Poseida Therapeutics

Ikena Oncology and Inmagene Biopharmaceuticals have appointed former Poseida Therapeutics CEO Kristin Yarema to lead the merged company ImageneBio following their anticipated July 2025 closing.

• A comprehensive review of global clinical trials for relapsed multiple myeloma (R/R MM) reveals key trends in trial locations, phases, and sponsor types. • The analysis identifies prominent drugs under investigation and highlights recent clinical trial news, including updates from ASH 2024 and other major meetings. • The review emphasizes the importance of understanding trial enrollment trends and success rates to inform business strategies and identify key opportunities in the R/R MM therapeutics market. • Recent data showcases promising results for novel combinations and CAR-T cell therapies, suggesting potential breakthroughs in treating R/R MM.

• Roche acquired Poseida Therapeutics for US$1.5 billion, signaling strong interest in cell therapy, particularly allogeneic approaches for blood cancers. • Arovella Therapeutics (ALA) is preparing to commence Phase 1 trials in 2025 with its iNKT cell therapy platform, targeting CD19-expressing blood cancers. • ALA's early preclinical data demonstrates promising results, including spontaneous secondary remission in mice, suggesting potential long-term efficacy. • ALA has strengthened its clinical advisory board with the appointment of Professor Sattva Neelapu, an expert in CAR-T therapy development and FDA approval.

• P-BCMA-ALLO1, an allogeneic CAR-T therapy from Poseida Therapeutics, demonstrates promising results in heavily pretreated multiple myeloma patients. • The Phase 1/1b trial showed a 91% overall response rate in patients receiving enhanced lymphodepletion, indicating improved efficacy. • No graft-versus-host disease was observed, and cytokine release syndrome was mostly low grade, highlighting a favorable safety profile. • P-BCMA-ALLO1 offers a potential off-the-shelf alternative to autologous CAR-T therapies, addressing the unmet need for immediate treatment options.

P-BCMA-ALLO1, an allogeneic CAR-T therapy, shows an 88% overall response rate in relapsed/refractory multiple myeloma patients in a phase 1/1b trial.

• Roche will acquire Poseida Therapeutics for $1.0 billion, expanding its CAR-T therapy portfolio, targeting hematological malignancies, solid tumors, and autoimmune diseases. • Merck's Winrevair phase III study met its primary endpoint, showing a statistically significant reduction in morbidity or mortality events in advanced pulmonary arterial hypertension. • AstraZeneca's Truqap, combined with Zytiga and ADT, significantly improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer. • Novartis received European Commission approval for Kisqali to treat HR+/HER2- early breast cancer patients at high risk of disease recurrence, based on the NATALEE phase III trial.

• Beam Therapeutics reported a patient death in their BEAM-101 sickle cell disease trial, likely due to the conditioning regimen. • AstraZeneca scientists engineered PsCas9 for therapeutic genome editing in mouse liver, showing promise for hypercholesterolemia treatment. • YolTech Therapeutics' novel LNP system delivers base editor mRNA to bone marrow cells, activating foetal haemoglobin production for blood disorder treatment.

• Poseida Therapeutics will present preclinical data on allogeneic CAR+TCR-T cells at SITC 2024, highlighting enhanced potency for targeting solid tumors. • Additional profiling of patient responses in the P-BCMA-ALLO1 Phase 1 study, along with preclinical data on P-CD19CD20-ALLO1, will be shared at ASH 2024. • P-BCMA-ALLO1 has received RMAT designation for relapsed/refractory multiple myeloma and is being developed in collaboration with Roche. • P-CD19CD20-ALLO1, a dual-targeting CAR-T therapy, shows superior efficacy over single-target products in preclinical studies for B-cell malignancies.

• Intellia Therapeutics has initiated a pivotal Phase 3 trial (HAELO) of NTLA-2002 for hereditary angioedema, evaluating its ability to reduce HAE attacks through plasma kallikrein activity reduction. • Poseida Therapeutics announced positive interim Phase 1 data for P-BCMA-ALLO1 in heavily pre-treated multiple myeloma patients, demonstrating a 91% overall response rate. • YolTech Therapeutics received Orphan Drug Designation for YOLT-203, an in vivo gene-editing therapeutic for primary hyperoxaluria type 1, aiming to correct AGXT mutations. • KSQ Therapeutics received FDA clearance for its IND application for KSQ-004EX, a CRISPR-Cas9 engineered TIL therapy, to treat advanced solid tumors by targeting SOCS1 and Regnase-1.

Poseida Therapeutics reported a 91% overall response rate with P-BCMA-ALLO1 in relapsed/refractory multiple myeloma patients in an optimized lymphodepletion arm.