On February 3, 2026 Insilico Medicine ("Insilico"), a clinical-stage, generative artificial intelligence (AI)-driven biotechnology company, reported that it has received USD 5 million from Menarini Group ("Menarini") as an additional milestone payment, following the completion of first-in-patient dosing in a Phase 1 study of MEN2501, which was licensed to Menarini in January 2025. MEN2501 (previously known as ISM9682) is a highly differentiated small molecule inhibitor of kinesin KIF18A motor protein with potent activity in cancers with chromosome instability.
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As part of a strategic collaboration to accelerate the development and delivery of transformative cancer therapies, the asset was subsequently licensed to Stemline Therapeutics, Inc. ("Stemline"), a wholly owned subsidiary of the Menarini Group, with the combined value of the agreements exceeding USD 550 million. Pursuant to the partnership, both parties actively advanced the program transition and subsequent development activities. Following IND approval for this program, Insilico received the first development and regulatory milestone payment of USD 3 million in July 2025.
"The program rapidly advanced into a Phase I clinical trial and successfully completed first patient dosing, fully demonstrating Menarini and Stemline’s exceptional agility and clinical expertise," said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. "This milestone shows our shared commitment to delivering innovative therapies for cancer treatment. We are proud to further strengthen our partnership and encouraged to see AI-discovered drug candidates reaching such a critical stage, bringing us closer to providing novel treatment options for patients worldwide."
"Getting the first patient dosed in our MEN2501 Phase 1 study is a meaningful milestone that underscores how quickly promising science can move forward through focused clinical execution," said Elcin Barker Ergun, CEO of the Menarini Group. "We value our partnership with Insilico as we translate AI-enabled discovery into clinical programs, with the goal of bringing new, transformational treatment options to patients facing aggressive cancers."
The collaboration between Insilico and Menarini has continued to expand since its inception. Prior to MEN2501, in January 2024, Insilico announced that it entered into an exclusive global license collaboration with Menarini for MEN2312, a novel KAT6 inhibitor for breast cancer and other oncology indications, with the combined value of the agreements exceeding USD 500 million. The MEN2312 program has progressed smoothly into clinical development, and Insilico has received early development milestone payments.
In addition to the collaboration pipelines, Insilico has extensive experience in AI-driven oncology, drug discovery and development. The company has established a robust oncology pipeline that targets multiple cancer indications, leveraging both moderately novel and well-established mechanisms. Among its most promising assets, the potential best-in-class pan-TEAD inhibitor ISM6331 and the MAT2A inhibitor ISM3412 are both undergoing global, multicenter Phase I clinical trials.
Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development, setting a benchmark for AI-driven drug R&D. While traditional early-stage drug discovery typically requires an average of 4.5 years, Insilico has nominated 20 preclinical candidates from 2021 to 2024, with an average timeline—from project initiation to preclinical candidate (PCC) nomination—of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.
(Press release, Insilico Medicine, FEB 3, 2026, View Source [SID1234662437])