Herceptin SC contains rhupH20 by definition-the formula sold all over Europe and South America:
"Herceptin SC is a new more convenient formulation of Herceptin that uses Enhanze™ Technology, developed by Halozyme Therapeutics, Inc. which contains the novel excipient (carrier for active ingredients of a medication), rHuPH20. rHuPH20 (recombinant human hyaluronidase) reversibly breaks down a gel-like substance (hyaluronan) that forms a barrier in the tissues between cells under the skin. This facilitates the distribution of injected volumes over a greater area and enables painless subcutaneous administration of the large volume of Herceptin SC (a fixed dose of 600 mg (5ml))."
HALO Just Received $8M for the THIRD LLY target- does anyone know any of the 3? Pfizer just chose another unnamed target ($1/2M) Progess is being made- we are just currently in the dark.
Once again you demonstrate an incomplete and in some way faulty understanding of the facts. Here is the description of the part of the dose finding P1 Roche study- NCT02738970- to which I referred- "Primary Outcome Measures:
SC Perjeta Loading Dosage (in Milligrams) that Results in Comparable Exposure to IV Perjeta (When SC Perjeta is Mixed with Herceptin SC and Given as a Single Injection) "
SO when Perjeta is mixed with Herceptin SC, it's being mixed with HALO rhupH20.
(as far a titers- You should read more - The FDA allows HyQvia to be used and is being studied in Pregnant women and the EU Just approved it in children- guess you're the last one concerned.)
I tweeted this Friday (May 20) Dimitrios Chandros is the reason for the Genentech credit- He's still working there while serving as Halozyme's VP for Clinical Development. In fact when HALO announced that they were expanding to a S SanFrancisco office on Gateway Blvd, they were announcing that their new hire(took over for Sam Dychter) was staying at his desk at Genentech. I confirmed this in December a month after the announcement- a Genentech operator picked up Chandros's phone. So I believe he is serving the same role Torley played for Amgen before they bid for Onyx. Like Torley, he is blinded to Stage 2 202 data but has a good sense of how good it is. As an employee of Genentech, he's free to share what he knows. I expect a run up and a bid in Q4.
Wait- you said there was no news, when obviously there was- HALO presented 1/15 update @ ASCO 15 and 1/16 @ ASCO 16- a one sentence blurb @JPM on HR doesn't count as a scientific presentation- OLD? Feb 2nd 2016 Was Abstract Submission Deadline for this ASCO mtg- Stage 1 data w CDx was presented 3 wks before. But you whined like a baby that there was no news.
In 2015 HALO presented 1/7/15 Data at ASCO- This Yr they presented 1/6/16 JPM data- no surprise- 0.48 is a great HR- a tie in Q4 would be fine but will probably be better given lack of interruption.
Accelerated Approval with a tie in Q4- and I expect better Stage 2 results given added length of uninerrupted Rx.
Will need the people's "Thought leaders" Like The Street, Seeking Alpha, etc to alert the masses.
Down from 42% in Stage 1 w addition of LMW Hep.
wake up- Stage 1 was haled then Low molecular weight heparin was added- Thromboemboli went down from 42% to SEVEN % and there was 4% in Non PegpH20 group as Cancer is a coagulable state.
Methods: Pts received PEGPH20 3 µg/kg twice weekly (C1), then weekly (C2+) with standard AG dosing. The protocol was amended after a temporary clinical hold (Apr-Jul 2014) for an imbalance in thromboembolic (TE) events to exclude high-TE-risk pts and add enoxaparin (LMWH) prophylaxis to both treatment arms. Primary endpoints are PFS and TE events. PFS and ORR data through Dec 2014 are for pts enrolled up to clinical hold (Stage 1); TE data through Dec 2015 (Stage 2) are outlined below. Results: 135 pts were treated (74 PAG, 61 AG). PFS results are shown below (median follow-up 7 mo). In HA-high pts receiving PAG vs AG, ORR was 55% (1 CR) vs 33%. TE events (PAG vs AG) were: Stage 1 (no LMWH) 42% vs 25%; Stage 2 (+LMWH 1 mg/kg/d) 7% vs 4%; overall (+LMWH 40 mg/d or 1 mg/kg/d) 12% vs 9%. No Grade 5 events have occurred with 1 mg/kg/day LMWH. Conclusions: Pts with HA-high tumors receiving PAG vs AG showed clinically meaningful improvements in PFS and ORR. TE events reduced with LMWH. A global phase III trial of PAG is scheduled to initiate in Q1 2016. Clinical Trial Information: NCT01839487.
