Cardiology

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ:CYAD), a leader in the discovery and development of cell therapies, today announced that the U.S. Food and Drug Administration (FDA)  has granted a Fast Track designation for its C-Cure® therapy.

• Celyad intends to leverage this designation to accelerate the search for a strategic partner
• Designation granted on the strength of the evidence in the subset of patients that were responders at 9 month,  further confirmed by the 12 months data recently presented

FDA granted Fast Track designation for reduction in mortality, hospitalization and improvement of quality of life in patients with chronic heart failure secondary to ischemic cardiomyopathy with baseline Left Ventricular End-Diastolic Volumes (LVEDV) between 200 and 370ml as Fast Track Development Program.

Celyad’s C-Cure® therapy is one of the most advanced cell therapies in the heart failure segment. The CHART-1 trial has identified a sizeable patient population with a positive response to C-Cure®, and a better defined optimal dosing.
This was further validated by the 12 months data recently presented by Prof. John Teerlink at the late breaking session of the European Heart Failure Society meeting (Paris, Mays 1st, 2017), and accepted for publication in the European Journal of Heart Failure.

In December 2015 Celyad received clearance from the FDA for CHART-2, a prospective multi-centre, randomized, sham-controlled, Phase III pivotal study for C-Cure®. The company is in the process of identifying strategic partners to initiate the CHART-2 clinical trial.

Dr. Christian Homsy, CEO of Celyad: “While Celyad focuses its resources in the development of our immuno-oncology platform, receiving Fast Track Designation is an important milestone for C-Cure® and is a testimony to the quality of the science and the strength of the 9 and 12 months CHART-1  data.  We hope, with the support of Piper Jaffray, to be able to identify a partner to carry the C-Cure program forward.”

The FDA’s Fast Track Drug Development Program is designed to expedite clinical development and submission of New Drug Applications (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available. For more information on Fast Track, visit the FDA website (http://www.fda.gov).

• A statistically-significant difference on the primary endpoint was not reached; however, a positive trend was seen across all treatment groups, and the primary endpoint was met (p=0.015) for a subset representing 60% of the population of the CHART-1 study (baseline End Diastolic Volume (EDV) segmentation).
• Based on the positive subgroup analysis, Celyad will contact the European Medicines Agency concerning a marketing authorization application.
• Prof. Jozef Bartunek will present the full 39 weeks’ data at the “Hot Line Heart Failure and Innovative Approaches” Late Breaking Clinical Trial Session at ESC on Sunday, August 28, 2016.
• Celyad will seek a partner to accelerate further development and commercialization of C-Cure^®.

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular diseases and immuno-oncology, today announced headline results for CHART-1, its European Phase III clinical trial for its lead cardiovascular disease product candidate.

Across the complete trial population, a positive trend was clearly identifiable. However, a statistically-significant difference between treatment and control (sham procedure) was not reached. 

For patients representing 60% of the overall study population and categorized by their End Diastolic Volume (EDV) at inclusion, significance was met for the primary endpoint (p = 0.015). Most importantly, in this subgroup, a strong trend or a statistical significant positive difference was seen in all individual elements of the composite primary endpoint (Mortality, Worsening Heart Failure Events, Quality of Life, 6 minutes Walking Test, End Systolic Volume and Ejection Fraction).

The study procedure was well tolerated with no safety concerns.

The CHART-1 trial has been selected by the European Society of Cardiology to be presented at the “Hot Line Heart Failure and Innovative Approaches” Late Breaking Clinical Trial session of the ESC congress in Rome on Sunday, August 28, 2016, at 11:54 am CEST. The European Society of Cardiology has organized a press conference scheduled at 8 am CEST on the same day.

Based on the positive results seen in this highly clinically relevant group of patients for whom treatment options are currently limited, Celyad will contact the European Medicine Agency concerning a marketing authorization application.

The Company will use the CHART-1 results as a foundation to optimize the design of the pivotal CHART-2 US trial. In line with this, Celyad confirms it is seeking partnerships to accelerate further development and commercialization of C-Cure^®. 

At the Company’s request, trading in Celyad stock (CYAD.BR) will be suspended on June 28, 2016, until the completion of the conference call scheduled at 2:00pm CEST (see details below).

Dr. Christian Homsy, CEO of Celyad, commented: “For the first time in a randomized, double-blind, controlled, Phase III cell therapy study, a positive effect, consistent across all parameters tested, was observed for a substantial, clearly definable, group of heart failure patients.

