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Galapagos 2018. De inhoudelijke discussie.

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pardon
1
quote:

Prof. Dollar schreef op 23 februari 2018 10:18:

Ik heb vier inhoudelijke vragen:

Hoe kijken jullie naar de resultaten van Vertex Pharmaceuticals (VRTX)? Ligt de lat voor
Galapagos niet te hoog als het om nog betere resultaten aankomt?

Hoe kijken jullie naar de patiëntenpopulatie? GILD, ABBV, ENTA

Waarom liet ABBV Filgotinib nu werkelijk schieten?

Jullie opvatting ten aanzien van het CF programma potentiators en correctors?
Als je allias prof.dollar is en je stelt hier zulke vragen kun je beter je allias aanpassen in leerling prof.
wiegveld
0
nog wat meer info over VRTX en de triple combination. FDA schrapt 9 maanden studietijd en dus zijn ze in 2019 klaar.
www.statnews.com/2018/02/21/vertex-fd...
is betaalsite dus hierbij verhaal. (niet goed nieuws voor GLPG)

Vertex Pharmaceuticals (VRTX) reached an agreement Wednesday with the Food and Drug Administration that shaves nine months off the length of its next pivotal cystic fibrosis clinical trial.

The speedy trial design means the first of Vertex’s three-drug regimens for cystic fibrosis could have top-line results by the end of this year or early in 2019 — faster than anticipated. The company’s accelerated timeline also makes it harder for any of its cystic fibrosis competitors to keep pace.

The first randomized, placebo-controlled Phase 3 study will investigate the combination of VX-659 with tezacaftor and ivacaftor, the new backbone recently approved under the brand name Symdeko. The study will enroll 360 patients who have cystic fibrosis caused by a genetic mutation known as F508del/Min, which renders them among the hardest to treat.

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Most important, efficacy of the VX-659/Symdeko regimen will be assessed by measuring the change in lung function after four weeks of treatment. The study will also assess safety out to 12 weeks.

That’s a big change from precedent, which required Phase 3 studies of cystic fibrosis drugs to run for 48 weeks.



Vertex Chief Operating Officer Ian Smith says top-line results from the study will be announced after the 12-week safety data are collected. That will also be the trigger point for any regulatory filing.

Smith wouldn’t proffer a guess on when results will be announced but Vertex expects the study to enroll quickly because there are no drugs currently approved to treat F508del/Min patients.

Impressive phase 2 results from the VX-659 triple combination regimen were announced in January.

Smith wouldn’t proffer a guess on when results will be announced but Vertex expects the study to enroll quickly because there are no drugs currently approved to treat F508del/Min patients.

Impressive phase 2 results from the VX-659 triple combination regimen were announced in January.

Loureiro
0
Onno Van De Stolpe :
Thank you, Bart. Well, this cash burn is increased over 2017, but as you can see on this slide, we are expecting a lot of return for the money being spent. We will be initiating trials in a number of diseases in IPF, the late stage 1690 trial. We also start a Phase 2 trial in IPF with 1205, then we got the triple trials for cystic fibrosis, the osteoarthritis trial with 1972, which we are conducting together with Servier, but we are responsible for the U.S. part of that trial and we are initiating a full Phase 2 on MOR106 in atopic dermatitis together with MorphoSys. We will also see POC data of filgotinib in psoriatic arthritis and ankylosing spondylitis. And we will see the data, the proof of concept data in the – of the PELICAN and the FALCON trials, so a lot of data on proof of concept. And even more important the pivotal data that we are expecting on filgotinib in the FINCH 2 trial and the decision to move filgotinib in Ulcerative colitis to a full Phase 3 the go, no go decision that will take place this year. And also as already announced by Walid we have – we are expecting full completion of recruitment for the FINCH 1 and FINCH 3 trials. So a lot of activity there and you can expect as an investor the news flow regarding these trials in the month to come.
Besluit :
Reden van de daling van de koers van gisteren : speculatie over een overname door Gilead is er voorlopig uit en het goede nieuws van Vertex over hun triples in CF.
Opop
2
Interessant interview: CFTR Modulators, Clinical Insights.

ecysticfibrosisreview.org/newsletters...

