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2 Poster Abstracts presenting @ BMT Tandem Meetings in Honolulu Sun Feb 21
BPX-501 Cells (Donor T Cells Transduced with iC9 Suicide Gene) Treatment Following TCR Alpha Beta Depleted Stem Cell Transplantation in Adults and Children with Hematological Disorders
Clinical Outcome after Adoptive Infusion of BPX-501 Cells (donor T cells transduced with iC9 suicide gene) in Children with Thalassemia Major (TM) Given Alfa/Beta T-Cell Depleted HLA-Haploidentical Stem Cell Transplantation (HSCT)
Buying into legit companies at the 52 week low is a pretty good time, 50%+ return is on the way
The cheapest mid-sized biotech in the market. Added this morning. :)
Bellicum Pharmaceuticals Announces Submission of BPX-701 and BPX-601 Clinical Trial Protocols for Review by the NIH RAC
HOUSTON--(BUSINESS WIRE)--
Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, today announced regulatory milestones and program updates on its CAR T and TCR product candidates.
Bellicum is preparing for the initiation of clinical studies in 2016 of its three most advanced CAR T and TCR adoptive cell therapy product candidates, BPX-701, BPX-601, and BPX-401. Today the Company submitted required documentation, including clinical trial protocols, for BPX-701 and BPX-601 for review by the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC). If selected for public review, such review would be expected to take place at the next RAC meeting scheduled for March 8-10, 2016.
The Company further announced that it expects to begin enrolling patients in Phase 1 trials of BPX-701 and BPX-601 in mid-2016, and BPX-401 in the second half of 2016, with IND filings to follow RAC review in each case.
BPX-701 is a CaspaCIDe®-enabled natural high affinity T cell receptor (TCR) product candidate designed to target malignant cells expressing the preferentially-expressed antigen in melanoma (PRAME). Initial planned indications for BPX-701 development are Refractory or Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) with an additional study planned for metastatic uveal melanoma. Each of these are orphan indications where PRAME is highly expressed and for which current treatment options are limited. The Company expects to submit European regulatory filings to allow initiation of clinical development at a European site after the U.S. IND has been allowed.
BPX-601 is a GoCAR-T™ product candidate containing Bellicum’s proprietary iMC (inducible MyD88/CD40) activation switch, designed to treat solid tumors expressing prostate stem cell antigen (PSCA). As reported at ASH, preclinical data shows enhanced T-cell proliferation, persistence and in vivo anti-tumor activity compared to traditional CAR T therapies. The initial planned indication for BPX-601 development is non-resectable pancreatic cancer.
BPX-401 is a CIDeCAR™ product candidate incorporating Bellicum’s proprietary MC co-stimulatory domain and the CaspaCIDe safety switch, designed to target blood cancers expressing CD19.
“Throughout 2015, we made significant progress across all of our adoptive cell therapy programs,” said Tom Farrell, President and CEO of Bellicum Pharmaceuticals. “We’re now poised to bring three novel CAR T and TCR product candidates into the clinic in 2016, utilizing our molecular switch and proprietary co-stimulatory domain technologies. Importantly, we have in place the financial and management resources needed not only to bring these novel programs forward but also to continue discovering exciting new ways that our technologies can potentially improve the treatment of cancers and other diseases.”
Background on the NIH RAC Process
Clinical trial protocols and other required information for product candidates that involve gene transfer are reviewed by both the FDA and the NIH, through the Recombinant DNA Advisory Committee or RAC. The NIH’s Office of Biotechnology Activities (OBA) convenes quarterly RAC meetings to make recommendations and selectively elicit public discussion of scientific, safety or ethical issues. The OBA notifies the FDA of the outcome of RAC reviews and reports are posted to the OBA website.
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company focused on discovering and developing cellular immunotherapies for cancers and orphan inherited blood disorders. Bellicum is using its proprietary Chemical Induction of Dimerization (CID) technology platform to engineer and control components of the immune system. Bellicum is developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT), and CAR T and TCR cell therapies. More information can be found at www.bellicum.com.
*CaspaCIDe® is a trademark registered with the U.S. Patent and Trademark Office. CIDeCAR™, GoCAR-T™ and GoTCR™ are trademarks of Bellicum Pharmaceuticals.
http://finance.yahoo.com/news/bellicum-pharmaceuticals-announces-submission-bpx-130500121.html
Thanks! I do have a sense about thing. I keep improving each year. Really happy with my returns. ;)
News out today, going to post! :)
Isn't it insane how many to choose from oversold?? Sure hope everything swings just as wild back up ... coming in here this week sure wish I'd taken heed when you mentioned this one Oct ..besides your biotech acumen you seem to have developed a sixth sense for great picks! Certainly can expect increased awareness and coverage 2016 the past few weeks have gotten a bum rap here & everywhere
Gap has more than filled on this dip (didn't quite do so last dip first week Dec where my GTC bid was at that time and it got away on me again lol) very likely this pps will be close to as good as it gets
Understatement of the week
So many biotech's broke their moving averages, so shorts and MM are taking advantage and trying to profit on these dips. I added just under $16. But market is uncertain right now.
