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 removed a partial clinical hold on Editas Medicine’s phase 1/2 clinical trial of experimental cell therapy EDIT-301 for the treatment of severe sickle cell disease (SCD; RUBY; NCT04853576) and the first patient in the trial has been dosed.
Celyad Oncology's phase 1b clinical trial, KEYNOTE-B79 (NCT04991948) in refractory metastatic colorectal cancer (mCRC) is back on track after the FDA lifted its clinical hold which was placed back in March 2022.
The FDA has accepted a biologics license application (BLA) with priority review for omidubicel, an allogeneic hematopoietic stem cell transplant candidate developed by Gamida Cell for the treatment of hematological cancers.
The FDA has placed a clinical hold on Beam Therapeutics’ investigational new drug application for BEAM-201, a chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T cell lymphoblastic lymphoma (T-LL).
The FDA has accepted the investigational new drug application for Krystal Biotech’s KB407, a gene therapy candidate being evaluated for the treatment of cystic fibrosis (CF).
Cellectis has received investigational new drug clearance for their dual-targeted allogeneic CAR T-cell therapy UCART2022 for the potential treatment of B-cell malignancies.
AGC Biologics' Milan-based facility will help push forward Altheia Science's autoimmunity treatments which focus on the modulation of PD-L1 expression in hematopoietic stem cells and progenitor cells.
The collaboration intends to use the software to learn more about optimal CAR-T therapy doses and regimens for multiple myeloma.
Li's previous experience includes providing leadership for cell therapy pipelines as chief medical officer of EXUMA Biotech.
The money will additionally help fund OriCell's proprietary discovery platform and a new manufacturing plant's construction.
A formal Data Safety Monitoring Board Review for the CardiAMP Cell Therapy Heart Failure Trial is scheduled for August 30, 2022, to evaluate the trial's safety and futility.
The strategic global collaboration and license agreement will focus on researching and developing allogeneic, "off-the-shelf" treatments for indications including multiple myeloma and B-cell lymphoma.