Four years after Bristol Myers Squibb Co.’s (BMS) $1.85 billion investment in Nektar Therapeutics Inc., the pair’s collaboration has stumbled mightily with a phase III failure. A first analysis their melanoma study, PIVOT IO-001, showed it missed three primary endpoints. The study of interleukin-2-targeting NKTR-214 (bempegaldesleukin) combined with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated, unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival and objective response rate.
Biohaven Pharmaceutical Holding Co. Ltd. signed a deal that could be worth more than $1 billion to take over Channel Biosciences LLC, a subsidiary of Knopp Biosciences LLC, and its Kv7 channel targeting platform. A key part of the deal is BHV-7000, formerly known as KB-3061, described as a potent activator of Kv7.2 and Kv7.3, key subunits involved in neuronal signaling and in regulating the hyperexcitable state in epilepsy. The compound is expected to enter clinical investigation this year, with focal epilepsy as the lead indication.
As investors await the Sept. 10 PDUFA date for deucravacitinib from Bristol Myers Squibb Co. (BMS) in psoriasis, handicappers continue to weigh the odds of other tyrosine kinase 2 (TYK2) inhibitors, and ponder what a regulatory victory – or defeat – might mean for the space.
LONDON – “I really believe we can start using the word cure,” said the pioneer of chimeric antigen receptor T-cell (CAR T) therapy Carl June, as he revealed two leukemia patients he treated in a phase I trial have now been in remission for 10 years. Both patients with chronic lymphocytic leukemia achieved complete remission shortly after treatment in 2010. The genetic modification has remained detectable in their CAR T cells for more than 10 years of follow-up, June said, describing details of the case studies published in Nature Feb. 2.
LONDON – “I really believe we can start using the word cure,” said the pioneer of chimeric antigen receptor T-cell (CAR T) therapy Carl June, as he revealed two leukemia patients he treated in a phase I trial have now been in remission for 10 years. Both patients with chronic lymphocytic leukemia achieved complete remission shortly after treatment in 2010. The genetic modification has remained detectable in their CAR T cells for more than 10 years of follow-up, June said, describing details of the case studies published in Nature Feb. 2.
Bristol Myers Squibb Co.’s Breyanzi (lisocabtagene maraleucel) CAR T-cell therapy has passed muster with European regulators as a therapy for relapsed or refractory large B-cell lymphoma, setting up a likely European marketing authorization in the coming weeks.
With data due the first half of this year from the phase III trial testing Opdivo (nivolumab, Bristol Myers Squibb Co.) plus Nektar Therapeutics Inc.’s bempegaldesleukin (bempeg) in metastatic melanoma, the possibilities for engineered cytokines such as the latter remain alluring in many quarters.
At least one biopharma company is under the magnifying glass in a U.S. Senate Finance Committee investigation into large multinational corporations that shift profits overseas to avoid U.S. taxes.
Century Therapeutics Inc.’s $3.25 billion deal with Bristol Myers Squibb Co. (BMS) was the largest of four billion-dollar-plus agreements announced Dec. 10, piggybacking on a busy week that includes the start of the 40th annual J.P. Morgan Healthcare Conference.
Following initial approvals for rheumatic diseases, Bristol Myers Squibb Co.'s Orencia (abatacept) has become the first FDA-approved drug for the prevention of acute graft-vs.-host disease (aGVHD), in combination with calcineurin inhibitors and methotrexate, both types of immunosuppressants.
