Corxel Pharmaceuticals Ltd. completed a $287 million series D round to advance its lead compound, an oral small-molecule GLP-1 receptor agonist, CX-11, for obese and overweight patients. Headquartered in Berkeley Heights, N.J., with operations in Shanghai, Corxel will use the funds to advance CX-11 (formerly VCT-220) through its ongoing U.S. phase II trial to treat obese and overweight patients, and through a planned global phase II trial to treat type 2 diabetes, as well as begin initial preparations for CX-11’s phase III trials, and to advance other cardiometabolic programs to the clinic.

UK reports increase in clinical trial approvals with new rules

Four years after they were first mooted, the finishing line is in sight for new U.K. clinical regulations, which will come into force on April 28. In the first major update since 2004, about 20% of lower risk studies are expected to be approved by a fast track, and the Medicines and Healthcare products Regulatory Agency will introduce a 14-day assessment route for phase I healthy volunteer trials, amongst other measures to streamline approvals. The overall ambition is to cut the time down to 150 days from the filing of a clinical trial application to the treatment of its first participant.

Undeterred by mixed data, Sanofi plans amlitelimab filings

Citing the “totality of data,” Sanofi SA plans to file global regulatory submissions this year for amlitelimab in atopic dermatitis, despite mixed results from two additional phase III trials testing the OX40-ligand (OX40L) inhibitor the pharma firm has been positioning as a potential successor to its Regeneron Pharmaceuticals Inc.-partnered blockbuster, Dupixent (dupilimab). Data from one phase III trial, Shore, solidly met its primary endpoints, while data from the Coast 2 trial were less clear.

Legislation seeks to guard NIH from politicization

The U.S. NIH may be weathering the budget storm thanks to bipartisan congressional support, but another squall line is forming on the horizon over politicization of the research agency. In introducing the Follow the Science Act in the House Jan. 21, Rep. Diana DeGette, D-Colo., said the legislation is needed to shield the NIH from political interference and protect the integrity of America's biomedical research. “We cannot allow partisan interference to compromise the research that develops tomorrow’s cancer treatments, Alzheimer’s therapies and life-saving vaccines,” DeGette said, adding that her bill “draws a bright line: science belongs to scientists, not politicians.”

Targetable ‘high-plasticity cell state’ important for cancer progression, drug resistance

Cancer cells expand through mutations – but not just through mutations. They also change their behavior in the absence of underlying genetic alterations. Such plasticity helps the cells both adapt to the cellular stress fueled by out-of-control growth and resist targeted and chemotherapies alike. Investigators from Memorial Sloan Kettering Cancer Center and Huazhong Agricultural University have gained new insights into the underlying mechanisms of plasticity, describing a high-plasticity cell state that was important for tumor progression, heterogeneity and drug resistance.

Asia roundup: Shionogi ups Viiv stake, Fosun spinoff plans, more

Shionogi & Co. Ltd. and Fosun Pharmaceutical (Group) Co. Ltd. were involved in separate divestment transactions this week, with Osaka, Japan-based Shionogi buying out Pfizer Inc.’s stake in Viiv Healthcare Ltd. to lift its holding to 21.7%. Shanghai-based Fosun Pharma plans to spin off its vaccine specialty subsidiary, Fosun Adgenvax Biopharmaceutical Co. Ltd. (and its subsidiaries), on the Hong Kong Stock Exchange. At least four smaller deals involving Asian companies were announced throughout the week as well.

Also in the news

Antev, Axogen, Bioage, Corcept, Corvus, Corxel, Daiichi, Dilafor, Erasca, Exeltis, Galderma, Gilead, Human Continuum, Intrabio, Ipsen, Kaida, Karolinska, Lifearc, MBX, Medicus, Mendra, Nkgen, Paq, Photonpharma, Rentschler, Resalis, Resolve M, United