Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
What had been viewed as a major catalyst for Gilead Sciences Inc. going into 2024 turned into a disappointment on the stock market, as antibody-drug conjugate Trodelvy (sacituzumab govitecan) failed to meet the overall survival primary endpoint in the phase III Evoke-01 study in previously treated metastatic non-small-cell lung cancer (NSCLC).
Elpiscience Biopharma Ltd. is out-licensing to Astellas Pharma Inc. two preclinical bispecific macrophage engagers – ES-019, an anti-PD-L1/SIRPα bispecific antibody, and another unnamed program – in a deal worth up to $1.7 billion. The deal marks the Shanghai-based company’s first out-licensing deal, Elpiscience CEO Darren Ji told BioWorld, noting that Astellas will have global rights to both molecules with a potential to in-license two more.
Elpiscience Biopharma Ltd. is out-licensing to Astellas Pharma Inc. two preclinical bispecific macrophage engagers – ES-019, an anti-PD-L1/SIRPα bispecific antibody, and another unnamed program – in a deal worth up to $1.7 billion. The deal marks the Shanghai-based company’s first out-licensing deal, Elpiscience CEO Darren Ji told BioWorld, noting that Astellas will have global rights to both molecules with a potential to in-license two more.
Shares of Checkpoint Therapeutics Inc. dropped 44.8% Dec. 18 on news that the U.S. FDA issued a complete response letter (CRL), delaying potential approval of PD-L1 antibody cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA had accepted in March the BLA, seeking use for treating patients who are not candidates for curative surgery or radiation, setting a Jan. 3, 2024, PDUFA date.
Demand for its COVID-19 vaccine might be declining, but Biontech SE is putting its revenue to good use, picking up rights to a bispecific antibody candidate from Biotheus Inc. in exchange for $55 million up front and potentially more than $1 billion in development, regulatory and sales milestones.
Demand for its COVID-19 vaccine might be declining, but Biontech SE is putting its revenue to good use, picking up rights to a bispecific antibody candidate from Biotheus Inc. in exchange for $55 million up front and potentially more than $1 billion in development, regulatory and sales milestones.
The narrative of TIGIT-targeting immunotherapy development, beset by negative news in recent months, has found a positive plotline again, thanks to what Roche Holding AG referred to as “an inadvertent disclosure” of a second interim analysis from the phase III Skyscraper-01 study testing anti-TIGIT candidate tiragolumab with anti-PD-L1 antibody Tecentriq (atezolizumab) in non-small-cell lung cancer.
One of the characteristics of chronic hepatitis B virus (HBV) infection is T-cell exhaustion, which, in turn, is mediated by the PD-1/PD-L1 axis. Researchers at Oligo Therapeutics Inc. reported on ALG-072571, a potent siRNA PD-L1 inhibitor active against HBV infection mouse models.