Two deals for antibody-drug conjugates (ADC) inked since May between Merck & Co. Inc. and Sichuan Kelun-Biotech Pharmaceutical Co. Ltd. have blossomed eight months later into the year’s biggest agreement, one that could bring Kelun-Biotech up to $9.3 billion in development, regulatory and sales milestones. Merck is paying an up-front $175 million to Kelun-Biotech plus promising to make an equity investment in the Sichuan, China-based company. Kelun-Biotech granted Merck exclusive global licenses to research, develop, manufacture and commercialize seven preclinical ADC therapies plus exclusive options for more licenses to ADC candidates.
Proqr surges as Lilly broadens RNA editing alliance
Shares in Dutch RNA editing specialist Proqr Therapeutics NV (NASDAQ:PRQR) surged by as much as 83% Dec. 22 on news that Eli Lilly and Co. is substantially expanding an existing alliance. It is paying Proqr an initial $75 million, which consists of an up-front payment and equity investment, a potential $50 million option fee should it decide to widen the scope of the partnership even further, and up to $2.5 billion in new research, development, and commercialization milestones. Proqr would also receive royalties on any resulting product sales.
Gilead’s twice-yearly HIV therapy Sunlenca wins FDA go-ahead
Gilead Sciences Inc. gained U.S. FDA clearance for twice-yearly Sunlenca (lenacapavir) in combination with other antiretroviral therapies for HIV-1 infection in heavily treatment-experienced adults with multidrug resistant infection. It’s the first and only approved capsid inhibitor-based HIV treatment option, and the green light was based on high rates of sustained virologic suppression the phase II/III study called Capella. Unlike other antiviral agents on the market, Sunlenca bears no known cross-resistance in vitro to existing drug classes. Shares of Foster City, Calif.-based Gilead (NASDAQ:GILD) were trading midday at $84.66, down 61 cents, or 0.72%.
Top Trends of 2022: For the first time …
Biopharma just wouldn’t be biopharma without continuing innovation. Even in a year rife with economic and regulatory turmoil, the industry still achieved major advancements set to change the health care landscape going forward. Standouts for 2022 include cell therapy and gene editing approaches making significant gains, while industry celebrated a new checkpoint inhibitor added to the oncology armamentarium.
Takeda’s maribavir bested by valganciclovir in post-transplant CMV study
Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, failed to meet the primary endpoint of noninferiority compared to valganciclovir in the phase III Aurora study for cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients. The multicenter, randomized, double-blind, double-dummy, active-controlled study was to form the basis for a future label expansion for the therapy.
Senescent cells are toxic to their neighbors, prevent muscle regeneration
The first in vivo cell atlas of senescent tissue in skeletal muscle has identified the damaging properties of these cells and explained why they block muscle regeneration. According to a study at Pompeu Fabra University led by scientists from Altos Labs Inc., cell damage caused the senescence of the cells, which secreted toxic substances into the surrounding microenvironment, causing fibrosis and preventing tissue regeneration.
Holiday notice
BioWorld's offices will be closed in observance of Christmas. No issues will be published Friday, Dec. 23 or Monday, Dec. 26.
Also in the news
Abivax, Acasti, Actinogen, ADC, Aeon, Aerami, Akebia, Akero, Aldeyra, Alnylam, Alvotech, Aquestive, Armata, Ascletis, Astrazeneca, Bavarian Nordic, Beckley Psytech, Benevolentai, Biontech, Bridgebio, Ceapro, Chemomab, Contrafect, Edesa, Elite, Everest Medicines, Exelixis, Genentech, Genmab, Gilead, Gradalis, Iaso, Imago, Imbrium, Innocare, Johnson & Johnson, Kempharm, Lexicon, Madrigal, Melt, Merck, Minovia, Mirati, Moleculin, Okyo, Oric, Osivax, Outlook, Pepromene, Pfizer, Phio, Radius, Regenxbio, Rocket, RQ, Sanofi, Sirnaomics, Small Pharma, Sobi, Sosei Heptares, Vir, Viridian, Zynerba