Latest Cell Therapy News

Imugene reports a second complete response in its Phase 1b trial of azer-cel combined with BTK inhibitors, including the first patient with Mantle Cell Lymphoma who had failed prior BTKi therapy.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Chimeric Therapeutics has appointed Hawkesbury Partners to lead a strategic review aimed at exploring options to enhance shareholder value, reflecting concerns that its market cap undervalues its clinical assets and infrastructure.

Imugene Limited reports a complete response in the first patient treated with azer-cel combined with BTK inhibitors in its Phase 1b trial, highlighting potential for resistant follicular lymphoma.

Mesoblast has drawn US$50 million from a new five-year facility that reduces its interest burden and retires expensive short-term debt, strengthening its financial position ahead of commercial expansion.

Cynata Therapeutics (ASX: CYP) has had its trading suspension lifted immediately following the publication of results from its Phase 3 Osteoarthritis and Phase 2 Graft versus Host Disease clinical trials.

Imugene’s off-the-shelf CAR T therapy azer-cel has won FDA Fast Track Designation for relapsed or refractory CLL/SLL and MZL, backed by compelling Phase 1b response rates.

Cynata Therapeutics secures a crucial regulatory green light from the EMA’s Paediatric Committee for its CYP-001 treatment in children with acute graft versus host disease, paving the way for sequential adult and paediatric trials in Europe.

Chimeric Therapeutics reports encouraging Phase 1/2 data for its CHM CDH17 CAR-T therapy in advanced gastrointestinal cancers, with 82% of evaluable patients achieving stable disease and durable responses lasting over a year.

Imugene has dosed the first patient in a new cohort combining its azer-cel CAR T therapy with BTK inhibitors, targeting patients with B-cell malignancies who failed prior BTKi treatment. This move broadens the trial’s scope and tackles a significant unmet need in blood cancer therapy.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.