がんは容赦ない敵であり続け、世界中の患者と医学界の両方に試練を与えています。この多面的な疾患と闘うための革新的で標的を絞った治療法の探求は、がん治療の分野で目覚ましい進歩をもたらしました。多くの新しい戦略の中で、腫瘍溶解性ウイルス免疫療法は、近年、がん治療の有望な手段として研究者や臨床医の注目を集めています。腫瘍溶解性ウイルス免疫療法の領域では、ウイルスの自然な特性を利用して、がん細胞を選択的に標的化して破壊し、治療へのユニークで精度重視のアプローチを提供します。この治療パラダイムが科学的発見の領域から商業的実行可能性へと進むにつれて、商業市場のダイナミクスを形作る多くの機会と課題がもたらされます。
これまで、オンコリン(H101)、イムリジック(Talimogene laherparepvec)、およびテセルパトゥレフ(G47?の3つの腫瘍溶解性ウイルス免疫療法。Delytact)は、頭頸部がん、黒色腫、悪性神経膠腫などのさまざまな種類のがんの治療薬として、10年以上にわたって承認されています。しかし、Oncos 102、CAN-2409、Pelareorep、CG070、VG161などの一握りの高度な腫瘍溶解性ウイルス免疫療法が、規制当局、FDA、EMAからファストトラック、希少疾病用医薬品、PRIMEなどの指定を受けているため、今後数年間でさらに多くの承認が見込まれます。
臨床分野では、腫瘍溶解性ウイルスは革新的な研究と治療開発の最前線にあります。これらのウイルスは、生来の腫瘍溶解性のために慎重に設計または選択されており、がん細胞に浸潤し、その中で複製し、同時に免疫応答を刺激しながら破壊を誘導するように設計されています。さらに、腫瘍溶解性ウイルス免疫療法の領域が実験室や臨床試験の枠を超えているため、その商業分野への道のりは、世界のがん治療環境におけるその軌道を形作るのに役立つ製薬会社の関与によって特徴付けられます。
目次
1 Introduction to Oncolytic Virus Immunotherapy
1.1 Overview
1.2 Need of Oncolytic Virus Immunotherapy
2 Globally Approved Oncolytic Virus Immunotherapies
2.1 Commercially Approved Therapies
2.2 FDA and EMA Designations: Breakthrough Therapy, Fast Track, Orphan, PRIME
3 Global Oncolytic Virus Immunotherapies Clinical Trials Overview
3.1 By Phase
3.2 By Country
3.3 By Company
3.4 By Indication
3.5 By Priority Status
3.6 Patient Segment
4 Global Oncolytic Virus Immunotherapy Market Trend and Developments
4.1 Current Market Outline
4.2 Future Market Forecast
5 Global Oncolytic Virus Immunotherapy Market Trends By Region
5.1 South Korea
5.2 Japan
5.3 US
5.4 Europe
5.5 UK
5.6 China
5.7 Australia
6 Global Oncolytic Virus Immunotherapy Market Trends By Indications
6.1 Melanoma
6.2 Head and Neck Cancer
6.3 Glioma
6.4 Pancreatic Cancer
6.5 Ovarian Cancer
6.6 Lymphoma
6.7 Lung Cancer
6.8 Breast Cancer
6.9 Prostate Cancer
6.10 Hepatocellular carcinoma
7 Global Oncolytic Viruses Immunotherapies Clinical Trials By Company, Indication and Phase
7.1 Research
7.2 Preclinical
7.3 Phase-I
7.4 Phase-I/II
7.5 Phase-II
7.6 Phase-III
7.7 Registered
8 Marketed Oncolytic Viruses Immunotherapies Clinical Insight
9 Global Oncolytic Virus Immunotherapy - Availability, Dosage and Price Analysis
9.1 Imlygic
9.1.1 Overview and Patent Insights
9.1.2 Pricing and Dosage
9.2 Oncorine (H101)
9.2.1 Overview
9.2.2 Pricing and Dosage
9.3 Delytact
9.3.1 Overview
9.3.2 Pricing and Dosage
10 Platforms used for Developing Advanced Oncolytic Virus Immunotherapy
10.1 KaliVir VET Backbone Technology
10.2 Calidi’s Platform Technology
10.3 RenovoRx TAMP Platform
10.4 ValoTx PeptiCRAd
10.5 ValoTx PeptiVAX / PeptiENV / PeptiBAC
10.6 Transgene’s Invir.IO Platform
10.7 Transgene’s myvac Platform
10.8 Imugene’s CF33 Technology
10.9 EpicentRx AdAPT Platform
10.10 Genelux’s Choice Discovery Platform
11 Oncolytic Virus Immunotherapy Combinations with Other Therapeutic Agents
11.1 Oncolytic Virus Immunotherapy with Nano materials
11.2 Oncolytic Virus Immunotherapy with Chemotherapeutic Drugs
11.3 Oncolytic Virus Immunotherapy with Peptides
11.4 Oncolytic Virus Immunotherapy with Targeted Immunotherapies
12 Global Oncolytic Virus Immunotherapy Market Dynamics
12.1 Market Drivers
12.2 Market Challenges
13 Competitive Landscape
13.1 AdCure Bio
13.2 Beijing SyngenTech
13.3 BioVex Inc. (Amgen)
13.4 Calidi Biotherapeutics
13.5 Genelux Corporation
13.6 Immvira Pharma
13.7 Jennerex Biotherapeutics
13.8 KaliVir
13.9 Lokon Pharma
