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After meeting the primary endpoints of a pivotal Phase II trial, UK-based Adaptimmune Ltd. is submitting an FDA Biologics License Application for its autologous T-cell receptor therapy (TCR-T) Lete-cel (letetresgene autoleucel).
Pharmahungary Group has announced it will be participating in a project aiming to set up standardised methods to examine intercellular and interorgan communication via extracellular vesicles, the next Big thing in the diagnosis and therapy of cancer and cardiovascular diseases
Swiss Alentis Therapeutics has raised US$181.4m in an oversubscribed Series D financing set to boost clinical development of its anti-Claudin-1 ADCs in solid tumours.
Biotech CSOs, CDMOs, CROs, lab specialists and AI developers gave an in-depth insight into next-generation antibody-based therapies to about 1,500 attendees at the 16th PEGS Europe in Barcelona. Several new formats are expected to enter the market in the next few years, promising to significantly reduce the side effects of CAR-Ts, bispecific antibodies, ADCs, etc. and improve their efficacy.
US spin-out of German MPI for molecular genetics, Harbinger Health Inc, has started a collaboration with Memorial Sloan Kettering Cancer Centre to turboboost recruiting for its Core-HH study. The study aims to validate a blood test that predicts tumour developement in cancer stage I.
Monoclonal antibodies still dominate the US$417bn biologics market. After decades of development, however, improved antibodies and protein formats with better target selectivity and safety profiles are now hitting markets and pipelines. A range of bispecific antibodies and antibody-drug conjugates – along with CAR-Ts, TCR-RTs and NK cell-based immunoreceptor constructs – were in focus at the PEGS Europe Summit.
In both, liver fibrosis and resolution of MASH, Novo Nordisk’s GLP1 modulator semaglutide has shown convincing results in the Phase III ESSENCE study suggesting a label extension of the obesity blockbuster.
Radiopharmaceuticals specialist Blue Earth Therapeutics Ltd will use a U$76.5m Series A financing to finance Phase II development of its targeted prostate cancer radiopharmaceuticals Lutetium (177-Lu) rhPSMA-10.1 and Actinium (225-Ac) rhPSMA-10.1.
As the first Nordic company seeking Novel Food approval for a mycoprotein ingredient, Finnish Enifer has filed a authorisation application for it brand PEKILO to the EU food watchdog EFSA.
Digital pathology specialist AIgnostics GmbH has topped up its cash position to US$55m with a US$34m Series B financing. The money will be used to optimise the company’s RudolfV Foundation Model and to develop and offer new services for target and biomarker identification selection, particularly in the US pharma market.