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Home  /   Forum   /   Celyad   /   CELYAD 2019 Nieuws

Aandeel Celyad BRU:CYAD.BL, BE0974260896

Laatste koers (eur) Verschil Volume
0,882   +0,212   (+31,64%) Dagrange 0,740 - 1,220 1.063.349   Gem. (3M) 32K

CELYAD 2019 Nieuws

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4.226 Posts
Pagina: «« 1 ... 85 86 87 88 89 ... 212 »» | Laatste | Omlaag ↓
  7. Dannyb44 5 november 2019 14:02


    Management to host webcast on Saturday, Nov. 9, at 12:35 p.m. ET/ 6:35 p.m. CET

    Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced that abstracts highlighting clinical and translational research data from the company’s pipeline of NKG2D-based candidates focused on the treatment of metastatic colorectal cancer (mCRC), including the allogeneic cell therapy CYAD-101, were published today ahead of the Society for Immunotherapy of Cancer’s 34th Annual Meeting (SITC).

    Filippo Petti, chief executive officer at Celyad, commented, “We are excited to provide additional updates at the upcoming SITC annual meeting from our current CAR-T program in metastatic colorectal cancer, including translational data from multiple approaches we have pursued with our NKG2D-based candidates for the treatment of the disease. Over the past few years, we have treated over thirty metastatic colorectal cancer patients within the program assessing various conditions. We continue to be encouraged by the results and prospects for the program and, in particular, from clinical data of our lead allogeneic candidate CYAD-101 where we have observed an absence of graft versus host disease and preliminary signals of clinical activity in a refractory, difficult to treat patient population.”



    SITC Analyst/Investor Event and Webcast Information

    Celyad will host an analyst/investor event on Saturday, Nov. 9, 2019, beginning at 12:35 p.m. ET / 6:35 p.m. CET to review both clinical and translational data that will be presented at the SITC 34th Annual Meeting. The event will be webcast live and can be accessed under Events & Webcasts in the Investors section of the Company’s website.



    Poster Presentation Details

    The following abstracts published today are now available on the SITC website, www.sitcancer.org/2019. Following presentation at the meeting, the posters will be available in the library section of Celyad’s website.
    Abstract P147: Effect of chemotherapy on cellular kinetics of NKG2D-based CAR T-cells in metastatic colorectal cancer patients
    Date & Time: November 8, 7 a.m. – 8 p.m. ET

    Abstract P331: Results from the completed dose-escalation phase I SHRINK study evaluating the autologous NKG2D-based CAR T-cell therapy CYAD-01 in metastatic colorectal cancer patients
    Date & Time: November 8, 7 a.m. – 8 p.m. ET

    Abstract P330: Results from the completed dose-escalation of the alloSHRINK phase I study evaluating the allogeneic NKG2D-based CAR T-cell therapy CYAD-101 in metastatic colorectal cancer patients
    Date & Time: November 9, 7 a.m. – 8:30 p.m. ET



    Background on SHRINK and alloSHRINK Trials

    SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients are planned to receive consecutive cycles of FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy every two weeks concurrently with multiple administrations of CYAD-01.

    alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of three consecutive administrations of CYAD-101 every 2 weeks administered concurrently with FOLFOX chemotherapy in patients with refractory mCRC.
  9. Speedbul 5 november 2019 15:44
    Results
    35 mCRC patients have been treated in THINK (14), SHRINK (9) and ALLOSHRINK (12). Preliminary results are available for 29 subjects. Cell kinetics for subjects having received one injection of autologous CAR T-cells show a seven-fold increase in mean peak levels of T-cell engraftment with CyFlu compared to FOLFOX. Mean AUC is four times higher with CyFlu compared to FOLFOX. Peak levels of engraftment and persistence observed with FOLFOX and without previous chemotherapy are similar. Additionally, allogeneic CAR T-cells exhibit a five-fold increase in mean AUC and a ten-fold increase in mean peak levels compared to autologous cells with the same prior chemotherapy regimen. Additional analyses will be presented during the congress.
  10. Speedbul 5 november 2019 15:50
    Conclusions
    Analyses of the initial 29 patients receiving either autologous or allogeneic NKG2D-based CAR T-cells demonstrate that CyFlu enhances peak levels and persistence of adoptively transferred cells. FOLFOX does not appear to influence engraftment or persistence of CAR T-cells. Allogeneic CAR T-cells show higher peaks and time-averaged persistence compared to autologous cells. Analysis of the results is ongoing.
  13. Speedbul 5 november 2019 16:08
    ID: P330
    Results from the completed dose-escalation of the alloSHRINK phase I study evaluating the allogeneic NKG2D-based CAR T-cell therapy CYAD-101 in metastatic colorectal cancer patients

    Hans Prenen, MD, University Hospital Antwerp (UZ Antwerp), Marika Rasschaert, MD, Alain Hendlisz, MD, Leila Shaza, MD, Erik Alcantar-Orozco, MD, PhD, Emilie Cerf, PhD, Florence Renard, Caroline Lonez, PhD, Anne Flament, Jeroen Dekervel, MD, Eric Van Cutsem, MD, PhD

    Background
    Current success of chimeric antigen receptor T-cell (CAR-T) therapy in hematological malignancies has been achieved using autologous cell products. Whilst feasible in such relatively small patient populations, delivering an autologous product to large cohorts of patients is likely beyond the current logistical capabilities. In the phase 1 alloSHRINK study, we tested the first-in-class non-gene edited allogeneic CAR T-cell therapy, CYAD-101, administered concurrently with chemotherapy, for the treatment of metastatic colorectal cancer (mCRC). The NKG2D-based CAR of CYAD-101 targets eight ligands present at high frequencies in mCRC, not only on tumor cells but also cells from the tumor microenvironment, and co-express a T-cell receptor (TCR) inhibiting molecule (TIM) that interferes with TCR signaling in an attempt to avoid the main issue of allogeneic T-cell therapy, the graft versus host disease (GvHD).