13.10 Oncolys BioPharma
13.11 PsiOxus Therapeutics (Akamis Bio)
13.12 Seneca Therapeutics
13.13 Shanghai Sunway Biotech
13.14 Takara Bio
13.15 TILT Biotherapeutics
13.16 Transgene
13.17 Virogin Biotechaa
List of Figures & Tables
Figure 1-1: Demonstration of Categorization of Oncolytic Viruses
Figure 1-2: Illustration of Major Events in Clinical Virotherapy
Figure 1-3: Comparison of Conventional Therapies v/s Oncolytic Virus Immunotherapy
Figure 1-4: Oncolytic Virus Immunotherapy - Advantages
Figure 3-1: Global - Oncolytic Virus Immunotherapies Clinical Trials By Phase (Numbers), 2024 -2030
Figure 3-2: Global - Oncolytic Virus Immunotherapies Clinical Trials By Country (Numbers), 2024 - 2030
Figure 3-3: Global - Oncolytic Virus Immunotherapies Clinical Trials By Company (Numbers), 2024 - 2030
Figure 3-4: Global - Oncolytic Virus Immunotherapies Clinical Trials By Indication (Numbers), 2024 - 2030
Figure 3-5: Global - Oncolytic Virus Immunotherapies Clinical Trials By Priority Status (Numbers), 2024 - 2030
Figure 3-6: Global - Oncolytic Virus Immunotherapies Clinical Trials By Patient Segment (Numbers), 2024 -2030
Figure 4-1: Global - Oncolytic Virus Immunotherapy Market Opportunity (US$ Million), 2023 -2030
Figure 4-2: Approved Oncolytic Virus Immunotherapy
Figure 4-3: Global Oncolytic Virus Immunotherapy Market - Key Players
Figure 4-4: Aspects Determining the Future of Oncolytic Virus Therapy Market
Figure 5-1: Barinthus Biotherapeutics - ChAdOx1-HBV and MVA-HBV Clinical Trials
Figure 5-2: GeneMedicine - Oncolytic Virus Pipeline
Figure 5-3: TBI-1401(HF10) Phase I Study - Initiation and Completion Year
Figure 5-4: Astellas Pharma - ASP1012
Figure 5-5: ASP1012 and Pembrolizumab Phase I Study - Initiation and Completion Year
Figure 5-6: CF33-hNIS-antiPDL Phase I Study - Initiation and Completion Year
Figure 5-7: Cretostimogene Grenadenorepvec Phase III Study - Initiation and Completion Year
Figure 5-8: Cretostimogene Grenadenorepvec FDA Designations to treat unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Figure 5-9: AdAPT-001 Phase I Study - Initiation and Completion Year
Figure 5-10: Pelareorep with INCMGA00012 Phase II Study - Initiation and Completion Year
Figure 5-11: Oncolytic Virus Immunotherapy Market Trend in the US
Figure 5-12: Aspects Influencing Oncolytic Virus Market in Europe
Figure 5-13: TILT-123 with Pembrolizumab Phase I Study - Initiation and Completion Year
Figure 5-14: BT-001 and Pembrolizumab Phase I Study - Initiation and Completion Year
Figure 5-15: Transgene - Oncolytic Virus Candidates
Figure 5-16: 21325-2-02 Phase IV Study - Initiation and Completion Year
Figure 5-17: OH2 - Combinations with Other Therapeutic Agents
Figure 5-18: VAXINIA - FDA Fast Track Designation
Figure 6-1: MQ710 and Pembrolizumab Phase I Study - Initiation and Completion Year
Figure 6-2: Combination of GALV-GP-R protein with PD1 antibody to Treat Melanoma
Figure 6-3: Replimune - Oncolytic Virus Candidates
Figure 6-4: Oncorine - Approved Oncolytic Virus Immunotherapy for Head and Neck Cancer
Figure 6-5: YSCH-01 Phase I Study - Initiation and Completion Year
Figure 6-6: Head and Neck Cancer - Clinical Pipeline of Oncolytic Viruses
Figure 6-7: Calidi Biotherapeutics - NSC.CRAd-S-pk7 for Glioblastoma
Figure 6-8: CRAd-S-pk7 Phase I Study - Initiation and Completion Year