Population mPFS, mo
Hazard Ratio [95% CI]
Treated 5.5 (n = 74) 5.2 (n = 61) 0.73 [0.46-1.15]
HA-High (n = 43
w/ evaluable HA data) 9.2 (n = 22) 6.3 (n = 21) 0.48 [0.16-1.48]
HA-Low (n = 75
w/ evaluable HA data) 5.3 (n = 44) 4.3 (n = 31) 0.69 [0.38-1.25]
0.48 Hazard Ratio Bests 0.69 Gem-Abrax in MPACT-
ASCO Embargo lifted 5PM 5/15.
What will be released 5/18 is all the Stage 1 202 (pre halt-interrupted-so worst case) as arranged by new Comp Dxtic- so expect control do do somewhat better- higher HA cutoff- some responders therefore in control group- BUT a 0.48 Hazard Ratio- which is what the interim data showed w Comp Dxtic- would be more than approvable- Gem-Abraxane in 0.67 range (lower= less likely due to chance). Again, HALO would not preempt their completed full study data - coming out in Q4 for unblinded bad data- expect positive results on 5/18.
The Abstract will be released at 5 PM ET on Wed 5/18- that will include results of Stage 1 (Pre Halt) 202 Data adjusted to meet Ventana Companion Diagnostic Criteria.
202 Stage 1 Data -Unblinded- Includes 15 High HA PegpH20 pts w 73% Response Rate- The Embargo is lifted on this presentation on Wednesday 5/18 - HALO Blinded Only to Stage 2
"HALO remains blinded to efficiency data from stage 2 of 202" HALO CEO 2/29
"Halozyme Therapeutics Inc believes it has a multibillion-dollar cancer drug on its hands."
Reuters | Thu Jan 8, 2015
Halozyme CEO sees blockbuster potential in its cancer drug
Halozyme discussed interim data from a Phase II study of PEGPH20 with analysts and investors in New York on Wednesday, demonstrating its likelihood of delaying a worsening of the deadly cancer. Final results of the pancreatic study are expected late this year or early 2016.
Kenneth C. Frazier - Chairman, President & Chief Executive Officer 5/5/16 In response to Goldman's Analysts's Keytruda Question:
Jami, thanks for the question. Let me start by saying what I was trying to say earlier this year and what I'm saying today are exactly the same thing. We feel it's very important for us to access the best external innovation, and we're very actively engaged with companies that we think have good science. You haven't seen the deals come through quite yet, but that doesn't mean that we're not very, very much engaged in active discussions with those companies.
We may get Keytruda-PegpH20 Dose Expansion Data at HALO 5/9 Earnings Mtg.
CRVS given $20 PT today initiated by Guggenheim, CS, Cowan- HALO Abstract 1472 @AACR puts HALO in lead in space- CRVS leased technology- run by a director of PCYC= good space.
42% Colon Ca KRAS + 13% also BRAF -HALO right place @ right time !
HALO has the BEST Lineup at AACR- PegpH20 enables Checkpoints, Peg-ADA 2 is a Checkpoint, HTI-1511 targets KRAS/BRAF- Rx for above 2 + Melanoma- Low HA- so Broadens HALO Scope of treatment + PDA, Oh and PegpH20 enables Lilly Almita the #34 Drug by Revenue World Wide- Going Up- w a PegpH20 partnership.
World J Gastroenterol. 2016 Jan 14; 22(2): 776–789.
Published online 2016 Jan 14. doi: 10.3748/wjg.v22.i2.776
Molecular targets for the treatment of pancreatic cancer: Clinical and experimental studies
Tasuku Matsuoka and Masakazu Yashiro