Adding another name to an impressive roster of partners assembled over the past few years, Skyhawk Therapeutics Inc. inked a deal with Merck KGaA aimed at discovering small-molecule RNA-targeted drugs for neurological diseases that could be worth more than $2 billion. Specific terms were not disclosed but include milestones and tiered royalties. Skyhawk will lead discovery and preclinical development efforts using its SkySTAR, or Skyhawk Small molecule Therapeutics for Alternative splicing of RNA, platform, with Merck able to exercise options for development and commercialization rights.

Novo’s Wegovy label broadens to MASH

Novo Nordisk A/S added noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) to the label of Wegovy (semaglutide) thanks to the U.S. FDA’s approval of the Bagsvaerd, Denmark-based firm’s sNDA. The glucagon-like peptide-1 receptor agonist was cleared for adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced calorie diet and increased physical activity. Wegovy was first green-lighted by the FDA for obesity in June 2021. Novo’s shares (NYSE:NVO) reacted only slightly and were trading at $54.47, up $2.64. Madrigal Pharmaceuticals Inc.’s thyroid hormone receptor-beta agonist Rezdiffra (resmetirom) won the go-ahead for adults with MASH last year.

Luzhu’s shingles vaccine outperforms Shingrix in phase III  

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 and is being developed to prevent herpes zoster and related complications caused by herpes zoster, including shingles and postherpetic neuralgia for adults aged 40 years and above. LZ-901 is the first shingles vaccine with a tetrameric molecular structure to prevent shingles caused by the varicella-zoster virus.

Vanda’s Hetlioz wins round against FDA over denial of hearing

A U.S. appeals court schooled the FDA as it handed Vanda Pharmaceuticals Inc. a “technical knockout” of sorts in its third bout with the agency – this one over a rejected jet lag supplemental indication for Vanda’s Hetlioz (tasimelteon). While the FDA doesn’t have to grant a hearing in response to every complete response letter (CRL) it issues, the Federal Food Drug and Cosmetics Act requires it to do so if “there is a material factual dispute,” the court said. In this case, there is such a dispute and, when trying to justify its denial of a hearing over its Hetlioz CRL, the FDA did not show that Vanda “‘manifest[ly]’ failed to carry its substantial evidence burden,” the court said as it remanded the case back to the FDA for further review consistent with the Aug. 15 opinion.

Proteina’s PPI Landscape to help reshape antibody drug design

“Our mission is to apply our protein-protein interaction (PPI) big data-generation platform to create novel antibody therapeutics,” Proteina Co. Ltd. CEO Yoon Tae-young recently told BioWorld. “We have been working to build a proprietary technology platform for more than 15 years,” Yoon said, “and we take pride in the fact that we made our own technology platform, instead of running a company based on licensed-in technology.” Proteina debuted with a ₩21 billion (US$15.1 million) IPO on the Korea Exchange July 29 to expand applications of its single-molecule protein interaction detection (SPID) technology, designed to analyze cellular signals that occur during PPIs, referring to when two or more proteins physically interact and bind. 

Anocca raises $46M for T-cell receptor trial in pancreatic cancer

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. Eligible patients will have a human leukocyte antigen (HLA) and KRAS mutation matching one of Anocca’s constructs. The first to be tested, Anoc-001, is directed at an HLA in KRAS G12V. 

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