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celyad 2020

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Celyad Oncology to Present Updates from Allogeneic and Autologous CAR T Programs at 62nd ASH Annual Meeting and Exposition

November 4, 2020 10:01 p.m. CET
Three accepted abstracts will be presented virtually in a pre-recorded poster session
Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that three abstracts have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held virtually from December 5-8, 2020. The presentations will focus on the company’s anti-BCMA allogeneic CAR T candidate, CYAD-211, and autologous NKG2D receptor-based CAR T candidates CYAD-01 and CYAD-02. In addition, the abstracts will be published online in the November supplemental issue of peer-reviewed journal Blood.

ASH 2020 Presentation Details:

The abstracts published today are now available on the ASH conference website. Following their presentation at the meeting, the posters will be available in the Scientific Publications section of Celyad Oncology’s website.
Noob nr1
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quote:

Twin schreef op 4 november 2020 22:18:

Hopelijk komt er vuurwerk na 5december ,
Laat ze ons maar verrassen op dinsdag 10-11 bij de cijfers.
Verwacht er niks van maar nieuws is welkom
Speedbul
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Publication in BLOOD

703.ADOPTIVE IMMUNOTHERAPY: MECHANISMS AND NEW APPROACHES| NOVEMBER 5, 2020
Clinical Development of a Non-Gene-Edited Allogeneic Bcma-Targeting CAR T-Cell Product in Relapsed or Refractory Multiple Myeloma
A. Samer Al-Homsi, MD, Sebastien Anguille, MD, Jason Brayer, PhDMD, Dries Deeren, MD PhD, Nathalie Meuleman, PhD MD, Gareth Morgan, MDPhDFRCP, Taiga Nishihori, MD, Panagiota A. Sotiropoulou, PhD, Laure Twyffels, PhD, Jennifer Bolsee, PhD, Nathalie Braun, Caroline Lonez, PhD, David E Gilham, PhD, Anne Flament, MD, Frédéric F. Lehmann, MD

Blood (2020) 136 (Supplement 1): 27–28.
doi.org/10.1182/blood-2020-139516

Background

Autologous CAR T-cell therapy targeting the B-cell maturation antigen (BCMA) has shown impressive objective response rates in patients with advanced multiple myeloma (MM). Clinical grade manufacturing of autologous CAR T-cells has limitations including vein-to-vein delivery time delay and potentially sub-optimal immunological capability of T-cells isolated from patients with advanced disease. Allogeneic CAR T-cell products, whereby cells from healthy third-party donors are used to generate an "off-the-shelf" CAR T-cell product, have the potential to overcome some of these issues. To circumvent the primary potential risk of graft-versus-host disease (GvHD) associated with the use of allogeneic T-cells, abrogation of the T-cell receptor (TCR) expression in the CAR T-cells, via gene editing, is being actively pursued. To avoid the potential safety risks and manufacturing challenges associated with gene editing, the allogeneic CYAD-211 CAR T-cell product exploits short hairpin RNA (shRNA) interference technology to down-regulate TCR expression thus avoiding the risk of life-threatening GvHD.

Aim

The aim is to generate a BCMA-specific allogeneic CAR T-cell product using a non-gene editing approach and study its activity both in vitro and in vivo. CYAD-211 combines a BCMA-specific CAR with a single optimized shRNA targeting the TCR CD3? subunit. Downregulation of CD3? impairs the TCR expression on the surface of the donor T-cells, preventing their reactivity with the normal host tissue cells and potential GvHD induction. Maintaining all the elements required for the therapy within a single vector (all-in-one vector) provides some significant manufacturing advantages, as a solitary selection step will isolate cells expressing all the desired traits.

Results

CYAD-211 cells produce high amounts of interferon-gamma (IFN-?) during in vitro co-cultures with various BCMA-expressing MM cell lines (i.e., RPMI-8226, OPM-2, U266, and KMS-11). Cytotoxicity experiments confirmed that CYAD-211 efficiently kills MM cell lines in a BCMA-specific manner. The anti-tumor efficacy of CYAD-211 was further confirmed in vivo, in xenograft MM models using the RPMI-8226 and KMS-11 cell lines. Preclinical data also showed no demonstrable evidence of GvHD when CYAD-211 was infused in NSG mice confirming efficient inhibition of TCR-induced activation.

Following FDA acceptance of the IND application, IMMUNICY-1, a first-in-human, open-label dose-escalation phase I clinical study evaluating the safety and clinical activity of CYAD-211 for the treatment of relapsed or refractory MM patients to at least two prior MM treatment regimens, is scheduled to begin recruitment.

