As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
Zymeworks Inc. has obtained IND clearance from the FDA for ZW-171, a novel T-cell targeting bispecific antibody for mesothelin (MSLN)-expressing cancers. Clinical development will begin this year, and additional applications will be filed in the second half of the year seeking trial clearances in other territories.
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates became a topic of talk during the recent American Society of Clinical Oncology meeting in Chicago.
Pierre Fabre Laboratories (Pierre Fabre SA) has filed an IND application to the FDA to initiate a first-in-human trial with PFL-002 (VERT-002) for solid tumors, including non-small-cell lung cancer (NSCLC).
Miami-headquartered Summit Therapeutics Inc. expanded rights to Akeso Inc.’s non-small-cell lung cancer (NSCLC) drug, ivonescimab (SMT-112; AK-112), June 3 while raising $200 million to advance the therapy.
Although details are scant, Akeso Pharmaceuticals Inc. reported that its PD-1/VEGF bispecific antibody, ivonescimab (AK-112), demonstrated statistically significant superiority as a first-line therapy for PD-L1-positive non-small-cell lung cancer (NSCLC) compared to Merck and Co. Inc.’s Keytruda (pembrolizumab).
The EMA has been sent back to the drawing board to re-evaluate PTC Therapeutics Inc.’s Duchenne muscular dystrophy therapy Translarna (ataluren), after failing to get the usual rubber stamp following its recommendation in January that the drug’s conditional approval be withdrawn.
It is known that an abnormal activation of the mitogen-activated protein kinase (MAPK) pathway is involved in tumor formation and progression, where MEK1 and MEK2 are the key proteins involved in this pathway. At the ongoing ASCO meeting in Chicago, Pasithea Therapeutics Corp. presented data on PAS-004, a macrocyclic MEK inhibitor for the potential treatment of cancer.
Although details are scant, Akeso Pharmaceuticals Inc. reported that its PD-1/VEGF bispecific antibody, ivonescimab (AK-112), demonstrated statistically significant superiority as a first-line therapy for PD-L1-positive non-small-cell lung cancer (NSCLC) compared to Merck and Co. Inc.’s Keytruda (pembrolizumab).
