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.

Novartis FDA Car T Approval – Most Exciting New Medicine Of Our Lifetimes

Big news: Novartis FDA Car T approval is likely coming soon after a Food and Drug Administration advisory panel unanimously recommended approval for Novartis’s leukemia drug tisagenlecleucel. The FDA usually follows its panels’ recommendations.

The big thing though will be price point. Car T is very expensive because it involves personalized treatment. If it’s too expensive, insurance companies won’t cover it.

Novartis FDA Car T

Novartis said that in patients with recurrent leukemia, 75% were still cancer free after CAR-T treatment.

Wells Fargo’s David Maris told clients that this ground-breaking approval is “the most exciting thing I’ve seen in my lifetime.”

CAR-T medicine is a new, personalized treatment which requires taking a patient’s own cells, removing them from the body, reengineering them for immunotherapy, and placing them back in the body.

The official Novartis FDA Car T approval is expected in October 2017.

Novartis Stock Chart

NVS has an ok setup pattern but I’m not really thrilled about it. I feel like we need more of a consolidation and a candle over candle reversal too so we know other buyers are stepping in at this level. There is a very little resistance above the current price. There is a support zone below the current price at 82.96, a stop order could be placed below this zone.

Add Merck To Your Watch List As It Pulls Back For Swing Long Setup

Add the stock of Merck to your watch list as it pulls back and becomes a compelling swing long set up.

Merck’s Keytruda got an amazing FDA approval. Keytruda produced data so incredible that the FDA approved it immediately for a specific genetic mutation, regardless of cancer location. The FDA has never given a drug a blanket approval like this. The Fool published an excellent report on this crazy FDA approval here.

Merck Stock Chart

I think we have to be cautious because there is no Pocket Pivot signal and the Twiggs Money Flow just went negative. Nevertheless, the chart does show a decent setup pattern after the most recent pullback. There is a resistance zone just above the current price starting at 64.13. Right above this resistance zone may be a good entry point. There is a support zone below the current price at 64.02, a stop order could be placed below this zone.

GO HERE TO CHART LARGE PLAYERS AND THE TWIGGS MONEY FLOW LIKE THE CHART ABOVE… EXCELLENT TIMING TOOL FOR SWING TRADERS

Sell Immunogen For an Incredible 101% Win

May 7, 2017: Sell Immunogen for a 101% win in 85 days and congratulations if you made money on the trade.

April 19, 2017: Immunogen’s stock popped 13% today on an upgrade from Leerink Partners. Leerink Partners raised Immunogen to an Outperform rating, from Market Perform, and set a price target of $8. Leerink Partners is upgrading Immunogen based on their higher level of conviction on lead asset mirvetuximab soravtansine providing an attractive risk/reward in context of the stock’s current valuation.

January 2, 2017: Biotechnology firm Immunogen announced that results from the Phase 1 expansion cohort evaluating mirvetuximab soravtansine (IMGN853) in patients with folate receptor alpha (FRa)-positive platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology. The data demonstrate the potential clinical benefit of mirvetuximab soravtansine for the treatment of platinum-resistant ovarian cancer.

Immunogen said, “Standard single-agent therapy for patients with platinum-resistant ovarian cancer typically has a response rate below 20% and median progression-free survival below four months. Mirvetuximab soravtansine generated encouraging efficacy and tolerability data in the Phase 1 trial that suggest the potential to improve clinical outcomes for this patient population.”

The Phase 1 expansion cohort enrolled 46 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors were positive for FRa. Patients were dosed with mirvetuximab soravtansine once every three weeks. Mirvetuximab soravtansine demonstrated single-agent activity in the 46-patient cohort with a 26% confirmed response rate and median progression free survival (PFS) of 4.8 months. In a subset of 23 patients with low, medium or high FRa, who had received three or fewer prior lines of therapy, there was a 39% objective response rate (ORR) and median PFS of 6.7 months. On the basis of the study findings and additional data demonstrating the importance of FRa expression levels with mirvetuximab soravtansine, the Company has designed the Phase 3 FORWARD I study to enroll patients with platinum-resistant ovarian cancer with one to three prior therapies and with medium or high FRa. This group of patients in the Phase 1 expansion cohort exhibited a 44% ORR and a median PFS of 6.7 months.

Mirvetuximab soravtansine exhibited a manageable safety profile. Adverse events (AEs) were generally mild with the majority being grade 1 or grade 2 (least severe grades). The most commonly observed AEs were diarrhea, blurred vision, nausea, and fatigue.

Immunogen said, “These results demonstrate that mirvetuximab soravtansine is active in platinum-resistant ovarian cancer, with encouraging response rates and progression-free survival combined with a manageable safety profile. On the basis of these findings, we have moved confidently into a Phase 3 registration study evaluating this promising agent against the standard of care in the platinum-resistant setting. In addition, we are evaluating combination regimens to assess mirvetuximab soravtansine in expanded patient populations and will begin reporting data from these combinations in mid-2017.”

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells.

Sell Cancer Genetics For an Awesome 133% Win!

April 16, 2017: Sell Cancer Genetics for an incredible 133% win in 85 days and congratulations if you made money on the trade.

