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IMMUNOTHERAPY The Future of Cancer Care Brad Loncar • Biotech commentator and investor for 8+ years. • Manager of a biotech-focused family office. • Franklin Templeton Investments and U.S. Department of the Treasury. • @BradLoncar - A widely followed voice on social media. • Blogger at LoncarBlog.com and previously Xconomy CANCER IMMUNOTHERAPY Cancer Immunotherapy Big Picture Immunotherapies can be a better way of treating cancer. • Chemotherapy can be toxic and affect the whole body. • The immune system is natural. It can learn and adapt. Immunotherapies are producing unprecedented results. • Immunotherapy has revolutionized the treatment of some cancers. • Cell-based therapies have awed in some early blood cancer trials. The first generation of immunotherapies are FDA approved and on the market now. • Immunotherapies from have been approved in over 6 unique cancers and are offered by large pharmaceutical companies. Second and third generation immunotherapies will likely drive this trend for many years to come. • Smaller biotech companies are driving this trend. INCREASINGLY IN THE NEWS Cancer Immunotherapy In the News In the news (continued) TYPES OF CANCER IMMUNOTHERAPY Immunotherapy Approaches Immunotherapy is NOT one thing. • • • • • • • Checkpoint Inhibitors Oncolytic Viruses ✔ Bi-specific Antibodies Cancer Vaccines ✔ CAR-T Natural Killer Cell T-cell Receptors ✔ ✔ • • • • DART STING Cytotoxic T-cells Tumor Infiltrating Lymphocytes • More… ✔ = FDA Approved CHECKPOINT INHIBITORS Checkpoint Inhibitors | Approved Today • Checkpoint inhibitors could be a foundational care for cancer and could have a huge impact on society. • They work by taking the brakes off the immune system. Checkpoints lower a stop sign that cancer cells usually present to immune cells. Bristol Myers - Opdivo Merck - Keytruda Checkpoint Inhibitors | Place in Cancer Care Foundational • Checkpoints are already approved in 6 unique cancers: Melanoma, Non-Small Cell Lung Cancer, Kidney, Bladder, Hodgkin Lymphoma, and Head and Neck Cancer. • In some cases these drugs are being used as on their own, and they will also be used as a base in combination with other drugs. The KEYTRUDA research program includes more than 300 clinical trials evaluating KEYTRUDA across more than 30 tumor types. To date, clinical activity has been shown in more than 20 tumor types. Checkpoint Inhibitors | A Famous Patient • Late stage melanoma that had traveled to the brain and liver. • Given Merck’s KEYTRUDA in September 2015 • Cancer was no longer showing up on scans in December 2015. Tolerability and quality of life can be just as important as efficacy. • President Carter is 91 years old. • You might not even offer chemotherapy to someone that age because it can be so debilitating. • He was able to continue daily life while on the immunotherapy. Checkpoint Inhibitors | Meaningful Results Melanoma • 40% of advanced melanoma patients taking Keytruda were alive after 3 years. That compares to about 10% to 20% of patients on standard chemotherapy treatments. Non-Small Cell Lung Cancer • 39% of recurrent NSCLC patients taking Opdivo were alive after 18 months compared to 23% for those treated with the standard chemotherapy Docetaxel. Kidney Cancer • Advanced kidney cancer patients treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with the standard of care Afinitor. CELLULAR THERAPIES CAR-T • Reprogram a patient’s own TCells to search for a marker that is over-expressed on cancer. JUNO • Think of this as attaching a GPS device to immune cells. • Has shows meaningful results in blood cancers. • Celgene signed a 10-year partnership with Juno and gave them $1 billion in up-front investment. KITE CLLS Meaningful Results - Juno Therapeutics JCAR017 - A phase 1 study of 22 children who had untreatable leukemia (ALL) - 20 (91%) had a complete remission of their cancer - The goal is to race to market in ALL & NHL, and learn to use CAR-T in more cancer types. CAR-T Therapy | Meaningful Results “In