PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
Clade Therapeutics Inc., which launched with an $87 million series A round, may have what sounds like an ambitious goal: to create scalable, off-the-shelf stem cell-based medicines that can be as accessible to patients as antibody therapies are today. But the startup, backed by more than two decades of advances in the area of induced pluripotent stem cells, is within sight of developing a cell therapy to take into clinical testing.
As if it were needed, Amicus Therapeutics Inc.’s spin-off of its gene therapy work and PDUFA VII’s provisions to increase the capacity of the FDA’s Center for Biologics Evaluation and Research offered further proof this week of the global explosion that’s happening in the regenerative medicine field.
The PDUFA commitment letter negotiated between industry and the U.S FDA every five years provides an inside look at the future of drug development. The PDUFA VII letter, which is to be presented to Congress by Jan. 15, is no exception.
DUBLIN – Treefrog Therapeutics SA closed a $75 million series B round this week, which will help to increase its reach and its profile, as it pursues its highly ambitious objective to drive the adoption of a new way of making induced pluripotent stem cells (iPSCs) at scale. The Bordeaux, France-based firm is not a CDMO in any sense, however. It is a fully fledged biotech, with early stage iPSC-based programs in Parkinson’s disease, cardiovascular disease and bone marrow transplant, among others. It’s just that it is also attempting to revolutionize how those cells are cultivated before it administers them as therapies.
The axolotl, which can regenerate many of its body parts, was the inspiration for Walking Fish Therapeutics Inc., which just closed on a $50 million series A financing to advance its B-cell therapies for oncology, rare disease, regenerative medicine, autoimmune disease and recombinant antibody production.
DUBLIN – In biopharma, U.S. patent grants hardly represent big news. Without them, you simply don’t get to sit at the table. So Onk Therapeutics Ltd.’s receipt of U.S. patent no. 11104735 covering CISH gene knockouts in natural killer (NK) cell therapies for cancer is not a major event in the general scheme of things. At the same time, it is a vitally important enabler for a company that is, paradoxically, both an early mover in the field but also a laggard in the highly competitive race to move NK cells into clinical development.
A new deal between Adaptimmune Therapeutics plc and Roche Holding AG's Genentech Inc. aims to develop allogeneic cell therapies for up to five shared cancer targets. Should the agreement win regulatory clearance, still pending, Adaptimmune will receive $150 million up front and additional payments of $150 million over five years. In addition, it could be eligible for development, regulatory and commercial milestones payments from Roche exceeding $3 billion, plus royalties.
Hebecell Corp. closed on a $53 million series A funding to continue advancing its off-the-shelf pluripotent stem cell CAR-natural killer cell (PSC-CAR-NK) therapy program into the clinic. Allen Feng, Hebecell’s chief scientific officer, has worked in stem cell development for more than 16 years. He’s seen a lot of technological change, especially in the past two years. Everyone is using the same technology, he said, but added that Hebecell’s technology is different from anyone else’s. It’s much simpler technology and has “very good potential” to move into large-scale industrial production.
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