Figure 6-9: CAN-3110 Phase I Study - Initiation and Completion Year
Figure 6-10: Pancreatic Cancer - Influencing Factors in Oncolytic Virus Immunotherapy Market
Figure 6-11: STI-1386 Phase I Study - Initiation and Completion Year
Figure 6-12: TBI-1401 (HF10) Phase I Study - Initiation and Completion Year
Figure 6-13: RenovoRx and Imugene - Collaboration
Figure 6-14: TILT-123 - Mode of Action
Figure 6-15: TILT-T563 Phase I Study - Initiation and Completion Year
Figure 6-16: Combinations of Oncolytic Virus with Other Therapies
Figure 6-17: Comparison of Olvi-Vec with Chemotherapy
Figure 6-18: RT-01 Phase I Study - Initiation and Completion Year
Figure 6-19: Advantages of Oncolytic Virus Immunotherapy to Treat Lymphoma
Figure 6-20: Lung Cancer - Commercial Market Landscape of Oncolytic Virus Immunotherapy
Figure 6-21: Pro2020000268 Phase II Study - Initiation and Completion Year
Figure 6-22: Combination of Radio Chemotherapeutic Drug with Oncolytic Virus
Figure 6-23: Prostate Cancer - Benefits of Oncology Virus Immunotherapy
Figure 6-24: HB-302/HB-301 Phase I/II Study - Initiation and Completion Year
Figure 6-25: CAN-2409 Phase III Study - Initiation and Completion Year
Figure 6-26: Reasons for Candel Therapeutics Decided to Reduce Staff
Figure 6-27: Pexavec - Mode of Action
Figure 6-28: OPTIONS-04 Phase III Study - Initiation and Completion Year
Figure 6-29: Replimune RP3 Oncolytic Virus Immunotherapy for Hepatocellular Carcinoma Treatment
Figure 9 -1: US - Cost of Supply of Imlygic 1 mpfu/mL and 100 mpfu/mL (US$), May’2024
Figure 9 -2: Imlygic - Dose for Initial Treatment Cycle and Subsequent Treatment Cycle (Million PFU/ml), September’2020
Figure 9 -3: Imlygic - Duration of Initial and Subsequent Treatment Cycle (weeks), September’2020
Figure 9 -4: Imlygic - Average Price of Initial Treatment Cycle and Each Subsequent Treatment Cycle (US$), September’2022
Figure 9 -5: Imlygic - Maximum Volume Administered by Size of Lesion (ml), September’2020
Figure 10-1: KaliVir Immunotherapeutics - VET Backbone Technology
Figure 10-2: Calidi Biotherapeutics Platform
Figure 10-3: ValoTx - PeptiCRAd
Figure 10-4: ValoTx - PeptiVAX / PeptiENV / PeptiBAC
Figure 10-5: Transgene - myvac
Figure 10-6: Genelux - Choice Discovery platform
Figure 11-1: Combination of Oncolytic Virus with Other Therapies
Figure 11-2: Combination of Oncolytic Virus Immunotherapy with Nano materials
Figure 11-3: Oncolytic Virus Immunotherapy and Nano materials - Mode of Action
Figure 11-4: Combination of Oncolytic Virus Immunotherapy with Peptides
Figure 12-1: Global Oncolytic Virus Immunotherapy - Market Drivers
Figure 12-2: Global Oncolytic Virus Immunotherapy - Market Challenges
Table 2-1: Approved Oncolytic Virus Immunotherapies
Table 5-1: US - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 5-2: Europe - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-1: Melanoma - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-2: Head and Neck Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-3: Glioma - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-4: Pancreatic Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-5: Ovarian Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-6: Lung Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-7: Breast Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 9-1: Imlygic - Recommended Dose and Schedule