CHART-1 has allowed us to better define the patient population that would benefit from 
C-Cure®. We are excited by the prospects for C-Cure® as a new potential treatment option for a highly relevant heart failure population. We are confident that the results will generate interest from potential partners that could accelerate the development and commercialization of 
C-Cure®.”

Prof. Jozef Bartunek, CHART-1 principal co-investigator, said: “This pioneering study has contributed greatly to our understanding of heart failure disease and the place of regenerative medicine in its management. The results seen for a large clinically relevant number of the patients are ground breaking. We look forward to completing the full analysis and making the data available to the medical community at ESC.

On behalf of the CHART 1 steering committee we wish to thank the patients and families who were enrolled in the study as well as all the physicians and medical teams that made this study possible.”

Prof. Gerasimos Filippatos, Immediate Past-President of the Heart Failure Association of the European Society of Cardiology, member of the CHART-1 dissemination committee, said, “The CHART-1 results have identified a well-defined group of patients with symptomatic heart failure despite optimal therapy. Those patients are a large subset of the heart failure population and present specific therapeutic challenges.  The outcome of CHART-1 indicate those patients could benefit from this therapy”.

Conference Call Details

A conference all will be held on Tuesday, June 28, 2016 at 2:00pm (CEST) / 8:00am (EDT) to review the topline results of the CHART 1 study. Christian Homsy, Chief Executive 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 dialing the numbers below and using the conference ID: 41106485

International:                      +44 (0) 1452 560304
Belgium:                                 024017052
France:                                    0800918149
UK:                                             08000738965
US:                                             18669265708

Download the Press Kit

Download the CEO letter to Celyad shareholders

The access to the conference call has expired. For more information, please contact us by email to investors@celyad.com

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced that it notified the European Medicines Agency (EMA) of its intent to submit a MAA for C-Cure^® in November 2016.

The MAA filing will trigger the appointment of Rapporteurs and Co-Rapporteurs who will review Celyad’s submission and therefore allows the Company to prepare the pre-submission meetings. Appointment of the (co-)Rapporteurs is expected by the end of April 2016.

Dr. Christian Homsy, CEO: “This notification to the EMA represents another step on the path to the commercialization of C-Cure^®. We are optimistically awaiting the CHART-1 Phase III results which are expected end of June 2016. These data will trigger the actual marketing authorization application”.

Dr. Jean-Pierre Latere, Head of the Cardiovascular Franchise: “Celyad continues on its journey to bring innovative best-in-class treatments to patients. Engaging with the EMA represents an important milestone and we are committed to work diligently to execute on our clinical development plan and to make C-Cure® available.”

Invetech to design and supply automated production systems for commercialization of autologous cell therapy based on Celyad’s cardiopoiesis technology platform.

San Diego (February 2) 2016 – Invetech, a global leader in instrument development, custom automation and contract manufacturing, and Celyad SA, (CYAD.BR) (“Celyad”), a biopharmaceutical company focused on identification and development of specialized cell-based therapies with product candidates in oncology and cardiology, today announced that they have entered into an agreement under which Invetech will develop and supply manufacturing systems to support production needs for C-Cure®, Celyad’s most advanced product candidate based on the cardiopoiesis technology platform. Under the terms of the agreement, Invetech will provide Celyad with a range of advanced design and manufacturing services to support development of customized manufacturing systems for commercial production of C-Cure®.

“Our feasibility study for automated manufacturing of C-Cure® delivered excellent results and provided strong support for the continued development of this promising automation platform. Importantly, this program also builds on and expands our expertise in core cell therapy development,” said Dieter Hauwaerts, vice president, operations, Celyad

In this collaboration, the system design and production teams at Invetech will supply Celyad with a modular, readily scalable and highly automated production suite able to facilitate simultaneous processing of multiple patient-specific therapies. The manufacturing system is designed to be rapidly expandable to accommodate anticipated increases in production volume to support future global commercialization pending regulatory approvals.

“We are pleased to be supporting Celyad in the translation of their exciting C-Cure® product from clinical trials to commercial production. Our experience with automating manual processes has enabled us to design a GMP compliant manufacturing system that meets Celyad’s need for efficient manufacturing combined with patient safety” said Richard Grant, Global Vice President, Cell Therapy, at Invetech. “This agreement reflects Invetech’s ability to adapt biopharmaceutical process design methodologies to address the unique demands and challenges presented by the cell therapy industry.”

