CEO Gil Beyen of Erytech Pharma AS said the firm is mulling next steps in the aftermath of phase III data with eryaspase in second-line pancreatic cancer, where the compound – which consists of L-asparaginase encapsulated in a donor-derived red blood cell – missed its primary endpoint of overall survival. “We will have to regroup and see how we can further continue on the different programs that are ongoing,” he said during a conference call with investors. Read More
Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone. Read More
Cedilla Therapeutics Inc., an oncology company targeting upstream aspects of native protein degradation pathways, extended its year-ago series B with a $25 million investment bringing the round's total to $82.6 million. Proceeds from the financing will support advancement of its two lead programs, an inhibitor of the transcriptional enhanced associate domain (TEAD) transcription factor in the Hippo signaling pathway for the treatment of solid tumors and a selective inhibitor of CDK2/cyclin E for the treatment of multiple tumor types. Read More
Interim data from a phase II/III study of Moderna Inc.’s COVID-19 vaccine show a robust antibody response in children ages 6 through 11, stronger than the one the company found in adolescents. Two 50-mcg doses given 28 days apart also produced a favorable safety profile that nearly mirrored that of adolescents and adults. Read More
LONDON – The U.K. Health Security Agency (UKHSA) has designated an offspring of the Delta variant of SARS-CoV-2 as a “variant under investigation” after uncovering some early evidence it may have an increased growth rate. Read More
LONDON – A U.K. study following up 32.5 million people for 28 days after their first dose of a COVID-19 vaccine has shown an increased risk of hemorrhagic stroke after receiving the Pfizer Inc./Biontech SE product, and confirmed case reports of an increased risk of developing Guillain-Barré syndrome after the Astrazeneca plc vaccine. Read More
The race for a Japan-made COVID-19 vaccine is heating up as players make progress with their trials. Daiichi Sankyo Co. Ltd. recently shared the results from its phase I/II trial for DS-5670, its mRNA vaccine. The mRNA vaccine candidate initiated studies in March 2021. The findings showed that in terms of immunogenicity, both neutralizing activity and IgG titer increased after the vaccination. Read More
Novartis AG has had another setback in its attempt to get canakinumab to work in oncology, after the interleukin-1beta (IL-1β) inhibitor flunked a phase III trial in first-line advanced lung cancer. Read More
New hires and promotions in the biopharma industry, including: Aadi, Alcyone, Aptose, Bridgebio, Delix, Karolinska, Medivir, Mersana, Nereid. Read More
Biopharmas raising money in public or private financings, including: Aura, CASI, Context, Entrada, Juventas Cell Therapy, Kadimastem, Onconano. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aadi, Akeso, Athira, Endo, Helixmith, Horizon, Humanigen, Leo, Metacrine, Ocular, OS, Reven, Sanofi, Servier. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akari, Astrazeneca, Canbridge, Daiichi, Evaxion, Merck, Scriptr. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: J&J, Kintor, Merck & Co., Moderna. Read More
