Immunic Inc. plans to forge ahead with oral psoriasis therapy IMU-935 despite stock-punishing results from a phase Ib trial that showed a higher placebo response than expected. Shares of the New York-based firm (NASDAQ:IMUX) closed at $2.08, down $7.12, or 77.4% after findings were made public from a preplanned interim group-level data analysis of the ongoing experiment, which is testing patients with moderate to severe disease. The group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms failed to separate from placebo at four weeks, Immunic said. Although the active arms performed as intended, placebo decreases in PASI proved greater than hoped. Read More
Celltrion Healthcare Inc. has signed a deal with Pinotbio Inc. to develop antibody-drug conjugates for up to 15 separate cancer targets incorporating the linker-payload platform technology Pinot-ADC. Celltrion could pay Pinotbio as much as ₩1.77 trillion (US$1.24 billion) to exercise options for all 15 targets in the collaboration. But, for starters, it will pay Pinotbio ₩1 billion up front. Read More
Approval of a new depression drug, stellar phase III data for both a schizophrenia therapy and an Alzheimer’s disease candidate, as well as an accelerated approval filing for a Duchenne muscular dystrophy gene therapy, are all reasons that BioWorld’s Neurological Diseases Index climbed from a negative position throughout much of 2022 to its 11% above-water mark as of Oct. 20. Read More
The extraordinary proliferation of different genetic therapeutic modalities in the last decade has not been matched by a commensurate flourishing of delivery technologies. The liver is the natural destination for many carriers when administered systemically. But getting beyond the liver to other organ systems has proven to be a significant challenge. Only a tiny percentage of carriers – even those with targeting moieties – escape first pass metabolism in the liver and reach their target destination. “The key issue is getting out of the liver,” Nessan Bermingham, founder and interim CEO of Liberate Bio, Inc., told BioWorld. “That’s not a trivial problem.” Read More
With roughly a decade of work behind it, Valitor Inc. is ready to put its Multivalent Polymer (MVP) platform to the test, having recently announced its presence with a $28 million series B round and appointment of biopharma veteran Steven Lo as CEO. The next step is IND-enabling studies for its lead ophthalmology candidate, with clinical testing slated to start in 2024. Read More
Peking University researchers in collaboration with the NIH have discovered a new biochemical pathway related to a bacterium that eliminates nicotine in the intestine. The findings could lead to new ways to improve nonalcoholic fatty liver disease in smokers. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AM-Pharma, Harbour, Iterum, Medicane, Palatin, Spikimm, Talaris, T-knife, Venatorx, Vivacelle, Xeris. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altamira, Kite, Novocure, Refuge, Zilentin. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biontech, Covis, Leo, Moderna, Novavax, Pfizer, Revance, Tvardi. Read More
