Poseida Therapeutics

Roche to present over 40 abstracts on nine blood disorders at the 66th ASH Annual Meeting, highlighting long-term follow-up data for Polivy®, Lunsumio®, and Columvi®, and new combination data, reinforcing commitment to advancing lymphoma patient outcomes.

DelveInsight's 'Hemophilia A Pipeline Insight 2024' covers global Hemophilia A therapies, highlighting over 40+ pipeline therapies, key companies like Spark Therapeutics, Pfizer, and Sanofi, and recent FDA approvals for Roctavian and ALTUVIIIO. The report assesses the therapeutic landscape, including product types, stages, routes of administration, and molecule types.

DelveInsight's 'Hemophilia A Pipeline Insight 2024' covers global Hemophilia A therapies, highlighting over 40+ pipeline therapies, key companies like Spark Therapeutics, Pfizer, and Novo Nordisk, and recent FDA approvals for Roctavian and ALTUVIIIO.

Nanoscope Therapeutics plans to file a BLA for MCO-010 to treat retinitis pigmentosa. Seven patients treated with bluebird bio's eli-cel developed hematologic malignancies. Poseida Therapeutics' P-BCMA-ALLO1 showed a 91% ORR in r/r multiple myeloma. Kiromic BioPharma's KB-GDT-01 provided disease stabilization in NSCLC. Adicet Bio's ADI-100 received FDA clearance for additional patient recruitment in lupus nephritis trial. ElevateBio's LNP platform successfully edited liver genes in mice with low immunogenicity.

P-BCMA-ALLO1, an allogeneic BCMA-directed T-cell therapy, showed high response rates in a phase 1/1b trial for relapsed/refractory multiple myeloma, with an overall response rate of 91% in the optimized lymphodepletion arm. The therapy received FDA's regenerative medicine advanced therapy designation in 2024.

Intellia Therapeutics initiates Phase 3 trial of NTLA-2002 for hereditary angioedema; Poseida Therapeutics reports positive Phase 1 data for P-BCMA-ALLO1 in multiple myeloma; YolTech Therapeutics receives FDA orphan drug designation for YOLT-203 to treat primary hyperoxaluria type 1; KSQ Therapeutics gets FDA clearance for Phase 1/2 trial of CRISPR-edited TIL therapy KSQ-004EX.

Poseida Therapeutics announced interim clinical data from its Phase 1 trial of P-BCMA-ALLO1 in relapsed/refractory multiple myeloma, showing a 91% overall response rate (ORR) in an optimized lymphodepletion arm, with 100% ORR in BCMA-naïve patients and 86% ORR in those previously treated with BCMA-targeting therapies. The therapy demonstrated no dose-limiting toxicities, low rates of CRS and ICANS, and no GvHD or Parkinsonism. P-BCMA-ALLO1 has been granted RMAT designation by the FDA and is being evaluated in a Phase 1/1b clinical trial.

Poseida Therapeutics' P-BCMA-ALLO1, an allogeneic CAR-T therapy, received FDA's RMAT designation for treating relapsed/refractory multiple myeloma. The therapy, rich in stem cell memory T-cells, targets BCMA and is in a phase 1/1b trial. Early data showed an 82% overall objective response rate and was well-tolerated, with no cases of graft versus host disease. Poseida plans to present updated results at the 21st International Myeloma Society Annual Meeting in 2024.

Poseida Therapeutics announced FDA's RMAT designation for P-BCMA-ALLO1, an allogeneic CAR-T therapy in phase 1/1b for relapsed/refractory multiple myeloma, based on early promising data. The designation includes Fast Track and Breakthrough Therapy benefits, facilitating early FDA interactions. Poseida plans to report new clinical data at the 21st International Myeloma Society Annual Meeting in 2024.

The FDA granted RMAT designation to P-BCMA-ALLO1, an investigational TSCM-based allogeneic CAR T-cell therapy for relapsed/refractory multiple myeloma, currently in phase 1/1b clinical development. Early results show promising efficacy and safety with no GVHD, low rates of cytokine release syndrome and neurotoxicity. New findings will be presented at the 21st International Myeloma Society Annual Meeting.