The field of oncolytic viruses was quite dormant in the first decade of the 2000s, characterized by slow clinical progress due to hypercautiousness and low, albeit steady, investments. The takeover of BioVex by Amgen in late 2011, worth up to US$ 1 bln, has woken up the field and became a game changer together with the 2015 approval of the first oncolytic virus Imlygic developed by BioVex in regulated markets. In addition, it was increasingly recognized that oncolytic viruses not only were able to directly lyse cancer cells, but they also „freed“ tumor specific neoantigens, indirectly acting as a cancer vaccine.
However, the efficacy of oncolytic viruses still was modest, but can be improved when combined with immune checkpoint inhibitors. This lead to an increased partnering interest of the major immuno-oncology (I-O) players, but also of investors who view oncolytic viruses as a must be for I-O combination regimens. As a consequence, total venture equity and private investments into oncolytic virus companies in 2016 was nearly 17-fold higher than in the year 2010.
Optimization of oncolytic viruses is ongoing and new constructs intend to solve some of the open problems regarding the way of administration (intratumoral vs systemic), higher cancer cell specific replication capacity, and longer persistence in vivo. Based on experience with several virus families over the last decades, a few virus families cristallized as well suitable backbones to carry more and more transgenes to express proteins or even single chain antibodies. This would position oncolytic viruses as independent therapeutics and could compete with immuno-oncology compounds and cancer vaccines.
This report „The Oncolytic Virus Landscape 2017: an analysis of pipeline, stakeholders, deals, industry trends & opportunities“ as of January 2017 brings you up-to-date regarding key players, key technologies, Oncolytic Virus projects, business deals and private and public financing rounds. The report analyzes the Oncolytic Virus pipeline and stakeholders in the field, especially among Big Pharma/Biotech and technology companies. The report highlights the value of oncolytic viruses in terms of partnering terms and conditions, venture and private financing and (initial) public offerings.
This report has been built in a bottom-up way by desktop search to identify and describe company, product, technology and business/financing profiles which then were evaluated and analyzed with a final outlook describing perspectives with challenges and opportunities.
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Table of Contents
1ÌýÌýÌýÌýÌýÌýÌýÌýÌý Executive Summary
2ÌýÌýÌýÌýÌýÌýÌýÌýÌý Introduction & Overview
