How tech transfer experiences lead to a biotech foundation:
VCN Biosciences case-report
April 10th, 2014
www.vcnbiosciences.com
The origin
Virotherapy Group at ICO / IDIBELL: The team
Name: Cancer Virotherapy
Created: 2001
Grou...
www.vcnbiosciences.com
The origin
normal cell:
abortive replication
Productive
replication
Mechanism of Action
Spread to n...
www.vcnbiosciences.com
Genesis of VCN Biosciences
Virotherapy Group at ICO / IDIBELL experience
2001 2002 2003 20072004 20...
www.vcnbiosciences.com
Dr. Ramon Alemany Dr. Manel CascallóDr. Gabriel Capellà
Internationally Recognized Scientifics
Expe...
About VCN Biosciences
Mission & View
www.vcnbiosciences.com
VCN Biosciences was created in 2009 with the aim of developing...
www.vcnbiosciences.com
Rational Design of a Clinical candidate
HAd5
(wild-type)
Clinical candidate
selectivity of replicat...
About VCN Biosciences
Mission & View
www.vcnbiosciences.com
BUSINESS MODELS in BIOTECH sector
HIGHInvestment Medium
© Natu...
Building up VCN Biosciences
www.vcnbiosciences.com
The three pillars of a biotech company:
TECHNOLOGY MANAGEMENT INVESTMENT
Building up VCN Biosciences
www.vcnbiosciences.com
INTELLECTUAL PROPERTY
- Prosecution of patents
- IP strategy
TECHNOLOGY...
Building up VCN Biosciences
www.vcnbiosciences.com
INTELLECTUAL PROPERTY
- Prosecution of patents
- IP strategy
TECHNOLOGY...
Building up VCN Biosciences
www.vcnbiosciences.com
1.- Biodistribution
Liver
PBS Wild-type
capsid
RGDK
capsid
1,00E+04
1,0...
Building up VCN Biosciences
www.vcnbiosciences.com
Preclinical Package: Pharmacology of VCN-01
Intratumoral
Administration...
Building up VCN Biosciences
www.vcnbiosciences.com
Preclinical Package: Pharmacology of VCN-01 ± Gemcitabine
day 0 day 80
...
Building up VCN Biosciences
www.vcnbiosciences.com
Preclinical Package: Toxicity profile
* p<0.05 vs PBS
Transaminases
1
1...
Building up VCN Biosciences
www.vcnbiosciences.com
MANAGEMENT INVESTMENT
BUDGET STRUCTURE
ACTIVITY SCHEDULING
FINANCIAL OP...
Building up VCN Biosciences
www.vcnbiosciences.com
MANAGEMENT
ORGANIZATION
TRAINING
& CONSULTING
FUNDING
SEARCH
GROWTH
STR...
www.vcnbiosciences.com
VCN Biosciences Pipeline
Proof of
concept
Phase II
Candidate
definition
Phase I
Regulatory
Preclíni...
www.vcnbiosciences.com
Clinical program with VCN-01
Phase I by Intravenous
Administration ±GE
(EudraCT number: 2012-005555...
Thank you!
www.vcnbiosciences.com
Dr. Manel Cascalló
Chief Executive Officer
VCN Biosciences SL
www.vcnbiosciences.com
Av ...
