yes and MERCK and Bristol Myer have enough riding on their monoclonals to make HALO a valuable friend when small molecules come through trials.
Please go to my Twitter stream- I pinned it at top- comes from a UBS report - not published
The report on the P3 design and 150 Enhanze targets I'm told was just released.
-Including Patient reported outcomes to ensure Pricing Support.
UBS also "Expects Additional Enhanze Deals with 150 targets identified for the Platform"
WILL SMALL MOLECULES OUTPERFORM ANTIBODIES IN CANCER IMMUNOTHERAPY?
September 22, 2015
A TEAM OF RESEARCHERS FROM THE LUDWIG CENTER AT STANFORD UNIVERSITY SCHOOL OF MEDICINE IN CALIFORNIA ENGINEERED A SMALL MOLECULE WITH HIGH AFFINITY FOR PDL-1 THAT WAS FOUND TO BE A MORE EFFECTIVE ANTICANCER IMMUNOTHERAPEUTIC THAN CONVENTIONAL ANTI-PD-L1 ANTIBODIES. THE TEAM PRESENTED THEIR FINDINGS AT THE CRI-CIMT-EATI-AACR INTERNATIONAL CANCER IMMUNOTHERAPY CONFERENCE, HELD SEPTEMBER 16-19.
Antibodies targeting immune checkpoints such as PD1, PD-L1, CTLA-4, and other immune-regulatory pathways have shown impressive results on cancer patients. The most common safety events associated with antibody therapy are related to the immune-based mechanism of action of these types of anticancer agents and may affect various organs, mostly the skin, gastrointestinal tract, endocrine system, and liver. However, corticosteroids treatment can significantly alleviate the symptoms of immune-related adverse event and accelerate patients’ recovery.
Nowadays clinicians and cancer researchers are mostly concerned with improving the effectiveness of these ever so popular drugs, which can be limited by their large size that prevents them from penetrating the core of the tumor. Moreover continuous administration of anti-PD1 or anti-PDL-1 antibodies can result in counterproductive collateral damage, depleting some of the very antitumor immune cells they are supposed to activate.
A team of researchers in the lab of professor Weissman worked on the hypothesis that a small engineered protein that targets PD-L1 could be capable of blocking PD-1/PD-L1 signaling while at the same time overcoming the size and immune cells depletion setbacks and function as a superior immunotherapy.
SMALL AND MIGHTY
The Stanford University researchers designed a small-protein that is 10 times smaller than an antibody and is capable of binding to PD-L1 50,000 times more strongly than its natural ligand, the PD-1 prot
Friend- I'm glad you love my DD and my Tweets- Kind of you to mention- But "For Pete's Sake" and your own please read the whole tweet- Here I stated "Immunotherapy partnerships will not yield a "mid single digit royalty"- the need will be too high." In other words HALO would do PegpH20 partnerships from a position of strength (IF it's not sold- and I have stated many times that I think it will be but I HOPE it is not)- so Eisai was is a cost and profit sharing collaboration- Keytruda financials haven't been disclosed- so I'm saying HALO will get More than Enhanze numbers. Finally what everyone forgets (I remind on some irregular schedule) HALO will own PegpH20-Docetaxel, Gemcitabine, and any other combination with a generic and "Keep it all." I don't know what you mean about keeping it all when PegpH20 is approved and used with proprietary Chemo Or say in an AMGN-KITE Solid tumor CAR-T combination. Remember PegpH20 is a combination drug.
See slide 34 from Jan 7, 2015 Halozyme Analyst Meeting - Shows how big Monoclonal antibodies Keytruda and Opdivo will enter tumors and behave like the smaller molecules in development. Immunotherapy partnerships will not yield a "mid single digit royalty"- the need will be too high.
Confidence Still waning? Keytruda is just the vehicle HALO was waiting for to hitch PegpH20 to - it's a big molecule that will rx multiple cancers in competition with Opdivo, but motre importantly in competition with small molecule PD(L)-1 inhibitors with much better access than Keytruda itself- hence the tie to HALO- Preclinical studies show a dramatic increase in tumor penetration by Keytruda when the tumor is 1st treated with pegpH20. This story is just beginning and no other company has a similar agent or patent dispute.
17,000 Shares traded in the $14.90's until 5:00 and at 5:08 a sale of 500 shares brough the price down to $13.62- shenanigans- Keytruda will be a big story for years to come and HALO will be part of it- providing access to the monoclonal and holding off small molecule anti PD-1 Competition.
Keytruda was approved for second line NSCLC Rx today- although not as expanded an approval as Merck was seeking- Merck actually dropped on the news at 1st while BMY went up. However at the AACR Immunotherapy meeting held in Manhattan in September, 2 Graduate students- from Stanford and Yale Presented a small molecule derived from PD-1 which possessed very potent anti-PD-1 activity. Since Keytruda and Opdivo are large molecules, they will need help with TME access in order to hold of this future challenge- that's where pegpH20 comes in. HALO has already done impressive preclinical work showing the significant added access checkpoint inhibitors gain when combined in Rx with pegpH20- impressive- as was today's 9.5% gain.
I posted them on Twitter, where I get more feedback- the latest were on the reduction of High Mol Weight HA by PegpH20 and the resulting reduction in antiTumor Immunosupression by T regulatory cells-which are pretreated before CAR-T because they interfere- all based on an Article published in 2015. It seems the scientific world is just getting around to pursuing this HA-CAR-T/TCR Connection- but I wouldn't want to bother an intellect of your size with it.
sorry, I just saw your question- yes- HALO is keeping data open- fabulous. Torley said this gets going in "2H 15"
I still think M&A at work- though I don't want it. The new trial MD is Chardros- has a Halozyme email though Linked In has him at Genetech and He hasn't been announced by HALO.
There is something up at Halozyme- even personnel changes of note not PR'd- but the trials are progressing , with new ones started, based on open data from 202- nothing bad is happening to warrant the drop- nothing more than the perception by some that HALO didn't yet deserve to have a $3B cap w importnat data pending. In other words, Show Me. I haven't reduced- I've added. No need to be pardoned- we're talking about a lot of money here.
If confidence is waning, it's doing so in those who don't get the science, just the price momentum. The Keytruda trial is now up- 202 is an Open (to HALO and Presumably to other companies they share it with) Data Trial. So if Eisai and Merck want to work with HALO, apparently their confidence is strong. So is mine. I added. Oh and Barclays knew that Hillary's comments, The Fed's promise to raise this year, and The Daraprim fiasco would hurt HALO in the short term- they don't have to explain it if that's the reason for the fall- as it seems to be. Once that Companion Diagnostic is out, the one's who should have waning confidence are the shareholders of the other companies w PDA treatments- Mack, Momenta, Threshold, and even GILD- what's the Hyaluronan content of THEIR control & Treatment groups- don't you think the FDA will want to use the new toy they will approve? Van Hoff- who works with HALO and others published a study at TGEN - High HA OS- 9 mo/ Low HA 24 mo. Yes I think the FDA will want to compare apples to apples.
Right On Time- "2H 2015" guided.