May 9, 2019
Cell and gene therapy news: some recent highlights
Things keep moving fast in the world of cell and gene therapy. Here are a few of the recent developments we’ve noted here at Vineti.
This proposal would standardize payment and reimbursement approaches for CAR-T cell therapy care in the United States. According to the Centers for Medicare and Medicaid Services, ‘the proposed National Coverage Determination would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.”
“This research is exploring CAR-T applications in disease areas such as autoimmune disorders.”
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Kite Pharma “announced plans for a new facility in Frederick County, Maryland, which will produce innovative cell therapies for people with cancer. The 20-acre site will significantly expand Kite’s ability to manufacture a variety of chimeric antigen receptor T (CAR T) therapies, including Yescarta (registered) (axicabtagene ciloleucel), Kite’s first commercially available CAR T cancer therapy, and investigational T cell receptor (TCR) cell therapies being evaluated in solid tumors.”
In this update, Autolus, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the U.S. FDA “has granted orphan drug designation to autologous enriched T-cell genetically modified with a retroviral vector to express two chimeric antigen receptor targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).”
“In this update, Marker Therapeutics, a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, announced a plan “to advance a Phase 2 Company-sponsored clinical trial in post-transplant acute myeloid leukemia (AML)–a disease area and patient population for which there are limited treatment options. We expect to finalize our clinical trial protocol in AML by the end of the second quarter of 2019 and to submit our IND in the third quarter, with the first patient enrolled by the end of the year,” said Peter L. Hoang, President & CEO of Marker Therapeutics.”
In this update, Tessa Therapeutics, a clinical-stage cell therapy company focused on autologous and allogeneic therapies for a wide range of cancers, ‘announced proof-of-concept data from the preclinical study of TT16, first-of-its-kind combination immunotherapy that integrates Chimeric Antigen Receptor (CAR) T cell therapy and oncolytic adenovirus expressing immunomodulatory molecules for the treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-positive solid tumors…The preclinical findings support the advancement of the multimodal immunotherapy into a Phase I clinical trial.”
In this company profile, BioCentury looks at Vineti and our software solution for personalized therapies: “Drawing on its experience with CAR T cell therapies, Vineti has developed a cloud-based software platform that standardizes processes and drives down costs in the supply chain for personalized medicines.”
(BioCentury subscription required)
We very much appreciated the chance to discuss our industry-leading Personalized Therapy Management Platform with BioCentury. If you’d like to see our platform in action for yourself, please contact us to schedule a demo.