PharmaFocus: HIV - R&D Strategies towards Cure and Prevention

Summary

It has been 30 years since the discovery that HIV is the causative agent of AIDS, and yet no preventative vaccine or cure that allows independence from lifelong antiretroviral treatment exists. Despite some recent setbacks, such as the discontinuation of the HVTN 505 clinical trial due to a trend of increased infection, there have been several promising advances in the cure and prevention of HIV infections. The RV144, a Phase III trial held in Thailand, reduced the risk of infection by 31.2% and energized the preventative vaccine field providing insight on how to better approach immunogen design. Other advances include therapeutic vaccines that induce immune responses that could clear infected cells, and histone deacetylase inhibitors to reverse latency and eliminate the viral reservoir. As it becomes more clear that combinations of different approaches can produce better results, in terms of viral clearance, companies begin to collaborate and initiate trials testing kick-and-kill approaches.

Highlights

Key Questions Answered

- What are the main unmet needs that remain despite current antiretroviral treatments?
- What opportunities arise from these unmet needs?
- What are the new technologies that are positioned to address these unmet needs?
- What are the environmental factors that will affect the uptake of these new technologies?
- What challenges will the current players working on these new technologies face in the clinical trial setting and how can they overcome them?

Key Findings

- Novel therapeutic interventions could steal market share from ART but cannot replace it, as many of these regimens will have to work in combination with ART.
- Despite the initial promising results, pre-exposure prophylaxis will not be an effective means to curb the HIV epidemic. These efforts highlight the need of a prophylactic vaccine.
- New vaccines should utilize the heterologous prime-boost approach, i.e., the use of sequential vaccinations each time delivering the same epitope using different technologies.
- New approaches towards prevention and cure of HIV infection, have yield moderate results. It is becoming clear that combination regimens-sometimes involving ART- will likely increase efficacy.

Scope

- Overview of the latest advances in curative and preventative technologies.

- Analysis of the interplay between current therapeutic approaches and future curative ones.

- Key topics covered include unmet needs, opportunities, and drivers and barriers specific to preventative and therapeutic vaccines, latency reversal agents and gene therapies.

Reasons to buy

- Understand the potential treatment paradigm shift and the challenges it might pose on the antiretrovirals market.

- Identify promising companies for collaborations to develop regimens for HIV functional cure.

- Develop business strategies by understanding the trends shaping and driving the future of HIV treatment and prevention.

- Understand the challenges associated with the development of novel therapies.

