Juno Therapeutics Inc., a Seattle, WA-based clinical stage company that develops cancer immunotherapy products, has been founded with a $120m Series A funding. Initial backers include ARCH Venture Partners and the Alaska Permanent Fund, through a partnership managed by Crestline Investors.
Launched by the Fred Hutchinson Cancer Research Center (Fred Hutch) and Memorial Sloan-Kettering Cancer Center (MSKCC), along with pediatric partner Seattle Children’s Research Institute, and led by Co-founder and Chief Executive Officer Hans Bishop, a longtime biotech industry veteran, Juno Therapeutics is developing technology to reprogram immune cell called T lymphocytes (T cells) to recognize cancer cells for a precision immunologic attack. In addition to its recent Receptos acquisition, Celgene Corporation (CELG) has strengthened its drug pipeline through collaborations with companies like AstraZeneca (AZN) and Juno Therapeutics (JUNO). The above graph shows that Celgene has also collaborated with MedImmune, a subsidiary of AstraZeneca, and Juno Therapeutics to develop novel drugs in the immuno-oncology market. In June 2015, Celgene entered into a ten-year collaboration with Juno Therapeutics to develop drugs for the treatment of patients with cancer and autoimmune diseases. Unlike Celgene’s oncology or cancer products, which are mainly chemotherapy drugs, Juno focuses on developing cellular immunotherapies to cure cancer.
According to the collaboration agreement, Celgene can choose to be the North American commercialization partner for Juno’s CAR-based drugs, CD19 and CD22.
In April 2015, Celgene entered into a collaboration agreement with MedImmune for developing a cancer drug called MEDI4736, which is based on a novel technology targeting blood-related cancers. The promising biotech field of CAR-T cell therapy got dealt a blow this week when the FDA put a stop to a clinical trial applying the treatment to leukemia patients. Juno Therapeutics, the Seattle-based company behind the clinical trial, says that the deaths were each the result of cerebral edema, a serious condition in which excess fluid accumulates inside the brain. The trial of the JCAR015 treatment was in phase two, or mid-stage, which involves testing the therapy's effectiveness.
JCAR015 is a form of cancer immunotherapy using gene-modified T lymphocytes, or T cells, which are key players in the immune system. The JCAR015 therapy involves extracting T cells from the patient's body and genetically modifying them to express chimeric antigen receptors (CARs) that can detect cancer-specific antigens. The phase 1 trial of JCAR015 showed great promise, with Juno reporting in December 2014 that 24 of 27 adult patients receiving the treatment had gone into remission, including six who remained cancer-free for more than a year. Juno Therapeutics itself had raised $264.6 million when the company went public in 2014, the biggest biotech initial public offering of that year. The Food and Drug Administration has temporarily stopped a study from continuing after death of three subjects who died during trial. The study is based on CAR-T therapy, which involves taking blood from a patient to extract immune cells, and then cells are altered by employing genetically engineering to turn them into something that could kill cancer cells.
Early studies have shown some striking results in treating certain types of leukemia and lymphoma. Juno, which has been developing a treatment that uses genetically engineered cells to go after a form of adult leukemia, said Thursday that the phase 2 trial had been put on clinical hold by the FDA.
The two deaths happened after Juno added fluradibine, a chemotherapy, to the treatment patients received before going through the gene-engineering process.
Cancer immunotherapy, buoyed by promising clinical data and a resurgence in research investment, is riding an optimistic wave and has many in the field redefining their expectations of success for new treatments from incremental advances in patient response to complete regression of tumors. Experts from academia, established biotech players and youthful startups came together this week at Fred Hutchinson Cancer Research Center to speak about the latest developments and the challenges ahead at a€?Whata€™s Hot in Cancer Immunotherapy,a€? an Xconomy Forum. The recent explosion in the field was underscored by the foruma€™s closing session, a Q&A with two members of the leadership team at Juno Therapeutics, the Seattle-based startup that announced Thursday it had closed its Series A round of venture funding with a jaw-dropping $176 million. One reason for the crescendoing buzz around cancer immunotherapy is that, unlike bone marrow transplantation, these treatments have the potential to tackle a wide variety of tumor types. The immune system is a powerful deterrent against cancer growth a€” at least until tumors adopt strategies to escape detection or keep immune attack in check. Speakers at the event shared highlights of some of the products now in development, including small-molecule drugs, antibody- and cell-based therapies, and engineered nanoparticles. Emcee Luke Timmerman, who has been covering biotech news for years, said he began to notice the momentum building around cancer immunotherapy nearly a decade ago.

