PIN-5018 / Pin Therap - LARVOL DELTA

Pin Therapeutics also plans to expand development into additional indication (PRNewswire) - "(i) PIN-5018 Achieves Complete Response in ACC PDX Models:...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...; (ii) 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....In colorectal cancer, the company is advancing a clinical program based on the innovative concept of 'synthetic activation of WNT signaling'."

New indication • Preclinical • Adenoid Cystic Carcinoma • Castration-Resistant Prostate Cancer • Colorectal Cancer

Pin Therapeutics Initiates First-Patient Dosing of CK1α Degrader PIN-5018 in Phase 1 Trial (PRNewswire) - "The first patient enrolled has adenoid cystic carcinoma (ACC), a rare malignancy with limited treatment options....The Phase 1 study employs a dose-escalation design to assess safety, pharmacokinetics (PK), and target engagement/pharmacodynamics (PD)."

Trial status • Adenoid Cystic Carcinoma

Pintherapeutics' CK1α molecular adhesive degrader 'PIN-5018' receives domestic approval for phase 1 clinical trials. [Google translation] (BioTimes) - "The company plans to commence full-scale clinical trials in Korea in the second half of this year."

New P1 trial • Solid Tumor

Pin Therapeutics taps AI firm ImpriMed to predict clinical response of blood cancer drug (Korea Biomedical Review) - "Pin Therapeutics announced on Friday that it has signed a strategic memorandum of understanding with ImpriMed, a company specializing in artificial intelligence (AI)-powered precision medicine platforms. The agreement is a strategic partnership to pre-validate the clinical success and differentiation of PIN-5018 in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (HR-MDS) in real patient-derived cell lines."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome

[ASCO 2025] Pin Therapeutics targets rare cancers with TPDs (Korea Biomedical Review) - "Pin Therapeutics evaluated the preclinical efficacy of its lead pipeline drug, PIN-5018, through this screening program....PIN-5018 is an orally administered CK1α-selective molecular glue degrader (MGD) that received phase 1 IND approval from the U.S. Food and Drug Administration (FDA) last month. The company plans to begin dosing the first patients in Korea for the phase 1a trial later this year....The promising preclinical data demonstrating PIN-5018 in the ACC PDX model provide new hope and valuable insights for the global ACC researcher and patient community."

New P1 trial • Preclinical • Adenoid Cystic Carcinoma

Pintherapeutics, CK1α Target Molecular Adhesion Degrader Receives FDA Phase 1 IND Approval [Google translation] (BioTimes) - "Domestic innovative new drug development company Pintherapeutics...announced on the 12th that it received approval for an investigational new drug (IND) plan from the US FDA last week for 'PIN-5018', a solid cancer treatment candidate based on a next-generation molecular glue degrader (MGD)....Phase 1a clinical trials are scheduled to begin in Korea in August-October 2025 for approximately 40 solid tumor patients, and initial results are expected before the second or third quarter of 2026."

IND • New P1 trial • Oncology • Solid Tumor

Next trip: a promising CK1α-selective molecular glue degrader in MSS colorectal cancer (AACR 2025) - "We recently developed PIN5018, a selective CK1α inhibitor, and reported that it exhibits promising anticancer activity in acute myeloid leukemia (AML) and adenoid cystic carcinoma (ACC)...Taken together, these findings demonstrate the potential of our CK1α-selective MGD as a promising therapeutic candidate not only for AML and ACC but also for MSS CRC. Lastly, we are aiming for clinical entry by 2025 Q1."

Acute Myelogenous Leukemia • Adenoid Cystic Carcinoma • Colorectal Cancer • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Pintherapeutics succeeds in raising 20 billion won in Series C amid bio-cold season [Google translation] (Hankyung) - "Pin Therapeutics, a protein degradation (TPD) drug development company, announced on the 23rd that it had attracted approximately KRW 20 billion in Series C investment....Through this investment, Pin Therapeutics plans to receive IND approval in the US and Korea in 2025 and advance its lead pipeline, a CK1α-selective degrader (PIN-5018), into the clinical stage. It also plans to discover additional next-generation pipelines based on platform technology."

Financing • IND • New trial • Oncology • Solid Tumor