3ÌýÌýÌýÌýÌýÌýÌýÌýÌý Selection, Design & Construction of Oncolytic Viruses
3.1ÌýÌýÌýÌýÌýÌý Herpes Simplex Virus (HSV) – based Oncolytic Viruses
3.2ÌýÌýÌýÌýÌýÌý Adenoviruses – based Oncolytic Viruses
3.3ÌýÌýÌýÌýÌýÌý Vaccinia Virus - Based Oncolytic Viruses
3.4ÌýÌýÌýÌýÌýÌý Vesicular Stomatitis Virus - based Oncolytic Viruses
3.5ÌýÌýÌýÌýÌýÌý Newcastle Disease Virus - based Oncolytic Viruses
3.6ÌýÌýÌýÌýÌýÌý Various Oncolytic Viruses
4ÌýÌýÌýÌýÌýÌýÌýÌýÌý Profiles of Oncolytic Viruses
4.1ÌýÌýÌýÌýÌýÌý HSV-based Oncolytic Viruses
4.1.1ÌýÌýÌý Imlygic; talimogene laherparepvec; T-Vec; OncoVEX(GM-CSF)
4.1.2ÌýÌýÌý G47Δ
4.1.3ÌýÌýÌý HF10; TB-1401
4.1.4ÌýÌýÌý HSV1716; seprehvir
4.1.5ÌýÌýÌý HSV-Rb-p450
4.1.6ÌýÌýÌý BV-2711
4.1.7ÌýÌýÌý ONCR-001
4.2ÌýÌýÌýÌýÌýÌý Adenovirus-based Oncolytic Viruses
4.2.1ÌýÌýÌý Oncorine
4.2.2ÌýÌýÌý CG0070
4.2.3ÌýÌýÌý DNX-2401
4.2.4ÌýÌýÌý OBP-301; telomelysin
4.2.5ÌýÌýÌý ONCOS-102
4.2.6ÌýÌýÌý Enadenotucirev; ColoAd1
4.2.7ÌýÌýÌý Adenoviral VirRx 007; INGN 007; VRX-007
4.2.8ÌýÌýÌý VCN-01
4.2.9ÌýÌýÌý LOAd703
4.2.10Ìý H103
4.2.11Ìý NG-348
4.2.12Ìý ORCA-010
4.2.13Ìý TILT-123
4.2.14Ìý UIO-112
4.2.15Ìý TILT-324
4.2.16Ìý DNX-2440; Delta-24-RGDOX
4.2.17Ìý DNX-2450
4.2.18Ìý OBP-702
4.3ÌýÌýÌýÌýÌýÌý Vaccinia Virus-based Oncolytic Viruses
4.3.1ÌýÌýÌý Pexastimogene devacirepvec; Pexa-Vec; JX-594; TG6006
4.3.2ÌýÌýÌý GL-ONC1
4.3.3ÌýÌýÌý JX-929; vvDD
4.3.4ÌýÌýÌý TG6002
4.3.5ÌýÌýÌý WO-12
4.4ÌýÌýÌýÌýÌýÌý Vesicular Stomatitis Virus-based Oncolytic Viruses
4.4.1ÌýÌýÌý MG1 Maraba/MAGE-A3 (MG1MA3)
4.4.2ÌýÌýÌý VSV-IFNbeta
4.4.3ÌýÌýÌý VSV-IFNbeta-NIS
4.4.4ÌýÌýÌý VSV-GP
4.5ÌýÌýÌýÌýÌýÌý Newcastle Disease Virus-based Oncolytic Viruses
4.5.1ÌýÌýÌý NDV-HUJ
4.5.2ÌýÌýÌý PV701
4.5.3ÌýÌýÌý recNDVGM-CSF
4.6ÌýÌýÌýÌýÌýÌý Various Oncolytic Viruses
4.6.1ÌýÌýÌý Rigvir
4.6.2ÌýÌýÌý Reolysin; pelareorep
4.6.3ÌýÌýÌý CAVATAK; CVA21
4.6.4ÌýÌýÌý MV-NIS
4.6.5ÌýÌýÌý NTX-010; SVV-001
4.6.6ÌýÌýÌý H-1PV
4.6.7ÌýÌýÌý PVS-RIPO
4.6.8ÌýÌýÌý MYX-135
4.7ÌýÌýÌýÌýÌýÌý Stem Cell-delivered Oncolytic Viruses
4.7.1ÌýÌýÌý TBX.OncV (CRad-Survivan-pk7)
4.7.2ÌýÌýÌý MSC-ICOVIR-5
5ÌýÌýÌýÌýÌýÌýÌýÌýÌý Analysis of Oncolytic Virus Pipeline
5.1ÌýÌýÌýÌýÌýÌý Overview of the Pipeline of Oncolytic Viruses
5.2ÌýÌýÌýÌýÌýÌý Approved and Âé¶¹Ô´´ed Oncolytic Viruses
5.3ÌýÌýÌýÌýÌýÌý Late Stage Development of Oncolytic Viruses
5.4ÌýÌýÌýÌýÌýÌý Combination of Oncolytic Viruses with Immune Checkpoint Inhibitors and Other Anti-Tumor Agents
5.5ÌýÌýÌýÌýÌýÌý Armed Oncolytic Viruses
6 Company Profiles
6.1ÌýÌýÌýÌýÌýÌý Pharma & Biotech
6.1.1ÌýÌýÌý Amgen
6.1.2ÌýÌýÌý Astellas Pharma
6.1.3ÌýÌýÌý AstraZeneca
6.1.4ÌýÌýÌý Boehringer Ingelheim
6.1.5ÌýÌýÌý Bristol-Myers Squibb
6.1.6ÌýÌýÌý Celgene
6.1.7ÌýÌýÌý Daiichi Sankyo