    Methods
    The alloSHRINK study (NCT03692429) evaluates the safety and clinical activity of multiple infusions of CYAD-101, administered concurrently with standard of care FOLFOX chemotherapy, in patients with non-resectable mCRC who received prior chemotherapy lines (i.e. rechallenge population). Three dose-levels (DL; 1x10E8, 3x10E8 and 1x10E9 T-cells per infusion) were evaluated through a 3+3 design.

    Results
    In total 12 patients have been enrolled in the dose escalation segment, now completed (3 at DL1, 3 at DL2 and 6 at DL3). At the time of submission, only data from the first two DLs were available. At DL1 and DL2, there was no report of dose-limiting toxicity (DLT) and no patient experienced Grade = 3 related adverse events (uncleaned database). No clinical evidence of GvHD has been recorded. Best overall response = 3 months include 1 partial response and 3 stable disease over the first 6 patients (DL1 and 2). At DL1 and 2, preliminary data show a dose-dependent effect on the cell kinetics and control of the host-versus-graft response against CYAD-101 cells as evidenced by the similar levels of CYAD-101 engraftment after 2nd and 3rd infusions.

    Conclusions
    As of August 2019, no GvHD has been observed following infusions of non-gene edited allogeneic CAR T-cells to mCRC patients at the first two DLs, with preliminary signals of clinical activity. The study will have reached protocol-specified endpoints for analysis at the time of presentation and safety, clinical and cell engraftment will be presented. The results from this study, in comparison with a study evaluating the autologous analog of CYAD-101 in mCRC will provide critical information to support the development of CAR-T therapy in solid tumors.
  14. Speedbul 5 november 2019 16:13
    ID: P331
    Results from the completed dose-escalation phase I SHRINK study evaluating the autologous NKG2D-based CAR T-cell therapy CYAD-01 in metastatic colorectal cancer patients

    Leila Shaza, MD, Institut Jules Bordet, Alain Hendlisz, MD, Ahmad Awada, MD, PhD, Jean-Luc Canon, MD, Javier Carrasco, Eric Van Cutsem, MD, PhD, Jeroen Dekervel, MD, Erik Alcantar-Orozco, MD, PhD, Florence Renard, Emilie Cerf, PhD, Caroline Lonez, PhD, Anne Flament, Marc Van den Eynde, MD, Jean-Pascal Machiels, MD, PhD

    Background
    Chimeric antigen receptor T-cell (CAR-Ts) therapies have yet to demonstrate positive results in the context of solid tumors largely due to the lack of suitable target antigens. NKG2D-based CARs target 8 stress ligands notably expressed to a very high frequency across the metastatic colorectal cancer (mCRC) patient population. The autologous NKG2D-based CAR-T therapy CYAD-01 achieved stable disease in several patients with mCRC when given as a monotherapy in a multiple injection setting without any other supportive therapy (THINK study). In the SHRINK phase 1 study, CYAD-01 was given concurrently with FOLFOX chemotherapy.

    Methods
    The SHRINK phase 1 study (NCT03310008) evaluated the safety and clinical activity of multiple infusions of CYAD-01, administered concurrently with FOLFOX chemotherapy in mCRC patients. Three dose-levels (DL; 1x10E8, 3x10E8 and 1x10E9 T-cells per infusion) were evaluated through a 3+3 design in two different mCRC patient populations: (i) resectable liver dominant mCRC with FOLFOX chemotherapy as 1st line treatment (i.e. neoadjuvant population), and (ii) non-resectable mCRC with prior chemotherapy lines for mCRC including FOLFOX and/or FOLFIRI (i.e. rechallenge population).

    Results
    The three DL have been completed with 9 patients in total (3 at each DL), without any report of dose-limiting toxicity (DLT). Only 1 patient experienced Grade 3 related adverse event (AE) and no patient experienced Grade 4 related AE (uncleaned database as of August 2019). Best overall response = 3 months includes 1 partial response and 6 stable disease out of 9 patients. Preliminary data show a dose-dependent effect on the cell kinetics. The study will have reached protocol-specified endpoints for analysis at the time of presentation.

    Conclusions
    Early data show preliminary signs of clinical activity with the concurrent administration of CYAD-01 and FOLFOX chemotherapy in the present SHRINK study. Safety, clinical and translational research data (cell engraftment) will be presented. The results from this study, in comparison with the results from a similar Phase I study evaluating the allogeneic analog of CYAD-01 in mCRC patients (i.e. CYAD-101), will provide critical information to support the development of CAR T-cell therapy in solid tumors.
4.226 Posts
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