The deaths of two cancer patients treated with the small molecule azenosertib has prompted the U.S. FDA to place a partial clinical hold on a phase I study and two phase II studies from Zentalis Pharmaceuticals Inc. The deaths are presumed by Zentalis to be from sepsis. Both patients who died were in the phase II Denali study of platinum-resistant ovarian cancer.
Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.
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.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
High weight is associated with a greater risk of developing many cancers, and with an increased risk of metastasis. But in some cancers such as renal cell carcinoma, it is also associated with better survival and a better response to immunotherapies in particular.
Myeloproliferative neoplasms (MPNs) can only be cured, to date, using allogeneic stem cell transplantation which, in turn, only works for up to 20% of patients. As calreticulin (CALR) frameshift mutations are the second most common cause of MPNs, targeting this endoplasmic reticulum resident protein is one of the strategies emerging at the forefront of hematological malignancies research.
Urogen Pharma Ltd. shares (NASDAQ:URGN) closed June 13 at $17.50, up $4.78, or 37%, on word of an 82.3% 12-month duration of response data by Kaplan-Meier estimate from its phase III Envision study with UGN-102. The finding was made in in low-grade, intermediate-risk, non-muscle invasive bladder cancer patients who achieved complete response at three months after the first instillation of the drug for intravesical solution.
Acepodia Inc.’s antibody cell conjugation platform could change the way CAR T-cell therapies are manufactured, clearing the way for an off-the-shelf model to treat numerous cancers that is safer and cheaper than current CAR Ts, Acepodia CEO Sonny Hsiao told BioWorld.
Abtis Co. Ltd., Dong-A ST’s newly incorporated subsidiary since December 2023, is making headway with its leading Claudin18.2-targeting antibody-drug conjugate (ADC) candidate, AT-211, according to Abtis CEO Taedong Han. “About 80% of gastric cancers do not have HER2 overexpression, but 77% overexpressed Claudin18.2,” Han told Bio Korea 2024 audience members on May 9, stressing that AT-211 was found to be highly potent against cancer cells expressing Claudin18.2 in ADC cell viability studies.
Two years after signing a $1.6 billion partnership with Marengo Therapeutics Inc., Paris-based Ipsen SA is back at it again, this time teaming up for two additional assets that target “cold” tumors in a deal that could bring privately held Marengo $1.2 billion. “We do something really novel and innovative and I think it’s very important to continue to validate it,” Marengo CEO Zhen Su told BioWorld, adding that with the newest deal, “we see validation all around this … It’s a success on success.”
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