T-MAXIMUM PHARMACEUTICAL Announces Latest Clinical Advances in Allogeneic CAR-T Cell Therapy Breakthrough for Solid Tumors

Summary

• T-Maximum Pharmaceutical develops allogeneic CAR-T therapies with a unique CRISPR/Cas9 Gene-Editing platform for solid tumors, provide a solution of two major pain points, GvHD and HvG, aiming to revolutionize cancer.
• MT027, the product of target B7H3 received US FDA orphan drug designation (ODD) on 2023 and will engage IND of US FDA in Q1 2025.
• As of March 2024, over 50 adult patients with recurrent high-grade glioma expressing B7H3 have undergone treatment with MT027. The preliminary safety and efficacy results demonstrate good therapeutic potential.
• Allogeneic CAR-T therapy has the potential to break through the bottleneck of advanced solid tumor treatment

YOKOHAMA, Japan , Aug. 8, 2024 /PRNewswire/ -- At the prestigious ASCO Breakthrough 2024, T-MAXIMUM PHARMACEUTICAL, a biotechnology company specializing in the development of universal cell-based therapies, received high acclaim from the international medical community for its groundbreaking work in allogeneic CAR-T cell therapy. The company presented an exploratory investigator-initiated trial involving the intrathecal or intracerebroventricular administration of B7H3-specific allogeneic CAR-T cells for the treatment of recurrent high-grade glioma. This study, focused on the use of B7H3-specific allogeneic universal CAR-T cells in patients with recurrent high-grade gliomas, was highlighted at the 2024 American Society of Clinical Oncology (ASCO) Breakthrough Summit. The presentation was honored with an Abstract Award, one of only 40 awarded globally at the conference.

About T-Maximum Pharmaceutical

T-Maximum Pharmaceutical was founded in 2017, and two core laboratories located in China and the United States.

T-Maximum Pharmaceutical is leading the development of universal cell therapies, advancing cell therapy as the definitive treatment for 'untreatable' diseases. T-MAXIMUM is currently focusing on advanced-stage solid malignancies, with its lead pipeline product for recurrent high-grade glioma (rHGG) demonstrating breakthrough efficacy and manageable safety in initial clinical studies and obtained Orphan Drug Designation (ODD) from the US FDA. The team includes top experts in immunotherapy, gene editing, and seasoned biopharmaceutical professionals. They utilize advanced gene-edited allogeneic immune cell therapy technology to develop universal CAR-T cell therapies. This technology effectively overcomes 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.

Why allogeneic CAR-T?

Most clinical trials to date have focused on CAR T cell therapies using autologous T cells, which are derived from the patient's own cells. However, this approach presents several challenges. The production process is both time-intensive and expensive, as it requires generating the therapy from each individual patient's cells. This can lead to delays in treatment, which is particularly concerning for patients with rapidly progressing diseases. Additionally, there is a risk of manufacturing failure, further complicating the timely delivery of therapy.

Another obstacle is the condition of the autologous T cells themselves. Patients often receive lymphodepleting chemotherapy or radiotherapy, which can reduce both the quantity and quality of their T cells. Moreover, the diversity of tumor antigen expression and the tumor's ability to evade the immune system necessitate CAR T cell products that can target multiple antigens. Unfortunately, in patients who have undergone extensive prior treatments, the supply of functional autologous T cells may be insufficient.

On the other hand, using T cells from healthy donors (allogeneic T cells) offers distinct advantages. These donor-derived cells are plentiful and fully functional, making it possible to create "off-the-shelf" CAR T cell products. This method not only overcomes the limitations of autologous T cell therapies but also enables greater scalability and availability for broader patient use.

Why Target Solid Tumors Like Glioblastoma?

Solid tumors account for approximately 90% of all cancers and are a major public health challenge, particularly late-stage solid tumors, which represent a significant unmet medical need. While cell therapies have shown remarkable promise in the treatment of hematological malignancies, progress in solid tumors has been limited, and the cost of these therapies remains prohibitively high.

Healthy T cells, when engineered as allogeneic CAR-T therapies, act as a living drug and represent one of the most promising weapons in the fight against solid tumors. 

T-MAXIMUM's allogeneic CAR-T therapies addresses two key challenges: enhancing efficacy and overcoming rejection.  By targeting solid tumors like glioblastoma, these therapies aim to overcome the limitations of autologous CAR-T approaches, including the exhaustion and reduced numbers of T cells in late-stage cancer patients.

Currently, T-MAXIMUM has demonstrated promising antitumor activity in initial clinical trials for recurrent glioblastoma and mesothelioma.  The therapy's half-life of allogeneic T cells exceeds industry standards, and its safety profile has been well-established in over 50 patients.

By targeting solid tumors with allogeneic CAR-T therapies, T-MAXIMUM aims to usher in a new era of "off-the-shelf" treatments for late-stage solid tumors.  This approach not only alleviates the financial burden on patients and their families but also reduces the strain on healthcare systems and improves overall healthcare efficiency.  The development of allogeneic CAR-T therapies represents a significant step forward in addressing the unmet needs of patients with late-stage solid tumors, offering hope for improved outcomes and quality of life.

About MT027

MT027, an allogeneic CAR-T cells modified by CRISPR/Cas9 Gene-Editing technology and targeting tumor antigen B7-H3 on recurrent glioblastoma and other solid tumors, as the lead product in T-MAXIMUM's pipeline, has been demonstrated breakthrough efficacy and manageable safety in preliminary clinical studies.

MT027 has the potential to be applied to different late-stage solid tumor indications, expanding its reach to treat various forms of aggressive cancers.  This versatility positions MT027 as a promising treatment option for patients with a range of challenging solid tumors.

Product Pipeline

As MT027 are preparing for registration and clinical trials in the United States, they are currently in the process of technology transfer. T-MAXIMUM's manufacturing process has been finalized, and are collaborating with a third-party manufacturer with facilities in both China and the United States. The MT027 has received Orphan Drug Designation from the U.S. FDA, which will facilitate a fast-track review and approval process. They anticipate that Phase I clinical trial will progress quickly and smoothly.

In addition to MT027, T-MAXIMUM is advancing two other allogeneic CAR-T cell therapy candidates: MT026 and MT020.  MT026 targets IL13Rα2 and is being developed for the treatment of solid tumors. Currently, there are 10 cases of recurrent high-grade glioma included in the Investigator Initiated Trial (IIT) clinical data, showcasing promising safety and efficacy results. Some of these data were also presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

MT020 is being developed to treat B-cell related autoimmune diseases. Based on T-MAXIMUM's mature allogeneic cell therapy platform, its unique mechanism of action targets specific pathways involved in autoimmune responses, potentially providing safer and more effective treatment options compared to existing therapies, MT020 is believed to have unique advantages that may break new ground in the treatment of B-cell-related autoimmune diseases. 

According to Dr. Xiaoyun Shang, CEO of T-MAXIMUM, they are also advancing the development of next-generation allogeneic CAR-T therapies for solid tumors, incorporating more sophisticated engineering of T-cells. Additionally, they are exploring optimal strategies for combining CAR-T cells with other tumor-reducing therapeutic regimens. T-MAXIMUM's objective is to enhance disease control rates in advanced solid tumors, with the ultimate goal of transforming tumors into a manageable chronic condition through the integration of cellular therapies in the near future.

CONTACT: Shelly Xiao, xiaoyh@t-maximum.com