Johnson & Johnson (J&J) gained the U.S. FDA’s accelerated approval of Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma in adults. The bispecific antibody targets G protein-coupled receptor class C group 5 member D (GPRC5D). J&J is not alone among pharma giants to go after GPRC5D; Bristol Myers Squibb Co. and Roche Holdings AG also have programs testing the approach.
Galera cuts staff by 70% to keep the company going
A complete response letter (CRL) from the U.S. FDA for GC-4419 (avasopasem) from Galera Therapeutics Inc. is the latest obstacle to approval. The delay has the company thinking about ways to extend its cash runway and that means cutting its workforce by about 70%. The CRL was for the therapy to treat radiotherapy-induced severe oral mucositis (SOM) in locally advanced head and neck cancer. The CRL noted phase III data in the NDA were not sufficient for approval and said that another clinical trial is needed. This isn’t the first problem in the road to an approval. An error in phase III data that seemed to sink chances for an approval about two years ago nearly derailed the selective small-molecule dismutase mimetic’s development. Galera’s stock (NASDAQ:GRTX) was down 84% at midday to 35 cents a share.
Novo Nordisk acquiring Inversago for $1B+, targeting CB1 for obesity
Building out its metabolic franchise, Novo Nordisk A/S is buying privately held Inversago Pharma for $1.075 billion, gaining lead asset INV-202, an oral CB1 inverse agonist. The candidate has demonstrated weight loss potential in a phase Ib trial and is currently in a phase II for diabetic kidney disease. Inversago’s other pipeline assets are being developed for metabolic and fibrotic disorders. Novo Nordisk’s interest in INV-202 is to explore its potential for obesity and obesity-related complications. The firm has long been a leader in tackling diabetes and obesity, first gaining approval of GLP-1 receptor agonists in 2014 with Saxenda (liraglutide), which was followed by Ozempic (semaglutide) in 2017 and its follow-on drug Wegovy in 2021.
Astellas returns two gene therapies to Modalis
Modalis Therapeutics Corp. – previously Edigene Corp. – has regained full rights to two gene therapy candidates for muscle disorders, MDL-201 and MDL-202, that were co-developed with Astellas Pharmaceutical Inc. since 2019. In a quarterly earnings call on Aug. 10, Modalis President and CEO Haru Morita noted that the “good news” is that development for MDL-202 “won’t have to be done from scratch” and that accumulated data and knowhow gained through developing MDL-201 could be applied in a “straightforward way” to MDL-202.
Newco news: Anoat takes aim at alternative chloride channel to treat cystic fibrosis
With more than 70,000 people living with cystic fibrosis (CF) worldwide, according to the Cystic Fibrosis Foundation, the introduction of CF transmembrane conductance regulator (CFTR) modulator therapies has revolutionized treatment of the disease. However, these drugs are not effective for around 10% of CF patients, driving a significant unmet therapeutic need. One startup hoping to address this is Anoat Therapeutics. Following its March launch, the company is leveraging academic work conducted by the French research institute Inserm Transfert SA, and plans to use €2 million (US$2.17 million) in seed funding to further develop its lead program – an antisense oligonucleotide designed to target an alternative chloride channel to CTFR.
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