Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a pioneer in the discovery and development of CAR-T cell therapies, today announces exciting early clinical results of the first dose-level in the hematological arm of its THINK trial (THerapeutic Immunotherapy with CAR-T NKG2D).

  • First ever morphologic complete response (MLFS1) with gene-engineered T cells without prior pre-conditioning chemotherapy for a patient with relapsed refractory acute myeloid leukemia (AML).

Christian Homsy, CEO of Celyad comments: “We are pleased to have demonstrated the first objective clinical response of CYAD-01 (a.k.a. CAR-T NKG2D) as this is the very first time a relapsed, refractory AML patient has reached a MLFS with gene-engineered T cells without pre-conditioning lymphodepletion nor additional other concurrent treatment to CYAD-01 administration. This success further reinforces our confidence in our approach and the validity of NKG2D ligands as a target. We will now use the collected data to move forward with the next stage of our product development: reinforcing responses in as many clinical settings as possible.”


At the first dose-level 3x108 CYAD-01 T cells were administered without any prior conditioning chemotherapy to a cohort of three patients with hematologic cancer (two with AML and one with Multiple Myeloma, MM). One AML patient has achieved a MLFS after administration with CYAD-01 at the H. Lee Moffitt Cancer Center and Research Institute (Florida, USA).


Dr. David Sallman, Assistant Member in the Malignant Hematology Department of Moffitt Cancer Center, comments “The results announced today regarding CYAD-01 provide the first clinical validity of CYAD-01 as a tumor-specific antigen-receptor and AML as a disease sensitive to gene-engineered cell therapies. As antigen targeting offers significant challenges in AML, this outcome brings hope for the further use of gene-engineered T cells for patients with AML that have run out of therapeutic options. It’s all the more striking that this outcome was observed without any prior lymphodepletion highlighting the potential of using a physiologic antigen-receptor.”

AML is a blood cancer characterized by a rapid increase of abnormal white blood cells in the bone marrow, which in turn affects the production of normal blood cells. More than 20,000 people in the US and almost as many people in Europe are diagnosed every year with this type of blood cancer. As AML’s incidence increases with age and as population ages, it is expected that a growing number of people might be affected by this type of cancer.


Dr. Frédéric Lehmann, Vice President Clinical Development and Medical Affairs at Celyad adds: “With this first objective and ongoing response, obtained without additional treatments such as lymphodepletion, CYAD-01 confirms the potential to treat relapsed refractory AML, one of the deadliest cancers with a median overall survival of less than 4 months. The concept of CAR-T cells with the NKG2D receptor is now progressing to further validation.”


The THINK trial, conducted in the US and in Europe, includes two stages: a dose escalation and an extension stage. The dose escalation is being conducted in parallel in solid cancers (colorectal, pancreatic, ovarian, triple negative breast and bladder) and in hematologic (AML and MM) cancer groups, while the extension phase will evaluate in parallel each tumor type independently. The dose escalation design includes three dose levels adjusted to body weight: up to 3x108, 1x109 and 3x109 CYAD-01. At each dose, the patients receive three successive administrations, two weeks apart, of CYAD-01 at the specified dose. To date, 14 patients have been dosed in the THINK trial. One Grade Three and one Grade Four event have been observed, both resolved within 72 hours. No dose limiting toxicities (DLT) nor deaths related to the investigational product have been reported.

Celyad’s management will host a conference call at 2pm CEST/8am EDT on Friday October 6, 2017


Conference Call Details
A conference call will be held on Friday October 6, 2017 at 2:00pm (CEST) / 8:00am (EDT) to provide an update on Celyad’s clinical strategy. Christian Homsy, Chief Executive Officer, and Patrick Jeanmart, Chief Financial Officer, will deliver a brief presentation followed by a Q&A session.
Participants are asked to call the assigned numbers approximately five minutes before the conference call begins.

The call can be accessed by dialling the numbers below and using the passcode: 95148855
International: +44 (0) 2071 928338
Belgium: 02 793 3847
France: 0170700781
UK: 0800 2796619
US: 1 877 8709135

 

1 MLFS for Morphological Leukemia-Free Status

 

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About Celyad

Developing breakthrough pioneering therapies for life-threatening diseases.

Celyad is a biopharmaceutical company, specialized in cell therapy, that is developing landmark technologies aimed at treating severe diseases with poor prognosis. Our scientific approach is inspired by the natural mechanisms that are used by the body to fight disease.

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