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CYAD-02 – Autologous NKG2D-based CAR-T

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CYAD-02 – Autologous NKG2D-based CAR-T

In June, the U.S. Food & Drug Administration accepted the Investigational New Drug (IND) application for CYAD-02, a next-generation, autologous NKG2D-based CAR-T candidate. CYAD-02 incorporates short hairpin RNA (shRNA) technology to target the NKG2D ligands MICA and MICB. The single shRNA modulates the expression of both ligands, which translates to encouraging increases in vivo engraftment and anti-tumor activity in preclinical studies.
The Company is scheduled to present preclinical data for CYAD-02 at the upcoming ASH conference. In addition, the company plans to initiate the Phase 1 CYCLE-01 study evaluating the CYAD-02 following preconditioning chemotherapy in r/r AML in early 2020.

Bron: www.trivano.com/aandeel/celyad-announ...
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“ Initiation of the Phase 1 dose-escalation CYCLE-01 trial evaluating CYAD-02, following preconditioning chemotherapy, for the treatment of r/r AML and MDS is expected in early 2020.”

www.trivano.com/aandeel/celyad-announ...
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Uit het andere draadje. Veel dank voor het delen @Speedbul:


quote:

Speedbul schreef op 24 nov 2019 om 03:20:


NEW Clinical Trial:

Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02 (CYCLE-1)

clinicaltrials.gov/

Celyad registered on 20/11/2019 into the "clinical trials" data base, a NEW trial called "CYCLE-01". This trial deals specifically for AML / MDS patients INCLUDING pre-conditioning - 2 sites in the US including Mayo Clinic in Florida and 3 sites in Belgium.
With this trial registration which will include up to 27 patients, Celyad indicates already the next phase by testing CYAD-02 using ShRNA and OptimAb process.
" Candidate shRNA (from HORIZON) were screened for efficient targeting of both MICA and MICB at the mRNA and protein level. T-cells transduced with a single vector encoding for the NKG2D-based CAR and the selected shRNA targeting MICA and MICB (CYAD-02) demonstrated 3-fold increased expansion during in vitro culture in the absence of the blocking antibody used to increase cell yield during manufacture. When injected into immunosuppressed mice, CYAD-02 cells generated with the Optimab process showed 10-fold higher engraftment one week after injection and potent anti-tumor activity resulting in 2.6-fold increase of mouse survival in an aggressive AML model.". (see poster 3931 that will be presented at ASH on Monday 9/12).
Celyad already received the IND from the FDA (in June 2019)
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