Top News Stories For November 13 2017

The day’s top news stories from stocks on the GuerillaStockTrading watch list.
Continue reading “Top News Stories For November 13 2017”

Top Weekend News Stories November 11 – 12, 2017

The top news stories this weekend from stocks on the GuerillaStockTrading watch list.
Continue reading “Top Weekend News Stories November 11 – 12, 2017”

Top 5 CAR T Stocks To Add To Your Watch List

CAR T stocks are the buzz right now. Even grocery store workers are talking about the FDA approval of the first CAR-T therapy from Novartis last week. Labiotech wrote about the Novartis CAR T approval here.

As swing traders we can’t chase any of these stocks. Back in July I wrote about going long both Cellectis and Novartis.

Back in February 2017 I linked to this YouTube video on how the National Cancer Institute cured leukemia that you may want to review to gain a fuller understanding of what this disruptive technology is about.

Had you bought Cellectis when I wrote about it back in July, you would be up more than 15% right now.

These stocks just can’t be chased higher right now.

My goal is that GuerillaStockTrading become the smartest stock trading website on the internet for amateur traders. Being smart means NEVER chasing a stock higher.

Most of you that watch the weekly Saturday show on YouTube already know that I made a New Year’s resolution to NEVER chase a stock higher in 2017. After making that resolution, my trading profits have improved by over 1000%.

You have to ask yourself, are you a predator or prey for some other predator? You want to be a predator. If you stalk and wait for a pullback to pounce, you’re a predator. If you chase a stock higher, you’re prey. Make sure to review this stock trading lesson on swing trading and the difference between being a predator or being prey.

CAR T Stocks

Be a smart trader. Instead of chasing, create a CAR T watch list and add these stocks to it:

CAR T Stocks Gilead

The next CART-T FDA approval will likely come from Gilead, which just announced the €10Bn acquisition of Kite Pharma that is currently waiting for an FDA decision on its CAR-T candidate KTE-C19.

GILD does not present an entry opportunity at the moment. Prices have been extended to the upside lately. For a good entry it is better to wait for a consolidation.

CAR T Stocks Novartis

Even though the FDA has approved Novartis’ CAR-T therapy Kymriah, officially blessing a new way to attack cancer, the stock has gone pretty much no where. That’s a cautionary yellow flag to traders who think that just because the FDA has approved a CAR-T therapy treatment that this translates into making money in CAR T stocks. Notice how the large players volume continues to downtrend and the Twiggs Money Flow is negative suggesting the stock is still under distribution. I think Novartis is a better setup for a long entry than Gilead. Prices have been consolidating lately and there is a support zone below the current price at $83.76, a stop order could be placed below this zone.

CAR T Stocks Cellectis

Cellectis is a death-trap stock. This is like the stock you tell your father-in-law to check out because it looks so good (wink, wink). Cellectis stock does NOT present a decent entry opportunity at the moment. Prices have been extended to the upside lately. For a good entry it is better to wait for a consolidation.

CAR T Stocks Juno Therapeutics

JUNO is a little better than CLLS but not by much. JUNO does not present a good swing long entry opportunity at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for more of a consolidation first.

CAR T Stocks Celyad

Large players have been selling CYAD into the upward move. We see reduced volatility while prices have been consolidating in the most recent period. There is a very little resistance above the current price. I don’t really like trading ADRs when I can find a similar opportunity in a non-ADR stock. The Twiggs Money Flow is weak and the falling large players volume means the stock is not a good setup right now unless both improve. I did this stock trading lesson on large players volume that you should review.

Make sure to leave your comments on CART T stocks and this exciting new medical technology below.

Wells Fargo Gives Buy On Juno One Day, Downgrades the Next!

February 23, 2017: Wells Fargo initiated coverage of JUNO on February 22, 2017 with an Outperform rating. Then, one day later on February 23, 2017, Wells Fargo downgraded JUNO to market perform! Was this a rotational dump at $24 and we just provided Wells Fargo the liquidity they needed? I don’t know but my trust in Wells Fargo analyst ratings is seriously damaged. Wells Fargo is normally solid in their analyst ratings so I think somebody messed inside Wells Fargo. I’m out of JUNO for a small loss around market open today. Ain’t nobody got time for WF analyst ratings stupidity. No worries, we’ll get Wells Fargo back on another trade.

