valecobulin (CKD-516) / Chong Kun Dang - LARVOL DELTA

[Exclusive] Chong Kun Dang, selection and focus on new drug research and development…Pipeline Tuning [Google translation] (Money Today Network (MTN)) - "Chong Kun Dang recently started adjusting its new drug pipeline to focus on new drug R&D capabilities....According to the industry on the 18th, Chong Kun Dang decided to discontinue R&D...'CKD-516', a colorectal cancer treatment, in the first quarter....In the future, Chong Kun Dang is expected to focus its research capabilities on...'CKD-702', an anti-cancer bispecific antibody biologic."

Discontinued • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The Efficacy and Safety of CKD516 Combined With Durvalumab in Patient Refractory Solid Tumors (clinicaltrials.gov) - P1/2 | N=25 | Terminated | Sponsor: Tae Won Kim | N=42 ➔ 25 | Trial completion date: Dec 2024 ➔ Mar 2023 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2022 ➔ Mar 2023; Recruitment difficulty

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CKD-516 potentiates the anti-cancer activity of docetaxel against epidermal growth factor receptor tyrosine kinase inhibitor-resistant lung cancer. (PubMed, Toxicol Res) - "In addition, docetaxel plus CKD-516 delayed tumor growth in-and extended the lifespan of-tumor-bearing mice. Thus, combination CKD-516 and docetaxel therapy could be used to treat EGFR-TKI-resistant NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS

A phase 1 dose-escalation and dose-expansion study to assess the safety and efficacy of CKD-516, a novel vascular disrupting agent, in combination with Irinotecan in patients with previously treated metastatic colorectal cancer. (PubMed, Invest New Drugs) - P1/2 | "Further studies to confirm these preliminary findings are warranted. Trial registration number NCT03076957 (Registered at March 10, 2017)."

Clinical • Combination therapy • Journal • P1 data • Cardiovascular • Colorectal Cancer • Coronary Artery Disease • Gastrointestinal Cancer • Hematological Disorders • Myocardial Ischemia • Neutropenia • Oncology • Solid Tumor

The Efficacy and Safety of CKD516 Combined With Durvalumab in Patient Refractory Solid Tumors (clinicaltrials.gov) - P1/2; N=42; Recruiting; Sponsor: Tae Won Kim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Rheumatoid Arthritis • Solid Tumor • PCR

The Efficacy and Safety of CKD516 Combined With Durvalumab in Patient Refractory Solid Tumors (clinicaltrials.gov) - P1/2; N=42; Not yet recruiting; Sponsor: Tae Won Kim

Clinical • New P1/2 trial • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Rheumatoid Arthritis • Solid Tumor

Involvement of ER stress and reactive oxygen species generation in anti-cancer effect of CKD-516 for lung cancer. (PubMed, Cancer Chemother Pharmacol) - "The findings suggest that CKD-516 exerts an anticancer effect in company with inducing ER stress and ROS production via microtubule disruption in lung cancer cells. CKD-516 may thus have therapeutic potential for lung cancer."

Journal • Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Anti-tumor efficacy of CKD-516 in combination with radiation in xenograft mouse model of lung squamous cell carcinoma. (PubMed, BMC Cancer) - "Taken together, our data show that when used in combination, CKD-516 and IR can significantly enhance anti-tumor efficacy compared to monotherapy in lung cancer xenograft mice."

Combination therapy • Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • CD31 • HIF1A • SLC2A1

Chong Kun Dang: expect solid 1Q20 results (Business Korea) - “In 2Q20, both CKD-702 (EGFR x cMET) domestic phase I IND approval and CKD-516 + Imfinzi (PD-L1) combo domestic phase I IND approval are expected.”

IND

Phase I and pharmacokinetic study of the vascular-disrupting agent CKD-516 (NOV120401) in patients with refractory solid tumors. (PubMed, Pharmacol Res Perspect) - "Of 11 patients without splenomegaly who completed at least one cycle of a daily CKD-516 dose of either 15 or 20 mg, only one patient (9.1%) suffered from any dose-limiting toxicity. We conclude that a daily oral dose of 15 or 20 mg CKD-516 five days per week could be tolerable in patients without liver cirrhosis."

Clinical • Journal • P1 data • PK/PD data

NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: National OncoVenture; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: National OncoVenture

Clinical • New P1 trial