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Celyad BE0974260896

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Celyad 2021

3.900 Posts
Pagina: «« 1 ... 32 33 34 35 36 ... 195 »» | Laatste | Omlaag ↓
  1. forum rang 6 effegenoeg 6 mei 2021 20:52
    quote:

    Stefzele1 schreef op 6 mei 2021 20:48:

    @Kojo2, ik vermoed dat we hier morgen kunnen op traden...
    Als je van de trap valt ben je gauw beneden.
  2. forum rang 4 egeltjemetstekel 6 mei 2021 20:59
    quote:

    TimCh schreef op 6 mei 2021 20:47:

    Galapagos kan straks voor een appel en een ei de pijplijn aanvullen met biotech die niet zo kapitaalkrachtig zijn....
    laten we er maar vanuit gaan dat als dat gebeurt dat eerder gilead degene is .
  3. forum rang 4 egeltjemetstekel 6 mei 2021 22:13
    Celyad Oncology Announces First Quarter 2021 Financial Results and Recent Business Highlights
    May 06, 2021 16:01 ET
    | Source: Celyad Oncology SA

    Enrollment continues in second dose cohort of Phase 1 dose-escalation IMMUNICY-1 trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for relapsed/refractory multiple myeloma (r/r MM); additional proof-of-concept data anticipated in second quarter 2021.
    Expansion segment of Phase 1 alloSHRINK trial evaluating allogeneic CYAD-101 administered concurrently with preconditioning chemotherapy for the treatment of advanced metastatic colorectal cancer (mCRC) ongoing; preliminary data expected in mid-2021.
    Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA® in patients with microsatellite stable mCRC expected to be initiated in first half of 2021.
    MONT-SAINT-GUIBERT, Belgium, May 06, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the “Company”), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced an update on its financial results and recent business developments for the fiscal quarter ended March 31, 2021.

    "We have entered 2021 with ever-increasing enthusiasm around the progress of our programs,” commented Filippo Petti, Chief Executive Officer of Celyad Oncology. “Our lead shRNA-based allogeneic candidate, CYAD-211, which is currently being evaluated in the Phase 1 IMMUNICY-1 trial for the treatment of multiple myeloma, has shown no safety concerns nor evidence of Graft-versus-Host Disease (GvHD) at dose level 1. We look forward to announcing additional proof-of-concept data from this trial by the end of second quarter of 2021. In addition, we have continued to enroll patients in the alloSHRINK expansion trial for CYAD-101 and will turn our attention to the KEYNOTE-B79 trial. Lastly, we are planning an R&D day for this summer that will provide an opportunity for our broader team to offer an in-depth overview of our clinical programs and strategy for advancing our next-generation shRNA platform and allogeneic pipeline.”

    Recent Highlights

    Appointment of Dr. Charles Morris as Chief Medical Officer to lead and provide strategic direction for Celyad Oncology’s medical, regulatory, and clinical development activities.
    Appointment of Marina Udier, Ph.D. to Board of Directors
    Announced a committed equity purchase agreement for up to $40 million in American Depositary Shares (ADSs) with Lincoln Park Capital Fund, LLC (“LPC”)
    First Quarter 2021 Financial Review

    As of March 31, 2021, the Company had cash and cash equivalents of €12.2 million ($14.3 million). Net cash burn during the first quarter of 2021 amounted to €5.1 million ($5.9 million), in line with expectations. In April 2021, the Company raised proceeds of €3.3 million ($4.0 million) from the sale of ADSs to LPC. The Company confirms its previous guidance that its existing cash and cash equivalents combined with the remaining access to the equity purchase agreement established with LPC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements until mid-2022.

    Update on Clinical Programs

    CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

    CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3? component of the T-cell receptor (TCR) complex. The Company is currently conducting the first-in-human, open-label, dose-escalation Phase 1 IMMUNICY-1 trial to evaluate the safety and efficacy of a single infusion of CYAD-211 following preconditioning chemotherapy cyclophosphamide and fludarabine in patients with r/r MM. The trial seeks to determine the recommended dose of CYAD-211 for the treatment of patients with r/r MM for further development as well as to establish proof-of-concept that single shRNA-mediated knockdown can generate allogeneic CAR T cells in humans without inducing GvHD. In March, the Company announced that no safety concerns nor evidence of GvHD had been reported in the first three patients treated at dose level 1 (30×106 cells per infusion) of CYAD-211 in the IMMUNICY-1 trial. In first quarter 2021, the Company initiated enrollment in dose level 2 (100×106 cells per infusion). The Company expects to announce additional proof-of-concept data from the IMMUNICY-1 trial by the end of the second quarter of 2021.

    CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC

    The Company’s first-in-class, non-gene edited clinical candidate, CYAD-101, which co-expresses the NKG2D receptor and the novel inhibitory peptide TCR Inhibitory Molecule (TIM), is currently in the expansion segment of the alloSHRINK Phase 1 trial for the treatment of advanced mCRC. To the Company’s knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication.

