• Strong safety signals, including no cases of cytokine release syndrome, cell-related neurotoxicity, auto-immunity, or CAR-T related death.
  • A new AML patient reported no progression (3+ months) and improvement in all hematological parameters under no additional therapy at the highest dose (3x107).
  • Cases of prolonged survival with improvements in hematological parameters were noted in both acute myeloid leukemia (AML) and multiple myeloma (MM) patients.
  • In vitro demonstration of NKR-2 specific functionality against autologous tumors in the two patients evaluated is a strong correlative evidence of the potential of this approach.
  • Conference call to be held Wednesday, December 7, 2016 at 2:00pm (CET) / 8:00am (EDT).

Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, presented new data from the Phase I trial of NKR-2 in patients with acute myeloid leukemia (AML) and multiple myeloma (MM) at the 2016 American Society of Hematology (ASH) Annual Meeting being held in San Diego, CA from December 3-6, 2016. NKR-2 is a CAR-T product candidate using NKG2D, an NK Cell activating receptor transduced on T lymphocytes.

We are pleased with the early evidence of activity in AML and MM patients in our low single dose regime testing. This efficacy and clean safety profile support our belief that NKR-2 is differentiated from other CAR-T therapies in development,” said Dr. Christian Homsy, CEO of Celyad. “We look forward to initiating our THINK (Therapeutic Immunotherapy with NKR-2) study designed to evaluate NKR-2 at higher doses and with multiple administrations in both solid and liquid tumors in the near term.”

Data presented demonstrate the drug to be safe and well tolerated in the highest dose level tested to date (3x107) as well as showing early efficacy signals, including prolonged survival in both AML and MM patients. Highlights of the data include:

  • Strong safety signals, including no cases of cytokine release syndrome, cell-related neurotoxicity, auto-immunity, or CAR-T related death.
  • Although no blast reduction was observed, an AML patient reported no progression (3+months) and improvement in all hematological parameters under no additional therapy at the highest dose (3x107).
  • Other previously reported patients also showed prolonged survival with unanticipated responses to subsequent treatments, and improvements in hematological parameters despite aggressiveness of baseline disease.
  • In vitro testing of the two patients for which tumor samples were available showed that CAR-T NKR-2 destroyed tumor cells, confirming the relevance of the previously published pre-clinical work.  

Dr. Frédéric Lehmann, VP Clinical Development & Medical Affairs at Celyad: “We are very encouraged by these interim clinical and correlative data of this Phase I safety trial evaluating CAR-T NKR-2 in refractory AML and multiple myeloma patients who have limited or no treatment options. Celyad is eagerly awaiting the initiation of the THINK study designated to evaluate CAR-T NKR-2 at higher doses and with a multiple administrations schedule in these hematological indications and in five solid tumor types.

CAR-T NKR-2 Phase I trial data results were presented at the poster session of the ASH Annual Meeting, on Monday, December 5th 2016.

  • Title: Safety Data from a First-in-Human Phase 1 Trial of NKG2D Chimeric Antigen Receptor-T Cells in AML/MDS and Multiple Myeloma (Poster Presentation)
  • Abstract: 4052
  • Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III
  • Location: San Diego Convention Center, Hall GH

About the CAR-T NKR-2 Phase 1 Trial

The CAR-T NKR-2 Phase I trial is a single infusion, dose escalation study evaluating the safety and feasibility of NKR-2 CAR-T cells in AML and MM patients. 12 patients were treated at low escalating doses NKR-2 cells (max 3x107). This study was completed in September 2016 with a successful safety follow-up for all dose level cohorts.

Post Conference Call 

Please find below the link for you to download the recording of your conference call (Username: celyad ; Password: 5-ugop6k).

https://sftp.intercalleurope.com/pcs/uploads/celyad/30079023mp3.zip 

The password to open the zip file is 68029901

Please note that this link will only be available for 7 days (so until 14 December 2006).

To download the presentation that was given, please click here (.pdf - 812 Ko)

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Press release

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Celyad Announces Registration of the first patient in the Belgian THINK trial

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Celyad Announces Registration of the first patient in the Belgian THINK trial