December 07, 2020
07:37
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Which one do we start with? The bad? Discontinuation of treatment for clinical futility. The good one: Another treatment shows encouraging results.
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La biotech Celyad Oncology
, specializing in the development of CAR T cell therapies for cancer treatment, decided to stop the development of the autologous CAR T candidate CYAD-01 due to clinical futility observed to date in the Phase 1 “Think” trial.
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This potential treatment aimed refractory / relapsing acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). A total of eight of the eleven protocol patients in the trial expansion were treated with CYAD 01 cells. Disease stabilization was achieved in two of the eight patients treated. But, noted Celyad, no objective response was observed following treatment with CYAD-01 cells produced by OptimAb.
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Bad news that has heavily weighed on the title, who has dropped by more than 11% to settle down at 6.91 euros at the close.
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It’s rolling for “Cycle-1”
On the other hand, the Walloon biotech reports that the preliminary data of the “Cycle-1” test evaluating CYAD-02, the next-generation autologous CAR T candidate, in patients with AML and MDS have shown encouraging clinical signals. For example, a high-risk MDS patient, treated at dose level 3, obtained an objective complete response from the cord. The CYCLE-1 Dose Level 3 cohort is ongoing.
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“While we are disappointed with the latest update to the Phase 1 ‘Think’ trial (CYAD-01), we are encouraged by the early clinical results of CYAD-02 (…).”
Filippo Petti
CEO de Celyad Oncology
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Nowadays, seven patients could be assessed for clinical activity. Of the five very high risk patients with MDS treated with CYAD-02, three patients demonstrated a anti-leukemic activity, the only patient evaluated at dose level 3 who achieved a complete marrow response in the first clinical evaluation (ongoing).
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Two other patients presented a lasting disease stabilization over five months. Of the two patients with AML treated with CYAD-02, a patient showed anti-leukemic activity with four-month disease stabilization (in progress), specifies biotech.
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“Immunicy-1”
Recall that, last week, Celyad announced that the first patient in the phase 1 trial “Imunicy-1” was infused with CYAD-211. Preclinical results of CYAD-211 for multiple myeloma (MM) showed strong antitumor activity without demonstrable evidence of graft versus host disease.
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