ADG138 IND clearance adds a second masked T-cell engager to Adagene's pipeline, but the Phase 1 has not yet enrolled. Near-term catalysts remain with muzastotug (ADG126) Phase 2 data in MSS CRC. Monitor enrollment updates for ADG138 and any partnership interest given the Enhertu-resistant preclinical data.
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Executive Summary
Adagene received NMPA clearance to begin a Phase 1 trial of ADG138, a double-masked HER2xCD3 bispecific T-cell engager, in advanced solid tumors in China. Preclinical data show activity in Enhertu-resistant models and a wide therapeutic window, but the program is at the IND stage with no human data yet.
Key Facts
- NMPA approved IND for ADG138, a double-masked HER2xCD3 bispecific T-cell engager
- Phase 1 first-in-human study expected to begin in Q4 2026 in China
- Preclinical data showed tumor regression in Enhertu-resistant models and synergy with anti-CTLA-4, anti-PD-1, and anti-CD137 antibodies
- ADG138 tolerated at doses over 300-fold higher than an unmasked T-cell engager with reduced cytokine release
- ADG138 achieved ~220-fold reduction in HER2 binding and >1,000-fold reduction in CD3 binding in masked state
Financial Impact
No financial figures disclosed; early-stage pipeline expansion with no revenue impact
Risk Factors
- Phase 1 has not started; clinical failure or safety issues could halt development
- No human efficacy or safety data yet for ADG138
- Cash runway into early 2028 per prior 20-F; additional dilution risk if ATM is used
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001104659-26-109485 |
| Document: tm2625845d1_6k.htm | 0001104659-26-109485 |
| Document: 0001104659-26-109485-index-headers.html | 0001104659-26-109485 |
| Document: 0001104659-26-109485-index.html | 0001104659-26-109485 |
| Document: 0001104659-26-109485.txt | 0001104659-26-109485 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 25, 2026 4w ago | 6-K | $3.20 | awaiting T+60 | — | $2.49 (−22.19%) |
Sep 22, 2026 4w ago | 6-K | $3.23 | awaiting T+60 | — | $2.49 (−22.91%) |
Sep 10, 2026 6w ago | 6-K | $3.31 | awaiting T+60 | — | $2.49 (−24.77%) |
Sep 9, 2026 6w ago | 6-K | $3.27 | awaiting T+60 | — | $2.49 (−23.85%) |
Aug 16, 2026 10w ago | Institutional Cluster | $3.83 | awaiting T+60 | — | $2.49 (−34.99%) |
Aug 12, 2026 10w ago | 6-K | $3.75 | awaiting T+60 | — | $2.49 (−33.60%) |
Aug 12, 2026 10w ago | Press Release | $3.75 | awaiting T+60 | — | $2.49 (−33.60%) |
Jul 6, 2026 16w ago | 6-K | $3.93 $3.21 | ▼ −18.32% | ▼ −20.04% | $2.49 (−36.64%) |
Apr 17, 2026 27w ago | 6-K | $3.89 $3.67 | ▼ −5.66% | ▼ −12.43% | $2.49 (−35.99%) |
Apr 2, 2026 29w ago | 6-K | $3.99 $4.20 | ▼ −5.26% | ▲ +8.90% | $2.49 (+37.59%) |
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