Rates of adverse events (AEs) gave pause to some on Wall Street, and shares of Viking Therapeutics Inc. (NASDAQ:VKTX) fell 42%, or $17.73, to close Aug. 19 at $24.36 after the firm reported 13-week data from the phase II trial with the oral tablet form of VK-2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
With the trial sites now open for its CRISPR-edited T-cell receptor immunotherapy trial, Anocca AB has raised SEK440 million (US$46 million) to fund the phase I part of the multicenter study to completion. The company’s engineered T-cell receptor T-cell therapy (TCR-T) is first being tested against KRAS mutations in pancreatic cancer.
Beijing Luzhu Biotechnology Co. Ltd.’s shingles vaccine LZ-901 outperformed GSK plc’s Shingrix (HZ/su) vaccine in a head-to-head phase III trial. A recombinant herpes zoster vaccine candidate independently developed by Luzhu, LZ-901 is the company’s core product.
Remegen Co. Ltd.’s telitacicept (RC-18) met the primary endpoint in a phase III trial for treating primary Sjögren's syndrome (pSS), and the company plans to submit a BLA to China’s National Medical Products Administration (NMPA) on the data.
Daewoong Pharmaceutical Co. Ltd. and Daewoong Therapeutics Inc. reported that their self-developed microneedle patch loaded with semaglutide demonstrated 80% relative bioavailability compared to an injectable subcutaneous formulation of semaglutide in a pilot human pharmacokinetic study. That far exceeds rates seen in other patches or oral formulations.
Taking weight off with a glucagon-like peptide-1 (GLP-1) receptor agonist and keeping it off once the drug has been discontinued has been a tall order but Response Pharmaceuticals Inc. is seeing progress. Top-line results from its randomized, double-blind, placebo-controlled, parallel-group phase II study of RDX-002, in those who had already wrapped up a GLP-1 receptor agonist course for reducing obesity, were positive.
Quince Therapeutics Inc.’s mid-July completion of enrollment in the pivotal phase III study in ataxia-telangiectasia (A-T) marked an important milestone for the South San Francisco-based firm, which is not the only contender in the space. The study called NEAT – a rough acronym for “Neurological Effects of eDSP on Subjects with A-T” – will evaluate Quince’s lead asset, eDSP, in the neurodegenerative illness.
Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels.
IO Biotech ApS will discuss this fall with the U.S. FDA the data package related to Cylembio (imsapepimut and etimupepimut, adjuvanted) after the off-the-shelf therapeutic cancer vaccine prospect missed “by a hair” the primary endpoint in a pivotal phase III melanoma trial, said CEO Mai-Britt Zocca.
The fibroblast growth factor 21 (FGF21) analogue space took another turn as Novo Nordisk A/S said during its second-quarter financial update that work with zalfermin (NNC0194-0499) will be discontinued. A phase II study testing the compound in combination with glucagon-like peptide-1 therapy failed to hit the primary endpoint related to liver fibrosis in metabolic dysfunction-associated steatohepatitis (MASH), without MASH worsening.
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