As impressive as responses to many of these experimental therapies can be, however, there are still many questions to address and barriers to overcome. Researchers are still in early stages of understanding how best to deploy these treatments, including in combination with conventional therapies as well as other immune-based approaches.
As researchers delve into such questions, they are also learning some surprising but encouraging lessons.
In a lively closing chat moderated by Timmerman, Juno Therapeuticsa€™ Hans Bishop and Robert Nelsen discussed small molecules, dramatic results, cell therapies, and the long-view approach theya€™re taking to building a biotech company and developing effective cancer immunotherapies. As Nelsen explained, Juno is a€?putting on the afterburnersa€? to move many different projects forward in parallel in the coming year.
The future of immunotherapy will be dramatic, explained Mitch Gold, previously the CEO at Dendreon, now executive chairman of Alpine Biosciences. Following opening remarks by Jim Edwards and Luke Timmerman, representing Xconomy, and Fred Hutcha€™s Dr. Deborah Law, vice president of biologics discovery at Merck, described her companya€™s antibody that targets an inhibitory molecule known as PD-1. Ira Mellman, vice president of cancer immunology at Genentech, presented data on an antibody that instead targets PD-1a€™s binding partner PD-L1. Teresa Foy, chief science officer at recent Seattle start-up Oncofactor, presented progress on an antibody they are developing to target another molecule involved in regulating the immune system, dubbed ONCO1.
Rob Hershberg, CEO of VentiRx, described VTX-2337, which stimulates immune cells to go after tumors.
Martin Oft, vice president of clinical and regulatory affairs at ARMO BioSciences, presented PEG-IL-10, a specially engineered cytokine that persists in the body and helps shepherd the immune system toward an optimal anti-cancer attack. Stanley Riddell, Fred Hutch researcher and Juno Therapeutics co-founder, described his teama€™s work on CAR T cells, killer immune cells engineered to seek out and attack cancer.
Mitch Gold, executive chairman of Alpine BioSciences, presented a new tactic: a synthetic a€?protocella€? designed to carry large molecule therapies to tumor cells.
Chad Robins, CEO of Adaptive Biotechnologies, discussed how QuanTILfy a€” a method that leverages research by Fred Hutch scientists Drs. Other Celgene collaborations involve companies such as Agios Pharmaceuticals (AGIO), Epizyme (EPZM), Bluebird Bio (BLUE), Forma Therapeutics (FORTHEP), Lycera Corporation (LYCERAP), and MorphoSys AG. Additionally, Celgene is exploring several major compounds, some of which they are developing in collaboration with companies like Acceleron Pharma (XLRN) and OncoMed Pharmaceuticals (OMED).
This agreement involves a payment of $1 billion to Juno Therapeutics in exchange for the company’s 9.1 million shares. These therapies genetically transform the patient’s T cells, a type of white blood cell active in the body’s immune functions, enabling them to identify and kill the cancer cells. Additionally, both companies can together develop and commercialize some of Celgene’s TCR-based drugs.
The deal involved an upfront payment of $450 million to MedImmune, and the collaboration is expected to strengthen Celgene’s cancer portfolio even further. The company suspects that the addition of a chemotherapy drug, fludarabine, is responsible for the fatal side effect. Juno is asking the FDA to allow a continuation of the JCAR015 trial without fludarabine, but for now the agency is holding off on giving them the go-ahead, asking the company to present a revised trial protocol and submit other required materials. These bio-engineered CAR-T cells are then introduced to the body, where their task is to find and kill cancerous cells. But the current setback has caused the company's stock to drop, with the share price falling by 27 percent in the after-hours trading following the FDA-mandated shutdown, reports the New York Times. Juno Therapeutics, which a biopharmaceutical company founded in 2013, used genetically engineered cells to treat brain tumors in patients, three of whom died due to swelling in the brain. Hans Bishop, the company’s chief executive, said deaths were difficult and humbling for everyone involved.