my years as an oncologist and as a research scientist, I have never seen a treatment that has that spectacular of a response rate in its initial testing in patients.” - Dr. Stanly Riddell, Fred Hutch Cancer Research Center BI-SPECIFIC ANTIBODIES Bi-Specific Antibodies • Bi-specifics are a competitor to CAR-T due to their relative ease of use. • One end of the drug attaches to a marker on the cancer cell, another attaches to a marker on the immune cell, and then an introduction is made. • Amgen’s Blincyto is FDA approved and on the market for acute lymphoblastic leukemia (ALL). AMGN XNCR MGNX CANCER VACCINES Cancer Vaccines • Cancer vaccines are used to prime the immune system to attack cancer. • Some use bioengineered bacteria to signal an immune system response. • Vaccines will one day be personalized to the makeup of each patient’s specific tumor. ADXS ADRO Private WHO IS INVESTING IN CANCER IMMUNOTHERAPY? Investing in immunotherapy | Government The Cancer Moonshot aims to leverage the unique promise of today’s new treatment approaches and make as much progress against cancer in 5 years as would normally take 10 years. Over $1 billion has been allocated to invest in this. Investing in immunotherapy | Philanthropy $125 Million $250 Million Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins – March 2016 Sean Parker Institute for Cancer Immunotherapy – April 2016 Investing in immunotherapy | Private Sector WHERE DOES IMMUNOTHERAPY FIT WITHIN BROADER BIOTECH? Biotech is Not One Thing!!! TECHNOLOGY • • • • • • • • • Cyber Security Semiconductors Telecom Equipment Software Social Media Devices and Smartphones Cloud Computing Storage and Data Networking Is the Nasdaq-100 still relevant? BIOTECHNOLOGY • It’s all the same thing Biotech is Not One Thing!!! TECHNOLOGY • • • • • • • • • Cyber Security Semiconductors Telecom Equipment Software Social Media Devices and Smartphones Cloud Computing Storage and Data Networking Is the Nasdaq-100 still relevant? BIOTECHNOLOGY • • • • • • • • • Cancer Immunotherapy Vaccines Antibiotics Autoimmune Diseases Price Gougers (Valeant) Diagnostics Diabetes Cardiovascular Diseases Central Nervous System Is the Nasdaq-biotech still relevant? Biotech is Not One Thing!!! • Not all areas of biotechnology represent high innovation just as not all areas of technology represent high innovation. • Cancer immunotherapy is a high innovation area within biotech. • Some areas of biotech like insulin/diabetes represent incremental improvements. Immunotherapy is not incremental to cancer. It is a breakthrough new approach. INNOVATION IS COMING AT THE RIGHT TIME The Bad News: A Growing Problem The global market for cancer drugs has been growing • The global market for cancer medicines has surpassed $100 Billion, and is estimated to be higher than $150 Billion by 2020. Source: IMS Institute 2015 Cancer Dynamics report HIGH STAKES FOR DEVELOPERS Immunotherapy is highly competitive Bristol 1st Line NSCLC Trial Failure – Aug 5 Immunotherapy is highly competitive FDA’S ROLE How Does FDA Fit Into This Picture? • FDA approved new drugs at 19-year high rate. • They have been fasttracking immunotherapy drug applications. • Announced in June a new Oncology Center of Excellence. Intended to accelerate cancer drug development. • Breakthrough therapy designation has helped. WHERE TO LEARN MORE Where to learn more Loncar Investments’ Charitable Partner • A nonprofit organization dedicated exclusively to harnessing the immune system’s power to conquer all cancers. • Founded in 1953. • Awards research grants and fellowships to support scientists at leading research universities and clinics around the world. • www.CancerResearch.org SUMMARY Summary Immunotherapies can be a better way of treating cancer. Immunotherapies are producing unprecedented results. The first generation of immunotherapies are FDA approved and on the market now. Second and third generation immunotherapies will likely drive this trend for many years to come. THANK YOU We hope this presentation has made you an optimist!