Enlivex Therapeutics Ltd. extolled the top-line “positive indication of effect and safety” from the phase II study of Allocetra in treating sepsis and sepsis shock, but the market took another view of the clinical trial. In an analysis of eligible adult patients from the cell therapy’s multicenter, randomized, placebo-controlled, dose-finding study of 120 enrolled patients, the company also reported low mortality rates.
On the heels of a $4.6 million series A round in December 2023, cell therapy company Rxcell Inc. is planning to raise another $15 million in 2024 to take its iPSC-derived photoreceptors to the clinic for retinitis pigmentosa and other degenerative diseases of the retina.
Regenerative medicine company Mesoblast Ltd. saw its stock shoot up 45% on the news that the U.S. FDA is satisfied with the additional data submitted from the company’s phase III study for remestemcel-L for treatment of adults with steroid-refractory acute graft-vs.-host disease (SR-aGVHD) to support filing a BLA in pediatric patients with SR-aGVHD.
One of the building blocks for newly launched Clasp Therapeutics Corp. is making the right patient choices for treatment. If those who receive the company’s therapy are correctly identified, CEO Robert Ross told BioWorld, it will have a profound effect on outcomes. The missing link in cancer treatment, Ross added, was how to identify a patient, something he said Clasp is able to do.
Asgard Therapeutics AB has raised €30 million (US$32.8 million) in a series A round to advance a novel approach to cancer immunotherapy, in which it is proposed to reprogram cancer cells into functional antigen-presenting dendritic cells in vivo, activating a host immune response against the tumor.
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial.
Newly approved gene therapies targeting sickle cell disease will be the first focus of the U.S. Centers for Medicare & Medicaid Services’ (CMS) Cell and Gene Therapy Access Model, the agency said Jan. 30.
2seventy bio Inc. shares (NASDAQ:TSVT) rose 15% or 52 cents, to close Jan. 30 at $4.01 on word that the Cambridge, Mass.-based firm is selling its R&D pipeline to Regeneron Pharmaceuticals Inc., which will move the work forward by way of a new company called Regeneron Cell Medicines.
IMU Biosciences Ltd. has raised £11.5 million (US$14.7 million) in a series A round to further develop and commercialize profiling technology that can identify from a blood sample which of more than 2,000 cell types are present in an individual’s immune system.
Kyverna Therapeutics Inc. disclosed a filing to raise up to $100 million in an IPO, becoming the sixth firm to announce plans for a U.S. listing in the new year, offering tentative hope that the public markets might prove more welcoming to biopharma firms after a lackluster 2023.
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