6.1.8ÌýÌýÌý Green Cross
6.1.9ÌýÌýÌý Jiangsu Hengrui
6.1.10Ìý Lee Pharma
6.1.11Ìý Medigen Biotechnology
6.1.12Ìý Merck
6.1.13Ìý Otsuka Pharmaceutical Co
6.1.14Ìý Pfizer
6.1.15Ìý Roche
6.2ÌýÌýÌýÌýÌýÌý First Generation Oncolytic Virus Companies
6.2.1ÌýÌýÌý Cold Genesys
6.2.2ÌýÌýÌý Genelux
6.2.3ÌýÌýÌý Latima
6.2.4ÌýÌýÌý Multivir / VirRx
6.2.5ÌýÌýÌý Neotropix
6.2.6ÌýÌýÌý Oncolytics Biotech
6.2.7ÌýÌýÌý Shanghai Sunway Biotech
6.2.8ÌýÌýÌý SillaJen
6.2.9ÌýÌýÌý Takara Bio
6.2.10Ìý Theravir
6.2.11Ìý Virttu Biologics & TNK Therapeutics
6.2.12Ìý Wellstat Biologics
6.3ÌýÌýÌýÌýÌýÌý Second Generation Oncolytic Virus Companies
6.3.1ÌýÌýÌý DNAtrix
6.3.2ÌýÌýÌý Oncolys BioPharma
6.3.3ÌýÌýÌý ORCA Therapeutics
6.3.4ÌýÌýÌý Oryx
6.3.5ÌýÌýÌý Targovax
6.3.6ÌýÌýÌý VCN Biosciences
6.3.7ÌýÌýÌý Viralytics
6.4ÌýÌýÌýÌýÌýÌý Third Generation Oncolytic Virus Companies
6.4.1ÌýÌýÌý Benevir BioPharm
6.4.2ÌýÌýÌý Lokon Pharma
6.4.3ÌýÌýÌý PsiOxus Therapeutics
6.4.4ÌýÌýÌý Transgene
6.5ÌýÌýÌýÌýÌýÌý Fourth Generation Oncolytic Virus Companies
6.5.1ÌýÌýÌý Duke University Start-Up Company
6.5.2ÌýÌýÌý IGNITE Immunotherapy
6.5.3ÌýÌýÌý Oncorus
6.5.4ÌýÌýÌý Replimmune
6.5.5ÌýÌýÌý TILT Biotherapeutics
6.5.6ÌýÌýÌý Turnstone Biologics
6.5.7ÌýÌýÌý Unleash Immuno Oncolytics
6.5.8ÌýÌýÌý ViraTherapeutics
6.5.9ÌýÌýÌý Vyriad
6.5.10Ìý Western Oncolytics
7ÌýÌýÌýÌýÌýÌýÌýÌýÌý Stakeholder Analysis
7.1ÌýÌýÌýÌýÌýÌý Pharma & Biotech
7.2ÌýÌýÌýÌýÌýÌý First Generation Oncolytic Virus Companies
7.3ÌýÌýÌýÌýÌýÌý Second Generation Oncolytic Virus Companies
7.4ÌýÌýÌýÌýÌýÌý Third Generation Oncolytic Virus Companies
7.5ÌýÌýÌýÌýÌýÌý Fourth Generation Oncolytic Virus Companies
8ÌýÌýÌýÌýÌýÌýÌýÌýÌý Financing & Partnering
8.1ÌýÌýÌýÌýÌýÌý Grants, Credits & Donations
8.2ÌýÌýÌýÌýÌýÌý Venture Capital, Private Equity & Private Placements
8.3ÌýÌýÌýÌýÌýÌý Partnering Deals
8.4ÌýÌýÌýÌýÌýÌý Listing on the Stock Âé¶¹Ô´´
8.5ÌýÌýÌýÌýÌýÌý Mergers & Acquisitions
9ÌýÌýÌýÌýÌýÌýÌýÌýÌý Trends & Opportunities
10ÌýÌýÌýÌýÌýÌýÌý References
Tables in the Text:
Table 1: Selection, Design & Construction of HSV - based Oncolytic Viruses
Table 2: Selection, Design & Construction of Adenovirus - based Oncolytic Viruses
Table 3: Selection, Design & Construction of Vaccinia Virus - based Oncolytic Viruses
Table 4: Selection, Design & Construction of Vesicular Stomatitis Virus - based Oncolytic Viruses
Table 5: Selection, Design & Construction of Newcastle Disease Virus - based Oncolytic Viruses
Table 6: Selection, Design & Construction of Various Virus - based Oncolytic Viruses
Table 7: Current Company-Sponsored Clinical Trials of T-Vec
Table 8: Clinical Trials of ColoAd1Ìý
Table 9: Clinical Trials with JX-594
Table 10: Clinical Trials with GL-ONC1
