Xspray Pharma Announces Fourth Product Candidate, targeting USD 2.3 billion Market

Regulatory press release 2024-04-22

STOCKHOLM, Sweden – Xspray Pharma AB announces the strategic decision to advance its fourth product candidate XS015 into clinical trials. The decision follows the successful scale-up of its innovative amorphous solid dispersion (ASD) formulation of the active substance cabozantinib, used in renal cell carcinoma and other cancers. This initiative targets the U.S. market for cabozantinib, projected to reach approximately USD 2.3 billion by 2026.

Using its proprietary HyNap™ technology, Xspray has enhanced the solubility and bioavailability of drugs, improving efficacy and patient outcomes for treatments like cabozantinib. The technology enables the delivery of products with better therapeutic outcomes, increased patient compliance, and fewer side effects. Today’s announcement of the decision to advance the product candidate XS015 into clinical trials has been made possible by the successful scale-up of the company’s ASD-formulation of cabozantinib.

Xspray is currently in the final phase of preparation for the anticipated launch of its first product, Dasynoc™, on September 1, 2024 pending final FDA approval. This launch marks a pivotal moment as the first output from Xspray’s development pipeline and reflects significant de-risking achievements for upcoming products such as cabozantinib, notably due to synergies found in the development processes of similar PKI class of compounds.

After today’s announcement, Xspray’s product candidate portfolio has four announced product candidates based on the company’s HyNap platform: XS004 dasatinib and XS003 nilotinib for treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), and XS008 axitinib and XS015 cabozantinibn used for treatment of kidney cancer. These are improved, amorphous versions of established and marketed protein kinase inhibitors. [CH1] 

As Xspray has decided to take a new product candidate to clinical trials and the portfolio moves towards commercial launch, these developments underscore the company's commitment to innovating cancer treatment, potentially transforming standards of care in oncology.