I just talked primarily about medications that are under development by Vertex, but other companies are also developing modulators that are well into clinical trials. These include Bayer, Galapagos in collaboration with AbbVie, Flatley Discovery Lab, and Novartis. Results were reported from many of these; they tended to be earlier phase studies but they provided evidence that we will have a variety of modulators available over time as these drugs continue to be worked through their studies.

En over de RNA therapie van ProQR (samenwerkingspartner van GLPG) waar Dr. Clancy wel clinical trials voor heeft gedaan:
Finally, I wanted to highlight one last approach that was a bit different. Modulators are basically pills taken by mouth that help improve the function in CFTR proteins. Another approach is using RNA antisense therapy — an inhaled therapy that helps make the RNA templates work more normally and produce a functional CFTR protein.
A company called ProQR has been looking at an RNA antisense therapy that is targeting F508. They provided data indicating that there was safety and a well-tolerated approach that was only taken three times a week. And when looking at different subgroups of patients treated with inhaled CFTR RNA antisense therapy, they were able to demonstrate some improvements in lung function and symptoms. These effects were exciting, but the caveat is that these are small studies. We look forward to them moving into phase 2, which will be more definitive to determine whether this approach can lead to clinical benefits.
[verwijderd]
0
"Job description

As scientist you will be part of a team that will be responsible for build-up of a platform for disease mechanism elucidation: for this you will advise or guide the setup, analysis and follow up of “omics” experiments (proteomics, transcriptomics, metabolomics) in support of our drug discovery programs.

(...)"


www.glpg.com/careers-job/job-info/sci...
NielsjeB
10
41st European Cystic Fibrosis Conference
www.professionalabstracts.com/ecfs201...

07.06.2018, 10:30 – 12:00
Mix and match! Combination CFTR modulation therapies and new trials
Galapagos : new study results/development pipeline
Katja Conrath, Mechelen, Belgium

07.06.2018, 15:00 – 16:30
Exciting news from CFTR modulator clinical trials
WS01.4 - GLPG2222 in subjects with cystic fibrosis (CF) and the F508del/ClassIII mutation on stable treatment with ivacaftor: results from a phase II study (ALBATROSS)


Abstracts worden 5 juni pas vrijgegeven. Mogelijk ook nog late breakers, de deadline daarvoor is nog niet verstreken.
Opop
5
Coming of Age for Autotaxin and Lysophosphatidate Signaling: Clinical Applications for Preventing,Detecting and Targeting Tumor-Promoting Inflammation. Published: 15 March 2018

In this review, we will summarize recent advances made in understanding LPA signaling with respect to chronic inflammation and cancer.
Overall, LPA, a simplemolecule thatmediates a plethora of biological effects, can be targeted at its levels of production by autotaxin, LPA receptors or through LPA degradation by lipid phosphate phosphatases. Drugs for these applications will soon be entering clinical practice.

Pharmacological Targeting of LPA-Mediated Inflammation and Cancer Progression:
Blz 13, 7.4. Inhibitors of LPA Signaling Entering into Clinical Trials:
The number of inhibitors against LPA signaling has now reached a critical mass, such that the first ATX and LPA receptor inhibitors have entered clinical trials [16] (Table 1). Galapagos NV have tested the first ATX inhibitor, GLPG1690, currently in Phase II trials for idiopathic pulmonary
fibrosis (IPF) [198] (Table 1). In a blelomycin-induced pulmonary fibrosis murine model, an analog of GLPG1690 reduced extracellular matrix deposition in the lung by nearly 50% and reduced the concentrations 18:2-LPA in bronchoalveolar lavage fluid by nearly 70%

Conclusions: In summary, we are at an exciting time where several therapeutics are in advanced clinical trials for blocking LPA signaling and inflammation. These agents are generally well tolerated and they could be tested as novel strategies for improving the effectiveness of existing cancer therapies. These approaches should be applicable to a wide variety of cancers since they target the tumor environment, which should be relatively independent of the specific mutation in the cancer cells. Overall, as mitigators of chronic
inflammation, inhibitors of LPA signaling could become viable therapeutic modalities for preventing cancer initiation, maintaining the efficacy of chemotherapy and radiotherapy and prolonging remission.

www.google.nl/url?sa=t&rct=j&...