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Manel Cascallo / VCN Biosciences open innovation case

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Presentation given by Manel Cascallo, from VCN Biosciences, in the framework of the Emergence Forum Barcelona

Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014

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Manel Cascallo / VCN Biosciences open innovation case

  1. 1. How tech transfer experiences lead to a biotech foundation: VCN Biosciences case-report April 10th, 2014
  2. 2. www.vcnbiosciences.com The origin Virotherapy Group at ICO / IDIBELL: The team Name: Cancer Virotherapy Created: 2001 Group Leader: Dr. Ramon Alemany IP’s: Ramon Alemany / Manel Cascalló
  3. 3. www.vcnbiosciences.com The origin normal cell: abortive replication Productive replication Mechanism of Action Spread to neighbouring cells Selective killing of tumour cells Self-amplification effect Potential stimulation of an antitumoral immune response Oncolytic Virotherapy = Use of replication competent viruses to selectively destroy cancer cells Technology (Extracted from Hedley et al. 2006)
  4. 4. www.vcnbiosciences.com Genesis of VCN Biosciences Virotherapy Group at ICO / IDIBELL experience 2001 2002 2003 20072004 2005 2006 2008 2009 2010 1rst patent (VA technology) 2nd patent (DM technology) 3rd patent (T1 tech.) Technology Acquisition by ORCA Therapeutics (Holland) EUREKA project VCN creation Regulatory Phase with ICOVIR-5 Approval by: - AEMPS - Environmental Ministry - Clinical committee at Hospitals 4th patent (hyal. tech.) Technology Transfer to DNAtrix (USA) Compassionate Use Assays ICOVIR-5 Technology Acquisition by Oncolytics BioTech (Canada) CONTRACT RESEARCH with Oncolytics BioTech.
  5. 5. www.vcnbiosciences.com Dr. Ramon Alemany Dr. Manel CascallóDr. Gabriel Capellà Internationally Recognized Scientifics Expertise in Clinical Development of Oncolytic viruses Inventors of >5 patents & Company Consultants Business Management Expertise ENTERPRENEUR TEAM adhoc Scientific Advisory Board Dr. Jose Costa (Yale Univ., USA) Dr. Nick Lemoine (QMCR, UK) Dr. Ramon Salazar (ICO, Spain) Dr. Manuel Hidalgo (CNIO, Spain) Strategic Consultancy BIOEMPREN SL (Mr. Jaume Amat) Hyaluronidase Tech. Transfer IDIBELL / ICO Commercial agreement with a CMO for viral batch production GenIBET (Portugal) Genesis of VCN Biosciences The decision
  6. 6. About VCN Biosciences Mission & View www.vcnbiosciences.com VCN Biosciences was created in 2009 with the aim of developing new agents for the treatment of cancer using a technological platform based on oncolytic adenoviruses. VCN Biosciences mission is the development of new candidate oncolytic adenoviruses from its design and preclinical studies to the validation of their antitumoural efficacy in human patients (Phase I and II clinical trials).
  7. 7. www.vcnbiosciences.com Rational Design of a Clinical candidate HAd5 (wild-type) Clinical candidate selectivity of replication in tumour cells Tumour potency (diffusion) biodistribution selectivity (tumour targeting) Mechanism of Action Selective killing of tumor cells by effect of its replication, which results in a self- amplification of the initial inoculum that is released after cell lysis and spread through the tumor mass The expression of a secreted soluble hyaluronidase, which degrades partially the extracellular matrix of the tumor facilitating the diffusion of the virus progeny and increasing the accessibility for chemotherapy About VCN Biosciences
