Momentum is building at Jnana Therapeutics Inc. The firm has raised $107 million in a series C round and banked another $50 million up front from a new drug discovery and development pact with Roche Holding AG, which could potentially deliver significant near-term milestones and more than $2 billion in future milestone payments. It also commenced recruitment onto a first-in-human study of its lead drug candidate, JNT-517, an inhibitor of the phenylalanine transporter SLC6A19, which is in development for phenylketonuria. Read More
Therapy delivery and the physicians who administer them are keys in CG Oncology Inc.’s drive to develop bladder cancer treatments. The company, which just closed an oversubscribed $120 million series E financing to continue on the development path, has its lead oncolytic immunotherapy, CG-0070, intravesically delivered via a catheter, in the clinic. Read More
China’s National Medical Products Administration (NMPA) awarded Akeso Inc. breakthrough therapy designation for its PD-1 checkpoint inhibitor/VEGF bispecific antibody, ivonescimab (AK-112), combined with docetaxel for locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients who failed to respond to prior PD-(L)1 inhibitors combined with chemotherapy. Read More
The number of biopharma deals with nonprofit or government entities has dwindled in recent months, while industry grants are climbing. Combined, however, a total of 936 bio/nonprofit deals and grants worth $11.17 billion is down by 37% in comparison with last year’s $17.8 billion and by 58.7% in comparison with 2020’s $27 billion. The volume also is down significantly by 16.8% from 2021 and by 33.4% from 2020. Read More
Neurons are specialized cells with a high metabolic demand to fulfill their function, survive or keep a healthy half-life. In this sense, the anabolism and catabolism of proteins and lipids could be associated to different neurodegenerative diseases. At the 2022 annual meeting of the Society for Neuroscience, scientists reported the latest discoveries on neuron metabolic needs at a session on 'Powering Thoughts: The Regulation of Neuronal Energy Metabolism and Mitochondria.' Read More
After years of dialogue between the U.S. FDA and industry, the agency’s long-awaited draft guidance for computer software assurance (CSA) for manufacturing facilities signaled a new, less cumbersome approach to validating these systems. However, drug and device manufacturers registered concerns about a lack of clarity in the draft, including 23andMe Holding Co., which said the draft’s references to methods that merely “help to fulfill” validation requirements leave too much gray area to be helpful. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aerogen, Affini-T, Avanzanite, Biotheus, Cansinobio, Cyclica, Elevatebio, Hansoh, Hutchmed, Immutep, Urogen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Alvotech, Ascendis, Astrazeneca, Avstera, Eagle, Ensysce, Gmax, Immune Bio, Merck & Co., Nuance, Oncopeptides, Protalix, UCB. Read More