IMMUNICY-1 will evaluate three dose-levels of CYAD-211 (3x107, 1x108 and 3x108 cells/infusion) administered as a single infusion after a non-myeloablative conditioning (cyclophosphamide 300 mg/m²/day and fludarabine 30 mg/m²/day, daily for 3 days) according to a classical Fibonacci 3+3 design. Description of the study design and preliminary safety and clinical data from the first cohort will be presented at ASH 2020.

Conclusion

CYAD-211 is the first generation of non-gene edited allogeneic CAR T-cell product based on shRNA technology. The IMMUNICY-1 clinical study seeks to provide proof of principle that single shRNA-mediated knockdown can generate fully functional allogeneic CAR T-cells in humans without GvHD-inducing potential. We anticipate that subsequent generations of this technology will incorporate multiple shRNA hairpins within a single vector system. This will enable the production of allogeneic CAR T-cells in which multiple genes of interest are modulated simultaneously thereby providing a platform approach that can underpin the future of this therapeutic modality.

ashpublications.org/blood/article/136...
Speedbul
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Clinical trial IMMUNICY has been posted on the afmps site for 3 clinical sites in Belgium (AZ Delta, UZ Antwerpen, Jules Bordet) with a starting date of 31/8/2020

banquededonneesessaiscliniques.be/fr?...
Garre
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en koopadvies blijft toch staan op € 18, 00 ben benieuwd wanneer we weer op die stand staan.
Twin
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Zou het opwindend nieuws zijn 5december? Na een jaar wachten mag er wel iets uit de bus komen ,
Sonsbeek
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Celyad is mijn grootste splinter. Ik heb hem er nu voor de helft uit getrokken, de opbrengst gestoken in aandelen waar ik hoop de verliezen recht te gaan trekken (Automotive, EV). Toch blijf ik stiekem hopen dat Celyad nog opveert, daarom de helft nog even laten staan. Ik blijf er wat vertrouwen in hebben, ondanks dat het steeds weer beschaamd wordt...
Speedbul
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As compared to CYAD-01, CYAD-02 cell expansion in vitro was 3-fold increased.

See the schedule at the bottom of this link

ashpublications.org/blood/article/136...

As compared to CYAD-01, CYAD-02 cell expansion in vitro was 3-fold increased. In an in vivo AML model, CYAD-02 showed 10-fold higher engraftment 1 week after injection and improved anti-tumor activity as compared to CYAD-01 manufactured with the initial mAb process. This led to a 2.6-fold increase of mouse survival as compared to CYAD-01 in a stress-test aggressive AML model where the dose of CYAD-01 was titrated down for minimal activity (figure).

The first-in-human study evaluating CYAD-02, the CYCLE-1 study (NCT04167696), has been initiated in early 2020 in patients with r/r AML/MDS. The study evaluates three dose-levels of CYAD-02 (1x108, 3x108 and 1x109 cells/infusion), administered as a single infusion after non-myeloablative preconditioning chemotherapy (cyclophosphamide 300 mg/m²/day and fludarabine 30 mg/m²/day, daily for 3 days, CyFlu) according to a classical Fibonacci 3+3 design.

As of August 2020, 6 patients have been treated with CYAD-02 at the dose of 1x108 or 3x108 cells/infusion. To date, the results demonstrate the safety and tolerability for CYAD-02 in patients with r/r AML and MDS with no dose-limiting toxicity observed. The study is currently enrolling at 1x109 cells/infusion. The CYAD-02 safety profile and preliminary clinical activity data together with the pharmacokinetics evaluation from the complete dose escalation segment will be provided at the time of presentation.

Twin
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Good morning speedbul, thank you for info, are we in the good way ? Thank you and have a nice sunday, Greetz twin
davidbxl
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november en weekend van 5 december worden doorslaggevende momenten :) ik zou zeker mijn posities nog versterken, heb dat trouwens zelf al gedaan aan 6.30€.
Met goede nieuws uit Amerika of corona gerelateerd staan we aan de 8.15€ voor dat het goede nieuws van Celyad komt.
Kan zeker boven de 10€ geraken voor 2021
Twin
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Misschien morgen een toelichting over resultaten , zou leuk zijn , zo kan ik mijn diepe put wat dichten
davidbxl
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davidbxl
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blijkbaar heeft Pfizer meegedeeld dat er mogelijks een vaccin zou zijn... mijn voorspellingen van eerder vandaag waren zeker dus juist :) we staan al 7.70€
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