Took a position here at 16.00. Quite pleased with the price but let's wait till next week haha.
Back to test highs. Expecting a breakout. Lots of catalyst ahead. :)
Is Bellicum A Worthy Index/Portfolio Addition?
http://marketexclusive.com/is-bellicum-a-worthy-indexportfolio-addition/1192/
Yes, beat up cuz of BLUE. Obviously will recover. :)
Wacky world of bio. Good buying opp.
2016 and 2017 are gonna be rainmakers. Hopefully early 2016
Thank you. Can we move up on cti* already!? :)
Congrats over here. Sweet move.
Did you end up buying? Disease free. :)
Bellicum Pharmaceuticals Reports Third Quarter 2015 Financial Results and Recent Program Updates
http://finance.yahoo.com/news/bellicum-pharmaceuticals-reports-third-quarter-210500004.html
So glad I bought more on Friday's dip. Imagine management likely bought shares too. One of the cheapest biotech's on the books, especially given their pipeline and cash position. :)
Long. But I will sell out my highest cost shares eventually.
Trade or long term hold for you?
Downtrend is losing steam. I hope it blast from here. Added more at $13.33. :)
On this one wait until it over sells. It might not drop much more but it does have the potential to head another 10-15% cheaper. People will want to take losses for the year and so selling might not be done. I added enough not to miss the ride up, but kinda hoping it stays dormant for the time being so that I can continue to accumulate. I have no doubt this will see new highs and more. Only thing that would change that is if they suddenly run into a safety issue. That seems unlikely at this point but no trial can guarantee that.
I got some 1.46's myself. My buy range on that one span three dollars...
Me too. $1.38 was my cheapest. :)
Yea I just keep buying more. Something has got to give soon.
Btw, I haven't sold any Ct$x for this. Nice publication on p53. Hopefully the time for that stock is soon. :)
I really suggest listening to the conference and doing your due diligence on this one. I believe that you'll see exactly what I see. Priority review next year, and NDA in 2017. And that's just one in their pipeline. :)
Might dump some ct!x for this.
Come down more, please. Still need time to accumulate. Love a good sale. :)
JUNO 1B deal with Celgene... Once again, BLCM lagging behind. Give Juno credit, a company with no trial IIs and inks a 1B deal...
Turned into the DUD of the 3 or 4. Build a big building, cash out stock at 22.50, interview with Houston news papers about how important they are. All the while get nothing done and watch others blow them out of the water. Am still surprised Baker Bros. bought this...
Nice move, RK! :)
With regard to your question earlier..I really dunno. My guess is that all the commotion was anything from trying to assist someone with a lower SP entry into a long position, facilitate a lower SP for covering shares or puts, or create a lower SP for reasons related to call options expiry this week.
One thing I do know for sure, there's a lot more going on lately than meets the eye ;) I'd love to hear more about your friend via PM if you can share. Go BLCM!!
Hoping the reason Celgene backed out of the Bluebird deal is to partner up with BLCM. BLCM still has no real partner and all they need is a celegene, Novartis, etc. and it is off to the races. They do have their own switch which has it own medical designated classification. That is a big deal on it's own and with a 40% death rate in this field, they are more important than others. Just not noticed yet... Baker Bros. get's it... Just waiting on others.. Should or could be gigantic.. Juno is a ploy at best, a stock selling and pumping machine, Kite has the connections...
Under the radar Bellicum has turned a Car-t into a solid tumor killer contender. Today's clinical abstract is fantastic.
http://ir.bellicum.com/phoenix.zhtml?c=253830&p=irol-newsArticle&ID=2054576
http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUxOTUxOTB8Q2hpbGRJRD01ODI3NDU=
Their pipeline is robust, with blood (t cell depleted), dendritic cells and Car-T on/off switch technologies.
http://ir.bellicum.com/phoenix.zhtml?c=253830&ut=1433006193&p=RssLanding&cat=news&id=2048147
I'm expecting the market to take notice soon. :)
this stock looks very interesting, looks like some more upside here.
I bought some BLCM back in February, love the action since.
Not looking too good here.
Tough week last week but I am looking forward to this breaking new highs...by friday!
I am looking forward to Bellicum releasing it's pricing. I missed out on KITE but am holding and long BLCM.
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