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Kiadis Pharma« Terug naar discussie overzicht

KIadis naar de €15,00 in november

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  1. Windkracht 29 november 2017 14:48
    Denk dat de beweging vanmiddag hier mee te maken kan hebben. Als de uitkomt postief zou zijn, is dat schitterend nieuws voor Kiadis aangezien zij ook met de anti-CD19 werken.
    Lees vooral het vetgedrukte gedeelte. Decision vandaag dus.
    -------------------------------------------------
    www.onclive.com/web-exclusives/dramat...

    Dramatic Improvement in NHL Outcomes With CAR T-Cell Versus Standard Therapy

    Published Online: Wednesday, Sep 20, 2017
    Print Button
    Sattva S. Neelapu, MD
    Sattva S. Neelapu, MD Treatment with the autologous anti-CD19 CAR T-cell therapy axicabtagene ciloleucel (axi-cel) significantly improved outcomes in refractory non-Hodgkin lymphoma (NHL) compared with standard therapies, a standardized analyses of 2 clinical trials showed.

    Three-fourths of patients treated with axi-cel achieved objective responses as compared with 20% of patients who received standard therapy. More than half of the axi-cel cohort had complete responses versus 6% of conventionally treated patients.

    Standardized survival analyses yielded a 6-month overall survival of 77% with axi-cell and 35% with conventional treatment for refractory NHL, Sattva Neelapu, MD, reported at the 2017 Society of Hematologic Oncology annual meeting.

    “Standardized analyses suggest that treatment with axi-cel in the ZUMA-1 trial yielded 8 to 10 times higher odds ratios for overall response and complete response, respectively, relative to currently available therapies,” Neelapu, associate professor of lymphoma and myeloma at MD Anderson Cancer Center, concluded in a poster presentation.

    “The estimated hazard ratio suggests an overall 77% reduction in the risk of death for patients treated with axi-cell in ZUMA-1 versus those treated with currently available therapies in the SCHOLAR-1 trial. Sensitivity analyses with ECOG performance status as a covariate yielded consistent results.”

    The ZUMA-1 study was the first multicenter pivotal trial of axi-cel (formerly KTE-C19) in patients with refractory, aggressive NHL. Initial results, reported earlier this year at the AACR annual meeting (abstract CT019), showed an 82% objective response rate, including complete responses in 54% of 101 patients.

    Based on data from ZUMA-1, the FDA granted a priority review to axi-cel in May 2017 for transplant-ineligible patients with relapsed or refractory NHL. Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision by November 29, 2017.

    SCHOLAR-1 was a pooled analysis of data for 635 patients with refractory, aggressive NHL treated with currently available therapies. The results showed low response rates and a 2-year survival of 20% (Blood. 2017;doi:10.1182/blood.2017.03.769620 [epub]).

    Neelapu and colleagues analyzed the ZUMA-1 data within the context of outcomes achieved with available therapies used in SCHOLAR-1, performing a comparative analysis that adjusted for imbalances in key covariates.

    The studies had balanced distribution of sex, disease type, and the proportion of patients with disease refractory to 2 consecutive lines of therapy. ZUMA-1 included more patients with 3 or more prior lines of therapy (69% vs 26%), with advanced (stage III-IV) disease (85% vs 67%), and less favorable IPI scores (=3, 48% vs 35%). More patients in ZUMA-1 had transformed follicular lymphoma or primary mediastinal large B-cell lymphoma (24% vs 4%), and more patients in SCHOLAR-1 had primary refractory disease (20% vs 2%).

    The patient population for SCHOLAR-1 comprised 2 phase III trials conducted at centers in the United States and Canada. Patients received available therapies for refractory NHL. Maximum follow-up for survival ranged from 7.6 to 14.8 years across participating centers.

    Patients in ZUMA-1 received the target dose of axi-cel (2 x 106 cells/kg) after low-dose conditioning with cyclophosphamide and fludarabine for 3 days. The modified intention-to-treat population involved 101 patients who received axi-cel. The trial had a median survival follow-up of 8.7 months.

    Standardized analyses included prespecified covariates selected for weighting: refractory disease status and whether a patient proceeded to stem-cell transplant after determination of refractory status. A sensitivity analysis incorporated ECOG performance status as a covariate for standardization.

    The primary analyses showed an objective response rate of 82% and complete responses in 54% of patients in the ZUMA-1 study, compared with 26% and 7% in SCHOLAR-1.

    The standardized comparison yielded an objective response rate of 74% and complete responses in 51% of patients versus 20% and 6% in SCHOLAR-1. The results for overall response rate translated into a standardized difference of 0.55 and an odds ratio of 7.97 in favor of ZUMA-1 (P <.0001). The results for complete response resulted in a standardized difference of 0.45 and an odds ratio of 10.2 in favor of ZUMA-1 (P <.0001).

    The median overall survival had yet to be reached for the ZUMA-1 cohort in either the primary analysis or standardized comparison. Medians for the SCHOLAR-1 study population were 6.3 and 3.9 months, respectively. The 6-month survival in the primary analyses was 80% in ZUMA-1 and 53% in SCHOLAR-1. The standardized comparison yielded 3-month survival of 93% for ZUMA-1 and 60% for SCHOLAR-1, and 6-month survival of 77% and 35% for ZUMA-1 and SCHOLAR-1, respectively (HR, 0.23; P <.0001).
  2. Windkracht 29 november 2017 15:26
    Bericht van 24 november.

    www.creative-biolabs.com/blog/car-t/l...

