| • | | One patient experienced an anemia adverse event (Grade 3) and neutropenia (Grade 4) possibly related to CYAD-211. |
Clinical activity:
Of the five evaluable patients at the first two dose levels (30×106 and 100×106 cells per infusion):
| • | | Two patients achieved a PR. Both patients were ‘triple-therapy exposed’ (previously treated with an immunomodulator (IMiD), a proteasome inhibitor and an anti-CD38 antibody). |
| • | | The three additional patients had stable disease (SD). |
Cell kinetics:
| • | | CYAD-211 cells were detected by PCR-based methods in all six patients from dose cohorts 1 and 2. |
| • | | Cell engraftment was seen in all three patients at dose level 2 at a similar magnitude. In addition, preliminary data suggest that all patients in dose level 2 showed deep lymphodepletion. Across dose level 1, the depth of lymphodepletion appears to correlate with the degree of observed systemic CAR T engraftment. |
Next steps:
| • | | Enrollment in dose cohort 3 (300×106 cells per infusion) is ongoing. |
| • | | Additional clinical data from the dose escalation trial are expected during second half 2021. |
| • | | shRNA technology platform to be highlighted at upcoming virtual R&D Day in Q3 2021. |
Conference Call and Webcast Details
Celyad Oncology will host a conference call to discuss the update from EHA on Friday, June 11, 2021 at 2 p.m. CET / 8 a.m. ET. The conference call can be accessed through the following numbers:
United States: #1 877-407-9208
International: #1 201-493-6784
The conference call will be webcast live and can be accessed here. The event will also be archived and available on the “Events ” section of the company’s website. Please visit the website several minutes prior to the start of the broadcast to ensure adequate time for registration to the webcast.
About CYAD-211
CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate for the treatment of r/r MM. CYAD-211 is engineered to co-express an anti-BCMA targeting chimeric antigen receptor and a single shRNA to knockdown the CD3V component of the T cell receptor complex.
About IMMUNICY-1 Phase 1 trial
The open-label, dose-escalation trial will evaluate the safety and clinical activity of CYAD-211 following cyclophosphamide and fludarabine preconditioning chemotherapy in patients with relapsed or refractory multiple myeloma. The trial will evaluate multiple dose levels of CYAD-211: 30×106, 100×106 and 300×106 cells per infusion. For more information, please visit www.clinicaltrials.gov, study identifier number NCT04613557.
About Celyad Oncology
Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. The Company is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors. Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY. The Company has received funding from the Walloon Region (Belgium) to support the advancement of its CAR T cell therapy programs. For more information, please visit www.celyad.com.
Forward-looking statements
This release may contain forward-looking statements, within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the clinical activity and safety and tolerability of CYAD-211 and expectations regarding enrollment and the announcement of additional clinical data. Forward-looking statements may involve known and unknown risks and uncertainties which might cause actual results, financial condition,