  8. 8. About VCN Biosciences Mission & View www.vcnbiosciences.com BUSINESS MODELS in BIOTECH sector HIGHInvestment Medium © Nature Group
  9. 9. Building up VCN Biosciences www.vcnbiosciences.com The three pillars of a biotech company: TECHNOLOGY MANAGEMENT INVESTMENT
  10. 10. Building up VCN Biosciences www.vcnbiosciences.com INTELLECTUAL PROPERTY - Prosecution of patents - IP strategy TECHNOLOGY MANAGEMENT CANDIDATE DEVELOPMENT - Preclinical package - Manufacturing - Clinical Program - Regulatory Validation PORTFOLIO CREATION - New technologies - Portfolio strategy MANAGEMENT INVESTMENT BUDGET STRUCTURE ACTIVITY SCHEDULING FINANCIAL OPPORTUNITIES MANAGEMENT ORGANIZATION TRAINING & CONSULTING FUNDING SEARCH GROWTH STRATEGY
  11. 11. Building up VCN Biosciences www.vcnbiosciences.com INTELLECTUAL PROPERTY - Prosecution of patents - IP strategy TECHNOLOGY MANAGEMENT CANDIDATE DEVELOPMENT - Preclinical package - Manufacturing - Clinical Program - Regulatory Validation PORTFOLIO CREATION - New technologies - Portfolio strategy 2019 Clinical Phase 2 i.v Pancreas Clinical Phase 2 Other tumor target ? 2010 2011 2012 2016 Preclinics + Manufacturing 2013 2014 2015 2017 Clinical Phase 1 intratumoral Clinical Phase 1 intravenous 2018 VCN-01 Regulatory Preclinics PRECLINICS VCN-02 Clinical Phase 1 VCN-02 VCN-02 Regulatory VCN-02 PRECLINICS VCN-03 VCN-03 Regulatory VCN-03 Phase 1 VCN-03
  12. 12. Building up VCN Biosciences www.vcnbiosciences.com 1.- Biodistribution Liver PBS Wild-type capsid RGDK capsid 1,00E+04 1,00E+05 1,00E+06 1,00E+07 1,00E+08 1,00E+09 1,00E+10 0 500 1000 1500 2000 Virusinblood Time (minutes) ICO17 VCN01 2.- Pharmacokinetics Orphan Drug Designation for the Treatment of Pancreatic Cancer Decision adopted by EMA on June 21th, 2011 (EU/3/11/880 - EMA/OD/008/11) Days post-injection %tumorgrowthvsday0 VCN-01 %tumorgrowthvsday0 VCN-01 3.- Antitumoral ACTIVITY
  13. 13. Building up VCN Biosciences www.vcnbiosciences.com Preclinical Package: Pharmacology of VCN-01 Intratumoral Administration *p<0.05 vs PBS # p<0.05 vs VCN-01 (4xE9vp) 0 500 1000 1500 2000 2500 -1 19 39 59 79 Volume(mm3) day pi Tumor volume NP-9 (Mean ± S.E.) PBS VCN01 Hyaluronic Acid (HA) staining Digested HA (neg. ctrl) vehicle VCN01 (day79 p.i.) hyaluronic acid hyaluronic acid Intravenous Administration *, p<0.05 vs vehicle group
  14. 14. Building up VCN Biosciences www.vcnbiosciences.com Preclinical Package: Pharmacology of VCN-01 ± Gemcitabine day 0 day 80 nude MICE day -15 Tumor cells - VCN-01 i.v. at 5.1010 vp (1X): day 0 - GE i.p. at 100 mg/kg (3X): day 0,2,4,6 Human xenograft model in mice Syngenic Model in Syrian Hamster day 0 day 45 Syrian Hamster day -15 Tumor cells GE i.p. at 50 mg/kg (7X): day 0,3,6,9,12,15,18) VCN-01 i.t. at 25.1010 vp (1X): day 0, 9 & 18) # P<0.01 vs GE ᵟP<0.01 vs VCN-01 P<0.01 vs PBS *
