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Stofke
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door Stofke »

maartenverhoeve schreef:
17 aug 2020 22:19
Arrowhead stapt in hepatitis, koers meteen 9 % omhoog vandaag, ik verwacht een stevige boost 31 augustus als ze nieuwe data bekend maken.
Stapt in ? Ze zijn daar toch al mee bezig samen met jNJ





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maartenverhoeve
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door maartenverhoeve »

Klopt Stofke, gisteren was er positief nieuws hierover, vandaar de koersopstoot. Ik drukte me verkeerd uit.
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maartenverhoeve
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door maartenverhoeve »

Weer nieuws. PB arwr start zijn 1b studie op ARO hif2. Het betreft een behandeling van personen, nu in fase 1b dus. Mensen met kankercellen die behandeld worden, open studie met elke 6 weken kans op nieuws hierover. Baanbrekend.
:clap: :clap: :clap:
In port; Enwave, Ageas, Western Cop, Retail estate, RDS, kbca, roularta, Tessenderlo.,oci, Forfarmers, American airlines en veel arrowhead pharma....

Stofke
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door Stofke »

maartenverhoeve schreef:
18 aug 2020 15:08
Weer nieuws. PB arwr start zijn 1b studie op ARO hif2. Het betreft een behandeling van personen, nu in fase 1b dus. Mensen met kankercellen die behandeld worden, open studie met elke 6 weken kans op nieuws hierover. Baanbrekend.
:clap: :clap: :clap:
Idd heel positief, vandaag alles wat in t rood, en nog heel wat shorters.

https://pbs.twimg.com/media/EfuDGzWWAAI ... me=900x900

Stofke
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door Stofke »

Piper Sandler reiterates Buy and $80 PT.

Same price target as before ENAC and HIF2 dosed so I guess he thinks they add little value currently. He would be incorrect

Both have the potential to read out quickly and have powerful effects

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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door Stofke »

Nog even het volledig persbericht van vandaag:

Arrowhead Pharmaceuticals Initiates Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma
Aug 18, 2020 at 7:30 AM EDT
PASADENA, Calif. --(BUSINESS WIRE)--Aug. 18, 2020-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has dosed the first patient in AROHIF21001, a Phase 1b dose-finding clinical study of ARO-HIF2, the company’s investigational RNA interference (RNAi) therapeutic being developed
PASADENA, Calif.--(BUSINESS WIRE)--Aug. 18, 2020-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has dosed the first patient in AROHIF21001, a Phase 1b dose-finding clinical study of ARO-HIF2, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with clear cell renal cell carcinoma (ccRCC).

Javier San Martin, M.D., chief medical officer at Arrowhead, said: “This Phase 1b study is designed to provide us with a robust readout on safety and dose response of ARO-HIF2, and may also deliver signals on preliminary efficacy in an advanced ccRCC patient population. Most patients with ccRCC, one of the most common forms of kidney cancer, have an inactivated mutation in the Von Hippel-Lindau gene rendering them unable to degrade HIF-2α, which leads to an increase in activity during tumor hypoxia and promotes tumor growth. We believe that HIF-2α is an attractive target for RNAi-based gene silencing and, more broadly, we are eager to achieve clinical validation for our tumor targeted TRiM™-enabled RNAi therapeutics so we can address additional unmet needs in oncology. We also recently announced that ARO-ENaC, our investigational RNAi therapeutic targeting cystic fibrosis, started dosing in a Phase 1/2 study. This means that our TRiM™ platform is now being studied in three different tissue types in human clinical trials. This is very exciting for us at Arrowhead and, we think, represents a significant step towards reaching the full therapeutic potential of RNA interference.”

AROHIF21001 (NCT04169711) is a Phase 1b dose-finding clinical study in up to 18 patients with advanced ccRCC to evaluate the safety of ARO-HIF2 and to determine the recommended Phase 2 dose. Secondary objectives include the assessment of pharmacokinetics and preliminary efficacy, based on Response Evaluation Criteria in Solid Tumors (RECIST). Exploratory objectives for AROHIF21001 are post-dose tumoral expression of HIF genes in response to treatment with ARO-HIF2, change in Karnofsky Performance Status (KPS), correlation of tumor response based on RECIST with tumor HIF2α gene expression and tumor integrin expression, correlation of integrin expression with changes in HIF gene expression, evaluation of serum biomarkers of ARO-HIF2 activity, correlation of RCC-related gene expression to ARO-HIF2 activity, and evaluation of plasma and urine metabolites.

Stofke
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door Stofke »

Hier nog even de volledige pijplijn na toevoeging van ARO-JNJ2 en 3

8A7B4BAF-BE67-42C7-85FE-7D614A018B0E.jpeg
Je hebt niet voldoende permissies om de bijlagen van dit bericht te bekijken.

Stofke
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door Stofke »

Positie verdubbelt vandaag. Gemiddeld 45,86
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maartenverhoeve
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door maartenverhoeve »

Ik koop er ook nog bij. Heb er al 400 maar heb er erg veel vertrouwen in als je die pijplijn en partners ziet.
In port; Enwave, Ageas, Western Cop, Retail estate, RDS, kbca, roularta, Tessenderlo.,oci, Forfarmers, American airlines en veel arrowhead pharma....

