• GIM-621 is a preclinical-stage, first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors.
• Georgiamune to receive $45 million in upfront and near-term payments, as part of a total deal value of up to $1.1 billion, plus royalties.

 -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, along with Georgiamune Inc., a clinical-stage biotechnology company discovering and developing first-in-class therapies that reprogram immune signaling pathways to treat cancer and autoimmune diseases,  announced an exclusive worldwide license and collaboration agreement for GIM-621. 

GIM-621 is a preclinical-stage first-in-class oral small molecule immunotherapy with potential application across multiple solid tumors. It is one of multiple therapeutic candidates generated from Georgiamune's research into novel mechanisms governing immune activation, suppression and homeostasis.

Under the terms of the license and collaboration agreement, Stemline receives an exclusive, worldwide license to develop, manufacture and commercialize GIM-621. Georgiamune will receive $45 million in upfront and near-term payments. Georgiamune is also eligible for preclinical, development, regulatory and commercial milestone payments, for a total potential deal value of up to $1.1 billion, plus royalties.

"At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology," said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. "GIM-621 is one of multiple programs to emerge from that work, alongside three programs already in clinical development across autoimmune disease and oncology. This agreement brings Menarini's global oncology development and commercial capabilities to GIM-621 while allowing Georgiamune to continue advancing a broad pipeline built on distinct immune mechanisms."

 "We are delighted to partner with Georgiamune, a company with deep expertise in immuno-oncology which has led to the discovery of GIM-621, a first-in-class oral immunotherapy with promise across multiple solid tumors," said Elcin Barker Ergun, CEO of the Menarini Group. "This program is a strong complement to our solid tumor portfolio, and our established oncology development and commercial capabilities position us well to accelerate its progress. We look forward to working closely with the Georgiamune team to unlock the full potential of this innovative approach to benefit patients with cancer."