The company also recently entered into a collaboration with Roche and was invested in by Astellas.
The FDA has cleared Poseida Therapeutics’ Investigational New Drug (IND) application for P-CD19CD20-ALLO1, its first allogeneic dual chimeric antigen receptor (CAR)-T cell therapy candidate, which targets both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies.1
"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," Kristin Yarema, PhD, president, cell therapy, Poseida, said in a statement. "The dual-targeting approach leverages our proprietary non-viral piggyBac® DNA Delivery System, which enables expression of 2 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."
Poseida plans to initiate a phase 1 multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of P-CD19CD20-ALLO1 in up to 70 adult patients with relapsed or refractory B-cell malignancies after a chemotherapy-based lymphodepletion regimen. Poseida is actively focused on opening clinical sites. P-CD19CD20-ALLO1 is a dual-targeted CAR T-cell therapy that uses a novel CD19 binder for greater potency. The therapy is being developed in partnership with Roche.
In other news, Poseida has also strengthened its collaborations in the last month. The company announced it was entering into a strategic global collaboration with Roche Therapeutics focused on developing allogeneic CAR T-cell therapies for hematologic malignancies including multiple myeloma (MM) and other B-cell malignanciesand also announced that Astellas Pharma had made a strategic investment to invest a total of $50 million to acquire approximately 8.8% of Poseida and to receive a right of exclusive negotiation and first refusal for any potential partnering of P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy product candidate for solid tumors.2,3
"We are excited to enter this strategic relationship with Astellas, a premier biopharmaceutical company that shares our long-term vision that cell and gene therapies represent an exciting growth area for the development of innovative medicines for improving patient care," said Mark Gergen, chief executive officer, Poseida, said in another statement.3 "This investment further validates the potential of our proprietary genetic engineering technology platform and cell therapy approach, and we look forward to working with Astellas to advance our shared vision and explore future opportunities for collaboration to further unlock that potential."