The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
The scene has been set for research into gene misexpression across different tissues, to understand the part it plays in a range of diseases and search for new drug targets, following publication of the first comprehensive survey of where genes are active when they are expected to be switched off.
Draupnir Bio is poised to advance a new approach to targeted protein degradation by engaging the sortilin receptor on lysosomes to promote the destruction of extracellular and membrane-bound disease proteins.
GPCR drug discovery and development specialist Confo Therapeutics NV has closed a €60 million (US$65.2 million) series B round that will fund a significant expansion of the inhouse portfolio while it continues to turn the handle on its technology platform to generate more compounds for partnering.
Those affected by primary biliary cholangitis (PBC) are fighting back against the recommendation by the EMA that the marketing authorization for Ocaliva (obeticholic acid), a second-line treatment used by 7,000 patients in Europe, be withdrawn. Earlier today, July 25, patients and their supporters staged a protest outside the European Commission building in Brussels to oppose EMA’s position that Ocaliva’s conditional license should be revoked.
Catalym GmbH has closed a $150 million series D to take its first in class immune potentiator visugromab into phase IIb development in a number of solid tumors. The round follows on the heels of data from a phase I/IIa trial which showed visugromab in combination with the PD-1 inhibitor antibody Opdivo (nivolumab, Bristol Myers Squibb) increased T-cell infiltration and generated durable antitumor responses in patients who had exhausted all other treatment options.
Asceneuron SA has raised $100 million in an oversubscribed series C to take its lead small molecule, ASN-51, into phase II, with aim of demonstrating it prevents the formation of tau tangles and slows the progression of Alzheimer’s disease.
New company Pan Cancer T BV is preparing for a clinical trial of a next-generation T-cell receptor-engineered T cell it has designed to remove the current barriers and make T-cell therapies effective in treating solid tumors. Its products have two distinguishing features: They are targeted at antigens the company has shown are exclusively and robustly expressed by multiple solid cancers, and have a minor genetic modification that enhances the durability of autologous TCR-Ts in the tumor microenvironment after they are administered back into a patient.
Ligand Pharmaceuticals Inc. is adding one more income stream to its portfolio, with the $100 million acquisition of Apeiron Biologics AG, owner of royalty rights to Qarziba, a treatment for high risk neuroblastoma that is currently marketed in 35 countries and is en route to approval in the U.S.
Myricx Bio Ltd. has closed the largest series A for a European biotech this year, raising £90 million (US$115.4 million), to take forward antibody-drug conjugates based on novel payload chemistry.
