#USA #Menarini #GIM-621 #Georgiamune #Florence, Gaithersburg

Georgiamune and Menarini Partner on GIM-621

Georgiamune Inc., a clinical-stage biotechnology company, has announced an exclusive global licensing and collaboration agreement with the Menarini Group, a prominent international pharmaceutical and diagnostics company. This agreement centers around GIM-621, which is an innovative oral immuno-oncology agent currently in preclinical development, showing immense potential for treating various solid tumors.

Under the terms of this agreement, Georgiamune will receive an initial and short-term payment of $45 million, with the total value of the deal potentially reaching up to $1.1 billion, in addition to royalty payments from future sales of the drug.

Dr. Samir N. Khleif, founder and CEO of Georgiamune, expressed enthusiasm about the partnership, stating, "At Georgiamune, we are committed to uncovering new mechanisms that govern immune cell function and translating that biology into innovative therapeutics. GIM-621 is one of the outcomes of this mission, alongside three other clinical programs targeting autoimmune diseases and oncology. This partnership enables us to leverage Menarini’s capabilities for the oncology domain on a global scale while continuing to advance a wide-ranging product portfolio based on distinct immune mechanisms."

The oral immunotherapy GIM-621 has shown promise as it is designed to engage the immune system in a controlled manner, which could revolutionize treatment options for patients facing various malignancies. As a cutting-edge candidate, the drug is a part of a broader research initiative by Georgiamune, which has focused on understanding the new mechanisms governing activation, suppression, and immune homeostasis.

Elcin Barker Ergun, CEO of Menarini, commented on the collaboration, indicating excitement about partnering with Georgiamune, which possesses deep expertise in immuno-oncology and the development of GIM-621. "This program perfectly complements our existing portfolio of solid tumor therapies. Our established capabilities in oncology drug development and commercialization position us well to expedite the progress of GIM-621. We look forward to working closely with Georgiamune to unlock the full potential of this innovative approach for the benefit of cancer patients worldwide."

About Georgiamune

Georgiamune is an innovative biotechnology firm dedicated to discovering and developing advanced therapies aimed at reprogramming immune signaling pathways to combat cancer and autoimmune diseases. Their research focuses on unearthing new mechanisms that regulate T-cell activation, the function of regulatory T-cells, and overall immune homeostasis. Currently, Georgiamune has three programs in clinical development: GIM-407, an oral T-regulator activator for autoimmune diseases; GIM-122, a bispecific antibody for oncology; and GIM-531, an oral T-regulator inhibitor in oncology. They are also developing a broader pipeline of preclinical candidates targeting solid tumors and autoimmune conditions, including GIM-621. Founded by Dr. Samir N. Khleif, Georgiamune’s initiatives stem from groundbreaking laboratory discoveries related to immune response regulation.

About Menarini Group

The Menarini Group is a leading international pharmaceutical and diagnostics company with annual revenues of around $5.5 billion and a workforce exceeding 17,000 employees. Menarini focuses on therapeutic areas with significant unmet medical needs, offering products in cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, anti-inflammatory treatment, and pain management. The company operates 18 manufacturing sites and nine research and development centers, distributing its products in 140 countries worldwide. For more information, please visit Menarini's website.

About Stemline Therapeutics Inc.

Stemline Therapeutics Inc., a wholly-owned subsidiary of the Menarini Group, is a biopharmaceutical company dedicated to providing transformative cancer treatments for patients. Its marketed products include elacestrant, an oral hormone therapy for women with advanced or metastatic ER-positive/HER2-negative breast cancer, and tagraxofusp-erzs, indicating commitment to addressing significant oncology needs. The company also conducts several open-label extension studies for elacestrant and tagraxofusp, demonstrating its robust clinical pipeline aimed at solid and hematologic cancers.