Actinium Pharmaceuticals Inc. is receiving an up-front $35 million with a possible $417 million in regulatory and commercial milestones in its new license and supply agreement with Immedica Pharma AB, of Stockholm. Immedica is getting the exclusive European, Middle Eastern and North African rights to Iomab-B, an antibody radiation conjugate comprising apamistamab, a CD45-targeting antibody, and the radioisotope iodine-131. Actinium is eligible for royalties in the mid-20% range on net sales.
Edigene Inc. has extended a long-running partnership with an academic lab at the Chinese Academy of Medical Sciences and Peking Union Medical College with the goal of co-developing hematopoietic stem cell regenerative therapies and technology for the treatment of inherited blood disorders, as well as the discovery of biomarkers to improve quality control of stem cell production.
Cancer therapy developer Immpact Bio USA Inc. has raised $111 million to further its "logic gate"-based CAR T-cell platform, the source of a CD19/CD20 bispecific in phase I testing for B-cell non-Hodgkin lymphoma patients whose disease has returned or who has stopped responding to treatment. New data from that study, showing complete remissions in seven of eight patients treated, accompanied the appointment of a new president and CEO for the company as well as a new board chair.
Century Therapeutics Inc.’s $3.25 billion deal with Bristol Myers Squibb Co. (BMS) was the largest of four billion-dollar-plus agreements announced Dec. 10, piggybacking on a busy week that includes the start of the 40th annual J.P. Morgan Healthcare Conference.
LONDON – Natural killer (NK) cell therapy specialist Onk Therapeutics Ltd. has raised $21.5 million in a series A, enabling it to move three lead programs into proof-of-concept animal testing and to progress manufacturing and scale-up of its cord blood-derived cells.
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.
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