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From Molecule to Business Health Valley/SMB September 24, 2015 Nijmegen CriPec ® Nanomedicines for Superior Therapeutic Performance Dr. Jeroen Tonnaer, CBO

20150924 smb cristal therapeutics jeroen tonnaer

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From Molecule to BusinessHealth Valley/SMB

September 24, 2015Nijmegen

CriPec® Nanomedicines for Superior Therapeutic Performance

Dr. Jeroen Tonnaer, CBO

2

Introduction

• Pharmaceutical company developing nanomedicines

• Founded in April 2011

• Located in Maastricht, The Netherlands

• Headcount: 10 fte

• Private - VC funded:

2

3

CriPec® Nanomedicines Improved efficacy and tolerability

CriPec® improves the therapeutic profile of drugs as a result of:

• Extended systemic circulation

• Improved disposition over the body

• Active or passive targeting to tissue, cellular and molecular targets

• Tuneable and timely release

3

CriPec® polymer

drug linker

entrapment of drug, so inactive

release native drug & degradation NP

coupling of drug

drug

linker

CriPec® polymer incl. linker

drug lactic acid

Unique CriPec® PlatformTransiently stable nanomedicines

4

PATENT PROTECTED BY 5 PATENT FAMILIES

range of therapeutic agents (small molecules - peptides)

biodegradable and safe fragments

multiple administration routes

controllable sizefrom 30 nm up to 100 nm

X

surface functionalisation for cellular and molecular targeting

ease of manufacturing

customised drug release

Unique Features of CriPec®

Highly flexible nanomedicinal platform

5

Therapeutic effect CriPec® DocetaxelBreast xenograft model

6

s.c. MDA-MB-231 xenografts in nude mice (n=8±SD)

0 14 28 42 560

250

500

750

1000

1250

1500

single dose

vehicle

Taxotere 60 mg/kg

CriPec docetaxel 60 mg/kg

time (days)

tum

our

volu

me (

mm

3)

s.c. MDA-MB-231 xenografts innude mice (n=10±SD)

0 14 28 42 560

250

500

750

1000

1250

1500

1750

2000

vehicle

Taxotere 30 mg/kg

CriPec docetaxel 125 mg/kg

single dose

time (days)

tum

our

volu

me (

mm

3)

Unique Opportunity

• CriPec® is unique and competitive nanotechnology platform that enables development of multiple (targeted) products

• CriPec® boosts efficacy and improves tolerability

• Applicable in disease areas with high unmet medical need

• First product started clinical development July 2015

• Attractive co-development potential

• CriPec® platform & products are protected by 5 patent

families

7

Value Drivers

• Clinical- Clinical phase I: safety of CriPec® docetaxel and PK profile

- Clinical phase IIa/IIb: efficacy of CriPec® docetaxel

• Platform- In house PoC for CriPec® peptide, CriVac® antigen, andCriPec® active targeting (ATN)

- A commercial viable, robust and generic cGMP-manufacturing process

• Business- Successful feasibility studies for partners

- Successful (license) partnerships (full (co-)development programs)

8

Pipeline

9

indication discovery PoC preclinical phase I phase IIa

Proprietary programs

CriPec® docetaxel solid tumours

CriPec® dexamethasone inflammatory

CriPec® active targeting solid tumours

CriPec® oligonucleotides various

Collaborative programs

CriPec® peptides solid tumours

CriVac® antigens solid tumours

achieved ongoing

General BD&L Considerations

DO:

• Understand the candidate licensee’s strategy and needs

- Unlikely our opportunity will move the company’s strategy

- Look for gaps we can fill

- Ask for specific guidance on what the company is looking for

• Appeal to licensee’s core values, for example:

- Cutting-edge science

- Novel medicines that make a difference

• Demonstrate how our offering fits into their pipeline or

research framework

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General BD&L Considerations

DON’T:

• Forget that there is a fundamental difference between

research (which advances technology without being

constrained by business requirements) and product

development (which must satisfy customer needs with safe,

proven therapies that are competitive and cost-effective)

• Expect to successfully license technology with no proven customer or market fit

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CriPec® Docetaxel BD&L Considerations

• Concept of disruptive vs. incremental innovation

• Understanding stakeholders’ innovation preference• Multinationals

• Regional players (e.g. Asian Pharma)

• Adopters (e.g. innovative generics manufacturers)

• Drafting CriPec® docetaxel licensing strategy• Analysis of market gaps in oncology

• New application areas for CriPec® docetaxel

• Competitive landscape (USPs vs. taxotere & NM competition)

• Stakeholders landscape

• Valuation of CriPec® docetaxel

• Outline licensing deal

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www.cristaltherapeutics.com