About C-Cure®
C-Cure® is Celyad’s most advanced product candidate based on its cardiopoiesis platform and is being developed for heart failure indications. The Company expects to release the full clinical data set for CHART-1, its Phase III trial in Europe and Israel, in the middle of 2016. The research underlying this technology was originally conducted at Mayo Clinic by the research team of Professor André Terzic and Atta Behfar, and has been published in numerous peer-reviewed publications.  C-Cure® consists of a patient’s own cells harvested from bone marrow, treated with cardiopoietic growth factors and then re-injected into the heart. It is designed to produce new autologous heart muscle cells that behave identically to those lost as a result of infarction, without the risk of rejection. C-Cure®’s potential has been demonstrated in a multi-center randomized controlled Phase II trial conducted in Europe. Results of the C-Cure® Phase II trial were published in April 2013 in the Journal of American College of Cardiology.

About Celyad
Celyad, previously Cardio3 BioSciences, is a biopharmaceutical company focused on translating breakthrough cell-based research into innovative therapeutics to improve the outcome of severe diseases. The Company is currently developing clinical stage cell therapies in cardiology and oncology, two healthcare segments with high unmet medical needs.

About Invetech
Invetech has been creating breakthrough products and custom automation systems for more than 30 years. With experience drawn from more than 5000 projects globally, Invetech partners with global leaders in industry to deliver product design and development, contract manufacturing and custom automation services. The company has experience in a broad range of market sectors including cell therapy production automation systems, laboratory diagnostics, point of care diagnostics, life sciences, industrial and consumer products.

 As it is a joint PR issued by Invetech, this information is only available in English.

Invetech to design and supply automated production systems for commercialization of autologous cell therapy based on Celyad’s cardiopoiesis technology platform.

The US FDA determined that the C-Cure®/C-Cathez™ combination safety profile obtained from the CHART-1 trial allows the initiation of the CHART-2 Heart Failure Clinical Trial in the US

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application to proceed thus allowing for the clinical testing of Celyad’s lead cardiology candidate (C-Cure cardiopoietic cells) delivered via the proprietary catheter (C-Cath_ez) in the Phase III Heart Failure Trial (CHART-2) in the US.

CHART-2 is intended to assess, the efficacy of C-Cure as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded Phase III study comparing treatment with C-Cure to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure.

Dr. Christian Homsy, Chief Executive Officer of Celyad: “CHART-2 study using Celyad’s lead cardiology candidate (C-Cure cardiopoietic cells) delivered via our proprietary catheter
(C-Cath_ez) will allow us to expand our Phase III clinical program and allow US clinical sites and patients to participate in our trials. We also expect that our fully proprietary approach will give us an innovative value added proposition when it comes to the potential commercialization of the treatment”.

Dr. Warren Sherman, Chief Medical Officer of Celyad: “Celyad’s patient centric approach is served by providing potentially the best possible combination of C-Cure with C-Cath_ezfor the treatment of ischemic heart failure. C-Cath_ez best in class catheter provides more than three times higher retention of viable cells one hour after the injection than other designs, and hence potentially optimizes the effect of C-Cure.”

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announces that a methods paper on the Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) clinical trial design has been published in the European Journal of Heart Failure (EJHF 2015).

CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy) is a patient prospective, controlled multi-centre, randomized, double-blinded Phase III clinical trial comparing treatment with C-Cure® to a sham treatment. The trial has recruited 240 patients with chronic advanced symptomatic heart failure in Europe and Israel. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at nine months post-procedure. The next milestone in the clinical trial will be the release of the full clinical data set, anticipated for mid-2016.

Dr. Christian Homsy, CEO of Celyad, said: “The publication of the CHART-1 methods paper in the European Journal of Heart Failure is a scientific acknowledgement of the work that has been done around the design of our clinical trial for ischemic heart failure. We are proud of this achievement and we thank all the people who have been involved in the writing process.”

Dr. Warren Sherman, Chief Medical Officer at Celyad, added: “The CHART-1 Study brings together two major scientific innovations: cells designed specifically for cardiac repair (C-Cure) and an injection catheter (C-Cath_ez^TM) designed specifically to increase the retention of cells by the heart.  It is most gratifying that such a prestigious journal has chosen to publish this paper.”

Download Celyad’s abstract on Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design, please click here (pdf – 358 Ko).