Insilico Medicine Doses First Patient in MEN2501 Phase I, Triggers $5M Menarini Milestone

Insilico Medicine (HKG: 3696) announced the first patient dosing in a Phase I clinical study for MEN2501, a KIF18A inhibitor out‑licensed to Menarini Group. The milestone triggered a HKD 39 million (USD 5 million) payment from the Italian company under a prior USD 550 million licensing agreement.

Milestone & Deal Structure

ItemDetail
CompanyInsilico Medicine (3696.HK)
PartnerMenarini Group (via Temline Therapeutics subsidiary)
DrugMEN2501 (KIF18A inhibitor)
MilestoneFirst patient dosed in Phase I
Payment TriggeredHKD 39 M (USD 5 M)
Total Deal ValueUSD 550 M licensing agreement
MechanismInhibits KIF18A for chromosomal instability cancers

Drug Profile & Technology

  • Target: KIF18A, a kinesin protein critical for chromosome segregation in cancers with high chromosomal instability
  • Preclinical Data: Demonstrates significant inhibitory activity against chromosomal instability cancers
  • Platform: Developed using Insilico’s generative AI drug discovery platform
  • Strategic Value: Validates AI‑driven discovery for novel oncology targets; expands Menarini’s oncology pipeline

Market Impact & Commercial Outlook

  • Chromosomal Instability Market: Represents ~30% : of solid tumors; targeted therapies offer $5 billion+ global opportunity
  • Milestone Revenue: $5 M payment provides near‑term cash; additional milestones tied to Phase II/III progress could reach $100 M+ :
  • AI Validation: Successful Phase I initiation reinforces Insilico’s platform credibility, potentially attracting additional partnerships
  • Next Steps: Dose escalation ongoing; Phase I data expected H2 2026 ; Menarini to lead global development

Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, milestone achievements, and revenue potential for MEN2501. Actual results may differ due to clinical trial outcomes, competitive dynamics, and regulatory review processes.-Fineline Info & Tech