As President Donald Trump endorses Regeneron's COVID-19 antibody cocktail, Eli Lilly reported positive phase 2 results for its two-drug prospect, made in collaboration with AbCellera and China's Junshi Biosciences. An inactivated COVID-19 vaccine by the Chinese Academy of Medical Sciences showed some promise in phase 1. Takeda penned a potentially $1 billion deal for an Arrowhead RNAi therapy, which is in development for alpha-1 antitrypsin-associated liver disease. And more.
Eli Lilly is seeking FDA emergency use authorization of its COVID-19 antibody cocktail upon an interim analysis of the phase 2 Blaze-1 trial, which showed the combo reduced viral load, symptoms, and the rate of hospitalization and ER visits. The therapy combines LY-CoV555, from a collaboration with AbCellera, and LY-CoV016, which Lilly licenses from China’s Junshi Biosciences.
China has reported early data from another inactivated COVID-19 vaccine. The shot, made by the Chinese Academy of Medical Sciences, passed the safety and tolerability test in a phase 1 trial. At day 14, individuals who got two shots of the middle dose had a seroconversion rate of 100% and antibodies at a geometric mean titer of 54.5. Neutralizing antibody titers declined afterward.
Takeda is paying $300 million upfront, with up to $740 million in biobucks, to license Arrowhead's ARO-AAT, a phase 2 investigational RNAi therapy designed to treat alpha-1 antitrypsin-associated liver disease (AATLD). The med works by blocking the production of mutant alpha-1 antitrypsin protein, the cause of AATLD progression. The pair will share responsibilities in the U.S., while Takeda takes full commercial rights elsewhere.
India’s Marksans Pharma has added an additional 76 lots of its metformin product to the U.S. recall list after finding high levels of probable carcinogen NDMA in some sample lots. The company already pulled a single lot off the market in June at the request of the FDA. Lupin, Apotex, Teva and Amneal were also included in that round of recall.
Patients with advanced Parkinson’s disease who use levodopa to help restore motor function may need to take as many as six tablets a day and may still experience “off” periods when the drug’s effect wanes. Now, scientists at Nanyang Technological University have developed a slow-release “floating micro-capsule” that can release drug from the stomach throughout the day. Treatment with capsules loaded with Novartis’ Stalevo helped mice achieve stable dopamine levels in the brain over 24 hours.
California oncology play Corvus Pharmaceuticals launched a wholly-owned subsidiary focused on China. Called Angel Pharmaceuticals, the $106 million unit came to life with investments from local CRO giant Tigermed, Betta Pharma, Hisun Pharma and Zhejiang Puissance Capital, and three of Corvus’ clinical-stage candidates and a preclinical BTK inhibitor.