A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the group remains solidly frustrated. Any transformative change will take years to complete, the panel said in a new report issued before next week’s World Health Assembly in Geneva. “The work underway to transform the international system lacks coherence, urgency, and focus,” the panel concluded. It noted weak health systems and market-drivers that limit access to vaccines, tests and therapies while calling for increased production and access to COVID-19 therapeutics and tests, especially in low- and middle-income countries. The panel also called for transforming the WHO’s Access to COVID-19 Tools Accelerator into a truly global end-to-end platform for vaccines, diagnostics, therapeutics and essential supplies, "shifting from a model where innovation is left to the market to a model aimed at delivering global public goods."
Three-plus years after Arikayce, companies still busy in NTM
A paper published May 3 in Nature Communications about a patient infected with Mycobacterium chelonae who was cured by way of bacteriophage treatment sparked more intrigue around how to attack the nontuberculous mycobacteria (NTM) group of bugs that cause lung infections. Companies at work in the space – where Insmed’s Arikayce (amikacin liposome) was approved by the FDA in 2018 – include AN2 Therapeutics Inc., Redhill Biopharma Inc., and Spero Therapeutics Inc.
Swanbio closes $56M series B round to move adrenomyeloneuropathy gene therapy to the clinic
Swanbio Therapeutics Inc. closed a $56 million series B round to take its lead gene therapy program, SBT-101, into clinical development later this year. The candidate, comprised of an adeno-associated virus type 9 (AAV9) vector encoding the ABCD1 peroxisomal ATP-binding cassette transporter, is in development for adrenomyeloneuropathy (AMN), an inherited disease that affects the central nervous system. AMN represents the most prevalent form of X-linked adrenoleukodystrophy. Given the downcast mood among investors – and gene therapy firms – of late because of a succession of serious safety issues on clinical trials, it demonstrates that the sector still has strong support, in certain quarters at least.
Patient assistance programs will live to see another year
A U.S. district court yesterday slapped down a controversial Health and Human Services rule that threatened the future of biopharma companies’ patient assistance programs, which are intended to help patients cover their out-of-pocket costs for pricy drugs. Scheduled to go into effect in January 2023, the rule would have saddled prescription drug manufacturers using the assistance programs with a heavy, and perhaps impossible, burden of policing whether insurance companies claim some of that patient assistance for themselves. The court’s “decision to vacate the patient assistance penalty – a provision of a Medicaid rule finalized in 2020 – is a win for patients,” said Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, which had challenged the rule.
Turning Point acquires global rights to ADC from Lanova in $220M deal
Turning Point Therapeutics Inc. has picked up near-global rights to develop and commercialize an antibody drug conjugate (ADC) targeting Claudin18.2 from Lanova Medicines Ltd. for $25 million up front. The deal excludes greater China and South Korea. In addition, Turning Point could pay up to $195 million in development, regulatory and commercial milestones, plus tiered royalties of mid-single digit to mid-teens percentages on net sales of the drug, should they materialize. As part of the deal, the duo will also collaborate to develop up to three additional ADCs.
Keros shares sag amid doubts over early trial results from PAH candidate
Keros Therapeutics Inc. announced preliminary results from a phase I trial of its engineered ligand trap KER-012 that gave its team confidence to proceed with larger studies in pulmonary arterial hypertension (PAH) and potentially some bone diseases. But company shares (NASDAQ:KROS) fell 20% by midday following the announcement, perhaps over concerns about trial subjects that emerged in a call with analysts.
Jiangsu Hengrui launches Luzsana to develop innovative drugs for US, Europe and Japan
China’s Jiangsu Hengrui Pharmaceuticals Co. Ltd. is launching a new biotech company called Luzsana Biotechnology that will develop and commercialize Hengrui assets in the U.S., Europe and Japan. A wholly owned subsidiary of Hengrui, Luzsana, which means “healing light,” will develop innovative products from Hengrui’s pipeline. “They’re not only our parent, but they’re also our partner,” Luzsana CEO Scott Filosi told BioWorld.
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