  15. 15. Building up VCN Biosciences www.vcnbiosciences.com Preclinical Package: Toxicity profile * p<0.05 vs PBS Transaminases 1 10 100 1000 10000 100000 male female male female UI/l Day 2 1 10 100 1000 10000 100000 male female male female UI/l Day 8 vehicle VCN-01 at 2,5E11 vp VCN-01 at 4E11 vp 1 10 100 1000 10000 100000 male female male female UI/l Day 28 AST ALT AST ALT AST ALT *p <0.05 vs vehicle group * * Total white blood cells count 0,001 0,01 0,1 1 10 100 male female male female male female male female male female x10E6cells/mL Day 2 0,001 0,01 0,1 1 10 100 male female male female male female male female male female x10E6cells/mL Day 8 vehicl VCN-0 VCN-0 Lymphocytes Neutrophils Eosinophils Basophils Monocytes Lymphocytes Neutrophils Eosinophils Basophils Monocytes * * * * 1 10 100 1000 10000 100000 male female male female UI/l Day 8 vehicle VCN-01 at 2,5E11 vp VCN-01 at 4E11 vp *p <0.05 vs vehicle group Mice Hamster Day 12Day 7
  16. 16. Building up VCN Biosciences www.vcnbiosciences.com MANAGEMENT INVESTMENT BUDGET STRUCTURE ACTIVITY SCHEDULING FINANCIAL OPPORTUNITIES FFF entrance Manel Cascalló (59,13 %) Ramon Alemany (7,39%) Gabriel Capellà (7,39%) BIOVCN Patrimonial (13,66 %) BIOCAPE Grup (12,43 %) Founders: 100% Manel Cascalló (35,5 %) Ramon Alemany (4,4%) Gabriel Capellà (4,4 %) BIOVCN Patrimonial (8,2 %) BIOCAPE Grup (7,5 %) New Investor (40%) Second Round Grifols (expected) Manel Cascalló (35,5 %) Ramon Alemany (4,4%) Gabriel Capellà (4,4 %) BIOVCN Patrimonial (8,2 %) BIOCAPE Grup (7,5 %) New Investor (40%) COMPANYVALUE Manel Cascalló (35,5 %) Ramon Alemany (4,4%) Gabriel Capellà (4,4 %) BIOVCN Patrimonial (8,2 %) BIOCAPE Grup (7,5 %) New Investor (40%)
  17. 17. Building up VCN Biosciences www.vcnbiosciences.com MANAGEMENT ORGANIZATION TRAINING & CONSULTING FUNDING SEARCH GROWTH STRATEGY Founder Team Dr. Alemany Virotherapy Expert Dr . Capellà Cancer Genetics Expert Contract Research with academia Scientific Advisory Committe Dr. Hidalgo CNIO Dr. Salazar ICO Dr. Costa Yale Univ. Dr. Cascallo, CEO / Founder Ms. Viaplana Clinical Research Manager Ms. Blasi Regulatory Affairs Manager Dr. Bazan R&D Manager Clinical Commitee Scientists Team Board of Directors Dr. Terencio Dr. Büscher Dr. Costa Mr. AmatDr. Cascalló
  18. 18. www.vcnbiosciences.com VCN Biosciences Pipeline Proof of concept Phase II Candidate definition Phase I Regulatory Preclínics Hyaluronidase Technology VCN-01 T1- Technology Out-licensed to ORCATherapeutics BV VCN-02 Technology VCN-02 Pre-candidates VCN Technologies Building up VCN Biosciences
  19. 19. www.vcnbiosciences.com Clinical program with VCN-01 Phase I by Intravenous Administration ±GE (EudraCT number: 2012-005555-16 ) Phase I by Intratumoral Administration ±GE (EudraCT number: 2012-005556-42 ) Study Type Open-label / Dose Escalation Open-label / Dose Escalation Dosage Range 1xE11 vp to 1xE13 vp/patient (6 dose levels) 1xE10 vp to 1xE12 vp/tumor (5 dose levels) Administration Continuous infusion EUS guided Number of patients 24 to 33 20 to 27 Clinical Sites 1. Institut Català d’Oncologia (BCN) 2. Centro Integral Oncológico Clara Campal (Madrid) 1. Institut Català d’Oncologia (BCN) / Hospital Bellvitge 2.Centro Integral Oncológico Clara Campal (Madrid) Starting Date January 2014 January 2014 Estimative Duration Enrollment 24 months 19 months Building up VCN Biosciences
  20. 20. Thank you! www.vcnbiosciences.com Dr. Manel Cascalló Chief Executive Officer VCN Biosciences SL www.vcnbiosciences.com Av de la Generalitat 152 08174 - Sant Cugat del Vallès (Barcelona, SPAIN) phone: +34 571 2359 / + 34 609432375 mcascallo@vcnbiosciences.com Funding: - NEBT2010 - ACC10 - Programa INNPACTO-2012 - CDTI – PiD 2013

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