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Celyad's Positive Data And Other News: The Good, Bad And Ugly Of Biopharma

Jun. 05, 2020 2:55 AM ETCelyad Oncology SA (CYADY)AGEN, CARS, CLYYF, SNY, SNYNF7 Comments


  • Celyad reports positive data for allogenic CAR-T.
  • Sanofi is approved in the EU for Sarclisa in Multiple Myeloma.
  • Agenus gets IND for its Covid-19 iNKT therapy.
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Celyad Reports Positive Update on Non Gene Edited Allogeneic CAR-T Therapy

Celyad (CYAD) announced update for its Phase 1 clinical trial alloSHRINK. The trial aims to assess the potential of its lead drug candidate CYAD-101 for patients suffering from metastatic colorectal cancer. It enrolled 15 patients with relapsed/refractory mCRC who progressed after chemo. Each patient was administered three consecutive doses of CYAD-101 concurrently with FOLFOX chemo.

The trial evaluated three consecutive dose levels of the drug candidate. The mean number of prior therapies received by patients enrolled in the trial were three and absolute number ranged between one and six. The patients were administrated the drug from a single cell bank which was generated in advance using two manufacturing runs. Each run was undertaken using fraction of an apheresis from a single healthy donor. The trial observed encouraging anti-tumor activity in two patients who achieved a confirmed partial response as per RECIST 1.1 criteria. One of the patients had KRAS-mutation, which is the most common oncogenic alteration found in all human cancers.

The trial did not find any correlation between clinical responses and the degree of human leukocyte antigen matching between patients and CYAD-101 donor cells. This finding implied that the drug candidate may be used in broad range of patient population irrespective of their HLA haplotype. Dr. David Gilham, CSO of Celyad said, “Preclinical data reported during ASCO over the past few days confirm the ability of a single shRNA hairpin to provide prolonged TCR knockdown, which our first shRNA-based allogeneic candidate, CYAD-211. In addition, the data demonstrated the breadth and depth of the shRNA platform, including the concurrent knockdown of up to four genes.” The company believes that its CYAD-200 series of CAR-T candidates has strong potential ahead.

The trial did not observe any clinical evidence of Graft

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Comments (7)

NDHT profile picture
13% ORR (2 PR out of 15) in r/r mCRC seems to be promising. Not sure how this compares with other treatment options. IIRC, PD (L) 1 inhibitors don't do much for CRC.

Little HLA limitation and no GvHD are good, especially for an allo.

G1 CRS may mean that the drug does stimulate the immune system, but not too much.

All good, except that they have just decided to add "Oncology" after Celyad for a name change. For what? Changing all the logos and prints?

Hope they listen to the science, not a fortune teller.
biogenius profile picture
@NDHT You may want to look at CRDF. ORR of 45%. finance.yahoo.com/...
NDHT profile picture

They have only nine patients.

Given the small samples, both are probably similar.

Due to different MOA, they may have synergistic effects:

"Let's make a deal," if the CEOs are reading SA's comments. :-)
biogenius profile picture
Am I correct to say that CYAD result not as good as CRDF?
Can you give me your thoughts on why Agenus stock price is so volatile and never has sustained gains over the last few years?
Nicki21512 profile picture
A typo in the Summary, it reads: ABIOMED gets IND for its Covid-19 iNKT therapy. Should be AGENUS.
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