Bristol Myers Squibb Co. (BMS) and Eisai Co. Ltd. inked a potential $3.1 billion agreement to co-develop and co-commercialize the antibody-drug conjugate (ADC) MORAb-202 for advanced solid tumors. Eisai’s first ADC, MORAb-202 pairs the company’s anti-folate receptor alpha (FRα) antibody with the Tokyo-based firm’s anticancer agent eribulin using an enzyme cleavable linker. It is characterized as a potential best-in-class candidate and is under investigation for tumors that include endometrial, ovarian, lung and breast cancers in two studies: a phase I effort in Japan and a phase I/II experiment in the U.S. The companies plan to enter the registrational stage of development as early as 2022. Read More
Shares in Orphazyme A/S cratered after the FDA rejected its arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition where fat builds in tissues and organs. Read More
CAR T specialist Carsgen Therapeutics Holdings Ltd.’s shares started trading on the Hong Kong Stock Exchange on June 18, helping the company raise HK$3.1 billion (US$400 million) from an IPO that will allow it to advance its phase II-stage BCMA CAR T therapy candidate, CT-053, in multiple markets. Read More
About a year-and-a-half after the sequencing of the SARS-CoV-2 virus and the onslaught of COVID-19 therapeutic and vaccine development that followed, the biopharma industry boldly tackles a slew of ongoing issues from vaccine hesitancy and supply inequities to the ramifications of a potential intellectual property waiver and the pressing need to prepare global systems for the next pandemic. Read More
Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints. Read More
A co-research agreement between Ubix Therapeutics Inc. and Debiopharm International SA aimed at creating a new antibody degraducer conjugates drug modality to treat cancer will combine Ubix’s Degraducer molecule with Debiopharm’s antibody-drug conjugate linker Multilink to specifically target cancer cells. Read More
Immvira Group Co. presented positive phase I data for MVR-T3011 as an intratumoral administration (MVR-T3011 IT) at the 2021 American Society of Clinical Oncology annual meeting this month, drawing attention to oncolytic viruses developed by Chinese scientists. Read More
Researchers from The Hong Kong Polytechnic University (PolyU) said they have used two-dimensional nanosheets (FePSe3) to develop a biomimetic nanosheet that can monitor tumor development, treat tumors and monitor the treatment progress in real-time. With positive results from mice, the team hopes to further test it on larger animals, then move on to clinical studies. Read More
Biopharmas raising money in public or private financings, including: Alzamend, Ambrx, Anacardio, Atai, Century, Cyteir, Hutchmed, Karolinska, Neuvocor, PDS. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biogen, Curevac, Harbour, Kancera, Pfizer, Qpex, Satsuma, Targovax, Tarsus, Viking. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aim, Altan, Antengene, Astrazeneca, Athira, Ethypharm. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Agenus, Amneal, Applied Therapeutics, Blueprint, Eagle, Innocare, Novartis, Sirnaomics, Turning Point, Xilio. Read More
