The EMA’s Committee for Medicinal Products for Human Use (CHMP) is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder.
FGFR3 genomic alterations, including S249C as the most common, are recognized oncogenic drivers in 10%-60% of bladder cancers depending on the disease stage. Onco3r Therapeutics BV recently reported the identification of a novel series of highly potent, isoform-selective small-molecule FGFR3 inhibitors.
Captain T Cell GmbH has successfully closed an equity financing round to support its T-cell receptor (TCR) T-cell therapies for solid tumors. The company’s autologous lead program, CTC-127, is a best-in-class TCR T-cell therapy targeting MAGE-A4-positive solid tumors and is expected to enter clinical trials in early 2027.
Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease.
Bladder cancer is among the 10 most frequent cancers around the world. While potentially effective treatments exist, they do not benefit all patients, so investigators continue to search for new targets. Researchers at Nanjing Drum Tower Hospital have identified sideroflexin 1 (SFXN1) as a potential therapeutic target.
Invasive bladder cancer can be treated through immunotherapy involving Bacillus Calmette-Guérin (BCG), but some 40%-60% of treated patients suffer progression or recurrence. In an effort to find more effective treatments for refractory disease, researchers at the Université de Sherbrooke and its hospital research center have engineered an oncolytic vesicular stomatitis virus encoding granulocyte-macrophage colony-stimulating factor (VSVd51-GM-CSF).
Aptevo Therapeutics Inc. has added a preclinical candidate, APVO-455, to its portfolio of CD3-directed candidates built on the CRIS-7-derived CD3 binding domain.
During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a “roller-coaster ride” sparked by a mixed-outcome advisory panel meeting held May 21. Zusduri is designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer.
More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
