An updated trial protocol providing expanded bridging therapies are part of the agreement between the U.S. FDA and Arcellx Inc. that allows the lifting of the partial clinical hold on the company’s pivotal phase II study of CAR T-cell therapy CART-ddBCMA in multiple myeloma (MM).
Avencell Therapeutics Inc. has received approval from the EMA for its clinical trial application (CTA) for AVC-201 for the treatment of relapsed/refractory acute myeloid leukemia (AML) and other selected hematologic malignancies positive for CD123. A phase I study will be conducted in Germany.
Maxcyte Inc. and Vittoria Biotherapeutics Inc. have signed a strategic platform license agreement for use of Maxcyte’s Flow Electroporation technology and Expert platform by Vittoria Biotherapeutics. Under the agreement, Vittoria will obtain nonexclusive clinical and commercial rights to use Maxcyte’s Flow Electroporation technology and Expert platform, and will pay Maxcyte platform licensing fees and program-related revenue.
Poseida Therapeutics Inc. has received FDA clearance of its IND application for P-CD19CD20-ALLO1, an allogeneic dual chimeric antigen receptor (CAR) T-cell product candidate being developed for relapsed or refractory B-cell malignancies in partnership with F. Hoffmann-La Roche Ltd. The company is actively focused on opening clinical sites for a phase I study in adults with relapsed or refractory B-cell malignancies.
Coimmune Inc. has exercised its option to obtain an exclusive license to IL-18 armored chimeric antigen receptor (CAR) technology under a prior agreement with Memorial Sloan Kettering Cancer Center (MSK). The company plans to couple the technology with allogeneic cytokine induced killer (CIK) cells to launch the clinical development of CMN-008 (armored CAR-CIK cells), with CD19 as the initial target in B-cell malignancies.
Researchers from Institut d'Investigacions Biomèdiques August Pi i Sunyer and affiliated organizations have reported the development of novel dual CD19/BCMA CAR T cells, referred to as ARI-0003, developed through co-transduction of two lentiviral vectors encoding CARs targeting CD19 (ARI-0001) and BCMA (ARI-0002h).
Coeptis Therapeutics Holdings Inc. has entered into a sponsored research agreement with the University of Pittsburgh to advance preclinical development of SNAP-CAR T cells targeting HER2, and to explore opportunities to expand the applicability of SNAP-CAR in oncology.
Sana Biotechnology Inc. has received FDA clearance of its IND application to initiate a first-in-human study of SC-291 in patients with various B-cell malignancies. Initial clinical data from the study are expected later this year. SC-291 is a CD19-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy developed using Sana's hypoimmune platform.
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.webp?height=488&t=1670008838&width=650 "Acute myeloid leukemia")
