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Biotech / Medical : Juno Therapeutics Inc. (JUNO) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (47)	11/23/2016 3:48:35 PM
From: scaram(o)uche	Respond to of 84

and here's the latest wrinkle on ablation with ganciclovir...... Mol Imaging Biol. 2016 Dec;18(6):838-848. Imaging of Sleeping Beauty-Modified CD19-Specific T Cells Expressing HSV1-Thymidine Kinase by Positron Emission Tomography. Najjar AM1, Manuri PR2, Olivares S1, Flores L 2nd3, Mi T1, Huls H1, Shpall EJ4, Champlin RE4, Turkman N5, Paolillo V6, Roszik J2, Rabinovich B1, Lee DA1,7, Alauddin M3, Gelovani J5, Cooper LJ8,9. Author information 1Division of Pediatrics, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. 2Melanoma Medical Oncology-Research, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. 3Department of Cancer Systems Imaging, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. 4Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. 5Molecular Imaging Program, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA. 6Center for Advanced Biomedical Imaging, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. 7The University of Texas Graduate School of Biomedical Sciences, Houston, TX, USA. 8Division of Pediatrics, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA. ljncooper@mdanderson.org. 9Ziopharm Oncology Inc., Boston, MA, USA. ljncooper@mdanderson.org. Abstract PURPOSE:We have incorporated a positron emission tomography (PET) functionality in T cells expressing a CD19-specific chimeric antigen receptor (CAR) to non-invasively monitor the adoptively transferred cells. PROCEDURES:We engineered T cells to express CD19-specific CAR, firefly luciferase (ffLuc), and herpes simplex virus type-1 thymidine kinase (TK) using the non-viral-based Sleeping Beauty (SB) transposon/transposase system adapted for human application. Electroporated primary T cells were propagated on CD19+ artificial antigen-presenting cells. RESULTS:After 4 weeks, 90 % of cultured cells exhibited specific killing of CD19+ targets in vitro, could be ablated by ganciclovir, and were detected in vivo by bioluminescent imaging and PET following injection of 2'-deoxy-2'-[18F]fluoro-5-ethyl-1-ß-D-arabinofuranosyl-uracil ([18F]FEAU). CONCLUSION:This is the first report demonstrating the use of SB transposition to generate T cells which may be detected using PET laying the foundation for imaging the distribution and trafficking of T cells in patients treated for B cell malignancies.

To: scaram(o)uche who wrote (47)	11/23/2016 4:23:10 PM
From: tuck	Read Replies (1) \| Respond to of 84

Well, we got that. Yup. Luckily for me, my sold puts expired worthless a few days ago. To a small extent, it seemed like other I-O plays were affected. I slept in a little and missed the initial fear spike down. At best, with JUNO, it will take some time to figure out a way forward. May need to infuse cells in the presence of a modulator, and slowly release the brakes. Need transformation-specific antigens, and tools to recognize extremely "weak" ones. Presumably they'd have to study this in an animal model first. My WAG is more than a year to do this, maybe a lot more (unless they've already been working on this, when the first hold pointed to a possible need). KITE will beat them to market, unless they also stumble again. I've not followed them closely for a few months, but it's now on my to-do list. Do other I-O plays look relatively tasty after this setback? I hold a bit of ADAP, and can't decide whether or not to add. Hard to say if the overall market is getting toppy. What's the expiration date on the Trump call? I've sold a number positions lately, and await the next general correction to take bios down with it. But will attempt short term put sales in liquid issues when I think I see a fat pitch, regardless of overall market. Hence my renewed interest in KITE. Cheers, Tuck

To: scaram(o)uche who wrote (47)	11/24/2016 4:28:07 PM
From: tuck	Read Replies (1) \| Respond to of 84

What if JUNO tried lower dose preconditioning a la KITE? RBC note on difference between KITE and JUNO approach Or have they already dismissed that? Also, here's a paper from earlier this year regarding, in part, the issue that just reared its ugly head again, by JUNO personnel. CD19 CAR–T cells of defined CD4+:CD8+ composition in adult B cell ALL patients If JUNO could find biomarkers that worked BEFORE dosing, they'd have something. KITE plans to file BLA soon. Data is thin, but KITE has accelerated approval hopes. How likely is it that FDA would not accept the filing, issue a CRL, or just plain not approve? I'm thinking it depends on the latest updates at ASH. Implied volatility on December KITE options isn't all that high. Toying with the idea of writing KITE puts. It would be a small bet, even smaller if done before ASH. Need to go look at their abstracts, but it'll have to wait till after Thanksgiving dinner. Edit: squeezed it in, because KITE gave the link, making it easy: A Phase 2 Multicenter Trial of KTE-C19 (anti-CD19 CAR T Cells) in Patients With Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL): Interim Results From ZUMA-1 Looks pretty copacetic, so a position as described above would be a bet on a black box swan not happening for a few weeks. Hmmm. There's also a DLBCL late breaker, no abstract available in advance. Hmmm. Cheers, Tuck