T-MAXIMUM PHARMACEUTICAL Unveils New Clinical Progress in Allogeneic CAR-T Therapy for Solid Tumors

At the esteemed ASCO Breakthrough 2024 held in Yokohama, Japan on August 8, 2024, T-MAXIMUM PHARMACEUTICAL garnered significant recognition from the global medical community for its innovative advancements in allogeneic CAR-T cell therapy. The biotechnology company, which focuses on universal cell-based therapies, showcased an exploratory investigator-initiated trial that demonstrated the administration of B7H3-specific allogeneic CAR-T cells via intrathecal or intracerebroventricular routes to treat recurrent high-grade glioma. This study was a key highlight at the 2024 American Society of Clinical Oncology (ASCO) Breakthrough Summit and was honored with an Abstract Award, placing it among a select group of 40 globally recognized presentations at the conference.

Founded in 2017, T-MAXIMUM PHARMACEUTICAL has established two core laboratories in China and the United States. The company is at the forefront of developing universal cell therapies with a focus on advanced-stage solid malignancies. Their lead product, targeting recurrent high-grade glioma (rHGG), has shown groundbreaking efficacy and manageable safety in early clinical trials and has received Orphan Drug Designation (ODD) from the US FDA. The company’s team comprises leading experts in immunotherapy and gene editing, who leverage advanced gene-edited allogeneic immune cell therapy technology to create universal CAR-T cell therapies. This technology addresses challenges like Host versus Graft Reaction (HVGR) and Graft versus Host Disease (GvHD), allowing allogeneic CAR-T cells to persist longer in patients and achieve optimal therapeutic outcomes.

Allogeneic CAR-T cells offer several advantages over the traditional autologous T cell approach, which uses the patient's own cells. The autologous method is time-consuming and costly, requiring individualized production for each patient. This can delay treatment, particularly for those with rapidly advancing diseases. Additionally, the condition of autologous T cells can be compromised due to prior treatments like chemotherapy or radiotherapy, which can reduce their quantity and functionality.

In contrast, allogeneic T cells are derived from healthy donors, providing a plentiful and fully functional source of cells. This approach enables the creation of "off-the-shelf" CAR-T cell products, overcoming the limitations of autologous therapies and allowing for greater scalability and broader patient availability.

Solid tumors, which account for approximately 90% of all cancers, present a significant public health challenge, particularly in their late stages. While cell therapies have shown promise in treating hematological malignancies, their progress in solid tumors has been limited, and costs remain high. T-MAXIMUM’s allogeneic CAR-T therapies aim to enhance efficacy and overcome rejection by targeting solid tumors like glioblastoma. These therapies offer a promising solution to the limitations of autologous CAR-T approaches and have demonstrated promising antitumor activity in initial trials for recurrent glioblastoma and mesothelioma. Their safety profile has been well-established in over 50 patients.

T-MAXIMUM’s lead product, MT027, which employs allogeneic CAR-T cells modified by CRISPR/Cas9 gene-editing technology to target the tumor antigen B7-H3 in recurrent glioblastoma and other solid tumors, has displayed breakthrough efficacy and manageable safety in preliminary studies. The versatility of MT027 allows it to be applied to various late-stage solid tumor indications, offering a promising treatment option for a range of aggressive cancers.

As MT027 prepares for registration and clinical trials in the United States, T-MAXIMUM is finalizing the technology transfer process and collaborating with a third-party manufacturer with facilities in China and the United States. The MT027 has received Orphan Drug Designation from the U.S. FDA, facilitating a fast-track review and approval process.

In addition to MT027, T-MAXIMUM is advancing two other allogeneic CAR-T cell therapy candidates: MT026, which targets IL13Rα2 for solid tumors and has shown promising results in initial trials, and MT020, developed for B-cell-related autoimmune diseases. These therapies leverage T-MAXIMUM’s mature allogeneic cell therapy platform and offer unique mechanisms of action that may provide safer and more effective treatment options.

Dr. Xiaoyun Shang, CEO of T-MAXIMUM, highlighted the company’s commitment to advancing next-generation allogeneic CAR-T therapies for solid tumors and exploring strategies to combine CAR-T cells with other therapeutic regimens. The ultimate goal is to transform advanced tumors into manageable chronic conditions through the integration of cellular therapies, marking a significant step forward in treating late-stage solid tumors.

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