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CYAD-101 – TIM-based Allogeneic NKG2D-based CAR-T

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CYAD-101 – TIM-based Allogeneic NKG2D-based CAR-T

Celyad’s first-in-class, non-gene edited allogeneic clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial. At the SITC 34th Annual Meeting, the Company presented preliminary data from the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 in patients with relapsed or refractory metastatic colorectal cancer (mCRC) who had progressed beyond second line metastatic chemotherapy. Preliminary data showed no clinical evidence of GvHD has been observed following 35 injections of CYAD-101, supporting the ability of the company’s novel inhibitory peptide T cell receptor (TCR) inhibiting molecule (TIM) to reduce signaling of the TCR complex through a non-gene edited approach. Treatment with CYAD-101 with prior FOLFOX preconditioning chemotherapy to control the host-versus-graft (HvG) reaction was well-tolerated, with no report of dose-limiting toxicity. No patients discontinued treatment due to adverse events. In addition, the regimen demonstrated encouraging anti-tumor activity, with two patients experiencing a confirmed partial response according to RECIST 1.1 criteria, and five patients experiencing stable disease of more than or equal to three months of duration. Tumor burden decrease was observed in six out of 12 patients in total.
Preliminary results from the completed dose-escalation segment of the alloSHRINK trial are expected in the first half of 2020. This will include three additional patients at dose level three (one billion cells per infusion) of the trial, for a total of nine patients in the cohort, as planned per the protocol.
Based on the data presented to date, the Company plans to expand the trial to further evaluate CYAD-101 with prior FOLFOX chemotherapy in refractory mCRC patients. Enrollment in the expansion segment of the trial is expected to begin in mid-2020 following the production of additional CYAD-101 cells.

Bron: www.trivano.com/aandeel/celyad-announ...
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Uit het andere draadje:

quote:

Kiadis-Kenner schreef op 23 november 2019 12:43:


[...]

Er waren 2 partial responses, bekijk de cijfers en data van de huidige medicijnen maar op de markt. Die bezitten amper een overal response van 6%. Uit 10 patienten 2 met PR is 20% en we wachten nog resultaten af van 3 patienten die de hoogste dosis toegediend hebben gekregen. Die info word gepubliceerd op ASH
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“ Updated results from the completed dose-escalation segment of the alloSHRINK trial are expected in first half 2020, including an additional three patients at dose level three (one billion cells per infusion) of the trial.”

“ Initiation of the dose-expansion segment of the alloSHRINK trial is anticipated to begin in mid-2020.”

Bron: www.trivano.com/aandeel/celyad-announ...
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het belangrijkste is volgens mij dat er geen toxicity is waargenomen, dit maakt de weg vrij voor de volgende fase van onderzoek:

“ data showed no clinical evidence of GvHD has been observed following 35 injections of CYAD-101, supporting the ability of the company’s novel inhibitory peptide T cell receptor (TCR) inhibiting molecule (TIM) to reduce signaling of the TCR complex through a non-gene edited approach. Treatment with CYAD-101 with prior FOLFOX preconditioning chemotherapy to control the host-versus-graft (HvG) reaction was well-tolerated, with no report of dose-limiting toxicity.“

Voor meer informatie over GvHD: nl.wikipedia.org/wiki/Graft-versus-ho...

“Preliminary results from the completed dose-escalation segment of the alloSHRINK trial are expected in the first half of 2020. This will include three additional patients at dose level three (one billion cells per infusion) of the trial, for a total of nine patients in the cohort, as planned per the protocol.
...
Based on the data presented to date, the Company plans to expand the trial to further evaluate CYAD-101 with prior FOLFOX chemotherapy in refractory mCRC patients. Enrollment in the expansion segment of the trial is expected to begin in mid-2020 following the production of additional CYAD-101 cells.”

Het onderzoek gaan ze dan ook uitbreiden en voortzetten nu de behandeling op het eerste gezicht veilig kan worden toegepast. Een belangrijke hobbel.
In deze fase kijkt men ook naar wat een hoogte van de dosis doet, etc. Dat ziet er dus allemaal goed uit.

Nu zal de aandacht zich meer richten op het onderzoeken van de werkelijke werking volgens mij.

Bron: www.trivano.com/aandeel/celyad-announ...
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