December 9, 2016: H.C. Wainwright/ Rodman & Renshaw reiterates a Buy rating on Cancer Genetics, and sets a price target of $6.

December 7, 2016: Cancer Genetics announced a collaboration with BeiGene, a global, clinical-stage, research-based biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer. The two companies will work together on BeiGenes immune marker and genomics initiatives to accelerate studies of tumor microenvironment in cancer patients, which will aid in drug target identification and biomarker discovery.

BeiGenes clinical-stage drug candidates inhibit four major oncology targets, including Brutons tyrosine kinase (BGB-3111), the immune checkpoint receptor PD-1 (BGB-A317), the PARP family of proteins (BGB-290), and the RAF dimer protein complex (BGB-283). Each of BeiGenes drug candidates has demonstrated promising early anti-tumor activity and a favorable safety profile and has the potential to be a best-in-class or first-in-class product. These drug candidates are being evaluated as monotherapies and in combination regimens for the treatment of a variety of cancers, including solid tumors and hematological malignancies. CGI will provide biomarker and central laboratory for multiple clinical trials for BeiGenes BGB-3111, BGB-A317, and BGB-290 programs to promote accelerated market entrance and identify subsets of patient populations.

December 5, 2016: Cancer Genetics announces it is on Merck’s list of national reference laboratories offering the PD-L1 22C3 pharmDx immunohistochemistry (IHC) assay, the first U.S. Food and Drug Administration (FDA)-approved companion diagnostic test for pembrolizumab, KEYTRUDA, for PD-L1 testing in non-small cell lung cancer (NSCLC). The company first started offering the DAKO PD-L1 IHC 22C3 pharmDx test in early 2016 and was recently listed as a national reference laboratory.

Cancer Genetics now offers all the available FDA approved companion diagnostics for PD-L1 testing across several cancer indications and is providing these tests for both patient management in the clinical setting as well as for immuno-oncology trials sponsored by leading pharmaceutical companies. Cancer Genetics is now supporting over 100 clinical studies and trials, and over 30 with a component for immuno-oncology testing and monitoring.

Cancer Genetics, Inc. offerers diagnostic products and services that enable precision medicine in the field of oncology. Products and services being developed at CGI are poised to transform cancer patient management, increase treatment efficacy, and reduce healthcare costs. CGI’s cutting-edge proprietary tests and state-of-the-art reference laboratory provide critical genomic information where patients and their physicians need it most – to diagnose, monitor and inform cancer treatment.

Sell Exact Sciences For a 55% Win!

March 4, 2017: Sell Exact Sciences for a 55% win in 37 days. Congratulations if you were able to make money on the trade and always remember to sell your positions before you get the sell alert from me. I review more than 200 open stock positions over the weekend when I have time and so my sell signals are always going to come later.

March 2, 2017: A study from Exact Sciences Corp. and Mayo Clinic released today by the American Association of Cancer Research (AACR) shows promise for the development of a blood-based lung cancer test. Researchers conducted a multi-round study of nearly 400 patients, which demonstrated high accuracy for detecting lung cancer at all stages.

AACR released an abstract of the study today, ahead of the presentation of the results on April 2, 2017, during the AACR 2017 annual meeting. The findings from the study of 398 patients (311 controls and 87 cancers) demonstrate that biomarkers in plasma achieved high accuracy for all types and stages of lung cancer. Using two independent regression modeling approaches, a panel of four novel methylated DNA markers demonstrated a sensitivity of 91-96 percent at a specificity of 90-94 percent.

More studies are needed to corroborate accuracy, however, this plasma DNA test approach appears to be a promising new method and may serve as a rational follow-up to the common findings of lung nodules on CT scanning and may have application in screening for lung cancer.

February 21, 2017: Roth Capital raised Exact Sciences to Buy from Neutral and set a price target of $26. The price target was raised to $26 from $15. Roth Capital says Exact Sciences announced Q4 revenues in-line with its pre-announcement beat driven by strong volumes and higher ASPs, and unveiled 2017 guidance above expectations.

February 5, 2017: On February 2, 2017, Exact Sciences announced that Cologuard® is included in the Medicare Advantage Advance Notice and Draft Call letter. Cologuard’s inclusion in the final Star Ratings will allow Medicare Advantage plans to increase their Star Rating when patients complete Exact Sciences’ non-invasive colon cancer screening test.

Kevin Conroy, chairman and CEO of Exact Sciences said, “The proposed inclusion of Cologuard in the Star Ratings program is an important step toward it becoming a standard of care for colon cancer screening. Health insurers would be eligible to receive Medicare Advantage Star Rating quality credit when their members are screened using Cologuard.”

The Centers for Medicare and Medicaid Services (CMS) Medicare Advantage Star Ratings are directly impacted by the Healthcare Effectiveness Data and Information Set (HEDIS). The HEDIS quality measures were updated by the National Committee for Quality Assurance (NCQA) on October 3, 2016, to include Cologuard on an every three-year screening schedule. CMS’s proposal to broaden the colorectal cancer screening quality measure is subject to a 60-day public comment period. The proposal aligns the Star Ratings with the HEDIS quality ratings and the colorectal cancer screening guidelines of the U.S. Preventive Services Task Force, the American Cancer Society and others. Just as HEDIS 2017 quality measures are used to audit and report the 2016 performance of providers and health systems, the Stars Ratings use the HEDIS data to calculate the quality performance of Medicare Advantage plans.

