The Menarini Group’s oncology unit Stemline Therapeutics has taken an exclusive worldwide license to GIM-621, a preclinical oral small molecule immunotherapy from Gaithersburg, Maryland-based Georgiamune, the companies announced on October 22. Georgiamune receives $45 million in upfront and near-term payments and is eligible for preclinical, development, regulatory and commercial milestones taking the total potential deal value to up to $1.1 billion, plus royalties. Stemline takes over development, manufacturing and commercialization.
GIM-621 is described by the companies as first-in-class, with potential application across multiple solid tumors. It comes out of Georgiamune’s work on the mechanisms that control immune activation, suppression and balance, the same research base that produced its three clinical-stage programs: GIM-531, an oral regulatory T cell inhibitor in oncology; GIM-122, a dual-functioning antibody in oncology; and GIM-407, an oral Treg activator for autoimmune disease. The companies have not disclosed GIM-621’s target or mechanism, and Menarini told European Biotechnology Magazine that the specific cancers it will pursue have not been named and human trials have no announced date.
Georgiamune, founded by Samir Khleif, raised a $93 million Series B last month on top of a $75 million Series A co-led by General Catalyst and the Parker Institute for Cancer Immunotherapy in 2023, Fierce Biotech reported. For Menarini, a private Italian group, Stemline already markets three approved oncology drugs, and GIM-621 adds an early, oral option to a portfolio built on later-stage assets. The honest read of the economics is that $45 million is the real price today and the remaining billion is a schedule of contingencies on a molecule that has not yet been dosed in a person.