NewB76
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Re: Arrowhead Pharmaceuticals (ARWR)

Bericht door NewB76 »

GS10
Short-term treatment with RNA interference therapy, JNJ-3989,
results in sustained hepatitis B surface antigen supression in
patients with chronic hepatitis B receiving nucleos(t)ide analogue
treatment
Edward Gane1
, Stephen Locarnini2
, Tien Huey Lim3
, Simone Strasser4
,
William Sievert5
, Wendy Cheng6,7, Alexander Thompson8
,
Bruce Given9
, Thomas Schluep9
, James Hamilton9
, Michael Biermer10,
Ronald Kalmeijer11, Maria Beumont-Mauviel11, Oliver Lenz10,
Gavin Cloherty12, Danny Ka-Ho Wong13, Christian Schwabe1
,
Kathy Jackson2
, Carlo Ferrari14, Ching Lung Lai13, Robert G. Gish15,
Man-Fung Yuen13. 1
Auckland Clinical Studies, Auckland, New Zealand; 2
Victorian Infectious Disease Reference Laboratory, Victoria, Australia;
3
Middlemore Hospital, Auckland, New Zealand; 4
Royal Prince Alfred
Hospital, Sydney, Australia; 5
Monash Health and Monash University,
Melbourne, Australia; 6
Royal Perth Hospital, Perth, Australia; 7
Linear
Clinical Research, Perth, Australia; 8
St. Vincent’s Hospital, Melbourne,
Australia; 9
Arrowhead Pharmaceuticals, Pasadena, United States; 10Janssen Pharmaceuticals BV, Beerse, Belgium; 11Janssen R&D,
Titusville, United States; 12Abbott Diagnostics, Abbott Park, United
Kingdom; 13The University of Hong Kong, Hong Kong, China; 14University of Parma, Parma, Italy; 15Hepatitis B Foundation,
Doylestown, United States
Email: tschluep@arrowheadpharma.com
Background and Aims: RNA interference (RNAi) therapy with JNJ3989 silences HBV RNA transcripts from episomal cccDNA and
integrated HBV DNA. In AROHBV1001 (phase 2a), JNJ-3989 (3
monthly doses 25–400 mg) + a nucleos(t)ide analogue (NA) demonstrated antiviral activity in patients (pts) with chronic hepatitis B
(CHB) by reducing serum viral parameters (AASLD 2019). 9-month
follow-up data for pts on ≥100 mg are presented.
Method: 8 CHB pts/cohort (NA experienced or naïve; HBeAg +ve or
−ve) received 3 subcutaneous JNJ-3989 doses (days 1, 27, 57) of 100,
200, 300 (n = 16) or 400 mg. Pts started/continued with an NA on day
1 and continued throughout the study. Safety and viral parameters
(HBsAg, HBeAg, HBV DNA, HBV RNA, HBcrAg) were assessed. For all
parameters, sustained suppression was defined as a ≥1.0 log10
reduction from day 1 or a value <lower limit of quantification at day
336.
Results: 40 pts were enrolled: 73% males; 85% Asian; median age 45
(26–66) yrs; HBeAg: 14 +ve, 26 −ve; 80% NA experienced. No deaths,
treatment discontinuations or drug-related serious adverse events
(AEs) were seen; 1 pt was lost to follow up. The most common drugrelated AEs were mild injection site AEs (7 pts). One AE of elevated
ALT (peak 136 U/L) was reported. HBsAg levels rapidly declined
during treatment. At the HBsAg nadir, 39/40 pts had a ≥1.0 log10
HBsAg reduction from day 1; range 1.11–3.77; for 1 pt the maximum
decline was 0.77 log10. Mean nadir for HBsAg (SE) log10 reduction
from day 1 was 1.72 (0.18; 100 mg), 1.79 (0.14; 200 mg), 2.04 (0.20;
300 mg; 11/16 HBeAg +ve) and 1.90 (0.18; 400 mg). 22/39 (56%) pts
had sustained HBsAg reductions (≥1.0 log10 reduction at day 336, ∼9
months after last JNJ-3989 dose, Fig); mean (SE; range) HBsAg
reductions in pts with sustained suppression were: 1.74 (0.77; 1.00–
3.38) vs 0.61 (0.06; 0.15–0.96) for non-sustained suppression. For pts
with quantifiable parameters on day 1 and available data at day 336, a
sustained suppression was observed for HBV RNA in 15/26, HBeAg in
9/14 and HBcrAg in 10/24 pts.
Conclusion: JNJ-3989 (100–400 mg) with an NAwas well tolerated in
CHB pts. A ≥1.0 log10 reduction in HBsAg at nadir was achieved in 98%
of pts. A subset of pts had sustained suppression of HBsAg ∼9 months
after the last RNAi dose (mean 1.74); sustained suppression of other
viral parameters was also seen. Studies with longer term dual therapy
(48 weeks) and triple therapy including a capsid assembly modulater are underway
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