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Hemofilie B; nog steeds on track?
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uniQure Announces FDA Breakthrough Therapy Designation for AMT-060 in Hemophilia B Print January 30, 2017 07:00 ET | Source: uniQure N.V. LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Jan. 30, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leader in human gene therapy, today announced that AMT-060, its proprietary, investigational gene therapy in patients with severe hemophilia B, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). This designation is based on results from the ongoing, dose-ranging Phase 1-2 study that show sustained increases in Factor IX (FIX), reductions in FIX replacement usage and a near cessation of spontaneous bleeding in patients with severe disease at up to 12 months follow-up. “We are very pleased the FDA has designated AMT-060 a Breakthrough Therapy for patients with hemophilia B,” stated Matthew Kapusta, chief executive officer of uniQure. “The FDA’s decision to prioritize and expedite the review of AMT-060 is an important milestone for uniQure and we are committed to working closely with the FDA to rapidly advance our hemophilia B program into late-stage development.”Phase 1-2 Data Updated clinical data from the ongoing, two-cohort Phase 1-2 trial of AMT-060 were recently presented at the 58th American Society of Hematology (ASH) Annual Meeting. The data included up to 52 weeks of follow-up from the low-dose cohort and up to 31 weeks of follow-up from the second dose cohort. Data from the second-dose cohort show a dose response with improvement in disease state in all five patients, including the discontinuation of precautionary FIX infusions in all four patients that previously required chronic replacement therapy. As of the data cutoff date for the ASH presentation, only one unconfirmed spontaneous bleed was reported during an aggregate of 94 weeks follow-up after discontinuation of prophylactic FIX replacement therapy. All five patients in the low-dose cohort, whose bleedings were previously uncontrolled despite being managed with prophylactic therapy, continue to maintain, constant and clinically meaningful levels of FIX activity for up to 52 weeks post treatment, resulting in a complete cessation of spontaneous bleedings in the last 14 weeks of observation. AMT-060 continues to be well-tolerated, and there have been no severe adverse events. Three out of the total of 10 patients (two in the second-dose cohort and one previously reported from the low-dose cohort) experienced mild, asymptomatic elevations of alanine aminotransferase (ALT) and received a tapering course of corticosteroids per protocol. Importantly, the temporary elevations in ALT were not associated with any loss of endogenous FIX activity or T-cell response to the AAV5 capsid. No patients across either cohort have developed inhibitory antibodies against FIX and no patients screened in the study tested positive for anti-AAV5 antibodies. About Breakthrough Therapy Designation The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) established the Breakthrough Therapy designation to expedite the development and review of new drugs with preliminary clinical evidence demonstrating that they may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. The Breakthrough Therapy designation is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met. According to FDA data for its fiscal year 2016, the Center for Biologics Research and Review received a total of 23 requests for Breakthrough Therapy designation with only 4 designations granted - or 17% of all requests.About Hemophilia B Hemophilia B is a serious and rare inherited disease in males characterized by insufficient blood clotting. The condition can lead to repeated and sometimes life-threatening episodes of external and internal bleeding following accidental trauma or medical interventions. Severe hemophilia is characterized by recurrent episodes of spontaneous joint bleeds, that cause long-term damage to the joints resulting in disabling arthropathy. Bleeds may be fatal if they occur in the brain. The deficient blood clotting results from the lack of functional human Factor IX, or hFIX. Treatment of hemophilia B today consists of prophylactic or on-demand protein replacement therapy, in which one to three times weekly intravenous administrations of plasma-derived or recombinant hFIX are required to prevent bleeding and once daily infusions in case bleeding occurs. Hemophilia B occurs in approximately 1 out of 30,000 live births.
