Gallium 68-labeled FF-10158

Novartis captured attention last week for its Phase III prostate cancer win with a radioligand therapy it picked up for $2 billion back in 2018. Now, Novartis is doubling down on the field. Novartis will acquire development and commercial rights to two iTheranostics radioligand therapies targeting fibroblast activation proteins on the surface of tumor cells, the Swiss drugmaker said Tuesday. The deal covers candidates FAPI-46 and FAPI-74. In targeted radioligand therapy, a radioactive isotope rides a targeted ligand to the tumor site and kills it, potentially offering a new path to cancer care. Novartis’ 177Lu-PSMA-617 recently hit both co-primary endpoints on overall survival and radiographic progression-free survival for prostate cancer patients in that Phase III trial, which will likely set up a FDA filing in the near future and could set the stage for annual sales at around $1.3 billion. This time around, Novartis’ in-licensed compounds will chase fibroblast proteins, a surface protein that is often found in large quantities on certain cancers. The proteins are key for cell growth, and a high amount of fibroblast in cancer cells is often tied to a worse prognosis for care. By doubling down on radioligands — and the broader field of radiopharmaceuticals in general — Novartis is squaring up with a slate of biotechs also looking to capitalize in the space. In November, startup RayzeBio released a breed of pharmaceuticals that use peptide binders and Actinium-225 to target cancer cells. In 2020, the founders of Aktis Oncology joined the radiopharmaceuticals space, winning Novartis backing in the process. In mid-March, biotech investor Peter Kolchinsky raised $300 million for Point Biopharma’s radiopharmaceuticals play. “We believe working across multiple approaches is the key to reimagining cancer care,” Novartis president Susanne Schaffert said in a statement. “FAP is an exciting target and these agents are a great fit with our radioligand therapy pipeline, which we are actively investigating across multiple tumor types. We believe this technology has the potential to transform many patients’ lives.” Novartis has been a major player in the space for the past several years, as the company rolled the dice on radiopharmaceuticals in 2018, acquiring rights to FF-10158 from Fujifilm Toyama Chemical after it picked up Endocyte in a $2.1 billion deal, and added it to the Advanced Accelerator Applications group that it acquired in 2017 for $3.9 billion.