KB113
- Indication
- Gorlin syndrome patients, with 83.1% of assessed basal cell carcinoma lesions regressing
- Stage
- phase0
- Event
- Conference Presentation
- Details
October 15, 2026: Krystal Biotech (NASDAQ: KRYS) reported a positive clinical update for KB113, an intratumoral IL-2/IL-12 immunotherapy, in a pilot study in basal cell carcinoma (BCC) patients with Gorlin syndrome. In the single-arm, open-label multicenter study, three adult patients received six doses over 14 weeks. At the final assessment 30 days after the last dose, 69/83 landmark lesions (83.1%) showed regression, including 29/36 injected lesions (80.6%) and 40/47 non-injected lesions (85.1%). More than 50% regression was seen in 42/83 lesions (50.6%), and at least 90% regression in 8/83 lesions (9.6%).
Responses were seen as early as two weeks after treatment start, including substantial regression in non-injected lesions, which the company said is consistent with an abscopal effect. One injected lesion from each patient with at least 90% regression was biopsied, and all three showed histologically confirmed complete response with no residual tumor.
KB113 was reported as well tolerated; all adverse events were mild to moderate, transient, and resolved during the study. The company said it has initiated discussions with the FDA on advanced clinical development plans. Study results are being presented at the 14th PeDRA Annual Conference, October 15-17, 2026.