By Fineline Cube ABM Therapeutics Inc. announced a licensing agreement granting Mosaica Medicines global rights to ABM‑168, an in‑house developed allosteric MEK1/2 inhibitor currently in Phase I clinical trials for advanced solid tumors with a focus on brain metastases and primary brain tumors.
Deal Structure
| Item | Detail |
|---|---|
| Licensor | ABM Therapeutics Inc. (Shanghai‑based) |
| Licensee | Mosaica Medicines (US‑based) |
| Asset | ABM‑168 (allosteric MEK1/2 inhibitor) |
| Upfront Payment | Undisclosed |
| Milestones | R&D, regulatory, and marketing milestone payments |
| Territory | Global rights |
| Clinical Stage | Phase I (US and China) |
Drug Profile & Mechanism of Action
- Mechanism: Allosteric MEK1/2 inhibitor that blocks the MAPK/ERK signaling pathway, demonstrating antitumor activity in multiple preclinical studies
- Differentiation: Designed to penetrate the blood‑brain barrier, making it suitable for brain metastases and primary brain tumors—an area with limited therapeutic options
- Administration: Oral small molecule with favorable pharmacokinetic profile
- Innovation: Potential first‑in‑class MEK inhibitor for CNS‑active oncology indications
Clinical Development Status
- US Approval: FDA IND approval granted October 2022
- Phase I ongoing at multiple US oncology centers in patients with advanced solid tumors
- China Approval: NMPA approval granted August 2023
- Phase I study in patients with advanced solid tumors, focusing on brain metastases and primary brain tumors
- Next Milestone: Phase I data expected Q3 2026 to support dose‑expansion cohorts
Market Opportunity & Competitive Landscape
| Parameter | US | China | Global |
|---|---|---|---|
| Brain Metastases (Annual Cases) | 200,000 | 450,000 | 1.2 million |
| Primary Brain Tumors | 25,000 | 80,000 | 300,000 |
| Addressable Market (2030E) | $1.2 billion | $2.8 billion | $6.5 billion |
| MEK Inhibitor Penetration | <5 % | <3 % | <4 % |
| CNS‑Active MEK Inhibitors | None approved | None approved | None approved |
Key Competitors:
- Trametinib (Novartis) – Approved for melanoma, NSCLC; limited CNS penetration
- Cobimetinib (Roche/Exelixis) – Approved for melanoma; no CNS activity
- Binimetinib (Pfizer) – Approved for melanoma; no CNS activity
- ABM‑168 – Only MEK inhibitor in development with CNS‑active design
Strategic Positioning
- Pipeline Value: Licensing deal validates ABM‑168’s differentiated CNS‑active profile and provides non‑dilutive funding for Phase I/II development
- Global Development: Mosaica Medicines will lead global Phase II/III development and regulatory submissions; ABM Therapeutics retains co‑development rights in China
- Manufacturing: ABM Therapeutics’ Shanghai facility will supply clinical material for China trials; Mosaica will establish US/EU supply chain
- Commercial Potential: If approved, ABM‑168 could capture $300‑500 million in peak annual sales from the CNS‑active MEK inhibitor niche
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory pathways, and commercial projections for ABM‑168. Actual results may differ due to clinical trial outcomes, competitive dynamics, and partnership execution.-Fineline Info & Tech