February 22, 2017: Juno had a huge volume surge on February 22, 2017. Volume was 700% higher than 3 month volume average. Wells Fargo just initiated coverage of JUNO with an Outperform rating and a price target of $34 to $36. I decided to pick up some Juno today in my personal trading account.

January 18, 2017: Hearing takeover rumors circulating about Juno Therapeutics. Vague rumors and could not confirm the source.

December 20, 2016: JUNO and CELG announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational drug JCAR017 for the treatment of patients with relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), Primary Mediastinal B-cell Lymphoma (PMBCL) or Grade 3B Follicular Lymphoma. In addition, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) have granted JCAR017 access to the Priority Medicines (PRIME) scheme for r/r DLBCL.

JCAR017 uses a defined CD4:CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates in clinical development. Earlier this month, data from multiple phase I studies with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia were presented at the 58th American Society of Hematology Annual Meeting.

December 19, 2016: The biotechnology company Juno Therapeutics defeats Kite Pharma’s challenge to CAR T-Cell patent. Juno Therapeutics announced that it has defeated an attempt to invalidate a patent exclusively licensed by Juno that covers, among other things, a chimeric antigen receptor (CAR) T-cell used for the treatment of B-cell malignancies, and that it is suing Kite Pharma, Inc., seeking a declaratory judgment that Kite’s lead product candidate, KTE-C19, will infringe the patent when commercially produced.

In August 2015, Kite Pharma, Inc. filed an inter partes review in the U.S. Patent & Trademark Office in an attempt to invalidate U.S. Patent No. 7,446,190 by challenging all of its claims. Juno exclusively licenses the ‘190 patent, titled “Nucleic Acids Encoding Chimeric T Cell Receptors,” from Sloan-Kettering Institute for Cancer Research, an affiliate of Memorial Sloan-Kettering Cancer Center. The patent covers, among other things, a construct for a CD-19 targeted CAR T cell treatment that employs a CD28 costimulatory domain.The U.S. Patent & Trademark Office instituted a review of the patent, and on December 16, 2016, issued a final written decision upholding all the claims of the patent.

The lawsuit is being filed in the U.S. District Court for the District of Delaware. Juno and the Sloan Kettering Institute are represented by Irell & Manella LLP in both the IPR and the litigation.

December 6, 2016: Juno provided an update of key data from studies of its investigational chimeric antigen receptor (CAR) T-cell product candidates, presented at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, December 3-6, 2016.

We are encouraged by the safety and efficacy results we see with JCAR017 and JCAR014 in several B-cell malignancy settings, including in non-Hodgkin lymphoma, chronic lymphocytic leukemia, and pediatric acute lymphoblastic leukemia, and the possibilities suggested by early data in treating patients with CD19-negative disease, said Hans Bishop, Junos President, and CEO. We are also learning more about factors that contribute to efficacy and managing the toxicities associated with CAR T therapy and will apply what we learn to our broader development pipeline.

Pediatric Acute Lymphoblastic Leukemia (ALL): JCAR017Final results from the Phase I Pediatric Leukemia Adoptive Therapy-02 (PLAT-02) study with JCAR017 in children and young adults with relapsed or refractory (r/r) CD19-positive ALL were presented in an oral session by Rebecca Gardner, M.D., of Seattle Children’s Research Institute (Abstract #219), on Saturday, December 4. JCAR017 uses a defined CD4: CD8 cell composition and 4-1BB as the costimulatory domain, which differentiates it from other CD19-directed CAR T product candidates in clinical development.

The presentation updated data previously presented at ASCO in June 2016. It included 43 pediatric and young adult patients treated with JCAR017 who were evaluable for response.

Key results:40/43 (93%) patients experienced a minimal residual disease (MRD)-negative complete remission (CR).

In patients who received preconditioning with fludarabine/cyclophosphamide (flu/cy) lymphodepletion, the overall response (OR) rate was 14/14 (100%) patients. The estimated 12-month event-free survival is 50.8% (95%CI 36.9, 69.9) and overall survival (OS) is 69.5% (95%CI 55.8, 86.5).Severe cytokine release syndrome (sCRS) was observed in 10/43 (23%) patients.

