Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
Ipsen SA, of Paris, struck a $461 million deal with Day One Biopharmaceuticals Inc. for ex-U.S. rights to tovorafenib, an oral drug for pediatric brain tumor that gained U.S. FDA accelerated approval April 23 as Ojemda (tovorafenib).
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.
Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter.
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marketing authorization for Ocaliva (obeticholic acid), a second-line treatment used by 7,000 patients in Europe, be withdrawn.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.
Triastek Inc., of Nanjing, China, scored a potential $1.2 billion collaboration and platform technology license deal with Biontech SE to manufacture oral RNA therapeutics with 3D printing technology.
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.
The lively antibody-drug conjugate (ADC) space chalked another collaboration as Taipei, Taiwan-based Foreseen Biotechnology Co. Ltd. scored a global licensing agreement worth as much as $1.03 billion with Ipsen SA, of Paris, for antibody-drug conjugate FS-001, which is said to bear first-in-class potential. The drug takes aim at a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis, the companies said.
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