FDA Clears IND Application for P-CD19CD20-ALLO1 Dual CAR-T for B-Cell Malignancies
“We are pleased to receive IND clearance for P-CD19CD20-ALLO1, our third fully allogeneic CAR-T cell product candidate and the second therapy in our partnership with Roche for hematological malignancies that will enter the clinic. We believe this represents the FDA’s first known IND clearance of an allogeneic dual CAR-T therapy targeting CD19 and CD20,” said Kristin Yarema, Ph.D., President, Cell Therapy at Poseida. “The dual-targeting approach leverages our proprietary non-viral piggyBac® DNA Delivery System, which enables expression of two fully functional CAR molecules into T cells from healthy donors for the treatment of B-cell malignancies that may have heterogeneous antigen expression. We believe that targeting both CD19 and CD20 has the potential to overcome the limitations of currently available CD19-directed CAR-T products where antigen escape has been observed as an important resistance mechanism. It has been estimated that up to 40% of cases where B-cell malignancies relapse or are refractory to CD19 targeting autologous CAR-T therapy may involve antigen escape. We look forward to dosing the first patients in this study.”
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000