January 8, 2017: Exact Sciences guides Q4 revenue from $34.9 million to $35.4 million versus the $29.5 million estimate. Q4 saw the completion of approximately 82,000 Cologuard tests during the fourth quarter of 2016, which represents growth of 114 percent from the same period of 2015.

More than 9,500 health care providers ordered Cologuard for the first time during the fourth quarter ended Dec. 31, 2016. The number of providers who have ordered Cologuard since it was launched increased to nearly 60,000 during 2016, an increase of 122 percent from the prior year.

Insurance coverage of Cologuard expanded by 67 percent during 2016. Coverage has increased by 62 million lives since June 2016, when Cologuard was included in the U.S. Preventive Services Task Force’s final colorectal cancer screening recommendations. More than 163 million people are in health plans that cover Cologuard as of January 6, 2017.

January 5, 2017: Exact Sciences announced that the Blue Cross Blue Shield Association’s (BCBSA) Center for Clinical Effectiveness “Evidence Street” recently released a positive review of Cologuard to its members. BCBSA is a national federation of 36 Blue Cross and Blue Shield companies that insure one in three Americans. This continues the positive momentum for Cologuard, as coverage increased by 67 percent in 2016 and nearly 163 million Americans are now in health plans that cover the non-invasive colorectal cancer screening option. The BCBSA’s Center for Clinical Effectiveness is an organization that assesses the effectiveness of medical devices, procedures, and biological products through comprehensive reviews and clinical evidence. The Evidence Street assessment follows other positive reviews of Cologuard, which is now included in the recommendations of the U.S. Preventive Services Task Force, and the colorectal cancer screening guidelines of the American Cancer Society and the National Comprehensive Cancer Network. This assessment is influential for association members and non-members who look to the Center for Clinical Effectiveness for guidance. BCBSA does not endorse specific companies or products nor make coverage decisions.

December 12, 2016: Exact Sciences announced today under a recently-signed contract, Humana Inc. agreed to cover Cologuard as an in-network service for its members, effective January 1, 2017. Under terms of the agreement, Cologuard will be available to most Humana beneficiaries with no co-pay. Humana covers nearly 10 million recipients and is the nation’s fifth-largest commercial insurer.

With Humana’s inclusion of Cologuard as an in-network service, the test is now covered by a cross-section of health plans nationwide with more than 153 million members. This is an increase of more than 50 million members since June 2016 when Cologuard was included as an A-rated service in the colorectal cancer screening guidelines of the U.S. Preventive Services Task Force. More than 68 percent of Cologuard’s addressable population are enrolled in plans that cover the test.

Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer.

CRISPR’s Brave New World

stock-market-videos MZqkHs - CRISPR's Brave New WorldJust a handful of technologies deserve to be called “game changers”—and CRISPR-Cas9, the new gene-editing tool, is one of them. Discovered just three years ago, CRISPR is sweeping through labs around the world and researchers are already using it to experiment on diseases like cancer and AIDS, engineer new sources of clean energy, and create hardier plants and animals with the goal of wiping out world hunger. This Salon gathers bioengineers and medical researchers to take a hard look at the monumental changes hovering on the horizon.

Salon: Game Change – CRISPR’s Brave New World

The Big Ideas Series is supported in part by the John Templeton Foundation. Additional support provided by The Jackson Laboratory.

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Original Program Date: June 4, 2016
MODERATOR: Robert Benezra
PARTICIPANTS: Ellen Jorgensen, Ben Matthews, Neville Sanjana, Jacob S. Sherkow, Stephen Tsang

Robert Benezra Introduction 00:05

Participant Introductions 00:57

How was CRISPR discovered? 3:31

Is it surprising how quickly CRISPR has been embraced? 8:34

What are the significant ways scientists are using CRISPR? 12:25

Do we want to manipulate the human genome? 22:50

What are the ethics that come with CRISPR? 30:17

How would we release a gene drive into the world 35:22

The first retinal gene therapy trial 41:44

Can CRISPR be used to replace dopaminergic neurons? 49:07

As CRISPR becomes more available could it suffer from under or over regulation? 1:00:47

How much can CRISPR cost? 1:06:25

Will CRISPR be the breakthrough for treating disorders? 1:17:36

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.

CAR-T Cells Destroying Glioblastoma Cells

Glioblastoma is a malignant and rapidly growing astrocytoma of the central nervous system and usually is detected in the brain. Glioblastoma is the worst grade of malignant glioma, a relatively uncommon but deadly class of brain tumors that kills 97% of those diagnosed within 5 years.

Below is a video of CAR-T cells destroying glioblastoma cells. Folks I’m thinking that in the future CART-T cells will be programmed to destroy pretty much any type of cancer.

CAR-T Cells Destroying Glioblastoma Cells | City of Hope