In 2013, Science magazine named cancer immunotherapy as the biggest breakthrough of the year. With this breakthrough, global pharmaceutical companies, as well as emerging startups, are researching and developing new cancer immunotherapy treatments.
Opposed to traditional cancer treatments targeting tumors, cancer immunotherapy targets and induces a cancer patients’ immune system to fight off cancer cells. Also known as biological therapy or biotherapy, immunotherapy either (a) triggers patients’ immune system to attack cancer cells or (b) supplies patients with immune system components such as man-made immune system proteins.
Below is a brief overview of the rise of cancer immunotherapy, increased spending on cancer drug treatments, the traditional dominance of big players, the innovations of immunotherapy startups, and the future of the industry. To stay up-to-date on cancer immunotherapy news and funding updates, follow the DataFox Cancer Immunotherapy List, which includes the following companies:
History of Cancer Immunotherapy
Cancer immunotherapy began in late 1980s when researchers discovered new protein receptors on the surface of T cells known as cytotoxic T-lymphocyte antigen 4 (CTLA-4). Based on this discovery, James Allison, currently at University of Texas MD Anderson Cancer Center in Houston, showed that blocking CTLA-4 allows the immune system to destroy cancer cells.
Although Mr. Allison had discovered cancer immunotherapy in the early 1990s, pharmaceutical companies initially were slow in testing cancer immunotherapy treatments. But encouraging results in recent years from cancer immunotherapy clinical trials have sparked genuine interests from major pharmaceutical companies.
Cancer Drug Spending Increasing In Past Decade
According to GLOBOCAN, there were 14.1 million new cancer cases, 8.2 million cancer deaths and 32.6 million people living with cancer (within 5 years of diagnosis) in 2012 worldwide. And in 2014 in the United States, there were an estimated 1,665,540 new cancer cases diagnosed and 585,720 cancer deaths. The rapidly growing number of cancer patients is driving increased spending on finding cancer treatments and cures.
According to data provide IMS Health, spending on oncology drugs was $91 billion in 2013, tripling from the spending in 2003. Worldwide expenditure on cancer drugs (including supportive care expenditure) is growing 5.4 per cent annually since 2009. And according to analysts at Citigroup, cancer immunotherapy drugs will generate sales of up to $ 35 billion per year over the next 10 years. These drugs are predicted to treat 60 per cent of all cancers.
Cancer immunotherapy drugs have the potential to be blockbuster drugs, which is inducing large pharmaceuticals like Bristol-Myers Squibbs to acquire early-stage companies developing cancer immunotherapy treatments.
In 2009, Bristol-Myers Squibbs (BMS) acquired Medarex, a company that was developing immunotherapy drug for skin cancer. Now, the drug, ipilimumab, is sold in the market under the trade name YERVOY®. Since its launch in 2011, YERVOY® has brought in $ 706 million in the first year and is continuing to gain sales for BMS. Buoyed by the success of YERVOY®, BMS is developing other immune-oncology drugs known as nivolumab and BMS-936559. Other companies such as MERCK, AstraZeneca and Roche also have immunotherapy drugs in their research pipeline.
Bristol-Myers Squibb has continued to seek investments in early-stage immunotherapy startups. In February 2015, Bristol-Myers paid $800 million to gain control of Flexus Biosciences' IDO1 immunotherapy treatment, with another $450 million set aside for milestones. Flexus' IDO therapy could be a "key ingredient to future cancer combination drugs." Along with acquiring Flexus' IDO therapy, Bristol-Myers has made multiple key acquisitions in the last year:
Juno Therapeutics' Rapid Rise
Currently, many other biotechnology companies are engaging in cancer immunotherapy. Juno Therapeutics, a Seattle-based company that went public in December 2014, is developing two different technologies to recognize cancer cells and activate T cells – Chimeric Antigen Receptors (CARs) and T cells Receptors (TCRs).
The company has shown that their drug candidates, JCAR017, JCAR015, and JCAR014 produced promising clinical responses in acute lymphoblastic leukemia and non-Hodgkin’s lymphoma. In January 2015, Juno Therapeutics announced that it will have 10 therapeutic candidates for 6 different diseases.
The success of Juno Therapeutics cancer immunotherapy treatments, combined with other drug successes, allowed Juno to raise $310 million between December 2013 and August 2014, followed by an initial public offering in December 2014 with a market valuation of $2.7 billion:
Emerging Players In Cancer Immunotherapy
Along with Juno Therapeutics, other companies are developing (or partnering with larger pharmaceutical companies to develop) immunotherapy treatments. Five Prime Therapeutics has several drug candidates in the clinical stage and is collaborating with Bristol-Myers Squibb on testing combination of immunotherapy drugs.
Ruga Corp is also a biotech startup which had obtained a license for a protein therapy developed by Stanford University. This therapy uses engineered decoy receptors to inhibit metastasis and disease progression. Having seen some treatment success in mice, the company’s scientists are hoping to treat breast-cancer and ovarian-cancer patients.
Meanwhile, a bio-pharmaceutical company, Omnis Pharma has developed a Vesicular Stomatitis Virus method to selectively attack cancer cells without disrupting the normal tissues. This technology is unique as it is a dual cancer-destroying mechanism: When the virus is delivered into the body, the virus would first replicate and destroy cancer cells. Later, the virus stimulates the immune system to eliminate residual tumor cells.
Another startup developing treatments attacking tumor cells is UNUM Therapeutics. UNUM raised a Series A round of financing in October 2014 to advance its antibody-coupled T-cell receptor (ACTR) therapeutics. ACTR enables genetically programmed T-cells to launch an antibody-directed attack on tumor cells.
Immunophotonics, based in Columbia, Missouri, is a new company designing an in situ autologous cancer vaccine (inCVAX). This treatment is also a dual process: A laser treatment is given first before injecting their experimental drug. Immunophotonics’ treatment has had success in the pre-clinical stage, which was conducted in South America.
Alpine Immune Sciences received $1.3 million of seed funding in January 2015 to launch a next-generation immunotherapy startup developing a recombinant protein-based therapeutic. Alpine will be led by former Dendreon CEO Mitchell Gold, along with two former Amgen scientists, Michael Kornacker and Ryan Swanson. Dendreon filed for bankruptcy in November 2014 after its flagship prostate cancer drug, Provenge, was too costly at $93,000.
U.S. Food and Drug Administration policy
In 2012, U.S. Food and Drug Administration (FDA) established an accelerated program for drugs that attempt to treat serious life-threating conditions while showing promising preliminary clinical evidence. This program grants novel drugs a Breakthrough Therapy designation. For such Breakthrough Therapy treatments, the FDA will speed up the approval process by guiding data collection, helping with clinical trial design, and coordinating the review of development program.
Genentech, which was acquired by the Roche Group in 2009, received Breakthrough Therapy Designation in February 2015 for its cancer immunotherapy treatment for non-small cell lung cancer. The Breakthrough designation was based on early test results of MPDL3280A.
This scheme definitely benefits the immunotherapy field players. In fact, 12 out of 37 drugs given this status in 2013 were oncology products.
Future of cancer immunotherapy
Promising results in clinical trials, coupled with faster timeline for pushing drugs into the market, pharmaceutical companies see cancer immunotherapy as a gold mine. Many big players will definitely be scrutinizing startups and seizing their onco-immunology drug development. Whether the drugs will be the ultimate cancer drugs remains to be seen. However, the prospect of finding cures is still a lot to cheer for by patients.