AC Immune SA has landed a potential $2.2 billion deal for its anti-amyloid beta Alzheimer’s disease vaccine, ACI-24.060, with Takeda Pharmaceutical Co. Ltd., under which it will get $100 million up front and is eligible to receive an option exercise fee, plus potential development, commercial and sales-based milestones of up to $2.1 billion. In addition, AC Immune is entitled to tiered mid- to high-teen royalties on worldwide net sales if ACI-24.060, which is designed to elicit an antibody response against the toxic forms of amyloid beta, makes it to market. The vaccine is currently in the phase Ib/II Abate trial in participants with early stage prodromal Alzheimer’s and adults with Down syndrome.
Fulcrum, Sanofi sign rare disease collaboration
Fulcrum Therapeutics Inc. scored a deal with Sanofi SA to develop and commercialize losmapimod for the rare genetic disease facioscapulohumeral muscular dystrophy (FSHD). Paris-based Sanofi gets exclusive rights to sell the p38 mitogen-activated protein kinase inhibitor in all territories outside the U.S., while Fulcrum, of Cambridge, Mass., keeps rights inside the country. The arrangement brings an $80 million up-front payment to Fulcrum, as much as $975 million more if milestones are met, and tiered escalating royalties starting in the low teens on sales outside the U.S., as the parties split future global development costs evenly. FSHD, which causes progressive muscle weakness in the face, upper arms, lower legs and hips, is passed on in an autosomal-dominant manner, so that 70% to 90% of patients inherit the disease-causing deletion from a parent.
Cassidy calls for NIH reforms, questions US ROI
Is the U.S. getting the best return on investment (ROI) for its NIH buck? That’s the basic question at the heart of a white paper Sen. Bill Cassidy (R-La.) issued last week to continue a conversation he started in September on the reforms needed at the country’s premier biomedical research institution. The paper noted that, over the past decade, the NIH has shifted its focus, and funding, toward applied research and away from the investigator-initiated, basic science that’s been the historic hallmark of its mission. While acknowledging that applied research often has a more immediate, tangible impact, Cassidy warned that “neglecting funding in the crucial beginning stages of research could ultimately limit the creation of lifesaving cures and treatments.”
Merck discontinues anti-TIGIT portion of phase III melanoma study
Citing a high rate of leaving the study by patients, Merck & Co. has discontinued the anti-TIGIT antibody vibostolimab and the anti-PD-1 Keytruda (pembrolizumab) portion of it phase III Keyvibe-10 clinical trial as an adjuvant treatment for those with resected high-risk melanoma. The arm compared the combination to Keytruda alone. A data analysis revealed that recurrence-free survival, the study’s primary endpoint, was not likely to be met because of the high rate of patient discontinuation. There also was trouble with the combination treatment late last year. In December 2023, Merck revealed data showing its phase II Keyvibe-002 study of vibostolimab and Keytruda plus docetaxel in treating metastatic non-small-cell lung cancer extended median progression-free survival by 2.4 months compared to those receiving docetaxel alone, but the results did not reach statistical significance.
Bio Korea 2024: Curocell CEO points to rise, fall of CAR T trends
As South Korea’s Curocell Inc. looks to develop the country’s first homegrown CAR T-cell therapy, CEO Gunsoo Kim highlighted rising and falling trends in the global CAR T development space at Bio Korea 2024. New approvals and record-breaking sales of ultra-expensive cell and gene therapies, like Zolgensma (onasemnogene abeparvovec, Novartis AG) and Yescarta (axicabtagene ciloleucel, Kite/Gilead Sciences Inc.), are breathing new life into the sector and overtaking synthetic and antibody drugs like Eliquis (apixaban) and Humira (adalimumab), Kim told the audience in Seoul, South Korea on May 9. Despite the breakthroughs, recent studies have shown therapeutic outcomes in lymphoma and myeloma have stagnated, with the complete response rate of large B-cell lymphoma at about 40%, multiple myeloma at 50% and B-cell acute lymphoblastic leukemia at 80%.
BioWorld reader feedback needed: Cyberattack impact survey
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Are there downstream impacts that are being overlooked in the biopharmaceutical and/or medical technology sectors? Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here.
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