Table 11: Clinical Trials of CAVATAK (CVA21)
Table 12: Clinical Trials with MV-NIS
Table 13: Overview of Oncolytic Viruses by Development Phase & Virus Family
Table 14: Profile of Approved and Âé¶¹Ô´´ed Oncolytic Viruses
Table 15: Pivotal Study Design of Oncolytic Viruses in Late Stage Development Based on Previous Clinical Results
Table 16: Approved Indications of Immune Checkpoint InhibitorsÌý
Table 17: Active Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI)
Table 18: Planned Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI)
Table 19: Active or Planned Clinical Studies of Oncolytic Viruses in Combination with Other Anti-Cancer Therapeutics
Table 20: Pattern of Transgenes in Oncolytic Viruses in Relation to Development Phase
Tables 21a and 21b: Indications and Frquency and Way of Administration of Oncolytic Viruses in Active and/or Positive Completed Clinical Studies
Table 22: Small and Medium Pharma & Biotech as Partner for Regional Co-Development of Oncolytic Viruses
Table 23: Immuno-Oncology Portfolio of Major Pharma & Biotech with Interest in Oncolytic Viruses
Table 24: Interests of Major Pharma & Biotech in Oncolytic Viruses
Table 25: First Generation Oncology Virus Companies and their Sources of Technology
Table 26: Second Generation Oncology Virus Companies and their Sources of Technology
Table 27: Third Generation Oncology Virus Companies and their Sources of Technology
Table 28: Fourth Generation Oncology Virus Companies and their Sources of Technology
Table 29: Grants, Credits & Donations
Table 30: Financing by Venture Capital, Private Equity and Other Private Placements
Table 31: Collaboration & Licensing Agreements
Table 32: Companies Listed on Stock Exchange & Offerings
Table 33: Mergers & Acquisitions
Companies mentioned in the report
Amgen
Astellas Pharma
AstraZeneca (MedImmune)
Bayer
Benevir Biopharm
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Cold Genesys
Daiichi Sankyo
DNAtrix
Duke University start-up Company
GeneLux
Green Cross
Grifols
GSK (GlaxoSmithKline)
IGNITE Immunotherapy
Jiangsu Hengrui
Latima
Lee’s Pharma
Lokon Pharma
Medigen Biotechnology
Merck
Multivir
Neotropix
Oncolys BioPharma
Oncolytics Biotech
Oncorus
Orca Therapeutics
Oryx
Otsuka Pharmaceutical Co
Pfizer
Profectus Biosciences
PsiOxus
Replimune
Roche
Shanghai Sunway Biotech
SillaJen
Sotio
StemImmune
StingInn
Takara Bio
Targovax
TheraBiologics
Theravir
TILTÌý Biotherapeutics
Transgene
Turnstone Biologics
Unleash Immuno Oncolytics
VCN Biosciences
Viralytics
ViraTherapeutics
Virttu Biologics (TNK Therapeutics)
Vyriad
Wellstat Biologics
Western Oncolytics
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*If Applicable.