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CELYAD MEI 2016

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  1. [verwijderd] 19 mei 2016 07:21

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    Celyad announces first quarter 2016 business update

    Significant progress made in NKR-2 trial
    CHART-1 data readout confirmed end of June 2016

    Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today provides an update on key clinical and operational developments over the three-month period ended 31 March 2016.
    HIGHLIGHTS OF THE FIRST QUARTER
    ? Infusion and 21 day-safety follow-up of the first patient of the third cohort in NKR-2 Phase I/IIa trial conducted at the Dana Farber Cancer Institute in Boston, USA.
    ? Strategic partnership with Institut Curie in Paris, France, to further develop the Company’s NKR-T pipeline in cellular immunotherapies for cancer.
    ? First US patent relating to a method of producing allogeneic primary human T cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR).
    ? Appointment of 10 leading international immuno-oncology experts to the Company’s Scientific Advisory Board to help guide Celyad’s development of its NKR-T platform.
    ? Certification for C-Cure® non-clinical data from the European Medicines Agency (EMA) and Notification of the EMA of its intent to submit a MAA for C-Cure®.
    ? Reinforcement of the corporate management team with the appointment of Pierre Brynaert as Chief Human Resources Officer, Richard Mountfield as VP of Global Regulatory Affairs and Jean-Pierre Latere as VP of Regenerative Medicine and Medical Devices Franchise.
    Dr. Christian Homsy, Chief Executive Officer of Celyad, commented: “The first quarter of 2016 has been a very productive period for Celyad. We successfully met our operational milestones in our NKR-2 trial and also established some key strategic collaborations and assets as we continue to make progress across our development programs.
    “We are surrounding ourselves with top international experts and partners to achieve our clinical and business development aims for our novel pipeline, as well as building strong patent portfolios which we believe will position Celyad as a major player in the field of regenerative medicine and immuno-oncology.

    “We now look forward to the expected announcement of the topline data from our CHART-1 Phase III trial and the safety and feasibility data on the first doses in our NKR-2 Phase I/IIa study at the end of June.”
    Patrick Jeanmart, Chief Financial Officer of Celyad, added: “We are delighted to report for the first quarter of 2016 a cash position in line with our expectations. We also paid during this first quarter the first clinical development milestones related to our NKR-2 clinical trial, which demonstrates the significant progress made in the clinical development of NKR-2.”
    OPERATIONAL AND FINANCIAL REVIEW
    Over the first quarter, Celyad has made significant progress in the preclinical and clinical development of its NKR-T platform. The Company successfully completed the safety follow-up of the patients of the second dose level cohort in NKR-2 T-Cells Phase I/IIa trial, a dose escalation study evaluating the safety and feasibility of the NKG2D receptor in cancer patients suffering from Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM). No dose limiting toxicity was reported of the second dose level.
    The Company also reported the completion of the 21-day safety follow-up of the first patient enrolled in the third dose level in the Phase I/IIa clinical trial. No treatment related safety issues were reported.
    In March, the Company strengthened its patent portfolio having been granted, by the U.S. Patent and Trademark Office (USPTO), the first U.S. patent relating to a method of producing allogeneic primary human T cells that are engineered to be T Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR). The first US patent (9,181,527) - that was granted to Celyad in November 2015 - was related to TCR deficient CAR T cells, regardless of the method used to generate them. This new patent fosters Celyad’s coverage for its proprietary CAR T cells by broadly protecting methods for making these modified allogeneic T cells, and providing them as medicines. The resulting products may benefit patients with various human disease conditions, particularly cancer. By reinforcing its patent portfolio in the CAR-T field, Celyad confirms its leadership in engineered cell therapy, and in the allogeneic CAR T space.
    Celyad also announced a strategic partnership with the Inserm “Cancer and Immunity” Unit of Institut Curie in Paris, France, to further develop its NKR-T pipeline in cellular immunotherapies for cancer. Through this partnership, Celyad and Institut Curie will pool their expertise to progress Celyad’s immuno-oncology pipeline with the aim of bringing novel cellular immunotherapies to cancer patients. The partnership will build on Institut Curie’s first-in-class expertise and state of the art translational, preclinical and clinical know-how in cancer biology and immunology, as well as Celyad’s widely recognized cell therapy and cell manufacturing capabilities.
    In March, Celyad notified the European Medicines Agency (EMA) of its intent to submit a Market Authorization Application (MAA) for C-Cure® in November 2016.

