Welcome to the first of our Q&A series with Kelly Scientific, a trusted provider of cutting edge market information within the pharma, biotech and healthcare industries.
Kelly Sci have scientific and business expertise in a number of therapeutic and diagnostic areas including transdermal and targeted drug delivery, anti-infectives, respiratory and gastrointestinal disease, pharmacogenomics, prenatal and maternal diagnostics and regenerative medicine.
Dr Deirdre Kelly answers our questions this week and provides a comprehensive overview of the cancer immunotherapy market.
KEY MARKET TRENDS
Q. What are the key trends influencing the cancer immunotherapy market? Why are science journals hailing cancer immunotherapy as a significant breakthrough treatment?
Dr Kelly: Immunotherapy is forecast to become the oncology treatment of choice by 2026 with an estimated 60% of previously treated cancer patients likely to adopt immunotherapy in this timeframe. Multiple treatment lines, combination therapy and the opportunity for repeat treatment are likely to accelerate fast growth. Cancer immunotherapy also expands into multiple indications and our analysis indicates that key immunotherapies including anti-PD-1 drugs, dendritic cell vaccines, T-cell therapies and cancer vaccines are all driving the market.
The rising incidence and prevalence of numerous cancers globally is a significant accelerator of growth. This is due to more sensitive early detection techniques, higher patient awareness and a growing aging population. Furthermore, the FDA’s pro-science attitude will accelerate development and regulatory approval for these drugs. To that end, the cancer immunotherapy market is forecast to hit $80 billion by 2020. Overall strong growth rates are expected due to a significant unmet need and increasing trends of hematological cancers.
Q. What are the most valuable R&D projects in cancer immunotherapy in 2017? How will these developments guide the industry in the coming years and what can we expect to see?
Dr Kelly: Opdivo (nivolumab) from BMS is one of the most exciting agents in the immunotherapy space, and is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer. It was given a fast-track approval on December 22, 2014. Other interesting agents include MK-3475 (Merck), RG7446 (Roche), palbociclib (Pfizer) and DCVax-L (Northwest).
The majority of these agents are anti-programmed death-1 (PD-1) monoclonal antibodies, which will certainly guide the market over the coming years. Projects that currently are valuable include combined immunotherapies on our knowledge of CD137 and PD-1 mechanisms. A study on a novel effector activating monoclonal antibody known as IMAB362 for the treatment of solid cancers is also exciting. Other projects comparing CAR-T cell effectiveness against T-cells that target CD19 or mesothelin are interesting in a preclinical setting.
WHAT IS CAR T THERAPY?
Q. What are the main challenges associated with CAR T therapy? And when do you expect the first CAR T therapeutics to be approved?
Dr Kelly: CAR T (chimeric antigen receptor T) cells are engineered specificity using antibody fragments directed to the tumor cell, and also T-cell CD8/CD3 plasma membrane proteins that elicit specific activity towards the tumor cell, via intracellular signaling pathways. To date publications have revealed a number of effective intracellular molecules in the engineered T cell including CD28, 4-1BB (CD137) and CD3 zeta. These engineered T cells have numerous advantages including:
- Intracellular domain can be modified to increase efficacy and durability of CAR-T.
- CAR-T are still subject to the same regulatory and tolerigenic constraints of natural T cells, including checkpoints, Treg, MDSC.
- CAR-T can be engineered to express cytokines and chemokines that further enhance function and migration.
- Can be modified to express suicide genes that limit CAR-T population if toxicity occurs.
To date, the main challenges associated with CAR T therapy include manufacturing, regulations, pricing and toxicity in patients. Currently there are over 20 active CAR-T clinical trials active globally. To date a number of CAR T Cells (autologous/allogeneic) trials have begun and are demonstrating clinical benefit to patients, but others have demonstrated toxicity such as cytokine release syndrome.
In July 2017, an FDA advisory panel determined that the benefits of CAR T outperform the risks. Tisagenlecleucel (CTL-019) by Novartis is indicated to treat children and young adults with acute leukaemia and performed well in the ELIANA trial. The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended this agent for approval, and a Biologics License Application (BLA) is currently under FDA priority review. Therefore if approved, CTL019 (tisagenlecleucel) would become the first CAR-T cell therapy on the US market.
About the Interviewee:
Kelly Scientific was founded by Deirdre Kelly Ph.D. whose career spans both industry and academia where she has worked with both start-up biotech and multinational pharmaceutical companies. Dr Kelly holds a PhD (Medicine, Immunology) from the Royal College of Surgeons in Ireland, a MSc Biotechnology from the National University of Ireland, Galway, and a B.A.(Mod) Biochemistry from Trinity College, Dublin.
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