Table Of Contents

Table of Contents

1 Table of Contents 8
1.1 List of Tables 11
1.2 List of Figures 12
2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14
3 Drivers and Barriers for Non-ART Interventions 15
3.1 Overview 15
3.2 Drivers 16
3.2.1 Driver: Approval of Gilead’s Truvada for PrEP 16
3.2.2 Driver: High Cost and Side Effects of Antiretroviral Therapy 17
3.2.3 Driver: Immunological Non-Responders 18
3.2.4 Driver: Aging Of HIV Patients with Related Comorbidities 18
3.3 Barriers 19
3.3.1 Barrier: Big Pharma Deprioritizes HIV Vaccine Development 19
3.3.2 Barrier: Challenging Uptake of Latency Reversal Agents for Fear of Carcinogenesis 20
3.3.3 Barrier: Difficulty in Recruiting Trial Participants 20
3.3.4 Barrier: High Cost and Risk of Gene Therapy Approaches 21
3.3.5 Barrier: Continuously Improving ART 22
4 Current Treatment Paradigm 23
4.1 Overview 23
4.2 Current Treatment Paradigm 23
4.3 Current Prevention Strategies 25
4.4 Summary and Outlook 27
5 Needs Assessment and Opportunity Analysis 29
5.1 Overview 29
5.2 Unmet Needs 29
5.2.1 Unmet Need: Prophylaxis against HIV 29
5.2.2 Unmet Need: Cure for HIV 30
5.2.3 Unmet Need: Drug Delivery Mechanisms that Reach Viral Reservoirs 31
5.2.4 Unmet Need: New Therapeutic Approaches for Patients Unresponsive to ART 32
5.2.5 Unmet Need: Increased Funding towards Research 33
5.3 Opportunities 34
5.3.1 Opportunity: Novel Approaches to Invigorate the HIV Treatment Algorithm 34
5.3.2 Opportunity: New Generation Combination Therapies to Foster Collaboration 35
5.3.3 Opportunity: Development of Cheap and Direct Diagnostic Tests 36
6 Novel RandD Strategies 37
6.1 Overview 37
6.2 Vaccines 39
6.2.1 Overview 39
6.2.2 Clinical Positioning 43
6.2.3 Categories of Vaccine Technologies 45
6.2.4 Promising Vaccine Regimens 52
6.3 Latency Reversal Agents 64
6.3.1 Overview 64
6.3.2 Clinical Positioning 68
6.3.3 Latency Reversal Agents in Development 69
6.4 Other Approaches 72
6.4.1 Cytokines 72
6.4.2 Genetic Modification of Stem Cells and Autologous Transplantation 75
6.5 Combination Therapies 78
7 Clinical Trial Design 81
7.1 Overview 81
7.2 Clinical Trials by Phase and Therapeutic Approach 82
7.3 Clinical Trial Challenges 86
7.3.1 Preventative Vaccines 86
7.3.2 Therapeutic Vaccines 89
7.3.3 Latency Reversal Agents 91
7.3.4 Gene Therapies 93
8 Appendix 94
8.1 Bibliography 94
8.2 Abbreviations 105
8.3 Methodology 107
8.4 Physicians and Specialists Included in this Study 107
8.4.1 Dr. Thomas Hanke, PhD 107
8.4.2 Dr. Jan van Lunzen, MD 107
8.4.3 Dr. David Margolis, MD 107
8.4.4 Dr. Giuseppe Pantaleo, MD 107
8.5 About the Authors 108
8.5.1 Analyst 108
8.5.2 Director of Infectious Disease and Cardiovascular and Metabolic Disease 108
8.5.3 Global Head of Healthcare 109
8.6 About GlobalData 110
8.7 Disclaimer 110



List of Tables

Table 1: Drivers and Barriers for Non-ART Interventions, 2013 15
Table 2: Most Commonly Used Drugs for the Treatment of HIV 24
Table 3: ART-Related Side Effects and Comorbidities 24
Table 4: Overall Unmet Needs - Current Level of Attainment 29
Table 5: HIV Novel RandD Strategies in Early-Stage Development, 2013 37
Table 6: Comparison of Novel Therapeutic Classes in Early Development for HIV, 2013 39
Table 7: Composition of the ALVAC/AIDSVAX Regimen 52
Table 8: Safety and Efficacy Features of ALVAC-HIV+VAXB/E 53
Table 9: Product Profile - ALVAC-HIV+VAXB/E 54
Table 10: ALVAC-HIV+VAXB/E Advantages and Disadvantages 2013 54
Table 11: Product Profile - GeoVax Vaccine 56
Table 12: GeoVax Vaccine Advantages and Disadvantages, 2013 56
Table 13: Product Profile - AGS-004 58
Table 14: AGS-004 Advantages and Disadvantages 2013 58
Table 15: Antigens Encoded by pLWXu1 60
Table 16: Product Profile - DermaVir Patch 61
Table 17: DermaVir Patch Advantages and Disadvantages, 2013 61
Table 18: Product Profile - Vacc-4x 63
Table 19: Vacc-4x Advantages and Disadvantages, 2013 64
Table 20: Latency Reversal Agents under Study 65
Table 21: Product Profile - Zolinza 71
Table 22: Zolinza Advantages and Disadvantages, 2013 71
Table 23: Challenges and Suggested Solutions for Novel RandD Strategies, 2013 86



List of Figures

Figure 1: Timeline of Transition from Treatment to Cure in HIV Treatment and Prevention 28
Figure 2: Mapping of Novel Interventions for HIV Cure and Prevention 38
Figure 3: Schematic of Complete and Lasting Protection Against HIV Infection 42
Figure 4: New Combinatorial Approaches for HIV Eradication 78
Figure 5: Number of Ongoing Phase I and Phase II Trials, 2013 83
Figure 6: Number of Terminated, Suspended and Withdrawn Phase I and Phase II Trials, 2013 85
Figure 7: Schematic Representation of Parallel Clinical Trial Design 88

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