Investors Sour on Data Debut For Dimension’s Hemophilia Gene Therapy Despite the early and in some cases stunning results produced by gene therapy treatments in handfuls of hemophilia patients, significant questions remain about their durability, safety, and how broadly they’ll be used if they are ultimately shown to work. The first human data produced by Dimension Therapeutics, one of several companies developing hemophilia gene therapies, are the latest example. Shares of Cambridge, MA-based Dimension (NASDAQ: DMTX) tumbled more than 49 percent on Tuesday on early data from a Phase 1/2 trial of DTX101, its experimental gene therapy for hemophilia B. DTX101 boosted the levels of the blood-clotting protein Factor IX in six patients. Those on the higher of two tested doses haven’t needed other drugs since getting treatment. But five of the six patients—and all three on the higher of the two tested doses—also saw a rise in liver enzyme levels, indicating an immune reaction to the gene therapy. While none of the five patients have had any safety problems, the liver enzyme spikes have caused a delay for Dimension. The company won’t test an even higher dose of DTX101 in patients until it gets feedback from the FDA. Gene therapy offers the potential of a long-lasting, if not permanent treatment for hemophilia patients, who—depending on how severe their disease is—may need frequent infusions of preventative drugs to stave off dangerous bleeds. A group of experimental gene therapies have been creeping their way forward in clinical trials, accumulating data in dribs and drabs. Spark Therapeutics (NASDAQ: ONCE) and UniQure (NASDAQ: QURE) are the furthest along in hemophilia B, while BioMarin Pharmaceutical (NASDAQ: BMRN) leads the way in the more common hemophilia A. Each experimental therapy has shown promise helping patients produce “meaningful” levels of the clotting proteins Factor IX and Factor VIII, respectively—more than 5 percent of the levels found in normal patients, which many view as the minimum bar for success—over the course of a year or more. And Spark and BioMarin have seen much higher numbers than that, in some cases. But there are caveats: Those results have come in small sample sizes, and they have varied patient to patient. Data today from Dimension show the three patients on a low dose of DTX101 had roughly 3 to 4 percent of normal Factor IX levels a year after treatment. The results are earlier for those on a higher dose: 5 and 8 percent, respectively, for two patients 12 weeks post-treatment; 7 percent for a third patient 7 weeks after DTX101. Additionally, so far, liver enzyme increases have been seen in clinical tests for each of the hemophilia gene therapies. Such increases could indicate that patients’ immune systems were attacking their liver cells, which are the ones that take up the therapeutic gene and churn out the new clotting protein. They’re typically treated with a short course of immunosuppressive steroids and haven’t caused bad side effects so far. But in some cases they’ve stifled a response to gene therapy, which is important because it means that certain gene therapies may not work—or at least won’t work as well as they could—for some patients who develop neutralizing antibodies. It also means that patients who develop those antibodies won’t be eligible for a second dose if the gene therapy wears off. This phenomenon reduces the potential market for the firms developing hemophilia gene therapies. Such immune responses were the impetus behind a deal Spark cut last year with Selecta Biosciences(NASDAQ: SELB), for example. “We continue to explore the therapeutic window for DTX101 as our data mature and in light of the [liver enzyme] rises that appear to be associated with a decline in [Factor IX] activity,” CEO Annalisa Jenkins said in a statement.www.xconomy.com/boston/2017/01/31/inv...
The FDA gives Fast Track Priority to uniQure's Hemophilia B Gene Therapy labiotech.eu/uniqure-fda-hemophilia-g...
Pat. voorkeur,vlgs.Leerink.......
flosz schreef op 9 februari 2017 21:43 :
Pat. voorkeur,vlgs.Leerink.......
Ha, ha, is opgesteld door Spark Therapeutics zelf....."slager die zijn eigen vlees keurt"...kunnen we toch geen waarde aan hechten, dunkt me.
$DMTX Discontinues Clinical Development of DTX101 #HemophiliaB investors.dimensiontx.com/phoenix.zht... The company announced its decision to discontinue the development of DTX101, an investigational AAVrh10-based gene therapy product in development for the treatment of moderate/severe-to-severe hemophilia B. The decision followed the review of the emerging DTX101 Phase 1/2 clinical study data, including the data as of the beginning of May 2017, and the observation that the data would not meet the company’s minimum target product profile for continued development or future commercialization. Dimension plans to present full study findings, including results from ongoing immune and biomarker analyses, at a future scientific conference. “We are disappointed with the outcome of our DTX101 program, addressing an important disease with significant unmet need; however, our Phase 1/2 open-label clinical study did not demonstrate an ability to achieve a minimum target product profile for continued development or future commercialization,” said Annalisa Jenkins, MBBS, FRCP, Chief Executive Officer of Dimension. “We deeply appreciate the participation by the investigators and staff, patients and caregivers who all contributed to the conduct and execution of this Phase 1/2 clinical trial. Further, Dimension remains committed to the hemophilia community through continued investment in the Company’s ongoing IND-enabling activities for DTX201 for hemophilia A, in collaboration with Bayer, and the follow-up of the six patients dosed with DTX101 in the Phase 1/2 clinical trial through an extension study that will monitor all patients for a total of five years.” Dr. Jenkins continued, “We remain excited about the opportunities around our IMD portfolio, which, unlike DTX101, utilizes the AAV8 capsid
Chiesi slides (April 2017) #HemophiliaB #GeneTherapy www.slideshare.net/mobile/timfrobinso...
