The failure of the Persevera study, sponsored by Roche Holding AG’s Genentech unit, disrupts advancement of giredestrant in combination with palbociclib (Ibrance, Pfizer Inc.) as a first-line treatment for ER-positive, HER2-negative, locally advanced or metastatic breast cancer. For competitor Olema Pharmaceuticals Inc., which has palazestrant for the same indication, missing the phase III Persevera primary endpoint of progression-free survival translated to a 25.8% stock slide (NASDAQ:OLMA) to a $16 close on March 9.
Orionis Biosciences Inc. is sticking with Genentech Inc. in a second deal to discover small-molecule monovalent glue therapies for treating cancer. Privately held Orionis is getting $105 million up front and could earn more than $2 billion in R&D, development, commercial and net sales milestones, plus royalties. The multiyear collaboration calls for Orionis to handle discovery and optimization of molecular glues, with Genentech in charge of later-stage preclinical and clinical development, regulatory filing and commercialization of any small molecules the partnership produces.
If the maximum fair prices the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition.
Privately held Dyno Therapeutics Inc. has added another notch to its adeno-associated virus (AAV) vectors development portfolio in a deal with the Roche Group that includes $50 million up front and ultimately could top $1 billion. Dyno will help in developing next-generation AAV vectors, optimized by artificial intelligence, to target neurological diseases.
Privately held Dyno Therapeutics Inc. has added another notch to its adeno-associated virus (AAV) vectors development portfolio in a deal with the Roche Group that includes $50 million up front and ultimately could top $1 billion. Dyno will help in developing next-generation AAV vectors, optimized by artificial intelligence, to target neurological diseases.
Hookipa Pharma Inc.’s nearly $1 billion collaboration with Roche Holding AG dissolved along with 30% of the company’s staff. The New York-based company said Roche ended the October 2022 deal involving the HB-700 program in treating KRAS mutated cancers but did not say why the agreement fell apart. Leerink Partners analyst Andrew Berens wrote Jan. 29 that the firm spoke to management, which indicated the program was progressing according to plan and that Roche's decision was based more on its own internal pipeline strategy, lessening its focus on oncology after high profile failures vs. the program having issues in development.
With Tofidence (tocilizumab-bavi), a monoclonal antibody from Biogen Inc., the U.S. FDA has approved the first biosimilar to the Roche Group AG’s Actemra (tocilizumab), a blockbuster with declining numbers. Tofidence was greenlighted Sept. 29 for treating rheumatoid arthritis in adults, and for treating polyarticular and systemic juvenile idiopathic arthritis in those ages 2 and older. It’s also the first biosimilar approved to treat systemic juvenile idiopathic arthritis.
Benzamide compounds acting as UDP-2,3-diacylglucosamine hydrolase (LpxH) (bacterial) inhibitors have been reported in an F. Hoffmann-La Roche Ltd. patent to be useful for the treatment of gram-negative bacterial infections, particularly Klebsiella pneumoniae and Escherichia coli infections.
F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. have identified 3-alkynyl carboxamides acting as legumain (asparaginyl endopeptidase; LGMN) inhibitors.
Researchers at F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. have disclosed zwitterionic compounds reported to be useful for the treatment of bacterial infections.
