Precision medicine startup Solu Therapeutics has raised $31 million in an oversubscribed seed round to advance a therapeutic candidate based on technology that identifies cell surface, tumor-associated targets that antibodies alone fail to latch onto. The company was founded by venture capital firm Longwood Fund and has high hopes for its cytotoxicity targeting chimera platform. “[It] has the potential to unlock new tumor-associated antigens and develop molecules that deplete pathogenic immune cells and extend the half-life of small-molecule antagonists and agonists,” CEO and co-founder of Solu, David Donabedian, told BioWorld. 

Rx quality issues lead to US import alert, manufacturing suspension

In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan. The FDA also hit two other prescription drug manufacturing plants in India – a Baxter Healthcare Corp. facility and a Centaur Pharmaceuticals Private Ltd. plant – with warning letters that were posted Aug. 1. As a result of the FDA’s inspection of its facility, Centaur is temporarily suspending manufacturing and distribution of drugs for the U.S. and is recalling two drugs already on the market.

China’s NMPA accepts Luye Pharma’s NDA for long-acting rotigotine for Parkinson’s disease

China’s NMPA accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease. The microsphere formulation delivers the dopamine agonist in a weekly injection. If approved, LY-03003 would be the first long-acting extended-release microsphere formulation for the treatment of Parkinson’s disease. The drug is also being developed in parallel in the U.S. and Japan.

IAS 2023: Will long-acting treatments be the next game changer for people living with HIV? 

For people living with HIV, the single greatest achievement to date has been the emergence of antiretroviral treatments (ART) that completely block the virus, resulting in reduced mortality and morbidity and improved quality of life. But taking one pill a day for life cannot be the end of this journey, speakers said during the International AIDS Society meeting held July 23 to 26 in Brisbane, Australia. Even with the success of ART, drug adherence remains a problem due to pill fatigue or depression and other mental health conditions, as well as drug-drug interactions, said Claudia Cortes, associate professor at the University of Chile in Santiago. New drugs that are longer lasting, more convenient, and affordable are desperately needed, she said.

Kickoffs for China drug trials: Leads, Hanchorbio, Transcenta, Everest

Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.

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