Was mij onbekend, nieuwe inzichten?
aston.martin
4
quote:

Opop schreef op 18 maart 2018 14:31:

Coming of Age for Autotaxin and Lysophosphatidate Signaling: Clinical Applications for Preventing,Detecting and Targeting Tumor-Promoting Inflammation. Published: 15 March 2018

In this review, we will summarize recent advances made in understanding LPA signaling with respect to chronic inflammation and cancer.
Overall, LPA, a simplemolecule thatmediates a plethora of biological effects, can be targeted at its levels of production by autotaxin, LPA receptors or through LPA degradation by lipid phosphate phosphatases. Drugs for these applications will soon be entering clinical practice.

Pharmacological Targeting of LPA-Mediated Inflammation and Cancer Progression:
Blz 13, 7.4. Inhibitors of LPA Signaling Entering into Clinical Trials:
The number of inhibitors against LPA signaling has now reached a critical mass, such that the first ATX and LPA receptor inhibitors have entered clinical trials [16] (Table 1). Galapagos NV have tested the first ATX inhibitor, GLPG1690, currently in Phase II trials for idiopathic pulmonary
fibrosis (IPF) [198] (Table 1). In a blelomycin-induced pulmonary fibrosis murine model, an analog of GLPG1690 reduced extracellular matrix deposition in the lung by nearly 50% and reduced the concentrations 18:2-LPA in bronchoalveolar lavage fluid by nearly 70%

Conclusions: In summary, we are at an exciting time where several therapeutics are in advanced clinical trials for blocking LPA signaling and inflammation. These agents are generally well tolerated and they could be tested as novel strategies for improving the effectiveness of existing cancer therapies. These approaches should be applicable to a wide variety of cancers since they target the tumor environment, which should be relatively independent of the specific mutation in the cancer cells. Overall, as mitigators of chronic
inflammation, inhibitors of LPA signaling could become viable therapeutic modalities for preventing cancer initiation, maintaining the efficacy of chemotherapy and radiotherapy and prolonging remission.

www.google.nl/url?sa=t&rct=j&...

Was mij onbekend, nieuwe inzichten?
Hoewel pas gepubliceerd, staat in dit artikel behoorlijk wat informatie die ondertussen achterhaald is.

De verschillende producten die de LPA moleculen blokkeren blijken niet of nauwelijks te werken. Dit schijnt niet de juiste invalsweg te zijn omdat er verschillende varianten bestaan van LPA (die niet allemaal tegelijkertijd kunnen geblokkeerd worden). Autotaxin (de weg die Galapagos volgt) kan dit wel.
Het kandidaatmedicijn van Bristol-Myers Squibb (een LPA inhibitor) faalde in IPF patiënten.

Voor zover mij bekend is Galapagos op dit ogenblik de enige speler van betekenis in het ATX/LPA domein met GLPG1690 dat fase 3 gaat beginnen in IPF.

Andere ATX remmers die in het artikel genoemd worden zijn van PharmAkea dat een samenwerking had met Celgene.
Volgens de laatste info op de website van PharmAkea heeft Celgene zijn optie op een licentie echter niet uitgeoefend. Als gevolg hiervan is PharmAkea sinds eind augustus actief op zoek naar andere partners. Tot nog toe zonder resultaat.