    Phase 1 alloSHRINK trial is ongoing, in which the Company is evaluating CYAD-101 following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy in refractory mCRC patients, at the recommended dose of one billion cells per infusion. The Company expects to announce preliminary data from the expansion cohort of the trial in mid-2021.
    Celyad Oncology will also conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI chemotherapy, with MSD’s anti-PD­1 therapy, KEYTRUDA® (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease. The Phase 1b KEYNOTE-B79 trial is expected to be initiated during first half of 2021.
  4. forum rang 4 egeltjemetstekel 6 mei 2021 22:15
    CYAD-02 – Autologous NKG2D receptor-based CAR T for relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndromes (MDS)

    Enrollment is ongoing in dose level 3 of the Phase 1 CYCLE-1 trial for the next-generation, autologous NKG2D receptor-based CAR T candidate CYAD-02. The dose-escalation Phase 1 CYCLE-1 trial is evaluating the safety and clinical activity of CYAD-02 following preconditioning chemotherapy in patients with r/r AML and MDS. To date, treatment with CYAD-02 has been generally well-tolerated. Of seven patients evaluable for clinical activity, five patients demonstrated anti-leukemic activity (at least 50% bone marrow blasts decrease), including a very-high risk MDS patient treated at dose level 3 who achieved a marrow complete response.

    Next-generation shRNA Multiplex Platform

    In 2020, the Company began developing a proprietary shRNA platform utilizing a novel framework to optimize and expand the expression of multiple shRNAs with our All-in-One vector approach. The Company’s novel framework has the capability to knockdown or silence up to six genes simultaneously, while providing several key advantages beyond the Company’s first-generation approach. The Company believes its next-generation shRNA multiplex platform will form the backbone for future allogeneic CAR T candidates, including several programs which are in the discovery phase of development. Our next-generation shRNA platform does not incorporate any of the Horizon Discovery technology.

    Upcoming Milestones

    Additional proof-of-concept data from the initial dose cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected by the end of second quarter of 2021.
    Preliminary data from the expansion segment of the alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients are expected in mid-2021.
    Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA® in mCRC patients with MSS/pMMR disease is anticipated in the first half of 2021.
    Additional data from dose level 3 of Phase 1 CYCLE-1 trial of CYAD-02 for r/r AML and MDS are anticipated in the first half of 2021.
    Financial Calendar

    First Half 2021 Financial Results.................August 4, 2021
    Third Quarter 2021 Financial Results..........November 10, 2021
  5. Stefzele1 6 mei 2021 22:19
    Nie echt negatief nieuws die de daling van 10% in de USA zou kunnen verantwoorden...als ze aandelen aanbieden aan €4,70 wil ik wel graag instappen me dunkt...
  6. Garre 6 mei 2021 22:19
    Nasdaq zegt niet alles, nu nieuws en geen slecht nieuws, wel dat er nieuws komt binnen enkele weken, maar dat wisten we al,
  7. forum rang 5 Hopende 7 mei 2021 06:08
    quote:

    Garre schreef op 6 mei 2021 22:19:

    Nasdaq zegt niet alles, nu nieuws en geen slecht nieuws, wel dat er nieuws komt binnen enkele weken, maar dat wisten we al,
    Jammer dat compleet niets van zich laat horen , is dit het grote nieuws waar ik zat op te hopen, leuke nacht achter de rug is vandaag mijn verjaardag en ik sta op met nog een diepere put ,gaat het hier ook nog eens een extra 7% naar beneden?
  8. Garre 7 mei 2021 06:28
    Kan ook zijn dat het meevalt, er is ook geen slecht nieuws, dan was het anders geweest.
    Ze worden steeds aantrekkelijker om door grote spelers even over te nemen, dus kan zo gebeuren. En ja we willen allemaal omhoog, ik wordt er ook triest van. Gefeliciteerd hopende.
  9. forum rang 5 Hopende 7 mei 2021 06:46
    quote:

    Garre schreef op 7 mei 2021 06:28:

    Kan ook zijn dat het meevalt, er is ook geen slecht nieuws, dan was het anders geweest.
    Ze worden steeds aantrekkelijker om door grote spelers even over te nemen, dus kan zo gebeuren. En ja we willen allemaal omhoog, ik wordt er ook triest van. Gefeliciteerd hopende.
    Thanks
    Jammer dat ik die paar maand niet meer heb , mijn vrouw (ex) geloofd mijn uitleg niet meer en wil het beetje dat nog over is afhalen
  10. Stefzele1 7 mei 2021 07:41
    Enig minpuntje bij Celyad is hun kaspositie die verder slinkt en is een kapitaalsverhoging binnenkort noodzakelijk...@Hopende, gelukkige verjaardag gewenst en maak er één leuke dag van...
  11. forum rang 5 Hopende 7 mei 2021 07:55
    quote:

    Stefzele1 schreef op 7 mei 2021 07:41:

    Enig minpuntje bij Celyad is hun kaspositie die verder slinkt en is een kapitaalsverhoging binnenkort noodzakelijk...@Hopende, gelukkige verjaardag gewenst en maak er één leuke dag van...
    merci dus zowiezo zal het met een kapitaalsverhoging nog zakken dus zullen meer dan een paar maand worden voor het stijgt , hopelijk kunnen jullie je Gak verlagen want ik denk dat ze deze morgend laag gaan open gaan
  12. Garre 7 mei 2021 07:59
    40 miljoen kunnen ze zo deels aanboren, en dat kan op dagkoers volgens mij, dan zou celyad ook wel willen dat de koers iets hoger staat.
    Kan wel even doorzakken maar net zo goed weer redelijk eindigen.
  13. COMPLEET 7 mei 2021 08:00
    Cijfermateriaal heeft niks te maken met hun ontwikkelingen. Koppel eens alles los van die koers. Ken je het Ablynx-verhaal... iedereen maar sjakken en snikken, massaverkoop wegens paniekerij. Die info van gisteren is van geen enkel belang. Hun innovatie in the summer is belangrijk.
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