Basilea Pharmaceutica and Roche Announce Collaboration to Evaluate Combination Immunotherapy for Advanced Urothelial Cancer

VCBeat (WeChat Official Account: vcbeat) has learned that Basilea Pharmaceutica Ltd recently announced a collaboration with the biopharmaceutical company Roche to test a combination immunotherapy for the treatment of advanced urothelial carcinoma.

Basilea Pharmaceutica Ltd. is a multinational pharmaceutical company headquartered in Switzerland. In October 2000, Roche, the global pharmaceutical giant, spun off a team of senior executives and R&D scientists from its Basel headquarters to establish Basilea Pharmaceutica. To this day, Roche remains one of Basilea’s three major shareholders.

In March 2004, Basilea Pharmaceutica was listed on the SIX Swiss Exchange. As an emerging pharmaceutical company driven entirely by new drug research and development, the company currently has one original drug marketed in 19 countries worldwide. Additionally, two other innovative original drugs have completed Phase III clinical trials in the United States and the European Union and are awaiting marketing approval from the U.S. Food and Drug Administration (FDA). Furthermore, the company has several other original drugs in preclinical and Phase II clinical development.

Basilea Pharmaceutica stated that drug resistance is a frequent challenge in the treatment of infectious diseases and cancer. The rising incidence of multidrug-resistant pathogens has become a primary concern for the medical community in many regions worldwide. Meanwhile, tumor resistance to currently available anticancer agents has significantly adversely affected patient outcomes. Basilea’s research focuses on identifying strategies to overcome resistance to antibiotics and cancer therapies.

Basilea primarily develops three drugs: ZEVTERA®/Mabelio® (ceftobiprole), Cresemba® (isavuconazole), and Toctino® (alitretinoin). The drug used in the combination immunotherapy being tested by Basilea in collaboration with Roche is an oral inhibitor named derazantinib. Basilea and Roche plan to combine this FGFR kinase family inhibitor with Roche’s PD-L1 checkpoint inhibitor, Tecentriq, for the treatment of patients with confirmed FGFR genomic alterations.

Derazantinib targets FGFR kinases, which play a role in promoting cell proliferation, differentiation, and migration, and have been identified as potential therapeutic targets for liver cancer, bladder cancer, breast cancer, lung cancer, and gastric cancer.

Basilea stated that derazantinib can also inhibit colony-stimulating factor 1 receptor kinase (a class of secreted glycoproteins that bind to receptor proteins on the surface of hematopoietic stem cells, thereby activating intracellular signaling pathways), thus helping to reduce the number of tumor-associated macrophages and improve response to T-cell checkpoint immunotherapy. Basilea announced interim data from the derazantinib registration trial, showing a response rate of 21% among 29 patients with intrahepatic cholangiocarcinoma (which forms in the bile ducts within the liver).

Derazantinib was licensed from ArQule in April 2018 for global development and commercialization in regions excluding mainland China, Hong Kong, Macau, and Taiwan.

Roche, founded in 1896 and headquartered in Basel, Switzerland, is a global leader in oncology pharmaceutical research and development. To date, Roche’s research laboratories worldwide have been associated with three Nobel Prizes. Historically, Roche’s business operations primarily spanned four sectors: pharmaceuticals, medical diagnostics, vitamins and fine chemicals, and fragrances and flavors. Additionally, Roche engages in the development, advancement, and commercialization of products in key therapeutic areas, including neuroscience, virology, infectious diseases, oncology, cardiovascular diseases, inflammation and immunology, dermatology, metabolic disorders, and orthopedic diseases.

ZEVTERA® / Mabelio® (ceftobiprole) is an intravenous cephalosporin antibiotic. Cresemba® (isavuconazole) is an azole antifungal agent available for both intravenous and oral administration. Toctino® (alitretinoin) is an oral product indicated for the treatment of chronic hand eczema.