The strong efficacy and safety profile in late-line PROC positions CTIM-76 as a potential best-in-class CLDN6 TCE. Watch for Q3W dosing data in 2H 2026 and Phase 1b expansion in 2027. The low CRS rate supports outpatient dosing, which could be a competitive advantage. Monitor competitor data (e.g., brenetafusp, ADCs) and any partnership interest.
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Executive Summary
Context Therapeutics announced positive interim Phase 1a data for CTIM-76, a CLDN6 x CD3 T cell engager, in heavily pretreated platinum-resistant ovarian cancer (PROC). The data showed a 29% confirmed ORR, 57% DCR, and only 11% Grade 1 CRS, with PK supporting a move to Q3W dosing. This is a significant clinical catalyst for a $128M market cap biotech with cash runway into mid-2027.
Key Facts
- 29% confirmed ORR per RECIST v1.1 in PROC patients (n=7 evaluable) at target doses of 140-280 µg
- 57% disease control rate (DCR) in PROC patients
- 11% Grade 1 CRS at target doses; no Grade 2+ CRS, no dose reductions or discontinuations
- Median 7 prior lines of therapy (range 5-16); 89% had prior ADC therapy
- FDA Fast Track Designation granted for CTIM-76 in PROC
- Cash runway expected into mid-2027
Financial Impact
Positive clinical data could significantly increase pipeline value for a $128M market cap company; no revenue yet. The addressable US R/R CLDN6+ patient population is estimated at >50,000 annually.
Risk Factors
- Small sample size (n=9 PROC evaluable); interim data may not be predictive of later-stage results
- Durability of responses is still emerging; median follow-up limited
- Competition from approved ADCs (mirvetuximab, enfortumab) and other TCEs in development
- Reliance on successful Q3W dosing schedule to reduce T cell exhaustion and improve convenience
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 7 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001628280-26-043042 |
| Document: a20260615-ctim76ph1ainte.htm | 0001628280-26-043042 |
| Document: cntx-20260615.htm | 0001628280-26-043042 |
| Document: ctim-76datapressreleasejun.htm | 0001628280-26-043042 |
| Document: 0001628280-26-043042-index-headers.html | 0001628280-26-043042 |
| Document: 0001628280-26-043042-index.html | 0001628280-26-043042 |
| Document: 0001628280-26-043042.txt | 0001628280-26-043042 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jun 15, 2026 19w ago | 8-K | $0.6791 $0.6299 | ▼ −7.24% | ▼ −5.86% | $0.2350 (−65.40%) |
Jun 15, 2026 19w ago | Press Release | $0.6791 $0.6299 | ▼ −7.24% | ▼ −5.86% | $0.2350 (−65.40%) |
May 18, 2026 23w ago | PRESS-RELEASE / 8-K | $2.15 $2.63 | ▲ +22.33% | ▲ +20.71% | $0.2350 (−89.07%) |
May 6, 2026 24w ago | Press Release | $2.33 $2.36 | ▲ +1.29% | ▼ −0.22% | $0.2350 (−89.91%) |
May 1, 2026 25w ago | 8-K | $2.30 $2.39 | ▲ +3.91% | ▲ +0.98% | $0.2350 (−89.78%) |
Apr 2, 2026 29w ago | 8-K | $2.72 $2.49 | ▼ −8.46% | ▼ −12.07% | $0.2350 (−91.36%) |
Mar 23, 2026 31w ago | Press Release | $3.18 $2.62 | ▼ −17.61% | ▼ −17.19% | $0.2350 (−92.61%) |
US Market Status
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