TY-302 / TYK Medicines - LARVOL DELTA

PHASE I CLINICAL TRIAL RESULTS OF TY-302, TY-2699a AND TY-0540 ACCEPTED FOR POSTER PRESENTATION AT THE 2025 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY (ESMO) CONGRESS (HKEXnews) - "The board of directors (the 'Board') of the Company is pleased to announce that the Phase I clinical trial results for three internally-developed clinical products of the Company, namely TY-302, TY-2699a, and TY-0540, have been officially accepted for poster presentation at the 2025 European Society for Medical Oncology (ESMO) Congress. Relevant detailed data from the trials will be presented during the conference....Data accepted for presentation comes from a Phase I multicenter combination therapy clinical trial (NCT04433494)...a Phase I multicenter monotherapy dose-escalation clinical trial (NCT05866692)...[and]...a Phase I multicenter open-label clinical trial (NCT06246071)."

P1 data • Solid Tumor

Study of TY-302 Capsules Combined With Abiraterone in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC） (clinicaltrials.gov) - P1/2 | N=48 | Not yet recruiting | Sponsor: TYK Medicines, Inc

New P1/2 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TY-302,a CDK4/6 inhibitor (CDK4/6i), combined with toremifene in patients with advanced solid tumors: Results from a phase Ia/Ib study. (ESMO 2025) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor

Sal is a proteobacterial bile acid aldolase that repurposes key thiolase catalytic residues for retroaldol cleavage of C5 steroid side chains. (PubMed, J Biol Chem) - "We identified Tyr302 and Cys304 as the catalytic residues in CtSal, different from the paired Tyr residues found in TcLtp2...Intriguingly, a Trypanosoma brucei homolog, annotated as a thiolase-like protein (TbSLP), shares catalytic architecture of CtSal, suggesting an aldolase rather than a thiolase function. This study provides the first detailed characterization of a C5 side chain steroid aldolase, revealing its unique catalytic features and expanding our understanding of steroid side chain catabolism in Proteobacteria."

Journal

TYK Medicines raises $74M IPO to fund EGFR cancer therapy (Firstwordpharma Press Release) - "TYK Medicines has raised about $74.3 million (HKD 579 million) through an IPO, with plans to allocate a portion to advance its core asset TY-9591....Additionally, TYK has been given the okay in China for Phase II and Phase III trials of TY-9591 in combination with chemotherapy for advanced or metastatic EGFR-mutated NSCLC, with plans to initiate Phase II testing in the second half....TY-302, a CDK4/6 inhibitor, is considered a key asset in Phase II development for second-line breast cancer in China, with plans to enter a registrational trial early next year. The biotech also has another Phase II trial planned for TY-302 in first-line prostate cancer, set to begin in the second half of 2024."

Financing • New P2 trial • New trial • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

TY-2699a is a highly potent CDK7 inhibitor to abolish dysfunctional tumor cell cycle for clinical development (AACR 2023) - P1 | "Currently, trilaciclib, palbociclib, ribociclib, and abemaciclib that bear dual specificities against CDK4 and CDK6 have been approved for clinical usage, and more CDK4/6 targeted agents are actively under clinical evaluations, among which, TY-302, a novel CDK4/6 inhibitor being developed by TYK Medicines, is under Phase II trial (NCT04433494)...Several CDK7 targeted agents, such as SY-5609 and Samuraciclib (CT7001), are under development...# Shengli Dong and Apeng Liang contributed equally to this work. * Jun Li, Shengli Dong and Apeng Liang are the correspondent authors."

Clinical • Tumor cell • Acute Myelogenous Leukemia • Breast Cancer • Gastrointestinal Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • CCNA2 • CCND1 • CCNE1 • CDK1 • CDK2 • CDK7

A Study of TY-302 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: TYK Medicines, Inc | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: May 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ER • HER-2 • PGR

A Study of TY-302 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: TYK Medicines, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ER • HER-2 • PGR

Tongyuankang's USD 40m Series B to support EGFR, CDK4/6 drug development (GBI Health) - "China-based oncology specialist Zhejiang Tongyuankang Pharmaceutical Co., Ltd reportedly raised RMB 260 million (USD 40 million) via a Series B financing round...Proceeds will go towards clinical development of two Category 1 products, pre-clinical filing for multiple small molecules, and further development of pipeline products. Tongyuankang Pharma has two drugs nodded for clinical studies: TY-9591...and TY-302, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor targeting hormone receptor positive and epidermal growth factor receptor 2 negative (HR+/HER2-) locally advanced or metastatic breast cancer and other advanced solid tumors or blood tumors."

Commercial • Breast Cancer • Hematological Malignancies • HER2 Negative Breast Cancer • Oncology • Solid Tumor

A Study of TY-302 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: TYK Medicines, Inc

Clinical • New P1 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer