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Featured Company News – Juno Therapeutics Shared Updated Data for TRANSCEND NHL 001 Clinical Trial at the IMCL Conference in Switzerland

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LONDON, UK / ACCESSWIRE / June 20, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Biopharma Company Juno Therapeutics, Inc. (NASDAQ: JUNO), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=JUNO. At the 2017 International Conference on Malignant Lymphoma held at Lugano, Switzerland, on June 17, 2017, Juno Therapeutics presented the data from its TRANSCEND clinical trial for JCAR017 used in the treatment of elapsed and refractory (r/r) aggressive B cell non-Hodgkin lymphoma (NHL). Non-Hodgkin lymphoma (also known as B and T- cell lymphoma) are forms of blood cancer affecting the lymphatic system. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Axovant Sciences Ltd (NYSE: AXON) for due-diligence and potential coverage as the Company reported on June 13, 2017, its financial results for Q4 FY17 and full fiscal year which ended on March 31, 2017, as well as general business updates. Tune in to our site to register for a free membership, and be among the early birds that get our report on Axovant Sciences when we publish it.

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Jeremy Abramson, M.D., of Massachusetts General Hospital Cancer Center, where the Phase-One multicenter TRANSCEND trial was conducted, presented the updated data at the conference.

Sharing his views on the development, Sunil Agarwal, M.D. and President of Research and Development of Juno said:

“We are pleased to again present TRANSCEND data, which show compelling results in the treatment of aggressive relapsed or refractory NHL. High rates of durable responses and the early survival data are especially exciting, as is the emerging safety profile. The majority of TRANSCEND patients experienced no cytokine release syndrome or neurotoxicity at all. While still early, these data suggest that JCAR017 could be administered on an outpatient basis.”

About JCAR017

Juno’s JCAR017 is a chimeric antigen receptor (CAR) T cell product candidate that targets CD19, a protein expressed on the surface of almost all B cell malignancies, and uses a defined composition of CD4 to CD8 T cells and a 4-1BB costimulatory domain, which differentiates it from other current CD19-directed CAR T product candidates. It is an investigational product candidate and its safety and efficacy has not been established.

The drug candidate has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of r/r aggressive large B cell NHL. The European Medicines Agency has given PRIME designation to Juno’s JCAR017 for treatment of r/r diffuse large B cell lymphoma (DLBCL), a type of NHL.

The TRANSCEND NHL 001 Clinical trial

The TRANSCEND NHL 001 was a dose-finding study for Juno’s JCAR017 after the patients have undergone Fludarabine* /Cyclophosphamide** Lymphodepletion***. Around 67 patients with r/r aggressive B cell NHL, including those with DLBCL or follicular lymphoma grade 3B formed a part of the trial and the results were based on the study of these patients.

These patients were given one of two dose levels (50 or 100 million cells) of JCAR017. The study focused on the evaluation for pharmacokinetics, disease response, and safety outcomes, including common CAR T side effects such as cytokine release syndrome (CRS) and neurotoxicity (NT).

*Fludarabine, sold under the brand name Fludara among others, is a chemotherapy medication used in the treatment of leukemia and lymphoma including NHL.

**Cyclophosphamide is a chemotherapy drug that works by slowing or stopping cell growth that is used to treat various types of cancer.

***Lymphodepletion is the destruction of lymphocytes and T cells, normally by irradiation, prior to immunotherapy.

Key findings of the TRANSCEND NHL 001 study

Results for the Core Group of 44 patients combining data across dose levels:

Overall response rate (ORR) is 86% (38/44) and the complete response (CR) is 59% (26/44).
Three-month ORR is 66% (21/32) and CR is 50% (16/32). Of patients in response at three months, 90% (9/10) continue in response at six months.
Early data suggest a dose response relationship at three months:
Dose level 1 (50 million cells) ORR is 58% (11/19) and CR is 42% (8/19).
Dose level 2 (100 million cells) ORR is 78% (7/9) and CR is 56% (5/9).
97% (37/38) of responding patients are alive and in follow-up as of May 4, 2017.
2% (1/44) experienced severe CRS and 18% (8/44) experienced severe NT.
66% (29/44) did not experience any CRS or NT. No deaths were reported from CRS or NT.

Results for the Complete of 55 patients combining data across dose levels:

Best ORR is 76% (41/54) and CR is 52% (28/54).
Three-month ORR is 51% (21/41) and CR is 39% (16/41).
2% (1/55) experienced severe CRS and 16% (9/55) experienced severe NT. 60% (33/55) did not experience any CRS or NT. No deaths reported from CRS or NT.
Early data do not suggest a dose toxicity relationship at the doses tested:
Severe CRS rate is 3% (1/30) at dose level 1 and 0% (0/19) at dose level 2.
Severe NT rate is 20% (6/30) at dose level 1 and 11% (2/19) at dose level 2.
11% (6/55) received tocilizumab and 24% (13/55) received dexamethasone.
The most frequently reported treatment-emergent adverse events were neutropenia (35%), CRS (35%), and fatigue (31%).

The patients of the TRANSCEND NHL 001 clinical trial were given the JCAR017 which was manufactured at JuMP, Juno’s manufacturing unit at Bothell, Washington. Juno is confident that it can start commercial production of JCAR017 within 21 days and has already invested in the manufacturing infrastructure for a reliable delivery time when it is launched.

About Juno Therapeutics

Fred Hutchinson Cancer Research Center, Memorial Sloan-Kettering Cancer Center, and pediatrics partner Seattle Children’s Research Institute jointly launched Juno in 2013 as a clinical stage Biotechnology Company focused on bringing forward novel immunotherapies for cancer. In June 2015, Celgene Corporation and Juno form a strategic 10-year collaboration to leverage T cell therapeutic strategies to develop treatments for patients with cancer and autoimmune diseases. Juno is focused on developing multiple cell-based product candidates to treat a variety of B-cell malignancies as well as solid tumors with a long-term goal of leveraging its cell-based platform to develop new product candidates that address a broader range of cancers and human diseases.

Last Close Stock Review

At the closing bell, on Monday, June 19, 2017, Juno Therapeutics’ stock climbed 3.91%, ending the trading session at $24.20. A total volume of 1.56 million shares have exchanged hands. The Company’s stock price surged 5.91% in the last three months and 29.90% in the past six months. Moreover, the stock rallied 28.38% since the start of the year. The stock currently has a market cap of $2.48 billion.

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