Paduaaaaa $QURE Hemophilia B Gene Therapy Program To Enter Pivotal Study With FIX-Padua Variant in 2018 globenewswire.com/news-release/2017/1...
In a PhIII showdown with Spark, uniQure switches out its lead gene therapy for hemophilia Bendpts.com/in-a-phiii-showdown-with-s...
$QURE Advancing AMT-061 in Hemophilia B - Slides from October19,2017 CC uniqure.com/investors-newsroom/uniQur...
flosz schreef op 19 oktober 2017 13:05 :
Paduaaaaa
$QURE Hemophilia B Gene Therapy Program To Enter Pivotal Study With FIX-Padua Variant in 2018
globenewswire.com/news-release/2017/1... Ik vind het toch wel een geniale manoeuvre van het $QURE management om in alle luwte te werken aan AMT061 en dan ineens vriend en vijand te verrassen met deze variant op AMT060, maar wel een variant die in potentie superieur is ten opzichte van ieder ander beschikbaar (gentherapeutisch) (pre)klinisch middel op dit moment voor de behandeling van hemofilie B. Waarom superieur: 1. In de HemofilieB populatie is de incidentie van antilichamen tegen de door Qure gebruikte vector (AAV5) erg laag, slechts een paar procent, in vergelijking tot bijvoorbeeld de bioengineered vector van Spark Therapeutics (incidentie circa 40%). Deze antilichamen verminderen de effectiviteit van de gentherapie, en dan zou de aanwezigheid van deze antilichamen een argument kunnen zijn om toediening van het (waarschijnlijk zeer dure) AMT061 in deze groep patiënten niet toe te passsen. UniQure heeft echter al aangetoond dat dat in het geval van AMT060/061 (AAV5) vooral een theoretische kwestie is. Kortom op basis hiervan hoeft Qure geen patiënten met hemofilieB uit te sluiten. Dat maakt de markt groter. Voor de andere gentherapieën die van andere vectoren (dan het door QURE voor deze toepassing gepatenteerde AAV5) gebruik maken is dit nog niet bewezen. 2. Weinig/geen aangetoonde immunologische reactie (reactie van het afweersysteem). Kortom de door AMT060/1 getransfecteerde levercellen, die het stollingseiwit waar het lichaam door een genmutatie te weinig van aanmaakte, worden niet aangepakt door het eigen afweersysteem. De studies van Spark laten zien dat dat geen theoretisch risico is: bij 2 van de 9 door Spark behandelde patiënten trad deze reactie wel op, met een vermindering van productie van het stollingseiwit tot gevolg. 3. gebruik van het Padua-gen zou kunnen leiden tot een verhoogd trombose risico bij een te sterke productie van de stollingsfactor IX. De hierboven geposte slideshow laat zien dat op basis van de data in non-humane studies bij de beoogde therapeutische dosis bij mensen verhoging van het trombose risico als 'unlikely' wordt beschouwd. Kortom qua veiligheidsprofiel lijkt AMT061 hoge ogen te kunnen gooien (zoals dat eigenlijk ook al voor AMT060 gold). Het gebruik van het Padua gen in AMT061 leidt echter ook tot een hogere factor IX activiteit in vergelijking met de Wild-type variant in 060. En in combinatie met een beter veiligheidsprofiel dan SPK-9001 (dat een veel hogere factor IX activiteit opleverde dan AMT060 door gebruik van het Padua-gen) van Spark leidt dit tot een zeer concurrerend middel. Het moet alleen nog wel even in een fase 3 trial worden waargemaakt... Maar intussen, daar nog niet teveel op vooruitlopend, is het denk ik erg knap dat uniQure het voor elkaar heeft gekregen bij FDA en EMA dat (waarschijnlijk op basis van het veiligheidsprofiel van AMT060) met