    There is no doubt that this year marks the beginning of CAR-T therapy owing to the advent of two CAR-T therapies and the changes that these therapies have brought to the lives of patients. However, at the same time, the potential risks of CAR-T itself are also of concern to the industry as a category of innovative therapies.

    Recently, at the annual meeting of the Society of Cancer Immunotherapy (SITC), Dr. Mark Gilbert, chief medical officer of Juno Therapeutics, shared the results of JCAR015 therapy. Last year, more than one patient died in clinical trials, leaving the development of the therapy stalled. Nowadays, the experience and lessons learned from setbacks can be applied not only to the latest CAR-T therapy of Juno, but also to the whole field of CAR-T therapy.

    “We’ve always believed that many factors led to the results of clinical trials,” Dr. Gilbert said. “But we did not find these factors until now.”

    Dr. Gilbert refers to brain edema that occurs in clinical trials. As Dr. Stephan Grupp, another CAR-T therapeutics expert, says, “this symptom is totally unexpected”.

    The latest analysis of Juno indicates that these symptoms are associated with the excessive growth of CAR-T cells in which IL-15 plays a key role. This protein is an important growth factor for T cells. When the patient’s IL-15 levels are elevated, T cells will prematurely and rapidly expand.

    “We want to see CAR-T cells peak on the 11th, 12th and 14th days,” said Dr Gilbert. “That’s exactly what we saw in the TRANSCEND trial of JCAR017. In the JCAR015 ROCKET trial, cells were expanded to peak in seventh days in some patients, and such amplification was what we wanted to avoid. ” The analysis also shows that IL-15 levels are associated with the combination of fludaribine and cyclophosphamide. To this end, Juno configured a milder lymphocyte clearance program for the subsequent CAR-T trial.

    In the meantime, Juno is also trying a more personalized cell therapy: researchers will tailor a set of therapies based on the type of cancer, age, disease burden, antigen levels and other factors of the patient, for treatment. In this way, we can reduce the risk of premature CAR-T cell expansion.

    “It’s great that Juno can publish this information,” commented Dr. Grupp. For other companies developing CAR-T therapies, testing of patients’ IL-15 levels before treatment is also expected to improve the therapy safety. The insights that Juno draws from his painful experience are valuable assets for the entire field, and we are also looking forward to the JCAR017 on sale to benefit more patients.
  3. Windkracht 29 november 2017 15:37
    Regelmatig post ik berichten zoals hierboven. Dit doe ik om met elkaar de ontwikkelingen bij te houden. Als dergelijke berichten/artikelen op dit forum gewaardeerd worden, ga ik hier graag mee door. kunnen jullie dit kenbaar maken door dit bericht te liken? Ik ga er graag mee door, maar alleen als daar behoefte aan is.
  4. Windkracht 29 november 2017 16:00
    ;-) ik zelf ook.
    Heb even gegoogled op CAR-t en de maand november; De hoeveelheid berichten geeft wel aan dat dit echt wel 'hot' is. Nu heb ik mijzelf nogmaals overtuigd om zeker te blijven zitten in Kiadis. Vandaag weer 1000 stuks bijgekocht.

    Even een korte stijging van en paar procent en dat niveau vasthouden zou inderdaad ook wel even mooi zijn. De dag is nog niet voorbij.
  5. [verwijderd] 29 november 2017 16:10
    quote:

    emergo schreef op 29 november 2017 16:06:

    Voor nieuwe kopers:
    lees je goed in.
    Dit is een uitermate slecht verhandelbaar flutaandeel.
    Dat zeiden ze ook bij pharming. Maar blijf vooral weg van dit flutaandeel. Wij wachten rustig af op de goedkeuring, en gezien de lage free float is het dan zo goed als zeker dat mensen de boot gaan missen.
  6. forum rang 4 DWB Happy 29 november 2017 18:59
    quote:

    emergo schreef op 29 november 2017 16:06:

    Voor nieuwe kopers:
    lees je goed in.
    Dit is een uitermate slecht verhandelbaar flutaandeel.
    Gemiddeld dagvolume is op dit moment bijna 200K.
    1 jaar geleden werd dat amper in 1 week gehaald.

    Een aandeel met een laag dagvolume is inderdaad niet geschikt voor een belegger met een KT horizon, zoiets moet je van te voren goed inschatten, anders kom je snel klem te zitten.

    Een beetje belegger neemt die zaken mee voordat hij in een aandeel stapt,
    dagvolumes en volaiteit.

    Het aandeel is goed, alleen dus niet geschikt voor jou, beleggen is vaak geduld leren hebben.

  7. Huil maar niet 29 november 2017 19:24
    Koersdoel ver hoging
    Het Kiadis Pharma- aandeel bereikte 0,36% tot 7,90 euro. De Amerikaanse makelaar Chardan begon de waarde te volgen met een aanbeveling om te "kopen". De richtprijs is vastgesteld op 19 euro, wat de meest optimistische mening is van analisten van Bloomberg.

    www.lecho.be/les-marches/homepage/Bio...
  8. [verwijderd] 29 november 2017 20:22
    Over de laatste emissie:

    Jefferies International Limited is acting as Sole Bookrunner and Canaccord Genuity Limited and Oppenheimer & Co. Inc. are acting as Lead Managers in connection with the Placing. Chardan and Saola Healthcare Partners are acting as financial advisors to the Company.
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