Daiichi Sankyo was ordered to pay Seagen $42 million in their antibody-drug conjugate patent lawsuit. Gene therapy delivery CDMO VectorBuilder will build a $500 million campus in China. Legend Biotech joins BeiGene, HutchMed and Zai Lab as the latest Chinese firm dinged by U.S. securities authorities for audit law violations. And more.
1. Seagen scores $41.8M in Enhertu patent case against Daiichi Sankyo
A U.S. jury ordered Daiichi Sankyo to pay Seagen $41.8 million in a patent infringement lawsuit after finding that Daiichi and partner AstraZeneca’s Enhertu infringes an antibody-drug conjugate patent held by Seagen. Daiichi said it disagrees with the verdict and will explore options to fight it. Seagen is also seeking royalties on future sales of the cancer drug until the patent expires in 2024.
2. VectorBuilder to spend $500M to construct gene therapy manufacturing site in China
Chicago-based VectorBuilder has unveiled a two-phase plan to build a $500 million gene therapy manufacturing facility and research institute in Guangzhou, China. The CDMO said the new facility will have 30 production suites to make plasmids, mRNA, cell lines, adeno-associated virus, lentivirus and other vectors for biopharma clients. The new campus is expected to be complete in four years.
3. Legend Biotech the latest Chinese firm to join SEC's warning list (filing)
Legend Biotech has been dinged by the U.S. Securities and Exchange Commission for potential future delisting under the Holding Foreign Companies Accountable Act. Legend joins fellow Chinese biotechs BeiGene, HutchMed and Zai Lab, because the U.S. auditing watchdog couldn’t inspect the auditors of these companies. Legend said it’s “evaluating measures to meet HFCAA requirements” before the deadline.
Through a collaboration with Presage Biosciences, Takeda has found early signs that its SUMOylation inhibitor subasumstat and STING agonist TAK-676 might help fight cancer. In the partnership, Presage offered its CIVO technology, which allows researchers to inject different cancer drugs through small channels directly into a living tumor and observe the results.
5. With $300M up for grabs, Engitix helps Takeda dig into extracellular matrix in search of IBD drugs
Takeda has expanded a previous drug discovery pact with Engitix to now include inflammatory bowel disease. For up to $300 million, Takeda taps into Engitix’s platform that allows it to study the composition and biology of the extracellular matrix in tissues to identify protein signatures linked to the targeted disease. The two first teamed up in 2020 to focus on liver diseases including nonalcoholic steatohepatitis.
6. Shionogi to not recommend COVID drug for pregnant women as animal study flags safety concern (Kyodo News)
Shionogi is considering leaving pregnant women out of the eligible patients for its investigational COVID-19 antiviral S-217622, which the company has filed for Japanese approval in February, Kyodo News reported. In a statement, Shionogi said it observed fetal skeletal abnormalities in preclinical tests but at doses higher than the clinical dose. It reported the findings to local regulators in December 2021 and said it believes the matter wouldn’t affect the drug’s approval.