DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics.
Lenz Therapeutics Inc. emerged from stealth mode with $47 million in series A financing to fund its mission to bring a drug therapy to bear on farsightedness, a problem that affects much of humanity, at one point or another.
DUBLIN – Ochre Bio Ltd. has raised $9.6 million in seed financing to drug the liver like never before, by combining genetics, single-cell genomics, spatial sequencing, imaging and machine learning to build a high-resolution, in silico model of the organ, which can provide new insights into disease biology and open up new drug targets.
DUBLIN – Mnemo Therapeutics SAS emerged from stealth mode having raised €75 million (US$91 million) in a series A financing round to take forward a new chimeric antigen T-cell (CAR T) platform, which is focused on selectively targeting both solid and liquid tumors expressing a previously undescribed class of antigens and on improving the persistence and fitness of CAR T cells.
Novavax Inc. reported an overall efficacy rate of 90.4% in a phase III trial of its COVID-19 protein subunit vaccine, NVX-CoV2373, which it conducted in the U.S. and Mexico. The vaccine provided 100% protection against moderate and severe disease and 100% protection against variants of SARS-CoV-2 deemed not to be of concern or interest. Gaithersburg, Md.-based Novavax is on track to file for approval during the third quarter. By the end of that period, it aims to ramp up production to a monthly run rate of 100 million doses and it aims to scale that to a monthly run rate of 150 million doses by the end of the fourth quarter.
DUBLIN – Verona Pharma plc is adding $25 million cash to its balance sheet, as well as $15 million worth of stock in Nuance Biotech Co. Ltd., and could earn up to $179 million more in milestones linked to the development in the greater China region of ensifentrine, its candidate maintenance therapy for chronic obstructive pulmonary disorder (COPD).
Bright Peak Therapeutics Inc. closed a $107 million series B round to progress a pipeline of engineered cytokines, which are produced using a chemical synthesis method instead of classical recombinant protein production approaches.
DUBLIN – Aelis Farma SAS is banking $30 million up front as part of a strategic collaboration and option license deal with Indivior plc involving AEF-0117, its candidate drug for treating cannabis-related disorders, including addiction and psychosis. It could receive another $100 million, should Invidior trigger the option on completion of a phase IIb trial in the U.S.
DUBLIN – The latest update from Merus NV’s phase I/II trial of zenocutuzumab (MCLA-128) – and its early access program – in patients with solid tumors harboring an NRG1-fusion offered a slight improvement on the data disclosed in an abstract released last month, in the run-up to the 2021 American Society of Clinical Oncology meeting.
DUBLIN – Auris Medical Holding Ltd., an early pioneer of targeted therapy for hearing disorders, is planning to exit the field and pivot into RNA-based therapeutics by acquiring a U.S. firm, Trasir Therapeutics Inc., which has developed an oligonucleotide delivery platform for delivery of short interfering RNA and other therapeutic RNA payloads to sites outside the liver.