A second study presented by Dr. Gardner examined toxicity management in the PLAT-02 trial (Abstract #586). In the study, two cohorts were given either anti-IL6 (tocilizumab) alone or the combination of tocilizumab and the steroid dexamethasone, with the goal of preventing sCRS. Results showed:

Both cohorts experienced similar overall rates of Grade 1-2 CRS following treatment: 21/23 (91%) in cohort 1 and 19/20 (95%) on in the early intervention group. In the tocilizumab arm, 7 of 23 (30%) patients experienced sCRS, versus 3/20 (15%) in the tocilizumab / dexamethasone arm.

Early intervention with immunomodulation appeared to decrease the rates of sCRS while preserving the previously observed high rates of MRD-negative CR.

Long-term persistence of CD19 CAR-T cells is protective against relapse.

Pediatric ALL: JCAR018Nirali N. Shah, M.D., of the National Cancer Institute, presented data from a Phase I study of JCAR018, a CAR T cell product candidate targeting CD22, in 16 pediatric patients with r/r CD19-negative ALL (Abstract #650) on Monday, December 5. The study is the first to evaluate CAR T cell therapy in patients expressing CD22. All of the patients had been previously treated with anti-CD19 CAR T cell therapy and had already undergone at least one allogeneic stem cell transplant.

Key results:

The primary adverse event was grade 1-2 cytokine release syndrome, with no severe or irreversible neurotoxicity. There was one death due to sepsis in a patient after resolution of CRS.

3/9 (33%) patients are in ongoing remission ranging 3-12+ months.

Results showed 7/8 (88%) patients achieved an MRD-negative CR with flu/cy lymphodepletion followed by JCAR018 at dose level 2 (1 x 106 transduced CAR T cells/kg).

The study continues to enroll patients. Juno is currently testing pre-clinical constructs to understand better the optimal way to target these two antigens in the same product.

Diffuse Large B-Cell Lymphoma (DLBCL): JCAR017In a poster presentation on Monday, December 5, Jeremy Abramson, M.D., of Massachusetts General Hospital Cancer Center, presented results from the Phase I TRANSCEND study in patients with r/r DLBCL, follicular lymphoma grade 3B or mantle cell lymphoma (MCL) who were treated with flu/cy lymphodepletion and JCAR017.

Topline results included a 12/20 (60%) complete response in patients with r/r DLBCL (N=19) and follicular lymphoma grade 3B (N=1) treated with a single dose of JCAR017 at dose level 1 (5×107 cells). No sCRS was observed; grade 3-4 neurotoxicity was seen in 3/22 (14%) patients, all of whom received the steroid dexamethasone for neurotoxicity. Also, the side effect profile plus cell persistence suggests the potential for combination therapy.

The Phase I TRANSCEND trial continues, enrolling more patients at dose levels 1 and 2. Juno intends to initiate a pivotal trial in the U.S. in patients with r/r DLBCL in 2017.Chronic Lymphocytic Leukemia (CLL): JCAR014In an oral presentation on Saturday, December 4, Cameron Turtle, M.B.B.S., Ph.D., of the Fred Hutchinson Cancer Research Center, reported on results from a Phase I study of heavily pretreated patients with CLL who failed treatment with ibrutinib, the standard-of-care treatment for CLL. Fifteen of 17 (88%) efficacy-evaluable patients who had bone marrow disease at the start of the trial and treated with flu/cy and the two lowest doses of JCAR014 had a complete marrow response by flow cytometry. Fourteen of the complete bone marrow response patients had a response assessment by the more sensitive method of IgH deep sequencing, with 7/14 (50%) having no detectable disease. All seven of these patients are alive and progression free with follow-up ranging from 3 to 26 months.

Two of 24 (8%) patients developed grade 3-5 sCRS and 6/24 (25%) patients developed grade 3-5 severe neurotoxicity. There was one treatment-related mortality (4%) in the trial in a patient who received flu/cy lymphodepletion, with both grade 5 CRS and cerebral edema.

Plans to study JCAR014 in combination with ibrutinib in CLL are underway, with a cohort expected to begin enrollment in early 2017. Juno is evaluating the use of this data with JCAR014 as a monotherapy and in combination with ibrutinib in support of a potential Juno-sponsored trial with JCAR017 in CLL.

Juno Therapeutics, Inc., a biopharmaceutical company, engages in developing cell-based cancer immunotherapies.