Juno currently has three CD19-directed product candidates in clinical development, including JCAR015, JCAR017, and JCAR014.
With regard to the latest development, the company is in the process to get the halted trial restarted as early as possible by reverting to the cyclophosphamide pre-conditioning. It is noteworthy that the company disclosed the news of the hold status in a press release yesterday, which came about due to a report of two deaths, following a new molecule addition. However, the FDA responded that Juno Therapeutics must submit a revised informed consent form, with modified investigation brochure and trial protocol, along with a copy of the presentation sent to the agency, which the company will provide this week. At Bidness, we are developing the most comprehensive and easy to use institutional financial data platform for investment management and investment banking.
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From a peer analysis perspective, relative outperformance last month is up from a median performance last year.
A mid-stage trial of Juno Therapeutics’ cancer killing T-cell is back on, after the US regulator last week called for a halt following two patient deaths. The US Food and Drug Administration said the ROCKET phase 2 trial can restart under a revised protocol using JCAR015 T-cells with cyclophosphamide pre-conditioning only.
The trial is investigating JCAR015 in adults with relapsed or refractory B cell acute lymphoblastic leukaemia. All three deaths were in young patients under the age of 25, and all were due to cerebral oedema.
Juno said last week that the deaths were related to the addition of fludarabine chemotherapy to the pre-conditioning regimen.
The news sent shares in Juno soaring in after-hours trading, after a slump when news about the trial deaths broke on Friday. Shares in rival T-cell biotech Kite Pharma had also fallen after  Juno’s setback, as its lead candidate uses the same CD28 co-stimulatory mechanism as JCAR015. Chimeric antigen receptor T-cell (CAR-T) therapies are expected to produce a new wave of cancer immunotherapies, following the success of drugs such as Bristol-Myers Squibb’s Opdivo (nivolumab), which work by instructing T-cells from the body’s immune system to attack cancer. In this case, T cells are genetically engineered to attack the B cells that become malignant in some blood cancer types. The potential pharma companies see in this type of therapy was demonstrated last year, when Juno signed a decade-long, billion-dollar deal with Celgene to develop CAR-T therapies. That metric got as high as 77.8% in April, though the 80% level hasn’t been seen since December 2014, says Nicholson. Of course, some say this market just needs to get the gains in check a little, given the breathless run since the post-Brexit vote chaos. After finishing near a one-week high, WTI crude is backpedaling amid worries upcoming U.S.


Returns have been driven by rising price-to-earnings ratios and share buybacks, rather than earnings growth, says BlackRock.
In a report issued on April 8, FBR analyst Edward White reiterated a Buy rating on JUNO, with a price target of $73, which implies an upside of 74.3% from current levels. Juno Therapeutics also mentioned that the flu has not been an issue in other studies, and that the ongoing JCAR014 and JCAR017 trials remain unchanged. Since the hold status is implemented on the JCAR015 trial only, the management remains confident that this will not impact other studies, especially the JCAR017 in non-Hodgkin Lymphoma (NHL), which offers a bigger opportunity. It proposed to the FDA to let it continue the Rocket trial with the cyclophosphamide pre-conditioning alone.
On the other hand, its trials and plans for its other CD19-directed CAR-T cell product candidates, which comprise JCAR017, are not affected.
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This suggests the company’s performance has improved more recently relative to peers. If they are undervalued, it can be a further advantage and may indicate sustained momentum. He says 84% of S&P 500 stocks are now above their 50-day moving average, and 74% are above their 200-day moving average, arguing that’s an even better omen. Japan was quashing talk about “helicopter money” overnight, but it could be oil prices that upset investors, with prices ticking lower this morning and nervousness building ahead of supply data later.
The good news is that it should stay cheap the for the annual pilgrimage of Americans to London this summer. The world’s largest money manager concludes with this zinger: “We have been borrowing from the future.
On Thursday, the Bank of England is expected to cut rates for the first time since 2009, though that may all but priced into this market.
Why is it so hyped, and what could limit the adoption of such a revolutionary technology?CAR-T is a type of engineered T-cell which is transformed in vitro to recognize cancer cells. With the exercise of this option, Celgenewill pay Juno a fee of $50 million and the companies will now share global development expenses for products in the CD19 program. Separately, on February 25, Citigroup’s Robyn Karnauskas initiated coverage with a Buy rating on the stock and has a price target of $45. The news prompted JPMorgan to downgrade JUNO stock, which added more weight to the sinking ship.
The firm added that while it sees hope in Juno Therapeutics’ Car-T platform, the near-term uncertainty prompted it to revise down its rating on JUNO shares. Jeffrey Gundlach, chief executive officer of DoubleLine Capital, has been pounding the table about frothy bonds.


Fretting over record-high supply was also heard from the International Energy Agency earlier. This small tinkering with the T-cells has initiated development of a whole new range of cancer treatments, and could potentially even one day lead to a cure.It exploits all the developments in immuno-oncology to make a super T-Cell therapy to attack tumors and cancer cells (and you can read more about how Biotech changed the field in my review from last month). Celgene has commercial rights outside of North America and China and will pay Juno a royalty at a percentage in the mid-teens on any future net sales of therapeutic products developed through the CD19 program in Celgene’s territories.
The CAR technology is designed to target cell surface antigens that are expressed on cancer cells.
However, the main advantage of Autologous CAR-T is that there is almost no immunogenicity, since its the patients own cells. Once a T-cell is activated, the CAR need to be expressed by the cell to recognize the tumors. This breakthrough was essentially responsible for the hype take-off in Immuno-Oncology.Now many actors jumped into the field and are advancing their own programs.
Results are really encouraging as well as Phase II clinical trial of Novartis.Asides this, a first proof of concept in human of  allogeneic has been presented by Cellectis in a baby girl who with ALL at Great Ormund Street Hospital in London (UK). I hope it won’t be like bi-specific antibodies where 130 are under development and only two approved.But what about the limits? Companies love to highlight the successes but we are here to balance it with the reality…which is what Cellectis is trying to do after we interviewed their CEO Andre Choulika last week. Four main limitations seems to be critical:(1) Patients need to have T-Cells left to be able to engineer them (for autologous).
This is extremely high, almost at the same level as the worldwide most expensive drug (from Genzyme).But in this case, we are not talking about an ultra-rare disease but about cancer.
As a matter of fact, it helps many patient in lack of therapeutic solutions: The rate of positive response and total remission is just amazing.So hold on guys, keep tackling those challenges! Because with such technology, you give hope to many, and only with time can revolutionary breakthroughs be refined to something truly great!P.S. Keep up the good job:  Facebook Twitter Google+ LinkedIn Email Pocket Related Posts Jobs Interested in jobs at Novartis or AbbVie? I love to highlight the great discoveries that are made every day in Biotech, ranging from monoclonal antibodies to biofuel.




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