MD Anderson researchers find mechanisms behind CAR-T cells’ efficacy, toxicity
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
The companies said Tuesday that the FDA had accepted their application for idecabtagene vicleucel, which they resubmitted in July after the agency initially refused to file it in May. The action date is in March of next year.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company said Friday that it had submitted for approval of Yescarta in follicular and marginal zone lymphoma, based on data from the ZUMA-5 study that were presented at the 2020 ASCO meeting in May.
The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology - currently in preclinical development - into human clinical trials. German drugmaker Bayer's venture capital arm led the round.
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
The companies' resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta. Tecartus is a similar product, but with a different manufacturing process.
The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of which are under investigation, the company said.
The co-founders of the company include Hans Bishop, who founded Juno Therapeutics - one of the earliest commercial developers of CAR-T cell therapy technology - in 2013.
Johnson & Johnson, which in-licensed Legend's CAR-T technology and is developing a version of its product under the name JNJ-4528, presented data from the Phase Ib/II CARTITUDE-1 study at the ASCO meeting.
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
Data on multiple CAR-Ts presented at the recent ASCO meeting have raised the prospect of outpatient use of the therapies, which is favorable for reimbursement as well as for patients. But experts pointed to significant infrastructure challenges that centers face.
In a presentation of data at ASCO on the Phase I/II study of orvacabtagene autoleucel in patients with heavily pretreated multiple myeloma, it was stated that the study added a new cohort of patients with prior exposure to therapies that, like orva-cel, target the BCMA antigen.
The company is seeking approval for Yescarta in follicular and marginal zone lymphomas. While it has a clear efficacy advantage over existing therapy options, experts said whether to use it in their place will entail complicated conversations with patients.
While cautioning that it's still early days, experts said the data - especially those showing much lower toxicity - raise the prospect that the therapy could replace autologous CAR-Ts, if its efficacy remains the same.
Data on the CAR-T, JNJ-4528, will be presented at the ASCO virtual meeting. In an interview, a J&J executive talked about how the therapy could be developed for outpatient use through patient self-monitoring.