Menarini adds Georgiamune’s oral immunotherapy candidate to its solid-tumor portfolio for $45M upfront

Why it matters: For Georgiamune, the license is a major vote of confidence: an established drugmaker is paying for a molecule still in lab testing. GIM-621 would be one of the few cancer immunotherapies taken orally, and the drug is also meant to fill a significant unmet need.

“GIM-621 is being developed for patients whose cancers don’t respond, or stop responding, to current immunotherapies,” Georgiamune and Menarini told European Biotechnology.

Zoom in: Checkpoint inhibitors, which block proteins that hold immune cells back, are the most common type of cancer immunotherapy. Georgiamune cited a 2019 analysis estimating that in 2018 about 44% of U.S. cancer patients were eligible for checkpoint inhibitors and about 12% responded (a 2025 update put the 2023 figures at about 57% and 20%, respectively).

• Stemline Therapeutics, Menarini’s oncology subsidiary, already sells elacestrant, a hormone therapy for a form of advanced breast cancer, in Europe and the U.S., and now adds GIM-621 to its pipeline. “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,” Menarini CEO Elcin Barker Ergun said in a press release.

Follow the money: Georgiamune will receive $45 million in upfront and near-term payments. Preclinical, development, regulatory and commercial milestone payments could bring that to as much as $1.1 billion, plus royalties.

• By mid-August, Georgiamune had raised $92.7 million (€82.6 million) in a Series B preferred stock offering, about twice Menarini’s $45 million. Venture firm General Catalyst and the Parker Institute for Cancer Immunotherapy co-led its $75 million (€67 million) Series A in 2023.

How it works: Stemline gets an exclusive worldwide license to develop, make and sell GIM-621. Menarini told European Biotechnology it “comes from Georgiamune’s research into the mechanisms that control immune activation, suppression and balance.” Georgiamune called it “a small molecule that acts on the immune system to fight cancer” and said such molecules can reach targets inside cells, which antibodies generally can’t.

• Georgiamune’s two oral drugs in the clinic work on regulatory T cells, or Tregs, which hold immune attacks in check: GIM-531 is designed to block them in cancer, and GIM-407 to activate them in autoimmune disease.

Reality check: The companies call GIM-621 first-in-class, but have not identified its target or released experimental results showing whether it can fight cancer.

• “At this time we are not disclosing the target or the mechanism,” Menarini told European Biotechnology, adding that the specific cancers GIM-621 will target have not been disclosed either.
• In 2018, another oral immunotherapy, Incyte’s epacadostat, designed to block the immune-suppressing enzyme IDO1, failed in a Phase 3 melanoma trial. Added to Merck’s antibody Keytruda, it did not slow the cancer more than Keytruda alone.

What’s next: Menarini is looking toward human trials but has yet to name a date. “Our development model is built for speed and focus, and we will share milestones as they are reached,” explained a company spokesperson to European Biotechnology.

• Meanwhile, Georgiamune — founded by immunologist Samir Khleif and advised by top scientists including Nobel laureate Fred Ramsdell — is pressing ahead with its other drugs. “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,” Khleif said in the press release.