Amgen and The University of Texas MD Anderson Cancer Center announced two multi-year collaboration agreements aimed at accelerating development of a variety of Amgen’s early-stage oncology therapies for patients with leukemia, myelodysplastic syndromes, multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies. The agreements combine Amgen therapies nearing clinical development or those that have already begun the process with MD Anderson’s translational medicine capabilities. The collaborations will focus on Amgen’s bispecific T cell engager BiTE , chimeric antigen receptor CAR T cell and small molecule programsThe five-year collaboration will begin with Phase 1 clinical studies for BiTE antibody constructs and CAR T cell therapies for multiple myeloma and small cell lung cancer. The second agreement spans four years and will study BiTE antibody constructs, CAR T and small molecule treatments in leukemia and myelodysplastic syndromes. The collaboration includes multi-institutional pre-clinical and clinical trials, some of which will be led by MD Anderson, which may offer the potential for identifying new biomarkers.
Thursday, May 31, 2018
Regeneron’s investigational Ebola treatment shipping to Congo
Regeneron Pharmaceuticals’ investigational therapy that combines three fully-human monoclonal antibodies, REGN-EB3, is being shipped to the Democratic Republic of the Congo for use in the current Ebola virus infection outbreak. REGN-EB3 is one of several investigational therapeutics evaluated for use by a panel of independent scientific experts convened by the World Health Organization and selected for inclusion in a potential WHO-coordinated clinical trial. A new publication from the Journal of Infectious Diseases describes development of REGN-EB3 and efficacy results at different doses in animal models. In three preclinical studies, REGN-EB3 was seen to treat advanced Ebola virus disease and prevent mortality of infected non-human primates. Regeneron worked with the WHO and FDA to develop an Expanded Access Program protocol to support use of this treatment in the most recent outbreak in the Congo. Regeneron has secured various regulatory approvals, country approvals and import licenses and has hundreds of doses of REGN-EB3 ready to ship beyond the initial shipment currently in process. REGN-EB3 has received orphan drug designation from both the FDA and European Medicines Agency. It is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
Reata gets Euro orphan drug tag for kidney med candidate
Reata Pharmaceuticals announced that the European Commission, or EC, has granted orphan drug designation, based on the positive opinion from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency, or EMA, for bardoxolone methyl for the treatment of Alport syndrome. Alport syndrome is a rare, genetic form of chronic kidney disease, or CKD, caused by mutations in genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. A majority of patients with Alport syndrome develop CKD and many progress to end-stage renal disease. In the Phase 2 portion of the Phase 2/3 CARDINAL study, bardoxolone significantly increased patients’ estimated glomerular filtration rate after 36 weeks of treatment
Globus started at buy by Cantor
Globus Medical initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Craig Bijou started Globus Medical with an Overweight rating and $65 price target. The analyst sees several sales growth drivers for the company, including a U.S. core market rebound, early success of emerging technologies and traction of the acquired ATEC international platform.
K2M started at buy by Cantor
K2M Group initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Craig Bijou started K2M Group with an Overweight rating and $28 price target. The company’s outperformance in the U.S. market over the last two years has been underappreciated, Bijou tells investors in a research note. He sees the U.S. momentum continuing in 2018 and beyond, driven by innovative new product launches and sales rep hires.
Orthofix started at buy by Cantor
Orthofix initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Craig Bijou started Orthofix with an Overweight rating and $62 price target. The analyst believes the recent share pullback provides a good entry point, especially ahead of more details on the benefit of re-domiciling to the U.S.
Tonix says Phase 2 study shows Tonmya reduces PTSD symptoms
Tonix Pharmaceuticals presented data from the Phase 2 AtEase study of Tonmya for the treatment posttraumatic stress disorder. The presentation focused on the rationale for including suicidal individuals in the clinical trial of a treatment for PTSD. “There are several examples in major psychiatric disorders in which pharmacological treatment of the underlying disorder may decrease suicidal behaviors,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix. “Individuals with military-related PTSD have an elevated risk for suicidal behaviors, and it was hypothesized that addressing underlying PTSD with Tonmya might have an impact on reducing suicidal behaviors. Suicidal individuals were included in the AtEase study as it provided for a more representative sample of the condition for evaluating the efficacy Tonmya 2.8 mg and 5.6 mg as a potential treatment for military-related PTSD.” “Taken nightly at bedtime and absorbed by a sublingual route, Tonmya is believed to reduce PTSD symptoms through improvement in sleep quality, potentially also addressing suicidal behaviors via upstream effects on sleep improvement,” Dr. Sullivan continued “While rates of suicidal ideation and behaviors were not high enough to allow meaningful statistical analyses in AtEase, these data, combined with other datasets acquired by similar methodology, may provide important new information and insights leading to better prediction of, and interventions to prevent, suicides in PTSD.”
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