Once altered, modified cells will be sent back to bloodstream where they will work as supposed.

Stanley Riddell, a Fred Hutch researcher and co-founder of Juno Therapeutics, delivered the keynote address at Xconomy's "What's Hot in Cancer Immunotheraphy" forum.
Stanley Riddell, the eventa€™s keynote speaker and Juno Therapeutics scientific co-founder, compared the improvements in patient survival that cancer immunotherapy researchers are seeing to those last seen decades ago, when bone marrow transplantation shifted the landscape of blood cancer treatment forever. Larry Corey, president and director of Fred Hutch, also highlighted this link in his opening remarks.
The foruma€™s eight presenters discussed approaches that are already being tested in more than a dozen cancer types, and researchers are only beginning to a€?touch the surfacea€? of the possible strategies that immune-based treatments make possible, said Riddell. Several therapies designed to help remove these roadblocks and unleash the immune system have passed or are nearing the finish line of FDA approval.
The common thread that emerged across the presentations (see below for a complete list) was a sense of excitement, both about the progress to date and the possibility of bigger and better results in the future. Ita€™s also unclear how to predict which patients will respond, how best to measure these responses, or even how to know which tumors are the best candidates for each therapy.
For example, immunotherapy may be an option for tumor types or patients previously thought to be poor candidates. The company is funneling a tremendous amount of resources into research and development, including taking a step back to gain deeper insights into tumor biology as well as exploring the best ways to systematize the production and distribution of immunotherapies. He stressed the necessity of working toward more effective, less toxic, and easier-to-administer therapies a€” and noted that the path to achieving this dream is as yet undefined. She has written about scientific research and the environment for The Scientist and OnEarth Magazine.
In one study, the therapy reduced tumor size in 74 percent of patients with advanced melanoma. In clinical trials, more than 20 percent of patients with resistant cancers responded to anti-PD-L1 treatment.
The strategy has shown dramatic effects in clinical trials, a€?meltinga€? tumors in some patients with advanced lymphomas. Harlan Robins and Chris Carlson a€” can give a window into the number and type of immune cells inside a patienta€™s tumors and potentially help researchers predict which patients will respond to immunotherapy. Differing in the manner of recognizing and destroying cancer cells, Juno’s developing technologies include CARs (chimeric antigen receptors) and TCRs (T cell receptors). Given Juno’s expertise, it is expected that Celgene’s cellular therapy research could generate blockbuster drugs.
A biotech technique called CAR-T cell therapy uses gene modified T cells to destroy cancer tumors.
According to him and other Juno company executives, the deaths may have occurred due to a combination of the particular cells being used and a chemotherapy drug.
But the therapy can lead to severe side effects such as immune system overreactions and neurological toxicity, including swelling in the brain, known as cerebral edema. The Hutcha€™s role in pioneering transplantation as a cure for certain blood cancers, he noted, made the organization a fitting venue for Xconomya€™s event. Therapies designed to release the brakes that cancer puts on the immune system showed dramatic results in patients with non-small cell lung cancer, though researchers a€?had no clue it would be immune-responsive,a€? explained Riddell. Peers such as Pfizer (PFE) and GlaxoSmithKline (GSK) are also active in exploring TCR-based therapies for curing cancer.
It is also not known whether the FDA will agree or not and it is also unclear when it will announce its decision. The discovery that bone marrow transplantationa€™s power lies in the ability of the donated immune system to eliminate the recipienta€™s cancer provided one of the first examples of a successful immunotherapy. And Ira Mellman, vice president of cancer immunology at Genentech, observed that immunotherapy has produced encouraging results even in patients whose immune systems were thought to have been ravaged by the chemotherapy theya€™d previously received.

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