Olaf Ray Benson@108dragonsx·42 mins42 minutes ago
@fezziwig2008 @AniuStudent He is a troll who clutters the yhoo mb with uninteresting bullsh@t
You're the "dummy" because I just explained to the board that HALO said at Analyst day that there were no deaths- not previously reported here or anywhere. It's $200 Dummy.
Only 2 reasons for Discontinuation of the Peg-Abrax-Gem Arm was Pulmonitis in 3 and Pulmonary Embolus in 2- Only 1 PE was "Potentially Fatal" per new CMO in audio of Webcast- Deaths would have been reported here. So, I was duped. Sorry I passed on eronious info- but the source had been right in the past.
Yes Jim Birchenough, MD the BMO Main HALO Analyst has been a long time fan of PegpH20 prospects and has had a steady $24 Price target- a reiteration.
Yes NK Cells are targeted by CAR-T- so PegpH20's role in increasing access of these activated immune cells will be quite valuable to whoever wins that battle.
Tumor-associated Hyaluronan Limits Efficacy of Monoclonal Antibody Therapy.
Singha NC1, Nekoroski T1, Zhao C1, Symons R1, Jiang P1, Frost GI2, Huang Z1, Shepard HM3.
Mol Cancer Ther. 2014 Dec 15. pii: molcanther.0580.2014. [Epub ahead of print]
Despite tremendous progress in cancer immunotherapy for solid tumors, clinical success of monoclonal antibody (MAb) therapy is often limited by poorly understood mechanisms associated with the tumor microenvironment (TME). Accumulation of hyaluronan (HA), a major component of the TME, occurs in many solid tumor types, and is associated with poor prognosis and treatment resistance in multiple malignancies. In this study, we describe that a physical barrier associated with high levels of HA (HA(high)) in the TME restricts antibody and immune cell access to tumors, suggesting a novel mechanism of in vivo resistance to MAb therapy. We determined that ~60% of HER23+ primary breast tumors and ~40% of EGFR+ head and neck squamous cell carcinomas are HA(high), and hypothesized that HA(high) tumors may be refractory to MAb therapy. We found that the pericellular matrix produced by HA(high) tumor cells inhibited both natural killer (NK) immune cell access to tumor cells and antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. Depletion of HA by PEGPH20, a pegylated recombinant human PH20 hyaluronidase, resulted in increased NK cell access to HA(high) tumor cells, and greatly enhanced trastuzumab- or cetuximab-dependent ADCC in vitro. Furthermore, PEGPH20 treatment enhanced trastuzumab and NK cell access to HA(high) tumors, resulting in enhanced trastuzumab- and NK cell-mediated tumor growth inhibition in vivo. These results suggest that HA(high) matrix in vivo may form a barrier inhibiting access of both MAb and NK cells, and that PEGPH20 treatment in combination with anti-cancer MAbs may be an effective adjunctive therapy for HA(high) tumors.
He was given responsibility for Launching Abraxane after Celgene paid $3B for it- who better to help orchestrate a strategic partnership between Celgene and Halozyme concerning PegpH20 and Abraxane?
Yah Student - 7.3 mo PFS longer than Folfirinox with weak gem as chemo agent- second only to peg- gem - Abrax which gets Breakthrough status - you fail again!
Biomarker demonstrated reduction of HA in extra cell space / Stroma after pegoH20
New CMO said estimated time of FDA meeting is end of this Q1.
Helpful advice- read Dr Evil's and my post below on Breakthrough status pending and then do some of your own Due Diligence.
Yes - yet to be unnamed but the same one for NSCLung Ca and Gastric Ca- I'm thinking the Roche PD-1 Rx MPDL3280A. Yes also that a combination of Folfirinox (modified) and PegpH20 - as studied by SWOG- may result in a few-at least in combination with the Whipple operation that clearing the metastases would allow.
Breakthrough status seems assured - if you look at Aduro's Breakthrough status - awarded by the FDA for a 2.2 mo Median overall survival advantage - 6.1 months w Aduro CRS-207 added to GVAX's 3.9 months in Panc ca, HALO's 9.2 mo PFS looks like a sure thing- again, that's Progression Free Survival 50% greater than Aduro's Overall Survival. Progression Free Survival time is spent with family at home/ after that comes the added Overall time in the hospital hooked up to tubes. That's why HALO did what they originally said they would not do- an interim trial data readout. That data should influence the same people who ruled that 2.2 mos of added OS was a breakthrough to award Halozyme the same.
(Interestingly, JNJ Partnered w Janssen last July.)
FDA "A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. In contrast, a fast track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition." True and True.