Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
The cell and gene therapy sectors are growing exponentially, with new players emerging daily and much progress being made both in and out of the lab. CGTLive’s Around the Helix is your chance to catch up with the latest news in cell and gene therapies, including partnerships, pipeline updates, and more.
The FDA has approved the first gene therapy for the treatment of bladder cancer, according to an announcement from the agency and the drug's manufacturer, Ferring.
The FDA’s partial clinical hold suspending enrollment, cell collection, conditioning, and infusion of patients under the age of 18 in bluebird bio's phase 3 HGB-210 clinical trial (NCT04293185) of lovotibeglogene autotemcel (lovo-cel; bb1111), an investigational gene therapy intended to treat sickle cell disease (SCD), has been lifted.
The agency granted OCU400 orphan drug designation for additional indications and agreed to a phase 3 trial design for NeoCart. Ocugen also announced that a new current Good Manufacturing Practice cell therapy manufacturing facility is under construction that will support clinical and commercial production of NeoCart.
The FDA has cleared the investigational new drug application (IND) of Invectys and CTMC’s human leukocyte antigen A (HLA-G) targeting chimeric antigen receptor (CAR) T-cell therapy IVS-3001 for treating solid tumors.
In addition to Tmunity's rapid manufacturing processes, ‘armored’ CAR-T technology platform, and other programs in various stages of development, the acquisition will also provide Kite with access to a strategic research and licensing agreement with the University of Pennsylvania.
It was noted that the MB-106 clinical trial is continuing to enroll patients, while the Safety Review Team for MB-102's clinical trial recommended a dose escalation to 300x106 CAR-T cells, and positive preclinical data regarding the company's MB-109 combination therapy was presented at the American Association for Cancer Research Annual Meeting 2022. An exclusive license agreement with the Mayo Clinic for an in vivo CAR-T platform technology was also highlighted.
In addition, the company announced that is has appointed Sukumar Nagendran, MD, as the new president and head of research and development.
The company intends to focus on intellectual property partnering and discovery research in several areas in the wake of its discontinuation of the CYAD-211 CAR-T clinical program for relapsed/refractory multiple myeloma.
After considering various strategic options, the Board of Directors determined that complete liquidation and dissolution is in the best interest of the company's shareholders.
The European Medicines Agency’s Committee for Medicinal Products for Human Use made the recommendation for the conditional marketing authorization based on results from HOPE-B (NCT03569891), a phase 3 clinical trial.
Oxford Biomedica Solutions will support the development of the biotechnology companies' gene therapies by providing access to its platform, which is intended to accelerate development and produce more doses per batch.
The technology is intended to enable macrophages to reduce autoimmune activity.
The Durham, North Carolina-based facility will be 80,000 square feet and will provide analytical development and testing services for biologics, including cell therapies and gene therapies.
The approval of Breyanzi is based on the results of clinical trials in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma after first-line therapy, including global phase 3 clinical trials (JCAR017-BCM-003), phase 2 clinical trials (017006) in the United States, and cohort 2 of phase 2 clinical trials (JCAR017-BCM-001) in Europe and Japan.