MaiCell Therapeutics Completes First-in-Human Dosing of MAC001, a HER2-Targeted CAR-Macrophage Therapy for Advanced Gastric Cancer

Oct 27, 2023 11:33 CST Updated 11:33

Macera Therapeutics

Macrophage Immunotherapy Drug Developer

Recently, the MAC001 injection, a CAR-macrophage therapeutic product targeting HER2 independently developed by Nanjing Yuanmai Cell Biotechnology Co., Ltd., has completed the first dosing in a subject.

This is an investigator-initiated, single-center, single-arm, dose-escalation clinical study aimed at evaluating the safety, tolerability, and efficacy of MAC-001 injection in treating patients with HER2-positive advanced gastric cancer. To date, the first subject is in good condition, and no related toxic side effects such as cytokine release storm have been observed yet. The recruitment of subjects for this clinical study is still ongoing.

Yuanmai Bio was established in September 2022, formed by a leading international team of macrophage researchers alongside senior pharmaceutical executives. It is a platform company focused on the development of macrophage immunotherapy drugs. Yuanmai Cell targets solid tumors with unmet clinical needs such as gastric cancer, liver cancer, prostate cancer, and autoimmune disease treatment areas, based on innovative CAR-Macrophage (CAR-M) technology research and development. Currently, Yuanmai Cell has developed an "integrating and non-integrating" molecular editing and manipulation system, iPSC-derived immune cell differentiation systems, and ligand-receptor information flow recognition and transmission technology platforms. Through intelligent gene editing and other steps, it can engineer live cells to empower CAR-M to not only accurately recognize target antigens but also achieve controllable manipulation of intracellular functional domain components, initiate specific cellular signal transduction networks, and achieve the goal of killing tumor cells and regulating autoimmune B-cell clones.

"CAR macrophages are a highly promising track within the field of adoptive cell immunotherapy technology. Yuanmai Cells hopes to leverage its accumulated experience and technology to create CAR-M living cell drug-related technologies with independent intellectual property rights, achieve breakthroughs in the treatment of solid tumors, autoimmune diseases, and other conditions, and simultaneously conduct ex vivo and in vivo editing through technological iteration," said Professor Shen Pingping, founder and chairman of Yuanmai Cells.

The breakthrough in adoptive immune cell therapy has transformed the landscape of cancer drug development. To date, multiple CAR-T products have been approved by the FDA/NMPA for the treatment of malignant hematological tumors, becoming a significant milestone in the history of clinical oncology. However, CAR-T therapy still faces a series of challenges. Professor Pingping Shen's team from Nanjing University and the team from the University of Pennsylvania almost simultaneously proposed the novel concept of macrophage-based immunotherapy. In 2020, they were highlighted by Nature Biotech as one of the leading teams in the international CAR-M technology field. Due to the high infiltration rate of macrophages in the tumor microenvironment (accounting for 50% of the total infiltrating immune cells), using them as carriers for adoptive cell therapy presents unique advantages: strong penetration into solid tumors, powerful phagocytic ability to rapidly kill tumor cells and prevent immune escape; they can also act as antigen-presenting cells to activate T cells, reshaping the immune cell interaction network, reversing the immunosuppressive microenvironment, and transforming "cold" solid tumors into "hot" ones. Given the unique immunobiological characteristics of macrophages, they show potential as standalone treatments for diseases like solid tumors and can be combined synergistically with drugs such as PD-1 antibodies and chemotherapy. This makes them highly promising for clinical applications, especially since macrophages, as living cell drug platforms, exhibit superior properties for in-situ modification and biosynthesis compared to engineered T cells.

About Yuanmai Cell

Yuanmai Cell is an innovative biotechnology company focusing on the research and development of cell immunotherapy drugs. Relying on four core technology platforms with independent intellectual property rights, including CAR module design, sequence screening, efficient gene delivery, and iPSC differentiation derivation, the company engages in the research of autologous CAR-M, universal CAR-M, and self-assembling CAR-M cell immunotherapy drugs, and has laid out multiple CAR-M cell product R&D pipelines. Since its establishment in September 2022, Yuanmai Cell has rapidly built a CAR-M cell therapy product process research and quality research system and established in vitro screening and in vivo efficacy/toxicology evaluation systems. The first dosing of a subject marks a new level of platform technology for Yuanmai Cell's CAR-M therapeutic products, providing strong technical support and systematic assurance for efficiently advancing subsequent R&D pipelines.

E.N.D

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