The NMPA accepted a BLA from Astellas Pharma Inc. for enfortumab vedotin, which is designed for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy. “In China, there were nearly 86,000 new cases of bladder cancer in 2020, and we are working with the NMPA to seek approval for enfortumab vedotin for patients with advanced stage disease,” said Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas.
Asieris Pharmaceuticals Co. Ltd. has divulged 7-nitro-8-hydroxyquinoline derivatives reported to be useful for the treatment of urinary tract infections, and bladder and prostate cancer.
Ferring Pharmaceuticals A/S has notched another U.S. FDA approval, this time for a bladder cancer treatment, Adstiladrin (nadofaragene firadenovec). The non-replicating adenovirus vector-based gene therapy’s approval comes only weeks after the FDA’s Nov. 30 approval of the privately held company’s Rebyota (fecal microbiota, live), the first fecal microbiota treatment in the U.S. Adstiladrin is another landmark, as the first FDA-approved gene therapy to treat high-risk, non-muscle-invasive bladder cancer. Saint-Prex, Switzerland-based Ferring said it anticipates the product becoming commercially available in the U.S. in the second half of 2023.
CSPC Pharmaceutical Group Ltd. has received IND approval from the FDA for a phase I study in the U.S. of its antibody-drug conjugate CPO-204 in patients with locally advanced or metastatic urothelial cancer.
Vitadx SA is preparing to close a new $8.3 million funding round, to ramp European distribution of its automated software platform for early detection of bladder cancer. The system is based on morphology analysis of cells in a urine sample on a digital cytology slide. “Our Visiocyt technology allows urologists to adjust patient pathways and thereby limit the number of invasive procedures necessary to confirm their diagnosis with people already presenting symptoms,” Allan Rodriguez, CEO and co-founder of Vitadx, told BioWorld.
AZD-4820 was evaluated in a cell viability assay performed in 30 human cancer cell lines, defining 12 different types of cancer, and testing a dose-range of multiplicity of infection (MOI); potent oncolytic activity was observed with EC50 values of <0.1 MOI in nearly all of the tested cells.
Therapy delivery and the physicians who administer them are keys in CG Oncology Inc.’s drive to develop bladder cancer treatments. The company, which just closed an oversubscribed $120 million series E financing to continue on the development path, has its lead oncolytic immunotherapy, CG-0070, intravesically delivered via a catheter, in the clinic.
Zhuhai Beihai Biotech Co. Ltd. has raised nearly ¥200 million (US$27.5 million) in a series B round slated to support clinical trials for its lead candidates as well as preparations to file an NDA for its core asset, BH-009.
Zhuhai Beihai Biotech Co. Ltd. has raised nearly ¥200 million (US$27.5 million) in a series B round slated to support clinical trials for its lead candidates as well as preparations to file an NDA for its core asset, BH-009, an injectable formulation of docetaxel that excludes polysorbate 80 (Tween 80), a surfactant that has been associated with increased risk of adverse events, including hypersensitivity. The company claims that no similar product is currently available worldwide.
