Latest Cell Therapy News

Arovella Therapeutics has filed an IND application for its lead CAR-iNKT therapy ALA-101, selected a CRO for its upcoming phase 1 trial, and secured $19.4 million in cash to fund clinical progress and pipeline expansion.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

NeuroScientific Biopharmaceuticals reports encouraging clinical responses in fistulising Crohn’s disease patients treated under Australia’s Special Access Scheme, setting the stage for pivotal Phase 2 trials later this year.

AdAlta Limited has raised A$1.2 million through a strategic placement to advance its innovative PD1 armored MSLN CAR-T therapy for solid cancers, reinforcing its unique 'East to West' cellular immunotherapy approach.

Mesoblast Limited reports a 60% jump in Ryoncil sales for the December quarter, underpinned by a new $125 million financing facility that strengthens its balance sheet and strategic flexibility.

AdAlta Limited and its subsidiary AdCella have partnered with Shanghai Cell Therapy Group to co-develop a pioneering CAR-T cancer therapy targeting solid tumours outside China. This collaboration aims to bring a novel, armored immunotherapy with promising clinical results to global markets.

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

Cynata Therapeutics has finalised patient enrolment in its pivotal Phase 2 trial of CYP-001 for acute graft versus host disease, setting the stage for critical data due mid-2026.

An independent meta-analysis presented at the ASH Annual Meeting reveals Mesoblast’s remestemcel-L achieves superior remission rates and safety outcomes compared to ruxolitinib in treating steroid-refractory acute graft-versus-host disease.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.