Celgene Corporation (NASDAQ:CELG) and AstraZeneca (NYSE:AZN), announced the initiation of the FUSION clinical development program of durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) in hematologic disorders.
The FUSION program is part of a strategic collaboration with AstraZeneca and its global biologics research and development arm MedImmune, to develop and commercialize durvalumab across a range of blood cancers including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.
The program will initially include four studies:
- MM-001 – A phase 1b multicenter, open-label study to determine the recommended dose and regimen of durvalumab as a monotherapy or in combination with pomalidomide with or without low-dose dexamethasone in patients with relapsed/refractory multiple myeloma
- CC-486-MDS-006 – A phase 2 international, multicenter, randomized, open-label, parallel-group study to evaluate the efficacy and safety of CC-486 alone or in combination with durvalumab in patients with MDS who fail to achieve an objective response to treatment with azacitidine for injection or decitabine
- MEDI4736 -NHL-001 – A phase 1/2 open-label, multicenter study to assess the safety and tolerability of durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia
- MEDI4736-MDS-001 – A randomized, multicenter, open-label phase 2 study evaluating the efficacy and safety of azacitidine subcutaneous in combination with durvalumab in previously untreated patients with higher-risk myelodysplastic syndromes or in elderly (≥ 65 years) acute myeloid leukemia subjects not eligible for hematopoietic stem cell transplantation
“The initiation of the FUSION program represents an important step forward in Celgene’s development of immuno-oncology approaches in hematologic disease,” said Robert Hershberg, M.D., Ph.D., Celgene’s Senior Vice President, Immuno-Oncology. “Checkpoint inhibitors hold tremendous promise in the treatment of cancer and we believe Celgene’s deep experience in hematology allows us unique perspective on this growing area of clinical research.”
“We’re pleased with the rapid start of the first clinical trials in the FUSION development program through our strategic partnership with Celgene,”Robert Iannone, Senior Vice President, Head of Immuno-oncology, Global Medicines Development at AstraZeneca. “Durvalumab is a highly promising investigational immunotherapy for a range of tumour types and we look forward to exploring its potential as a PD-L1 inhibitor for patients with blood cancers, for whom current treatment choices are limited.”
The Celgene partnership with AstraZeneca/MedImmune is part of a comprehensive commitment to immuno-oncology that includes not only clinical-stage checkpoint inhibitors and t-cell activators, but also earlier stage research efforts on the tumor microenvironment focused on tumor-associated macrophages, monocytes, natural killer cells and regulatory T cells. (Original Source)
Shares of Celgene Corporation shares are trading at $110.00. down $0.36 or -0.33%. CELG has a 1-year high of $140.72 and a 1-year low of $92.98. The stock’s 50-day moving average is $116.24 and its 200-day moving average is $119.51.
On the ratings front, Celgene has been the subject of a number of recent research reports. In a report issued on December 1, Jefferies Co. analyst Brian Abrahams reiterated a Buy rating on CELG, with a price target of $141, which represents a potential upside of 27.8% from where the stock is currently trading. Separately, on November 23, J.P. Morgan’s Cory Kasimov reiterated a Buy rating on the stock and has a price target of $152.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Abrahams and Cory Kasimov have a total average return of 25.0% and -0.5% respectively. Abrahams has a success rate of 62.7% and is ranked #128 out of 3645 analysts, while Kasimov has a success rate of 45.9% and is ranked #2646.
The street is mostly Bullish on CELG stock. Out of 6 analysts who cover the stock, 6 suggest a Buy rating . The 12-month average price target assigned to the stock is $147.00, which implies an upside of 33.2% from current levels.
Celgene Corp is a biopharmaceutical company. It is engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases.