News Related to CD19

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Swissmedic Authorizes Three Orphan Drugs for Rare Diseases: Breyanzi, Alhemo, and Ekterly

Jun 22, 2026

Swissmedic has authorized three orphan drugs for rare diseases: Breyanzi for mantle cell lymphoma, Alhemo for haemophilia A and B, and Ekterly for hereditary angioedema. The decisions include a new indication extension for Breyanzi, an expanded indication for Alhemo, and the initial authorization of Ekterly as part of a joint international regulatory initiative.

Off-the-Shelf CAR-T Therapy CB-011 Shows High Response Rates in Multiple Myeloma; Broader CAR-T Advances Presented at 2026 Tandem Meetings

Jun 09, 2026

Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.

Phase III frontMIND Trial Shows Tafasitamab-Lenalidomide-R-CHOP Boosts PFS in High-Risk B-Cell Lymphomas

May 30, 2026

The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.

Clinical Trial Advances in Cancer Immunotherapy and Targeted Therapies

Apr 02, 2026

Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.

Tempest Therapeutics Reports 2025 Financial Results and Clinical Progress

Mar 30, 2026

Tempest Therapeutics reported 2025 financial results showing $7.7 million in cash and highlighted clinical progress including 100% complete response rate in TPST-2003 CAR-T trial and multiple FDA designations for amezalpat in hepatocellular carcinoma. The company completed strategic CAR-T asset acquisition and plans Phase 2b registrational study for its lead program in 2026.

Autolus Reports $74.3M Revenue in First Commercial Year, Aims for Positive Margins by 2026

Mar 28, 2026

Autolus Therapeutics reported $74.3 million in 2025 revenue during its first commercial year, while facing a -265% gross margin. The company aims to achieve positive margins by 2026 through scaling production and expanding into autoimmune diseases with promising early lupus trial results. The broader CAR-T therapy market is projected to reach $9.85 billion in the US by 2033.

Denileukin Diftitox Shows Promise Before CAR-T Therapy in High-Risk DLBCL

Mar 25, 2026

A phase 1 trial shows denileukin diftitox administered before CAR-T therapy has a favorable safety profile and encouraging efficacy in high-risk DLBCL patients, with an 86% overall response rate and 77% one-year progression-free survival. The treatment demonstrated consistent regulatory T-cell depletion, supporting its immunomodulatory mechanism. Larger controlled studies are needed to confirm these preliminary findings.

Cell Therapy Market Growth Accelerates with CAR-T Dominance and New Research Milestones

Mar 24, 2026

The cell therapy manufacturing market is projected to reach $14.01 billion by 2035, with CAR-T therapies dominating at 65% market share. Recent FDA approvals for new CAR-T indications and Japanese regulatory acceleration highlight growing clinical adoption, while research advances include new anti-aging protein platforms and CRISPR-based treatments.