On November 24, 2025 Pin Therapeutics, a clinical-stage biotechnology company specializing in targeted protein degradation, reported that it has administered the first dose of its CK1α-selective degrader PIN-5018 in a Phase 1 clinical trial. The first patient enrolled has adenoid cystic carcinoma (ACC), a rare malignancy with limited treatment options.
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PIN-5018 is an oral CK1α degrader developed based on the novel hypothesis of "synthetic activation of p53." The company is evaluating PIN-5018 as both a monotherapy and in multiple combination regimens. The Phase 1 study employs a dose-escalation design to assess safety, pharmacokinetics (PK), and target engagement/pharmacodynamics (PD). Pin Therapeutics also plans to expand development into additional indications.
PIN-5018 Achieves Complete Response in ACC PDX Models
The company highlighted compelling preclinical data in ACC, a disease with no approved standard-of-care therapy. In two patient-derived xenograft (PDX) models, treatment with PIN-5018 resulted in a complete response (CR) in one model and marked tumor regression in the other, demonstrating robust antitumor activity and supporting clinical translation.
Expansion Planned into mCRPC, Colorectal Cancer, and Other Rare Tumors
Pin Therapeutics notes that CK1α plays a key biological role in resistance mechanisms that emerge during androgen receptor (AR) inhibitor therapy. Based on this insight, the company is pursuing a strategy aimed at enabling rapid entry into the first-line (1L) setting for metastatic castration-resistant prostate cancer (mCRPC) through combination therapy with an AR signaling inhibitor (ARSI). In colorectal cancer, the company is advancing a clinical program based on the innovative concept of "synthetic activation of WNT signaling."
Advancing Mechanism-Based Precision Oncology
Pin Therapeutics emphasized its commitment to mechanism-based precision oncology across its entire pipeline by applying sophisticated biological mechanisms. Ongoing initiatives include mode-of-action studies, integrated PK/PD analysis, and biomarker development to identify the most appropriate patient populations for each indication.
"Our goal is to leverage our innovative degradation modality and novel biological frameworks to provide meaningful therapeutic options for cancer patients with limited or no existing treatments," Pin Therapeutics CEO Hyunsun Jo said. "We look forward to demonstrating the clinical value of PIN-5018 across multiple tumor types."
(Press release, Pin Therapeutics, NOV 24, 2025, View Source [SID1234660919])