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This report focuses on the rising potential for the newest and most promising of cancer treatments: cancer immunotherapy. Cancer immunotherapy was once just a dream in the minds of physicians, clinicians and patients, but only recently (2010s era) has it actually been within reasonable reach. Cancer Immunotherapy: immune checkpoint inhibitors, cancer vaccines, and adoptive T-cell therapies covers three principle therapies that have been in the works for cancer patients.

One principle therapy that has been on the rise is checkpoint inhibitors. Checkpoint inhibitors are a class of monoclonal antibodies that inhibit pathways responsible for blocking the response of T-cells to antigens. Not only have results from clinical trials of these therapeutics been promising, but treatments have already been approved both in the U.S. and Europe for metastatic melanoma. There are several agents and targets covered in this section, including the September 5, 2014 approval of Merck's PD-1 inhibitor: pembrolizumab (Keytruda), as well as the future outlook of potential combination checkpoint inhibitor therapies.

Another principle therapy under investigation are anticancer vaccines. This is another major strategy surfacing in cancer therapeutics and, unlike traditional vaccines which are given to prevent illness (i.e. smallpox, measles, and pertussis), these vaccines are given to patients who already have cancer and are designed to elicit an antitumor response to even the most aggressive of cancers. Though this is a theoretically good approach to combat cancer, there have been an unfortunate number of clinical failures and the industry has gained only one U.S. approved anticancer vaccine. Combination therapies are also a possible route these vaccines will take in the future.

Finally, the last therapy addressed in this report is adoptive cellular immunotherapy. Adoptive cellular immunotherapy is when syngeneic activated T-cells are infused in patients to attack their cancers. There are a few types of cellular immunotherapies including: tumor infiltrating lymphocyte (TIL) therapy, genetically engineered T cells bearing chimeric antigen receptors (CARs), and recombinant TCR technology. Improving these therapies is the goal over the next few years and researchers have been working heavily to commercialize these products and technologies.

The report is further coupled with an in-depth introduction and history as well as with data for market outlook. Also featured in this report are exclusive interviews with three high-end professors, researchers and CEOs:

- Adil Daud, MD, Clinical Professor, Department of Medicine (Hematology/Oncology), University of California at San Francisco (UCSF); Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center.
- Matthew Lehman, Chief Executive Officer, Prima BioMed (a therapeutic cancer vaccine company with headquarters in Sydney, Australia).
- Marcela Maus, MD, PhD, the Director of Translational Medicine and Early Clinical Development, Translational Research Program, Abramson Cancer Center, University of Pennsylvania in Philadelphia.

Furthermore, Insight Pharma Reports also conducted and analyzed survey data representing a population sample from the R&D industry. This survey depicts market outlook, and portrays industry opinions and perspectives.

Table Of Contents

Cancer Immunotherapy: immune checkpoint inhibitors, cancer vaccines, and adoptive T-cell therapies
Executive Summary
Checkpoint inhibitors
Therapeutic anticancer vaccines
Adoptive immunotherapy for cancer
TIL therapy
Adoptive immunotherapy with genetically engineered T cells bearing chimeric antigen receptors (CARs)
Recombinant TCR technology
The future of adoptive immunotherapy for cancer
Outlook for cancer immunotherapy
CHAPTER 1: Introduction
The early history of cancer immunotherapy
Cytokines as immunomodulatory drugs
Interleukin-2
Alpha-interferons
Interleukin-12
Interleukin-12 as a bridge between innate and adaptive immunity
Investigation of interleukin-12 as an anticancer therapeutic
CHAPTER 2: Checkpoint Inhibitors
What are immune checkpoints?
CTLA-4 blocking agents
Ipilimumab
Tremelimumab
PD-1 blocking agents
Nivolumab
Nivolumab in NSCLC
Combination therapy of nivolumab plus ipilimumab in melanoma
Pembrolizumab (Merck's Keytruda)
PD-L1 expression as a biomarker for response to pembrolizumab in melanoma and in NSCLC
Merck's strategy for development and approval of pembrolizumab
Other anti-PD-1 agents
PD-L1 blocking agents
Roche/Genentech's MPDL3280A
MPDL3280A in NSCLC
MPDL3280A in urothelial bladder cancer
MedImmune/AstraZeneca's MEDI4736
Medarex/BMS's MDX-1105
Are there other clinical-stage checkpoint inhibitors on the horizon?
Discussion of the Adil Daud interview
Conclusions
Interview with Adil Daud, MD
CHAPTER 3: Therapeutic anticancer vaccines
Introduction
Cancer vaccines—a field rife with clinical failures
Why has the cancer vaccine field been so prone to clinical failure?
Marketed and selected late-stage cancer vaccines in development
Dendreon's sipuleucel-T (APC8015, Provenge)
Talimogene laherparepvec (Amgen's T-Vec)
Celldex' rindopepimut (CDX-110)
Tecemotide (Oncothyreon/Merck Serono)
PROSTVAC-VF (Bavarian Nordic)
AGS-003 (Argos Therapeutics)
CVac (Prima BioMed)
Cancer vaccine failure the result of poor clinical trial design?
Conclusions
Interview with Matthew Lehman
CHAPTER 4: Adoptive Immunotherapy for Cancer
Introduction
Adoptive immunotherapy with tumor infiltrating lymphocytes (TILs)
A specific immunodominant mutation in a melanoma patient who had a durable complete remission due to TIL therapy
Adoptive immunotherapy based on mutation-specific CD4+ T cells in an epithelial cancer
Commercializing TIL therapy
Adoptive immunotherapy with genetically engineered T cells bearing chimeric antigen receptors (CARs)
University of Pennsylvania/Novartis' CD19-targeting CAR T-cell therapy CTL019 (formerly CART19)
Pilot studies of CTL019
Later studies of CTL019
Commercialization of CTL019 therapy
The Marcela Maus interview and CTL019
Juno Therapeutics' 19-28z CD19-targeting CAR T-cell therapy
Serum cytokine levels and safety of 19-28z CAR T-cell immunotherapy
Efficacy of 19-28z CAR T-cell therapy in patients with CD19+ malignancies
Can CAR T-cell therapy be applied to treatment of solid tumors?
CAR T-cell therapy targeting mesothelin on malignant pleural mesothelioma and pancreatic cancer
CAR T-cell therapy targeting GD2 on neuroblastoma
Other companies developing CAR-based immunotherapies
Recombinant TCR technology
Adaptimmune
Autologous recombinant TCR therapies under investigation in Dr. Steven Rosenberg's group at the NCI
Market issues
Interview with Marcela Maus, MD, PhD
CHAPTER 5: Summary and Conclusions
Checkpoint inhibitors
Therapeutic anticancer vaccines
Adoptive immunotherapy for cancer
TIL therapy
Adoptive immunotherapy with genetically engineered T cells bearing chimeric antigen receptors (CARs)
Recombinant TCR technology
The future of adoptive immunotherapy for cancer
Insight Pharma Reports survey on cancer immunotherapy
Outlook for cancer immunotherapy

