In December 2020, Servier Pharmaceuticals LLC bought Agios Pharmaceuticals Inc.’s big seller, Tibsovo (ivosidenib), and the rest of its oncology business in a deal valued at up to $2 billion. Now, the U.S. FDA has approved one of those assets, with the brand name Voranigo (vorasidenib), for treating gliomas. With the approval comes a $1.1 billion milestone payment for Agios, which looks to get a $905 million payment from Royalty Pharma Inc. and $200 million from Servier. The priority NDA for the oral, brain-penetrant isocitrate dehydrogenase (IDH)-mutant glioma drug was approved two weeks before its Aug. 20 PDUFA date. It is the first and only FDA-approved targeted treatment in grade 2 IDH-mutant glioma. Paris-based Servier maintains it is the first breakthrough in the specific disease area in almost 25 years.

Sangamo inks $1.9B-plus licensing agreement with Roche

Sangamo Therapeutics Inc. disclosed a licensing deal with Roche AG’s Genentech unit, following up the Aug. 6 news with an earnings call during which details of the pact were discussed. The pair agreed to develop intravenously administered genomic medicines to treat certain neurodegenerative diseases, with Sangamo providing Genentech an exclusive license to zinc finger repressors directed to the tau gene, a key player in Alzheimer’s disease and other tauopathies, as well as an undisclosed second neurology target. Sangamo is also exclusively licensing to Genentech – for tau and the second target – the neurotropic adeno-associated virus capsid STAC-BBB. Genentech will provide Sangamo with $50 million in near-term up-front license fees and milestone payments. The latter is eligible to earn as much as $1.9 billion in development and commercial milestone rewards that are spread across multiple potential products. Included as well in the terms are tiered royalties on net sales.

Genor wins $440M+ cancer drug deal with Third Rock/Two River firm

China’s Genor Biopharma Co. Ltd. agreed to out-license GB-261, its bispecific antibody candidate primarily targeting B-cell lymphomas, to TRC 2004 Inc., a U.S.-based newco co-founded by Third Rock Ventures LLC and Two River Group Holdings LLC. GB-261 is a novel CD20/CD3-bispecific T-cell engager designed from rituximab (Rituxan, Biogen Inc./Genentech Inc.), according to Cortellis, with indications of B-cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia and small lymphocytic lymphoma. Genor said that the bispecific antibody has potential to reach beyond oncology into immunology and autoimmune indications.

Pressure building for bipartisan 340B reforms

With time running out on the 118th U.S. Congress, a group of lawmakers is urging the leadership of the House Energy and Commerce Committee to consider a bipartisan path forward on strengthening the 340B drug discount program. “We are all committed to the long-term viability of the program, and we are encouraged that a bipartisan group of senators [has] invested years seeking wide stakeholder input and developing a set of policy reforms aimed at achieving consensus,” the House members said in a recent letter to Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) and Ranking Member Frank Pallone (D-N.J.). Given the Senate effort, the lawmakers said the House needs to have looked at all the issues involved.

Jellyfish genes rejuvenate intestinal stem cells in fruit flies

Researchers in Japan were able to transfer genes from jellyfish into common fruit flies and discovered that the transferred gene suppressed an age-related intestinal issue in the flies. The findings suggest that studying genes specific to animals with high regenerative capability like jellyfish may uncover new mechanisms for rejuvenating stem cell function and extending the healthy lifespan of unrelated organisms.

Also in the news

89bio, Abivax, Akeso, ALX Oncology, Artax, Aytu, Biomarin, Cellectis, Concentric Analgesics, Cyclerion, Daiichi Sankyo, Dong-A St, Elevation Oncology, Entos, Equillium, Exelixis, George Medicines, Immunitybio, Immunoforge, Indapta, Levicept, Melinta, Merck, Neurobo, Neurotherapia, Quantro, Quotient, Release, Remegen, Sellas, Shinobi, Symbiotic, Tenax, TFF, Tris, Vascular Therapies