Advancing New Therapies For Childhood Cancer
Cesare Spadoni PhD, MBA – Chief Operating Officer & Founder
Mission-
Driven
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Parents -
Entrepreneurs
Strong
Board
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Marc Goldberg, JD, MBA, Founder, BoDSeasoned Life Sciences VC
BioVentures Investors, MBRI, MassBio co-founder
Marco Muñoz, Founder, BoDSenior Fundraiser
Senior Director Strategic Initiatives Office of the MIT
Chairman
CorporateGoals
Worldwide Leader in
pediatric oncology
Partner of Choice for
pharma/biotech industry
First Investment Choicefor foundations and patient associations
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Incentives
Sales
Sub-License
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Creating
Valuefor investors
and patients
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Senior Leaders with Strong Drug
Development,
Commercial Track
Track Records
Eva Méndez, PhD Head of Drug Discovery+20 years in drug discoverdiscoverFerrer, Inst. Of Research in Biomedicine (Barcelona)
Michel Janicot, PhD Chief Scientific OfficerJanssen, Rhone-Poulenc Rorer
Marta Princep, PhDSenior Strategy Advisor+20 years in drug dev. Ferrer, Biocat BoD
Jeffrey Skolnik, MDSenior Board AdvisorPediatric oncologist, GSK, AZ, Inovio Pharmaceuticals
Evie Mengou, MScHead of Regulatory20+ years in drug dev. (biothecs and CROs)
Kirk G. Tanner PhDSenior Board AdvisorVertex Pharmaceuticals
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BostonClinical Development
Drug Discovery
Barcelona
Bench-to-bedside
CONFIDENTIAL – NOT FOR DISTRIBUTION
DISCOVERYPhase CLINICAL DEVELOPMENT Phase
Clinical Studies
I II III
Target identification
Hit Identification
Hit to Lead
RegulatoryApproval
Patient
In- license opportunitiesFrom academia or industry at different
development stages from preclinical to
clinical
Pre-clinicalStudies
In-licensing opportunities
from academia or industry
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IP generation
volasertibDevelopment
Background
Polo-Like-Kinase 1 (PLK1) Inhibitor
Developed by BI for acute myelogenous leukemia (AML) for adults
Program stopped after unsatisfactory Phase III
Phase I pediatric clinical trial completed
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volasertibRationale - 1
PLK1 link to RMS
Thalhammer V. et al Cancer Res. 2015 Jan 1;75(1):98-110
Ove
rall
surv
ival
pro
bab
ility
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volasertibRationale - 2
Mechanism: Degradation of Fusion Protein
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Thalhammer V. et al Cancer Res. 2015 Jan 1;75(1):98-110
volasertibRationale - 3
Preclinical efficacy
Hugle M. et al. Cell Death Differ. 2015 Dec;22(12):1946-56
* Standard of care
Patient derived xenograft model
11© 2020 Oncoheroes Biosciences CONFIDENTIAL – NOT FOR DISTRIBUTION
2025Phase II completionNDA/MAA submission
2026
FDA/EMA regulatory approval. PRV granted
2021Volasertib Phase Ib/II trial begins
August 2019Licensing agreement with BI
These timings are estimations based on discussions with KOLs and analogies to similar development projects
2023Volasertib Phase II
trial begins
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volasertibRoad Map
volasertib
additional
indications
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Pediatric Indications
• Diffuse Intrinsic Pontine Glioma (DIPG)
• Hepatoblastoma
Adult Indications
• Breast Cancer
• Others
Criteria for
new asset
identification
and pipeline
building
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1 Unmet Medical Need
2 Strong Science
4 Clear Go/No-Go decision points
3 De-risked approach
Drug Discovery project for Medulloblastoma
Novel drug combinations – New IP
AI, Systems Biology partnerships (external collaborations)
Preclinical candidate expected by Q4 2021
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2HitMedulloblastoma
“Test-then-build”
Prototyping
n-mycDrug Discovery
Project
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In silico screening – up to 1B compounds
Iterative Med. Chem. rounds
Lead compound identification
Project Discovery Preclinical Phase I Phase II/III Approval
2Hit
volasertib
n-mycinhibitor
Asset #2
Asset #3
Evaluating
medulloblastoma
multiple pediatric cancers
Building a
robust pipeline
Evaluating
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LeadershipOpportunity
Mission-driven
Risk-containedStrategy
Robust Ecosystem
1
2
3
Investment
Opportunity
4
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3
4
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“Be the change
that you want
to see in the
world”Mahatma Gandhi
Road Map