AMT061 de fase 1 en 2 studies (inclusief behoud van fast track/BTD) overgeslagen mogen worden. Volgens mij is zoiets niet eerder vertoond. Waar ik zelf nog nieuwsgierig naar ben is in hoeverre het feit dat QURE een exclusieve licentie voor het gebruik van het Padua-gen heeft verkregen dit ook gevolgen heeft voor het genproduct van Spark. De koers van het aandeel Spark Therapeutics ($ONCE) lijkt onaangedaan door het goede nieuws dat $QURE vorige week naar buiten bracht, ondanks het feit dat SPK-9001 van $ONCE gebruik maakt van deze zelfde (gepatenteerde) genetische variatie. Wie zou daar op dit forum iets meer over kunnen zeggen? Tot slot maakt de aap die QURE vorige week even uit de mouw liet komen mij nieuwsgierig naar de toekomst. Ik ben benieuwd naar wat de disclosure van de tot dusverre undisclosed targets nog gaat brengen. En of AMT061 tot nieuwe, deals met aansprekende partners gaat leiden.
Tex Mex schreef op 24 oktober 2017 00:43 :
[...]
Waar ik zelf nog nieuwsgierig naar ben is in hoeverre het feit dat QURE een exclusieve licentie voor het gebruik van het Padua-gen heeft verkregen dit ook gevolgen heeft voor het genproduct van Spark.
[..]
Strikt genomen spreekt QURE niet van een 'exclusieve licentie' maar van 'Acquisition (of Patent Family)', waarmee ze feitelijk nog sterker staan. Dit zou inderdaad gevolgen kunnen hebben voor Spark (of hun partner).
Prof. Dollar schreef op 24 oktober 2017 09:36 :
[...]
Strikt genomen spreekt QURE niet van een 'exclusieve licentie' maar van 'Acquisition (of Patent Family)', waarmee ze feitelijk nog sterker staan. Dit zou inderdaad gevolgen kunnen hebben voor Spark (of hun partner).
fd.nl/ondernemen/1224013/spectaculair... "Uniqure heeft ook het patent verworven op het Padua-element, een vinding van de Italiaanse hoogleraar Paolo Simioni, die les geeft aan de Universiteit van Padua in Italië. Simioni werkte in het verleden in Amsterdam samen met Van Deventer. Indien Spark Therapeutics gebruik wil maken van hetzelfde Padua-element zal het Amerikaanse biotechbedrijf nu een licentie moeten verkrijgen van uniQure." Dit artikel in FD suggereert in ieder geval hetzelfde. De bron hiervoor wordt mij echter niet duidelijk. Hoe dan ook, ik zal de volgende hemofilie B update van Spark Therapeutics met interesse volgen, met deze omkering van perspectief.
ASH17 abstracts 602 Stable Elevations in FIX Activity and Reductions in Annualized Bleeding Rate over up to 2 Years of Follow-up of Adults with Severe or Moderate-Severe Hemophilia B Treated with AMT-060 (AAV5-hFIX) Gene Therapy ash.confex.com/ash/2017/webprogram/Pa... 2058 Predictable Protein Expression with Enhanced Factor IX Activity Following Administration of a Modified AAV5-hFIX Vector to Nonhuman Primates ash.confex.com/ash/2017/webprogram/Pa...
Advances in Gene Therapy for Hemophilia $QURE $ONCE $SGMO etc.online.liebertpub.com/#/doi/full/10.1... Hemophilia Gene Therapy: Ready for Prime Time? $QURE $ONCE etc.online.liebertpub.com/#/doi/full/10.1... Unraveling the Complex Story of Immune Responses to AAV Vectors Trial After Trial $QURE $ONCE etc.online.liebertpub.com/#/doi/full/10.1...
~ New Nonclinical Data on AMT-061 to be Presented Saturday, December 9, 2017 ~ uniQure Announces Presentations at the 59th American Society of Hematology (ASH) Annual Meetingtools.eurolandir.com/tools/Pressrelea...
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