advancing new therapies for childhood cancer€¦ · advancing new therapies for childhood cancer...

Advancing New Therapies For Childhood Cancer

Cesare Spadoni PhD, MBA – Chief Operating Officer & Founder

Mission-

Driven

© 2020 Oncoheroes Biosciences 2

Parents -

Entrepreneurs

Strong

Board


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


Incentives

Sales

Sub-License


Creating

Valuefor investors

and patients

© 2020 Oncoheroes Biosciences

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


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


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


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

© 2019 Oncoheroes Biosciences CONFIDENTIAL – NOT FOR DISTRIBUTION 9

https://www.ncbi.nlm.nih.gov/pubmed/25398439/


Mechanism: Degradation of Fusion Protein

© 2020 Oncoheroes Biosciences CONFIDENTIAL – NOT FOR DISTRIBUTION10

Thalhammer V. et al Cancer Res. 2015 Jan 1;75(1):98-110

https://www.ncbi.nlm.nih.gov/pubmed/25398439/


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

https://www.ncbi.nlm.nih.gov/pubmed/?term=Hugle+et+al+2015,+Cell+Death+Differ

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


volasertibRoad Map

volasertib

additional

indications

©2020 Oncoheroes Biosciences 13

Pediatric Indications

• Diffuse Intrinsic Pontine Glioma (DIPG)

• Hepatoblastoma

Adult Indications

• Breast Cancer

• Others

Criteria for

new asset

identification

and pipeline

building

©2020 Oncoheroes Biosciences 14

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


2HitMedulloblastoma

“Test-then-build”

Prototyping

n-mycDrug Discovery

Project


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


LeadershipOpportunity

Mission-driven

Risk-containedStrategy

Robust Ecosystem

1

2

3

Investment

Opportunity

4


3

4


“Be the change

that you want

to see in the

world”Mahatma Gandhi

Road Map

The TimeHas Come,

OncoheroesIs Ready

[email protected]

advancing new therapies for childhood cancer€¦ · advancing new therapies for childhood cancer...

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