RephImmune is pioneering a new frontier in cancer immunotherapy with its proprietary platform, Reconstitute-Immunity Antigen-Cell Engager (RACE). This cutting-edge technology is rooted in regeneration biology and is specifically designed to reprogram and rebuild the immune system to effectively target and eliminate solid tumors.

At the core of RACE is a sophisticated algorithmic framework developed by RephImmune, which enables the identification, reassembly, and regeneration of immune components. The platform begins with the selection of 150 promising protein candidates and expands into a vast library of over 500,000 synthetically engineered novel proteins. These proteins are carefully designed and verified for their ability to modulate immune responses and engage tumor-specific antigens.

What sets RephImmune apart is its capacity to reconstitute cellular immunity across 13 different types of immune cells, including various subsets of T cells and innate immune cells. Through this process, the company has developed a novel engineered RACE-T cell specifically designed to attack and destroy solid tumors.

Importantly, the RACE platform is AI-compatible, meaning it can be trained and optimized through machine learning models. This integration of computational biology and artificial intelligence allows for continuous improvement and personalization of immunotherapy strategies, making RephImmune’s approach not only innovative but also scalable and adaptive to future clinical challenges.

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.

State-level Storage Equipment and Technology
U-NEURON BIOMEDICAL is devoted to the development of stem cell isolation, storage and clinical applications. It owns the Patent on the Technology of Isolation and Culture of Amniotic Fluid Stem Cell, and has signed a service contract on the support of cell operation laboratory facilities and instruments with Bioresource Collection and Research Center; meanwhile, it has completed the pre-clinical trial for treatment of urinary incontinence with amniotic fluid stem cells with National Yang-Ming University. Recently, U-NEURON BIOMEDICAL has cooperated with Linkou Chang Gung Memorial Hospital on clinical trials of a rare disease – osteogenesis imperfecta (glass doll), and continues the research and development of the latest cell treatment and applications. Through continuous research, U-NEURON BIOMEDICAL carries out manufacturing that meets clinical specifications, creates new stem cell therapy technologies to fill current medical gaps, and popularizes stem cell technology and cell therapy products through professional technology development and medical research, creating real value of regenerative medicine and a better life for humankind.