email protected]
Cristina Geroni, CEOCarmela Salvatore, COO
Hispano-Italian Biopharma spin-out from
& Shell Company focused on R&D of innovative oncology drugs
Company Overview
The Mission To move validated inventive findings by the two parent companies into clinical development To offer first-in-class drug candidates to commercial partners
Hispano-Italian Biopharma spin-out from
& Shell Company focused on R&D of innovative oncology drugs
Company Overview
Management Team
Skilled industry veterans and senior entrepreneurs
Expertise in oncology R&D combining 180+ years experience and 220+ patents
Advisor
Cristina Geroni, CEO 35+yr Oncology R&D Farmitalia, Pharmacia, Pfizer>55 patents
Carmela Salvatore, COO 15+yr Oncology R&D Menarini Ricerche
Paolo Lombardi, CSO 35+yr Oncology R&D Farmitalia, Menarini, IBI, ChrysalonCEO of Naxospharma (Italy)>60 patents
Carmen Plasencia, Co-founderCEO of Aromics (Barcelona, Spain)
Narcis Clavell, Co-founderEngineer, MBACo-owner of Aromics Founder and owner of Ateknea Solution.
Federico M Arcamone 40+yr Oncology R&DFarmitalia, Menarini RicercheBoard of Naxospharma>100 patents
People who know how to do the job because they have already done it
Two different unmet Cancermedical needs
Two different unmet Cancermedical needs
Malignant Mesothelioma (MT) rare treatment-resistant cancer one drug approved (Alimta)
Thymidilate Synthase a marker of drug responsiveness
HER2-positive breast cancer (BC) aggressive, poor prognosis metastatic type of cancer
Gold standard drugs targeting HER-2 show modest efficacy and side effects
The Solution(US Patent 8,188,109B2)
Innovative proprietary compoundsInnovative proprietary compoundsviavia rational chemical modifications of plant rational chemical modifications of plant
alkaloid berberinealkaloid berberine
Active on clinically validated targets in cancer treatment Active on clinically validated targets in cancer treatment First in class compounds with high antitumor efficacy and First in class compounds with high antitumor efficacy and
good tolerabilitygood tolerability
The Solution(US Patent 8,188,109B2)
Innovative proprietary compoundsInnovative proprietary compoundsviavia rational chemical modifications of plant rational chemical modifications of plant
alkaloid berberinealkaloid berberine
Active on clinically validated targets in cancer treatment Active on clinically validated targets in cancer treatment First in class compounds with high antitumor efficacy and First in class compounds with high antitumor efficacy and
good tolerabilitygood tolerability
NAX035
Active on tumours with high levels of
Thymidilate Synthase
NAX014
Active on HER-2 positive tumours
NAX035Activity on TS overexpressing MT cells
STO
MesoII
Human peritoneal mesothelioma
(STO) cells
NAX035 shows target inhibition in vitro and in
vivo mesothelioma
Effect of NAX035 on TS protein levels in mesothelioma tissues (STO)
Therapeutic focus MesotheliomasCompetitive Landscape
Compound (Company) Mechanism of ActionNGR-hTNF (MolMed)* Vascular target agent
Raltitrexed (Astra Zeneca) Folate antimetabolite
Onconase with Doxorubicin (Alfacell Corporation)
Ribonuclease enzyme
Vorinostat (Merck Sharp & Dohme) Histone deacetylase inhibitor
Pemetrexed and Cisplatin + Bevacizumab (Genentech/Roche)
Monoclonal Antibodyagainst VEGF
May 2014: Fails to improve OS in 2nd-line mesothelioma (Add On to invest. choice)
The current market dominated by Alimta (in combination with cisplatin)Alimta patent expires in 2016
HER2 positive Human BC cells (SK-BR-3)
NAX014Activity on HER-2 positive BC
Antitumor efficacy on spontaneous mammary tumorHER-2/neu transgenic mice (oral)
HER2
p-HER2
β-actin
NAX014
Effect on HER2/neu expressionand phosphorylation
SK-BR-3 cells
NAX014 shows unique ability to reduce HER-2
expression in breast cancer
HER2 pathway and targets
NAX014 “unique” mechanism
to inhibit HER-2 expression
Compound (Company) Mechanism of Action
BKM120, LEE011 (Novartis); Palbociclib (Pfizer);Neratinib (Puma Biotechnology); Afatinib (Boehringer Ingelheim)
Kinase inhibitors Targeting HER2 downstream pathway
MM-302 (Merrimack) HER2 targeted antibody-drug conjugated nanoliposomal doxo
SB3 (Samsung Bioepis Co); PF-05280014 (Pfizer); APB980 (Amgen) trastuzumab biosimilar: "me-too's"
UDT1 (Beijing Biostar Technologies) Tubulin inhibitor (epothilone)
Therapeutic focus HER2+Breast CancerCompetitive Landscape
Business Model
Investment and Use of Funds
>3YR INVESTMENT PLAN FOR TWO COMPOUNDS AND INDUSTRIAL COSTS
Funds(€
Million)
Seedinvestment€M 0.485
1st investment round
€M2,420
2nd investment round
€M 3,675Time Y1
1QY12Q
Y13Q
Y14Q
Y21Q
Y22Q
Y23Q
Y24Q
Y31Q
Y32Q
Y33Q
Y34Q
Y41Q
Use of funds
Preclinical requirement
s of drug candidate
Preclinical development and
Fist Patient InTo perform Phase I clinical study
Milestone
PC Approved
First Time in Man Clinical Proof of Concept
Euro 6,6 million in capital to finance product candidates development up to Phase I clinical study completion (3+years)
Project Value and ROI
Project Value and ROI
The median total value for Oncology Deals is higher Projects Revenue for Aesis at first possible exit: IND = €10M plus milestones
Oncology Companies(Drug – Phase)
Upfront Payme
nt(in
cash)
Total Announced Deal Value
Lpath/Merck Serono (Asonep in Phase I) $23 M $445 MS*BIO/Onyx (SB1518/SB1578 in preclinical/PhaseI) $25 M $575 MArdea Biosciences/Bayer (RDEA119/other MEK inhibitors in Phase I/preclinical)
$35 M $407 M
EOS/CLOVIS Oncology (Lucitanib in Phase I/Iia) $10 M $400 M
Innovative Innovative Candidate Candidate
CompoundsCompoundsto overcome current to overcome current therapy drawbackstherapy drawbacks
Skilled Team with a track record of achievements in
Oncology R&D
Sustainable Portfolio
in unmet medical need in cancer
HER-2+ Breast Cancer
Compound Annual Growth Rate (CAGR)
Market Opportunity Market Opportunity Breast CancerBreast Cancer
MesotheliomasMesotheliomas
Global pharma market was valued USD 9.8 bn in 2013with forecast CAGR of 5.8% reaching USD 18.2 bn in 2023The highest-growing segment of the market is the HER2-positive subtype, with a CAGR of 7.6% over the period, rising from USD 5.6 bn to USD 12.5 bn
Global pharma market was valued USD 165m in 2010with forecast CAGR of 4.1% to reach USD 218m by 2017.The major incidence peak expected in the next 15-20 years