References

About Cambridge Healthtech Institute

TABLES

Table 1.1: Cytokines in cancer immunotherapy
Table 2.1: Select checkpoint inhibitors—approved and in development
Table 3.1: Types of cancer vaccines that have been developed by academia and industry
Table 3.2: Select cancer vaccines—approved and in development
Table 4.1: Select adoptive T-cell therapies in commercial development
Table 5.1: What Best Describes Your Organization?
Table 5.2: Do You Work in Any Aspect of Discovery and Development of Cancer Immunotherapies?
Table 5.3: What types of agents do you work on?*
Table 5.4: What aspect(s) of the drug development process do you work in?*
Table 5.5: What is your role in developing and/or using cancer immunotherapy agents?*
Table 5.6: Efficacy of PD-1 inhibitors vs. CTLA-4-targeting drugs in future clinical studies
Table 5.7: Do you believe, as predicted in a recent FierceBiotech article, that the PD-1 inhibitor class may reach $12.5 billion in peak sales?
Table 5.8: Do you believe that anti-PD-L1 agents will prove to be superior to both anti- CTLA-4 and anti-PD-1 agents, in terms of efficacy and safety?
Table 5.9: Do you believe that researchers will be able to find means to overcome the severe adverse effects seen in some patients treated with checkpoint inhibitors?
Table 5.10: Do you believe that researchers will be able to develop biomarkers that will enable clinicians to identify which cancer patients will benefit from treatment with checkpoint inhibitors?
Table 5.11: Do you believe that the intense competition in the checkpoint inhibitor field will result in lowering the costs to patients and payers of these expensive therapies?
Table 5.12: Do you believe that the expected high cost of combination therapies for cancer will limit their use?
Table 5.13: Impact of regulatory agencies
Table 5.14: CAR to adoptive immunotherapy
Table 5.15: Do you believe that these groups (mentioned in previous question) can make adoptive immunotherapy reimbursable and commercially viable?
Table 5.16: Future of commercializable adoptive immunotherapies
Table 5.17: Do you believe that researchers will be able to find means to overcome the severe adverse effects seen in some patients treated with adoptive immunotherapy?
Table 5.18: Do you believe that companies such as Novartis and Juno will be able to successfully manufacture T cells for use in personalized adoptive immunotherapies?

FIGURES

Figure 2.1: T Cell Costimulation by CD28 and Checkpoint Control by CTLA-4
Figure 3.1: Structure of EGFRvIII, as Compared to Wild-type EGFR
Figure 4.1: Structures of Chimeric Antigen Receptors (CARs)
Figure 5.1: Growth of Immunotherapies
Figure 5.2: Impact of immunotherapy Inhibitors on NSCLC
Figure 5.3: The Future of Immunotherapy
Figure 5.4: Anti-cancer Vaccines as Anti-cancer Therapies
Figure 5.5: T-cell Based Adoptive Immunotherapy
Figure 5.6: Availability of CAR-based Adoptive Immunotherapies

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