MGC026's 27% ORR with zero discontinuations in late-line SCCHN is competitive vs other B7-H3 ADCs (I-DXd 14%, HS-20093 17%). The clean safety profile supports the planned pembrolizumab combo study in front-line SCCHN, a key catalyst. Monitor enrollment updates and mid-2027 data readout for the Simon's 2-stage monotherapy cohort (n=40).
Price Chart
Executive Summary
MacroGenics reported positive interim Phase 1 data for MGC026, a B7-H3-directed ADC, at ESMO 2026. In heavily pretreated SCCHN patients (median 3 prior lines), MGC026 showed a 27% best overall response rate (6/22, 4 confirmed PRs) and a 64% disease control rate with no treatment-related discontinuations, ILD, or ocular toxicity. The company plans to initiate a front-line SCCHN combination study with pembrolizumab in early 2027.
Key Facts
- MGC026 demonstrated 27% best ORR (6/22) in heavily pretreated SCCHN patients at 7.5 mg/kg Q3W
- Confirmed ORR of 18.2% (4/22) and disease control rate of 63.6% (14/22) in SCCHN expansion cohort
- Median duration of response of 10.2 months across dose escalation at ≥6 mg/kg
- No treatment-related discontinuations, ILD, pneumonitis, or ocular toxicity in SCCHN cohort (N=27)
- Grade 3+ TRAEs occurred in 48% of SCCHN patients; most common were anemia (30%) and neutropenia (26%)
- Plan to initiate front-line SCCHN cohort evaluating MGC026 + pembrolizumab in PD-L1+ patients in early 2027
- Next MGC026 data update anticipated mid-2027
Financial Impact
No financial data provided in filing; clinical-stage biotech with no product revenue
Risk Factors
- Phase 1 data are preliminary with small sample sizes; response rates may change with full enrollment
- Competitive B7-H3 ADC landscape with multiple programs (I-DXd, HS-20093, YL201) advancing
- No financial data provided; company is pre-revenue with reliance on financing for pipeline development
- Combination study with pembrolizumab has not yet initiated; execution risk remains
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001125345-26-000066 |
| Document: mgnx-20261023.htm | 0001125345-26-000066 |
| Document: a991pressreleasedatedoctob.htm | 0001125345-26-000066 |
| Document: 0001125345-26-000066-index-headers.html | 0001125345-26-000066 |
| Document: 0001125345-26-000066-index.html | 0001125345-26-000066 |
| Document: 0001125345-26-000066.txt | 0001125345-26-000066 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | Press Release | $2.30 | awaiting T+60 | — | $1.99 (−13.70%) |
Oct 23, 2026 2d ago | 8-K | $2.44 | awaiting T+60 | — | $1.99 (−18.65%) |
Oct 22, 2026 3d ago | 144 | $3.63 | awaiting T+60 | — | $1.99 (−45.32%) |
Oct 15, 2026 10d ago | Press Release | $3.25 | awaiting T+60 | — | $1.99 (−38.92%) |
Jul 8, 2026 15w ago | 8-K | $4.57 $3.58 | ▼ −21.66% | ▼ −23.30% | $1.99 (−56.56%) |
Jul 2, 2026 16w ago | Press Release | $4.71 $3.80 | ▼ −19.32% | ▼ −22.33% | $1.99 (−57.86%) |
Jun 12, 2026 19w ago | Institutional Cluster | $3.96 $4.32 | ▲ +9.09% | ▲ +5.83% | $1.99 (−49.87%) |
Jun 11, 2026 19w ago | Institutional Cluster | $4.01 $4.40 | ▲ +9.73% | ▲ +5.33% | $1.99 (−50.50%) |
May 13, 2026 23w ago | 8-K | $4.16 $4.08 | ▼ −1.92% | ▼ −5.51% | $1.99 (−52.28%) |
May 12, 2026 23w ago | 8-K | $3.52 $4.01 | ▲ +13.92% | ▲ +9.54% | $1.99 (−43.61%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers