CS3002 / CStone Pharma - LARVOL DELTA

Leaf spot of Acorus calamus var. angustatus Caused by Alternaria alternata in Anhui Province, China. (PubMed, Plant Dis) - "The ITS region of isolate SCP-1 was 100% similar to A. alternata TCS3002 (MN394880, Wang et al...This report will help identify the disease based on field symptoms and provide a basis for disease management strategies of A. calamus var. angustatus."

Journal

First report of leaf spot on Chaste-Tree Caused by Alternaria alternata in China. (PubMed, Plant Dis) - "The multigenes phylogenetic analysis revealed that isolate Aa1 and Alternaria alternata TCS3002 + CBS 916.96 clustered within the same clade with 99% bootstrap support...2020) to cause leaf spot. To our knowledge, this is the first report of A. alternata causing leaf spot disease on chaste-tree and provides an important reference for further biology and epidemiology research."

Journal • GAPDH

[VIRTUAL] CS3002, a novel CDK4/6 inhibitor with unique kinase inhibition spectrum which may expand indications beyond breast cancer and delay acquired drug resistance (AACR-II 2020) - P1 | "Selective CDK4/6 inhibitors, such as palbociclib, ribociclib, and abemaciclib have been approved by US FDA as single agent or in combination with endocrine therapy to treat patients with HR+/Her2- breast cancer...Furthermore, CS3002 showed excellent in vivo activity as a single agent, and in combinations with either endocrine therapy (fulvestrant) or PD-1 blockade (CS1003) in a set of tumor models, together with desirable ADME/PK and safety profile...Across a panel of 19 AML cell lines, CS3002 demonstrated a similar sensitivity profile to gilteritinib (an approved FLT-3 inhibitor), but overall higher sensitivity compared to palbociclib. Interestingly, when MCF-7 breast cancer cell line was treated continuously with CS3002 in vitro, the emergence of drug-resistance was much delayed compared to treatment with palbociclib or abemaciclib. Given the encouraging preclinical properties as well as the unique potential in allowing indication expansion and delaying drug..."

Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCND1 • CDKN2A • FLT3 • HER-2 • NTRK • NTRK1

A Study of CS3002 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=10; Terminated; Sponsor: CStone Pharmaceuticals; N=46 ➔ 10; Trial completion date: Feb 2022 ➔ Feb 2021; Recruiting ➔ Terminated; Trial primary completion date: Nov 2021 ➔ Feb 2021; The study has been stopped for strategic and business reasons.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Oncology • Solid Tumor

CStone Pharmaceuticals Released Preclinical Data on its Four Pipeline Products (CStone Pharma Press Release) - "CS3002: The preclinical data presented at the 2020 AACR Annual Meeting II demonstrated the anti-tumor effect of CS3002 in cells selected for resistance to approved CDK4/6 inhibitors, as well as its immunomodulatory functions, indicating CS3002 has potential application in drug-resistant tumor cells and IO combination therapies."

Preclinical • Oncology

CStone Pharmaceuticals to present preclinical data on its three pipeline products at the 2020 AACR Virtual Annual Meeting (CStone Pharma Press Release) - "The preclinical data to be presented at the 2020 AACR Virtual Annual Meeting II further illustrate the anti-tumor effect of CS3002 in cancer cells selected for resistance to CDK4/6 inhibitors, as well as its inhibitory activity in acute myeloid leukemia cells, indicating that CS3002 may have broad therapeutic potentials in multiple tumor types and combination therapies."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

A Study of CS3002 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=46; Recruiting; Sponsor: CStone Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of CS3002 in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=46; Not yet recruiting; Sponsor: CStone Pharmaceuticals

Clinical • New P1 trial

CStone completes registration filing for the phase I trial of CDK4/6 inhibitor CS3002 in Australia and will soon initiate the study (PRNewswire) - "CStone Pharmaceuticals...announced that the Company has recently received ethics approval from the Human Research Ethics Committee in Australia for the Phase I clinical trial of CS3002, and Australia's Therapeutic Goods Administration (TGA) has acknowledged the electronic Clinical Trial Notification (eCTN) the Company submitted for the trial. This clinical trial is an open-label, multi-dose, dose-escalation, and dose-expansion Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of CS3002 in patients with advanced solid tumors."

New P1 trial