Regulatory T-cell specialist Quell Therapeutics Ltd. has sealed a potential $2 billion agreement under which Astrazeneca plc is taking rights to two autologous Treg cell therapies for treating inflammatory bowel disease and type 1 diabetes. Quell will receive $85 million up front, the majority of which is in cash, with a modest (undisclosed) equity investment. Reaching the $2 billion headline figure will involve a series of development and commercial milestones and royalties on sales. The programs will be handed over after completing development and manufacturing through to the end of first-in-human studies, but Quell will retain an option that can be exercised either after approval of an IND application or on completion of phase I/II testing, to co-develop the diabetes therapy in the U.S.
FDA adcom considers full approval of Leqembi for Alzheimer’s
In the early hours of the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee meeting on June 9, panelists listened to Eisai Co. Inc. and Biogen Inc.’s presentation on Leqembi’s (lecanemab) confirmatory phase III Clarity trial, which showed the amyloid-beta targeting antibody slowed Alzheimer’s disease (AD) progression by 27% at 18 months. The main concern of panelists, however, were the adverse events of infusion-site reactions, cerebral hemorrhage and amyloid-related imaging abnormalities (ARIA), including edema in 0.8% and hemorrhage in 0.6% of drug-treated patients. The ARIA effects were higher in those who were carriers vs. non-carriers of the ApoE ε4 allele. Michael Irizarry, senior vice president and chief clinical officer at Eisai, told panelists that the company intends to monitor ARIA through MRIs prior to the fifth, seventh and 14th infusions and by educating patients to identify and report symptoms. The advisory committee is expected to vote in the afternoon on whether to recommend the supplemental BLA for traditional approval for AD, a condition that affects more than 6 million Americans.
Vicore Pharma raises $46M to fund phase IIb trial in IPF
Vicore Pharma Holding AB grossed about SEK500 million (US$46 million) in a directed share issue that will fund a phase IIb trial of its lead drug candidate, C-21, in idiopathic pulmonary fibrosis (IPF). The offering of 29.875 million shares was priced at SEK16.75 per share. The transaction, which took the form of an accelerated book-building procedure, added two U.S. institutional investors to its shareholder roster, Orbimed and Suvretta Capital Management. The Stockholm-based company has an appetite for more. “The climate for investment in the U.S. is better than in Europe, and we need to go there,” Vicore Pharma CEO Carl-Johan Dalsgaard told BioWorld. “This is a first step.”
Addimmune launches to create a functional cure for HIV
Addimmune Inc., a new company spun out of American Gene Technologies, has launched to develop gene and cell therapies for a functional cure for HIV. It will build on data from American Gene Technologies’ phase I study and plans a phase II trial that it intends to launch within the next 12 months. In the phase I, no patients had serious adverse events, all participants’ modified T cells were engrafted, then expanded after infusion and maintained their reactivity to HIV. The data also showed no rejection of cells found in the participants, until the final measurement at 180 days.
Lynk nets $28M to develop JAK inhibitors for autoimmune diseases
Lynk Pharmaceuticals Co. Ltd. raised ¥200 million (US$28 million) in a series C1 financing round to accelerate the clinical development of its second-generation and third-generation JAK inhibitors for cancer and autoimmune diseases. Prior to the latest round, the company, founded in 2018, completed a series B round worth $50 million in August 2021. “Currently, four indications of our candidates have entered the phase II trial stage,” Lynk told BioWorld.
Overall deal value keeps last year’s pace as M&A values tumble
Biopharma deal values are continuing to track at a similar pace to last year, down only 0.312% compared to the first five months of 2022, while the number of deals remains lower. M&A values are at their lowest value in all years tracked by BioWorld (2016-2023). So far in 2023, 562 deals have brought in $78.46 billion, compared to 735 deals worth $78.71 billion in the same timeframe last year.
The BioWorld Insider Podcast: Preventing opioid overdoses with a smart patch
Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.