    During the first quarter of 2016, Celyad reinforced its management team with the appointment of Pierre Brynaert as Chief Human Resources Officer, Richard Mountfield as Vice President of Global Regulatory Affairs and Jean-Pierre Latere as Vice President of Regenerative Medicine and Medical Devices Franchise.
    The Company ended the quarter with €94.7 million in cash. Use of cash of the quarter amounts to €12.8 million, of which €7.4 million cash used to finance the operations of the Group. In January, the Company paid its first clinical development milestone ($5.0 million) to Celdara Medical Inc, former owner of the NKR-T technology platform. Investments made in capital expenditures over the quarter amounted to €0.8 million.
    EVENTS SUBSEQUENT TO QUARTER-END
    The Company recently reiterated its market guidance regarding the availability of C-Cure® CHART-1 data. CHART-1 data readout in expected by end of June 2016.
    In April, Celyad received certification for C-Cure non-clinical data from the European Medicines Agency (EMA). This certification is the second of three modules, following the certification of quality data obtained in May 2014, made in preparation for a marketing application. It provides confirmation that the Committee for Advanced Therapies (CAT), recognizes that the C-Cure® development program continues to meet the rigorous standards set by the EMA for a successful development and submission package.
    Also in April, Celyad announced the appointment of 10 leading international Immuno-Oncology experts to its Scientific Advisory Board in order to develop its NKR-T platform and potentially open the path to new treatment options for cancer patients. (Dr. Hinrich Abken, Dr. Scott Antonia, Dr. Marco Davila, Dr. Stéphane Depil, Dr. Marc Ernstoff, Dr. David Edward Gilham, Dr. Sebastian Kobold, Dr. Daniel Olive, Dr. Charles Sentman and Dr. Jeffrey S. Weber).
  2. Zo gaat dat 19 mei 2016 09:26

    • Zo gaat dat

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    “We now look forward to the expected announcement of the topline data from our CHART-1 Phase III trial and the safety and feasibility data on the first doses in our NKR-2 Phase I/IIa study at the end of June.”

    Dus Mid 2016 is echt Mid 2016 ;-)
  4. [verwijderd] 19 mei 2016 18:28

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    €44 dat gaat richting en mogelijk bijkoop moment.
    Helaas wordt het algemene sentiment er niet beter op.
    Ook de biotech (NBI weer onder de 2700) staat weer onder druk.
  6. [verwijderd] 20 mei 2016 22:27

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    quote:

    Zo gaat dat schreef op 19 mei 2016 20:58:

    Ik wacht nog even aan de zijlijn. Maar zorg wel dat ik voor juni er weer in zit.
    Je hebt gelijk. Herstelletje vandaag maar nasdaq gaat even diep in de min.
    De correlatie tussen koers VS en EU is voor mij een raadsel. Maar goed soit.
    Nog 5 weken.
  9. [verwijderd] 26 mei 2016 10:37

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    Celyad successfully completes safety follow-up of the third dose level of its NKR-2 Trial
    * The trial is a dose escalation study evaluating safety and feasibility of NKR-2 T-cell therapy in patients with Acute Myeloid Leukemia or Multiple Myeloma.
    * No dose limiting toxicity reported in the last patient of the third dose level.
    * Process to enroll the first patient of fourth dose cohort has commenced.

    Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced the completion of the 21-day safety follow-up of the last patient enrolled in the third dose level cohort in its Phase I/IIa clinical trial evaluating the safety and feasibility of its NKR-2 T-cell therapy using T-cells with NKG2D receptor in Acute Myeloid Leukemia and Multiple Myeloma patients. No safety issues were reported.

    Dr. Christian Homsy, CEO of Celyad: “The study is progressing as planned, with the third dose level successfully completed and the upcoming initiation of the fourth dose level cohort, and no adverse safety signals observed so far for the 9 treated patients. We are now preparing the next dose levels and look forward to the data that are expected in the next few months.”

    Dr. Frédéric Lehmann, Head of Immuno-Oncology at Celyad: “We are pleased that no adverse safety signal has been reported for the patients of the third dose of this first-in-human Phase I/IIa study. This technology has great potential in multiple cancer indications and we look forward to completing this Phase I/IIa and moving to the next stage of our clinical development. I am grateful to our principal investigator who has positioned us so well to complete the fourth dose by mid-2016.”

