Stabilization of the disease at 3-month follow-up for two patients suffering from metastatic cancer of the colon
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No signal of toxicity observed to date
Mont-Saint-Guibert, Belgium Celyad (Euronext Brussels and Paris, and NASDAQ : CYAD), the biopharmaceutical company, belgian leader in the development of cellular therapies, AS-T, today announced the initial clinical results are promising at 3 months of follow-up to the first level of dose in the group of solid tumors, its clinical study THINK (THerapeutic Immunotherapy with NKR-2).
The first dose level (3 x 108 cells) and administered to a total of three patients with metastatic cancer, two patients suffering from metastatic colorectal cancer (mCRC) refractory after at least two earlier phases of chemotherapy, are stable and do not show tumor progression (Stable Disease : SD) according to RECIST at three months. According to recent studies conducted on populations of patients who are refractory to similar, subject to the treatment standards existing, the median duration of progression-free survival is between 1.9 and 3.2 months.
The third patient cohort, a patient with pancreatic refractory, is up to three months.
No signal of toxicity was observed for each of the patients.
Dr Christian Homsy, CEO of Celyad, said : «We are delighted to have registered these encouraging preliminary results in a population at such an advanced stage of the disease. In spite of a dosage administered corresponds to the tenth of the effective dose expected on the basis of animal experiments, the results show a stabilization of the disease. We are looking forward to analyze the next results of the test THINK. »
Dr. Frederick Lehmann, Vice-President of Clinical Operations and Medical Affairs at Celyad, added : «These first results in patients with mCRC heavily pretreated are encouraging, given the clinical results, little evidence obtained by the existing treatments for this population of refractory patients. On the basis of these preliminary results, we continue to execute our clinical development plan, particularly with higher doses and longer follow-up in the study THINK. We also plan to soon launch clinical trials SHRINK cells (CAR-T NKR-2 in combination with chemotherapy) and LINK (administration of cells CAR-T NKR-2 on the site of the solid tumor) «.
Patients of the second dose of the pane solid tumors (1 x 109) are in the process of recruitment and treatment. To this day, the cells CAR-T NKR-2, have submitted a security profile that would allow for a clinical approach to ambulatory care.
As for the pane hematologic neoplasms, including patients with relapsed or refractory Leukemia Myeloid Aïgue (AML) and Multiple Myeloma (MM) patients of the first dose have been recruited and are processed without any signals of toxicity to this day.
The trial THINK conducted in the United States and Europe consists of two phases : one phase with increasing dose and a phase of expansion. The phase increasing dose is carried out in parallel in groups of solid tumors (colorectal, pancreas, ovarian, triple-negative breast and bladder) and hematological (AML and MM), while the expansion phase will assess in parallel, each type of tumor independently. The scheme increasing dose consists of three levels of dosage adjusted according to body weight : up to 3×108, 1×109 and 3×109 cells CAR-T NKR-2. At each dose, patients receive three administrations of successive, two weeks apart, of cells CAR-T NKR-2 in the specified dose. The therapy CAR-T NKR-2 has been designed to act as a targeted therapy with a persistence in the short-term and multiple injection in order to provide a safety profile better-controlled and more predictable. The main objective is to avoid cell expansion in vivo uncontrolled and long-term persistence, to replace when this paradigm by a pharmacokinetic well-controlled.
Celyad is a company’s clinical-stage biopharmaceutical in the development of cellular therapies, BECAUSE-T. 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
About the platform cell NKR-T Celyad
Celyad is developing a platform cell CAR-T single, using a Receptor of Natural Killer Cells (NK) transduces on lymphocytes T. The target platform for a wide range of solid and hematologic tumors.
Unlike the approaches, BECAUSE-T conventional, which only target one type of tumor antigen, the receptors of natural killer cells (NK) allow a single receptor to recognize multiple tumor antigens. The principal product candidate of Celyad, BECAUSE-T NKR-2, is a T lymphocyte, BECAUSE that one was modified so that it expresses a receptor for human NK cells : the activating receptor NKG2D. BECAUSE-T NKR-2, triggers the destruction of cancer cells when it binds to one of the eight types of ligands it is known that they are upregulated by more than 80 % of the tumors.
The preclinical results indicate that AS-T NKR-2 mechanisms of action, multiple that go beyond the direct destruction of cancer cells. BECAUSE-T NKR-2 inhibits the mechanisms that allow tumors to evade the immune system, activates and recruits immune cells, anti-tumor and blocking the blood supply to the tumor. These mechanisms induce an adaptive immune response, that is to say, the development of immunological memory specific and durable against the antigens of the tumor-targeted.
In contrast to therapeutic approaches BECAUSE T-traditional, and on the basis of preclinical studies, the program AS-T NKR-2 current Celyad does not use any preparatory treatment, which decreases the lymphocytes, which avoids the toxicities associated with chemotherapy and preserves the integrity of the immune system.
Celyad works with both the development of an approach for autologous and allogeneic CAR-T NKR-2. In the framework of the approach, BECAUSE-T NKR-2 autologous, Celyad takes the own T lymphocytes of the patient and the program to express NKG2D in order to efficiently target cancer cells. In the approach to allogeneic Celyad, in T cells from healthy donors are programmed to also express inhibitory molecules of T cell receptors (TCR Inhibitory Molecules — TIM), so that the reprogrammed cells of the donor are not rejected by healthy tissue of the patient (disease of the graft against the host).
Preclinical research underlying this technology was initially conducted at Dartmouth College by Dr. Charles Sentman, and has been the subject of numerous publications in scientific journals.
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