LONDON – Astrazeneca plc is broadening its antibody-drug conjugate (ADC) relationship with Daiichi Sankyo Co. Ltd. in a potential $6 billion development and commercialization deal. The two companies are to work together on DS-1062, Daiichi’s trophoblast antigen2 (TROP2) ADC, which is in phase I development in multiple tumors that express the cell surface glycoprotein. These include breast cancer and non-small-cell lung cancer (NSCLC), areas of strategic focus for Astrazeneca. The agreement builds on the March 2019 $6.9 billion pact between the two for Enhertu (trastuzumab deruxtecan), the HER2-targeted ADC now on course for blockbuster status, following FDA approval in December 2019 and U.S. launch at the start of the year. Read More
Moderna Inc. dosed the first of what could be as many as 30,000 healthy volunteers Monday morning as it began its phase III COVID-19 vaccine trial. Read More
Biopharma companies that are focused on cell therapies have reported promising clinical trial results in their ability to treat acute respiratory distress syndrome (ARDS), a condition that has shown to be a significant contributor to higher mortality in COVID-19 cases. Read More
As Carmel, Ind.-based MBX Biosciences Inc., taking aim at rare endocrine diseases, disclosed $34.6 million in a series A financing, CEO and co-founder Kent Hawryluk told BioWorld that “everyone on the leadership team we’ve worked with in prior lives, so to speak,” adding that he’s “excited to have the band back together.” Read More
“Nothing to see here” seems to be the general reaction to the four executive orders President Donald Trump signed Friday in an effort to reduce U.S. prescription drug prices. Two of the orders – one on importing drugs from Canada and the other on kicking the safe harbor out from under the rebates pharmacy benefit managers (PBMs) get from drug companies – instruct Health and Human Services (HHS) to continue, or resume, rulemaking on those measures. Read More
By deleting the gene for uridine monophosphate synthetase (UMPS), an enzyme in the pathway for uridine synthesis, researchers have made cells, including embryonic stem cells and T cells, dependent on dietary uridine. The work, which was published in the July 13, 2020, online issue of Nature Biotechnology, adds a new potential way of controlling cell therapies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Molecular, Aerie, AI Therapeutics, Amarin, Dalcor, Dare, Destiny, Eyepoint, Immunic, Jcyte, Moderna, NGM, Opthea, Promab, Puma, Rezolute, Rigel, TCR2. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Can-Fite, Carisma, Celltrion, Checkmate, Diffusion, Eton, Generex, Gilead, Kite, Kyowa, Merus, Neoimmunetech, Ocugen, Oculis, Pharmacyte, Scpharmaceuticals, Solid. Read More
