Allogene Therapeutics

Allogene Therapeutics has discontinued the FC plus ALLO-647 lymphodepletion arm in its ALPHA3 trial after a patient death from hepatic failure attributed to disseminated adenovirus infection.

• The FDA has removed a clinical hold on all five of Allogene Therapeutics' AlloCAR T studies that was imposed in October 2021 following a chromosomal abnormality in a single patient. • A three-month investigation concluded that the chromosomal abnormality was unrelated to Allogene's manufacturing process and had no clinical significance for the patient. • The pivotal phase II trial of ALLO-501A in relapsed/refractory large B-cell lymphoma is scheduled to commence in mid-2022. • Allogene's stock rose over 4% in premarket trading following the announcement of the clinical hold removal.

The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions.

DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area.

Allogene Therapeutics invests $37.3M in an expanded collaboration with Foresight Diagnostics to develop a minimal residual disease (MRD) assay for large B-cell lymphoma treatment.

• Allogene Therapeutics' cema-cel demonstrates sustained efficacy with 23.1-month median response duration in relapsed/refractory large B-cell lymphoma patients from ALPHA trials. • The allogeneic CAR T-cell therapy achieves remarkable complete response rates in first-line consolidation treatment for patients with low disease burden. • Long-term follow-up data reinforces cema-cel's safety profile and therapeutic potential as an off-the-shelf treatment option for lymphoma patients.

Phase 1 ALPHA and ALPHA2 trials demonstrate cemacabtagene ansegedleucel achieves 67% overall response rate and 58% complete response rate in relapsed/refractory LBCL patients using the selected Phase 2 regimen.

The FDA has cleared Allogene Therapeutics' IND application for ALLO-329, a dual-targeting allogeneic CAR T-cell therapy, to treat autoimmune diseases.

• CD40 targeted therapies are under investigation for cancer, autoimmune, and infectious diseases, with the first approval expected by 2027. • CD70 targeting therapies show potential in treating hematological malignancies like AML and solid tumors such as renal cell carcinoma. • Antibody therapies dominate CD40 research, while CD70 therapies explore monoclonal antibodies, CAR-T cells, and antibody-drug conjugates. • Major pharmaceutical companies like Sanofi, Genmab, Amgen, and Allogene are investing heavily in CD40 and CD70 targeted therapies.

• Ultragenyx seeks accelerated FDA approval for UX111, a gene therapy for MPSIII, based on Phase 1/2/3 trial data. • Arbor Biotechnologies' CRISPR-based therapy ABO-101 receives clearance for US trial in Primary Hyperoxaluria Type 1. • Allogene Therapeutics' ALLO-329 cleared by FDA for Phase 1 trial in rheumatology indications including lupus. • uniQure progresses in trial for SOD1-ALS gene therapy AMT-162, advancing to the second cohort enrollment.