ARCE THERAPEUTICS, INC.
Update：2024/07/15
Industries
Main Industry
Biotechnology
Main Product/Service
ARD103
ANTI-CLL1 auto-CAR-T
ARD103, our priority product, is an autologous CAR-T cell manufactured by DashCARR technology with an ultra-fast processing time and stem cell-like phenotypes. ARD103 specifically targeted C-type lectin-like molecule-1 (CLL-1) antigen on both blast cells and leukemia stem cells of acute myeloid leukemia (AML), and was demonstrated to mediate in vitro cytotoxicity, in vivo tumor growth inhibition and ex vivo anti-tumor activity. CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and other potential myeloid malignancies.
The pre-IND meeting consultation with the US FDA was conducted in Q4, 2023, and the following non-clinical studies on CMC and safety evaluation were executed. FDA has cleared ARD103 IND application for a phase 1/2 clinical trial in patients with relapsed/refractory AML and MDS in Oct, 2024. The phase 1/2 clinical trial is an open-label, dose-escalation and expansion study to evaluate the safety and efficacy of ARD103 in r/r AML and MDS patients (NCT06680752).
FDA has granted Orphan Drug Designation (ODD) to ARD103 for AML.
ANTI-CLL1 auto-CAR-T
ARD103, our priority product, is an autologous CAR-T cell manufactured by DashCARR technology with an ultra-fast processing time and stem cell-like phenotypes. ARD103 specifically targeted C-type lectin-like molecule-1 (CLL-1) antigen on both blast cells and leukemia stem cells of acute myeloid leukemia (AML), and was demonstrated to mediate in vitro cytotoxicity, in vivo tumor growth inhibition and ex vivo anti-tumor activity. CLL-1 is highly expressed on both myeloid blasts and leukemia stem cells (LSCs) but is absent on normal hematopoietic stem cells (HSCs), suggesting CLL-1 as an excellent therapeutic target for AML and other potential myeloid malignancies.
The pre-IND meeting consultation with the US FDA was conducted in Q4, 2023, and the following non-clinical studies on CMC and safety evaluation were executed. FDA has cleared ARD103 IND application for a phase 1/2 clinical trial in patients with relapsed/refractory AML and MDS in Oct, 2024. The phase 1/2 clinical trial is an open-label, dose-escalation and expansion study to evaluate the safety and efficacy of ARD103 in r/r AML and MDS patients (NCT06680752).
FDA has granted Orphan Drug Designation (ODD) to ARD103 for AML.
Founded Year
2020
Unified Business No.
83505884
Status
Active
Number of Employees
0
Total Paid-in
Capital
2,195,000 (NT$)
Year of establishment, company status, responsible person, paid-in capital amount, and registered address are sourced from the "Commerce Industrial Services Portal, Department of Commerce, Ministry of Economic Affairs.
Location of Company
Taiwan
, Taipei City
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Introduction
Our Vision: Focus on the needs of patients to achieve the goals of effective treatment of diseases and reasonable medical expenses through our "innovative immune cell therapy". To make cellular gene therapy faster, cheaper, and better and to make them affordable and accessible to patients.
Our Mission: Transform the lives of patients with unmet medical needs through pursuing science in action, conquering adversity with resilience, teamwork in collaboration, and a commitment to excellence.
ARCE Therapeutics, Inc. is a global biotech company, established in 2020 to develop patented intellectual properties in immune cell & gene engineering technology. ARCE is developing first-in-class and best-in-class CAR-T/CAR-NK cell therapy products for the treatment of various forms of cancers, including hematological cancers and solid tumors. Through ARCE’s innovative immune cell therapy and commercialization development, ARCE provides state-of-the-art products of new generation CAR-T/CAR-NK cell therapy, to make cellular gene therapy faster, cheaper, and better and to make them affordable and accessible to patients.
Our Mission: Transform the lives of patients with unmet medical needs through pursuing science in action, conquering adversity with resilience, teamwork in collaboration, and a commitment to excellence.
ARCE Therapeutics, Inc. is a global biotech company, established in 2020 to develop patented intellectual properties in immune cell & gene engineering technology. ARCE is developing first-in-class and best-in-class CAR-T/CAR-NK cell therapy products for the treatment of various forms of cancers, including hematological cancers and solid tumors. Through ARCE’s innovative immune cell therapy and commercialization development, ARCE provides state-of-the-art products of new generation CAR-T/CAR-NK cell therapy, to make cellular gene therapy faster, cheaper, and better and to make them affordable and accessible to patients.