[verwijderd]
1
De GLPG1690 data die genoemd wordt is al bekend (publicatie uit 2017 wordt aangehaald). Ik weet niet of het artikel meteen impliceert dat GLPG1690 in het specifiek voor combinatie therapie voor kanker kandidaat is, maar meer dat het als voorbeeld wordt genoemd van middelen die een target (ATX-LPA) hebben dat (het target dus) o.a. op het gebied van kankerbehandeling een rol zou kunnen spelen.
Opop
1
quote:

asti schreef op 18 maart 2018 16:12:

De GLPG1690 data die genoemd wordt is al bekend (publicatie uit 2017 wordt aangehaald). Ik weet niet of het artikel meteen impliceert dat GLPG1690 in het specifiek voor combinatie therapie voor kanker kandidaat is, maar meer dat het als voorbeeld wordt genoemd van middelen die een target (ATX-LPA) hebben dat (het target dus) o.a. op het gebied van kankerbehandeling een rol zou kunnen spelen.
Dank voor jullie reactie aston.martin en asti.

Ja, het ging mij om de conclusie dat GLPG1690 (testresultaten) kan worden gebruikt in een nieuwe aanpak voor het verbeteren van bestaande kankertherapieën.
aston.martin
5
quote:

Opop schreef op 18 maart 2018 16:46:

[...]

Dank voor jullie reactie aston.martin en asti.

Ja, het ging mij om de conclusie dat GLPG1690 (testresultaten) kan worden gebruikt in een nieuwe aanpak voor het verbeteren van bestaande kankertherapieën.
Kanker behoort in ieder geval niet tot de kernactiviteiten van Galapagos.

Een eventuele toepassing van GLPG1690 in dit domein zou dan alleszins via een samenwerking met een groot farma- of biotechbedrijf moeten verlopen.
Gezien mijn opmerking over de Celgene - PharmAkea alliantie, of beter gezegd het stopzetten daarvan, geloof ik hier niet erg in.

Positieve resultaten met ‘1690 in andere vormen van fibrose (dus naast IPF) zou al een zeer groot succes zijn.
De POC resultaten moeten in fase 3 trouwens nog bevestigd worden.

Los hiervan: de functie van chef marketing voor fibrose blijkt ondertussen ingevuld te zijn. Ook de functie van hoofd marketing ontstekingsziekten trouwens.

k61
0
Beyond Kite, many other takeover targets exist. It could buyout the rest of Galapagos (GLPG) for the rights to Rheumatoid Arthritis and Crohn's Disease drug filgotinib. If approved, filgotinib is projected to reach peak sales of nearly $3 billion. Galapagos has a market cap around $5.3 billion of which Gilead already owns 13% under a prior deal. Assuming a 30% premium, an acquisition of Galapagos would only cost around $7 billion in total, barely a dent in Gilead's large wallet. Management has been rather slow when pulling the trigger on these types of deals. But now with dwindling product sales every year, it is crucial that they do something to stop the bleeding.
andelopendeband
0
quote:

k61 schreef op 19 maart 2018 19:07:

Beyond Kite, many other takeover targets exist. It could buyout the rest of Galapagos (GLPG) for the rights to Rheumatoid Arthritis and Crohn's Disease drug filgotinib. If approved, filgotinib is projected to reach peak sales of nearly $3 billion. Galapagos has a market cap around $5.3 billion of which Gilead already owns 13% under a prior deal. Assuming a 30% premium, an acquisition of Galapagos would only cost around $7 billion in total, barely a dent in Gilead's large wallet. Management has been rather slow when pulling the trigger on these types of deals. But now with dwindling product sales every year, it is crucial that they do something to stop the bleeding.
Bron aub.
nelis h
0
quote:

andelopendeband schreef op 19 maart 2018 19:36:

[...]

Bron aub.
even googlen op een deel van de tekst:

seekingalpha.com/article/4157512-biot...

maar direct een link erbij zou comfortabel zijn
k61
0
quote:

nelis h schreef op 19 maart 2018 19:48:

[...]

even googlen op een deel van de tekst:

seekingalpha.com/article/4157512-biot...

maar direct een link erbij zou comfortabel zijn
Ja hier heb je een punt Nelis, toch vond ik dit stukje tekst het meest relevant in het geheel, vandaar copy-paste
Gr k61
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