MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)--Regulatory News:
Celyad (Paris:CYAD) (Brussels:CYAD) (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 the issuance of United States Patent No. 9,273,283 (“US Patent 9,273,283”) relating to a method of producing allogeneic primary human T cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR).
The US Patent 9,273,283 is the second patent of Celyad allogeneic intellectual property portfolio that is awarded by the United States Patent and Trademark Office (USPTO). The first US patent (9,181,527) - that was granted to Celyad in November 2015 - was related to TCR deficient CAR T cells, regardless of the method used to generate them. This new patent strengthens Celyad’s coverage for its proprietary CAR T cells by adding broadly protecting methods for making these modified allogeneic T cells, and providing them as medicines. The resulting products may benefit patients with various human disease conditions and particularly cancer. By this reinforcement of the Company’s patent portfolio in the CAR-T field, Celyad confirms its leadership in engineered cell therapy, and in the allogeneic CAR T space.
Allogeneic technology has the potential to broaden the therapeutic applications of CAR T-Cell immunotherapies as it does not depend on cells derived from the patient.
Dr. Christian Homsy, CEO of Celyad: “We are pleased to have obtained this new patent. To our knowledge, this is the first patent covering a method of producing allogeneic TCR-deficient CAR T-cells and administering them to patients. Thanks to the combination of this patent with the US Patent 9,181,527 that we received a few months ago, we have a strong patent portfolio covering key elements in the allogeneic TCR-deficient CAR T-cells production value chain. We intend to maximize the significant potential of our allogeneic CAR T-cells platform internally and externally through strategic collaborations and partnerships”.
Dr. Peter de Waele, VP R&D and Intellectual Property at Celyad: “Obtaining this patent once again illustrates not only the innovative approach of our NKR-T cell platform, but also our proprietary independence. It provides support for our continuous efforts developing promising allogeneic effective therapies, improving process efficiency and broadening availability significantly”.
Celyad currently has pre-clinical studies underway to develop allogeneic cancer therapies by using a TCR Inhibitory Molecule, or “TIMTM”, in combination with a next generation CAR construct that incorporates a Natural Killer Receptor, or “NKR”. This proprietary process results in a TCR-deficient NKR T-Cell aimed at eliciting no or a greatly reduced graft- versus-host-disease (GVHD) response.
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About Celyad
Founded in 2007, and based in Belgium, Celyad is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiology and oncology. Celyad is developing its lead cardiovascular disease product candidate, C-Cure®, for the treatment of ischemic heart failure, and has completed enrollment of a Phase III trial in Europe and Israel. In addition, the Company is developing a novel portfolio of CAR T-cell therapies that utilize human Natural Killer cell receptors for the treatment of numerous blood and solid cancers. Its lead oncology product candidate, NKR-2 T-cell, entered a Phase I clinical trial in April 2015.
Celyad’s ordinary shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CYAD and Celyad’s American Depositary Shares are listed on the NASDAQ Global Market under the ticker symbol CYAD.
To learn more about Celyad, please visit www.celyad.com
About NKR-T
Celyad’s lead immuno-oncology product candidate, NKR-2, is a T-Cell encoded to express the Natural Killer activating receptor, NKG2D. The technology developed by Celyad uses a human natural killer cell (NK cell) receptor which, unlike traditional CAR technologies, targeting the CD19 antigen, has the potential to target ligands expressed on a broad range of solid tumors and blood cancers.
The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology in 2009, Cancer Research in 2006, and Blood in 2005. NKR-2 has an active Investigational New Drug (IND) application with the FDA for a Phase I clinical trial in certain hematologic cancers.
NKR-2 entered a Phase I clinical trial in April 2015. The full data readout from the Phase I dose escalation trial is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKR-2 in acute myeloid leukemia and multiple myeloma patients, with secondary endpoints including clinical efficacy.
Forward looking statements
In addition to historical facts or statements of current condition, this press release contains forward-looking statements, including statements about the potential safety and feasibility of NKR-2 T-cell therapy and C-Cure and the clinical potential of the Company’s technology platform generally and the timing of future clinical trials, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements.
In particular it should be noted that the 30-day safety data described in the release are preliminary in nature and the Phase 1 trial is not completed. There is limited data concerning safety and feasibility of NKR-2 T-cell therapy. These data may not continue for these subjects or be repeated or observed in ongoing or future studies involving our NKR-2 T-cell therapy, C-Cure or other product candidates. It is possible that safety issues or adverse events may arise in the future.
These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including risks associated with conducting clinical trials; the risk that safety, bioactivity, feasibility and/or efficacy demonstrated in earlier clinical or pre-clinical studies may not be replicated in subsequent studies; risk associated with the timely submission and approval of anticipated regulatory filings; the successful initiation and completion of clinical trials, including Phase III clinical trials for C-Cure® and Phase I clinical trial for NKR-2 T-cell; risks associated with the satisfaction of regulatory and other requirements; risks associated with the actions of regulatory bodies and other governmental authorities; risks associated with obtaining, maintaining and protecting intellectual property, our ability to enforce our patents against infringers and defend our patent portfolio against challenges from third parties; risks associated with competition from others developing products for similar uses; risks associated with our ability to manage operating expenses;, and risks associated with our ability to obtain additional funding to support our business activities and establish and maintain strategic business alliances and business initiatives. A further list and description of these risks, uncertainties and other risks can be found in the Company’s Securities and Exchange Commission filings and reports, including in the Company’s prospectus filed with the SEC on June 19, 2015 and future filings and reports by the Company. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. The Company expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.
C3BS-CQR-1, C-Cure®, NKR-2 T-cell, , OnCyte, Celyad®, Cardio3 BioSciences, , C-Cathez®, CHART-1, CHART-2 and OnCyte logos are signs internationally protected under applicable Intellectual Property Laws. Mayo Clinic holds equity in Celyad as a result of intellectual property licensed to the Company.