Significant progress has been made in the test THINK. No event related to the toxicity of the product reported to date.
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Mont-Saint-Guibert, Belgium Celyad (Euronext Brussels and Paris and NASDAQ : CYAD), a biopharmaceutical company, belgian leader in the development of cell therapies, today publishes its report on developments in clinical and operational important in the first quarter of 2017 for the year ended 31 march 2017.
HIGHLIGHTS OF THE FIRST QUARTER OF 2017 AND THE EVENTS IN RECENT
Launch of the test THINK in Belgium and the United States on patients suffering from hematological cancers and solid
No problem of toxicity carried over to this day
Confirmation of the USPTO of all claims in the patent u.s. Celyad relative to cells allogeneic CAR-T-deficient TCR
Non-exclusive license agreement signed in may 2017 with Novartis on patent of Celyad cell-related allogeneic CAR-T
Dr Christian Homsy, CEO of Celyad, commented : «The first quarter of 2017 has been very productive, and indicative of what will be the rest of the year. The concentration of all our
teams on the development of our platform, BECAUSE-T NKR has allowed the achievement of important milestones : the approval of the trial by the FDA, the injection with success of the first patients suffering from tumors of the blood, the marrow osseurse and solid tumors, and the demonstration of the safety of our product, AS-T NKR-2 to the first dose tested. «.
Patrick Jeanmart, Chief Financial officer of Celyad adds : «The decision of the USPTO to confirm our patent relating to the cells in allogeneic CAR-T-deficient TCR confirms the value of our patent portfolio, and the recent licence agreement signed with Novartis is a first recognition of the intrinsic value of this asset. »
BUSINESS AND FINANCIAL REVIEW
In January, the u.s. patent Office (USPTO) has decided, for the third time, to confirm the u.s. patent no. 9.181.527 of Celyad relative to T cells human primary allogeneic, which are developed to be TCR-deficient and express a receptor antigenic chimeric (BECAUSE). In march, the USPTO has rejected another request for reconsideration on the same patent. All claims of this patent Celyad therefore remains valid and binding.
On the operational level, the company has recorded significant progress in the clinical trial THINK, which consists of two groups : a group of «solid tumors» cancer (cancer of the colon, pancreas, ovarian, triple-negative breast and bladder) and a group «tumor-liquid» process, in which the acute myeloid leukemia (AML) and multiple myeloma (MM). All patients of the first dose (3×108 ) of the group «solid tumors» of the testing have been injected with success and no problem of toxicity has not been reported to date. The first cohort is made up of two patients suffering from colon cancer and a patient with cancer of the pancreas. In the group » tumor-liquids «, the first patient AML was injected and two MM patients have been recruited.
With the approval received from the Food and Drug Administration (FDA) in march, the trial THINK is now global and is recruiting patients in Belgium and the United States. In the United States, the recruitment of patients is planned in three clinical centers, including two trained and approved (Rosewell Park (NY) and the University of Pittsburgh Medical Center (PA)). Celyad ended the quarter with cash and cash equivalents 72.4 million euros. The cash consumption for the first quarter of 2017 amounted to 10.2 million euros, in line with forecasts. The company confirms that this cash will cover the operational expenses as well as the financing needs for all our activities, and this, until mid-2019.
EVENTS SUBSEQUENT TO THE END OF THE QUARTER
On April 28, Celyad announced the injection of the first patient in the second dose (1X109) in the group «solid tumors» of his essay THINK. This first patient with a cancer of the ovary has been injected successfully at the Roswell Park Cancer Institute (Buffalo, New York).
On may 2, Celyad announced that it has signed a non-exclusive license agreement with Novartis for the patents of Celyad related to allogeneic cells BECAUSE-T. This license agreement covers two targets in the course of development at Novartis. The contract includes the rights of intellectual property of Celyad covered by u.s. patent n°9.181.527 relative to T lymphocytes primary human expressing an antigen receptor chimeric (AS) and modified to be deficient in receptors of T lymphocytes (TCR) and express a receptor antigenic chimeric (BECAUSE).
According to the terms of the contract, Celyad will receive an upfront payment and will receive payments utlérieurs based on the clinical development, regulatory and commercial targets developed by Novartis. In case of success of all these key steps, Celyad will be able to receive a total amount of us $ 96 million, including the initial payment. Celyad will receive further royalties at a figure on the sales of both target and associated products. Novartis has the option to extend this agreement to other targets and/or to negotiate the terms of a possible conversion of his license into an exclusive license. Celyad retains the right to grant other licenses to third parties active in the development of cells CAR-T and allogeneic.
Celyad will not be involved in the development of cells CAR-T of Novartis. Celyad will continue to focus on the development of its portfolio of CAR-T, including the cells BECAUSE T-NKR-2 allogeneic in Europe and the USA, as well as with his partner ONO Pharmaceuticals in Japan, Taiwan and Korea.
On may 11, Celyad has announced that the FDA had granted a Fast Track designation for its therapy C-Cure®. Celyad intends to take advantage of this designation to speed up the search for a strategic partner. The FDA granted the label Fast Track to reducing mortality, number of hospitalizations, and to improving the quality of life of patients with chronic heart failure due to ischemic cardiomyopathy, with an end-diastolic volume of the left ventricle (Left Ventricular End Diastolic Volume LVEDV) between 200 and 370 ml.
Celyad is a company’s clinical-stage biopharmaceutical in the development of cellular therapies. The Company uses its expertise in cellular development to target the cancer. The platform NKR-T Celyad is based on T-Cell changes in order to push them to express a Receptor of Natural Killer Cells (NK). This technology offers a potential therapeutic very wide, both in solid tumors than in the blood. BECAUSE-T NKR-2 is the product most advanced candidate of Celyad in oncology. This therapy has been the subject of a first clinical study of Phase I study to evaluate the safety of the product in patients with two types of blood cancer, Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM), This study was successfully completed in September 2016. Celyad was founded in 2007. The Company is based in Mont-Saint-Guibert, Belgium, and Boston, in the United States. The actions of Celyad are listed on Euronext Brussels and Euronext Paris under the symbol CYAD. The ADSS are quoted on the NASDAQ Global Select Market under the symbol » CYAD «.
For more information on Celyad, go on www.celyad.com
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