    About Celyad’s NKR-T program
    NKR stands for Natural Killer Receptor. NKG2D CAR T-cells are now called NKR-2 T-cells and the product development name is NKR-2.
    Existing CAR-T cells are engineered using constructs encoding an antibody single chain variable fragment, the signaling domain of CD3 zeta and one or more co-stimulatory domain(s). In contrast to existing CAR-T cells, Celyad’s lead immuno-oncology product candidate, NKR-2, is a T-Cell encoded to express the human Natural Killer activating receptor, NKG2D. Using the human Natural Killer cell receptor, unlike traditional CAR technologies, has the potential to:
    * Bind to 8 different ligands that are expressed by a vast majority of cancer cells, both hemaetological and solid malignancies.
    * Target and kill tumors as well as the blood vessels that feed them and also express the ligands of the NKG2D receptor.
    * Target and kill the inhibitory mechanisms preventing the tumor from evading the immune system.
    * Induces adaptive auto-immune response thanks to the creation of a long term cell memory against the targeted tumor.
    The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications. NKR-2 has an active Investigational New Drug (IND) application with the FDA for a Phase I clinical trial. The full data readout from the Phase I dose escalation trial is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKR-2 in acute myeloid leukemia and multiple myeloma patients, with secondary endpoints including clinical activity.The safety follow-up period post-infusion has been decreased to 21 days after approval by the U.S. Food and Drug Administration (FDA) and Institutional Review Board (IRB).
  10. Zo gaat dat 27 mei 2016 13:11

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    Op dit slappe dagje toch maar weer gedeeltelijk ingestapt. Koers blijft goed liggen rond 45,50 en ik wil slag eind juni bij afronding Phase III niet missen. Bij positieve resultaten moeten 50+ koersen haalbaar zijn.
  12. [verwijderd] 27 mei 2016 15:20

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    quote:

    Zo gaat dat schreef op 27 mei 2016 13:11:

    Op dit slappe dagje toch maar weer gedeeltelijk ingestapt. Koers blijft goed liggen rond 45,50 en ik wil slag eind juni bij afronding Phase III niet missen. Bij positieve resultaten moeten 50+ koersen haalbaar zijn.
    Idem. Nog 5 weken.
  14. [verwijderd] 27 mei 2016 19:47

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    Na recente koersstijging Galapagos nu posities wat afbouwen en richting eind juni langzaam posities in Celyad uitbreiden.

    N.B. Geen zorgen over KBC. Analist Jan de Kerpel is erg conservatief met zijn koersdoelen.
  16. tonneke 27 mei 2016 23:56

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    Natte krant en Dr Bob denken jullie dat Celyad meer en harder gaat stijgen dan Glpg, zo ja waarom dan.
  17. [verwijderd] 29 mei 2016 09:53

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    quote:

    tonneke schreef op 27 mei 2016 23:56:

    Natte krant en Dr Bob denken jullie dat Celyad meer en harder gaat stijgen dan Glpg, zo ja waarom dan.
    Nee dat ik niet Tonneke.
    Eind juni worden resultaten bekendgemaakt. In aanloop naar die datum zou de koers kunnen oplopen mogelijk 5-10%.
    Zijn de resultaten goed dan zal dat wel weer wat consolidatie geven. Zie je bij gala ook.
    Is er minder goed nieuws dan weet je het wel. Het is biotech. Dan is het horror.
    Ik verwacht goed nieuws.
  18. Zo gaat dat 30 mei 2016 08:15

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    Hoi Tonneke,

    Zelf zit ik verhoudingsgewijs zeer dik in GALA en dit houd ik ook zo. Wel verwacht ik voor Celyad een forse stijging als Fase III resultaten positief zijn. De berichten die tot nu toe naar buiten zijn gekomen, laten een gedegen beeld zien van het bedrijf. Celyad blijft ook een zeer volatiel aandeel, die zich lastig laat lezen en waarover (naar mijn mening) relatief weinig informatie op internet te vinden is. Hierdoor houd ik mijn investeringen in Celyad beperkt. Omdat nu binnen een paar weken de resultaten bekend worden, heb ik een deel van mijn Tigenix aandelen verruild voor Celyad.
  19. [verwijderd] 30 mei 2016 10:34

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    CYAD heeft veel korte termijn stijgingspotentieel. Eerst door de grens van 50 euro en dan minimaal een stijging tot 60 euro, maar wellicht 70 euro.
  20. [verwijderd] 30 mei 2016 13:44

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    quote:

    Dr. Bob schreef op 30 mei 2016 10:34:

    CYAD heeft veel korte termijn stijgingspotentieel. Eerst door de grens van 50 euro en dan minimaal een stijging tot 60 euro, maar wellicht 70 euro.
    Wel vandaag is al weer een voorbeeld dat de druk opwaarts is..
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