Nobel Laureate-Backed Off-the-Shelf γδ2 T-Cell Therapy Advances into Clinical Development for EGFR-Positive Solid Tumors

Recently,U.S. FDAAcepodia, Inc.'s IND application for ACE2016, a product that isAllogeneic γδ2T Cell Therapy for the Treatment of EGFR-Positive Solid Tumors.

Leveraging the advantages of Antibody-Cell Conjugation (ACC) and Acepodia's proprietary γδ2T cell platform, ACE2016 has demonstrated efficacy in various preclinical study models.Demonstrating nearly 100% αEGFR antibody conjugation and exhibiting EGFR-specific binding activity, with potential cytotoxicity against several EGFR-positive tumors.ACE2016 can be significantly activated when co-cultured with tumor target cells, while increasing perforin and cytokine production, and significantly inhibiting EGFR-positive breast cancer cells in an orthotopic xenograft model.

Acepodia is expected to begin trials within the next few months andTreat the First Patient in the Second Half of 2024, toEvaluate the safety, tolerability, and pharmacodynamics of ACE2016 therapy in adult patients with locally advanced or metastatic EGFR-positive solid tumors.。

The 6th Symposium on Tumor Immunotherapy and Cell Therapy Techniques

• Challenges and Clinical Experience in CAR-T Frontline Treatment Development

• Clinical Development Progress of CD19 Dual-Target CAR-T

• Innovative Space in Hematologic Tumor Cell Therapy

• Construction of a Rapid CAR-T Manufacturing Process Platform

• Strategies for the Armed Upgrade of CAR-T in Solid Tumors

• How TCR-T Overcomes Tumor Antigen Escape

• Frontier Breakthroughs in Universal Cell Therapy

• Innovative Development of Solid Tumor Targets

• mRNA Technology Empowers Cell Drug Development

• Non-Viral Vector CAR-T

• Logic Gate Design in Cell Drugs

• Innovative Design of CAR Molecules

• Opportunities for China-produced CAR-T to Enter Overseas Markets

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Acepodia is a clinical-stage biotechnology company,With its unique ACC technology platform、Allogeneic γδ2T Cell PlatformAndReady-to-use allogeneic NK cell technology has developed more powerful and effective cell therapies to address limitations in cancer treatment.

Acepodia has developed a unique γδ2T cell, which is enriched to enhance NK function through its proprietary selection and expansion technology.When γδ2T cells express high levels of activating receptors or low levels of inhibitory receptors, their ability to directly kill tumor cells and indirectly activate other immune factors against malignant tumors is enhanced.. In addition,Due to the characteristics of γδ2T cells in both innate and adaptive immune systems, they have become an ideal target for cell therapy development.

Acepodia's proprietary ACC technology platform can link tumor-targeting antibodies with its proprietary immune cells to create new Antibody Cell Effector (ACE) therapies. Unlike CAR-T and TCR-T cell therapies, which require viral vector delivery of transgenes, this technology...Using click chemistry technology to conjugate antibodies onto living cells, oNK cells or γδ2 T cells are endowed with the ability to target specific antigens, combining the precise targeting of monoclonal antibodies with immune cells that kill cancer cells.

▲ Technology PlatformImage Source:Acepodia Official Website

It is worth mentioning that, in September 2023,Acepodia Announces Carolyn Bertozzi, PhD, Winner of 2022 Nobel Prize in Chemistry for "Click Chemistry and Bioorthogonal Chemistry," Joins the Company, and serve as the Chief Scientific Advisor. It is reported that Dr. Carolyn Bertozzi will leverage her research in Click Chemistry to combine with Acepodia's ACC technology platform, supporting the company’s development and innovation in cell therapy.

At the same time, this technology is able toUnlock multiple receptor signaling pathways, thereby significantly enhancing the ability of oNK cells and γδ2 T cells to recognize and infiltrate tumors, with the potential to overcome the challenges of solid tumors.. And the technologyThe simplicity and modularity of the "plug-and-play" feature can make cell therapy more accessible to patients., and further expand to indications beyond oncology.

Currently, the company has developed multiple candidate pipelines based on this technology platform.

ACE1702 is aHER2-targeted cellular therapy can target solid tumors expressing HER2 through oNK cells conjugated with HER2 antibodies., The drug candidate has now entered the clinical trial stage. In both in vivo and in vitro studies, ACE1702 has demonstrated enhanced tumor cell killing activity. Additionally, in GLP toxicology studies, ACE1702 maintained a favorable safety profile. Previously released Phase 1 clinical trial data also preliminarily confirmed the efficacy and safety of this therapy. It is reported that in 2020, JW Therapeutics reached an agreement with Acepodia, obtaining exclusive priority rights for the clinical development and commercialization of ACE1702 in mainland China, Hong Kong, and Macau.

ACE1831 is aTargeted CD20, Off-the-Shelf ACC-γδ2 T Cell Therapy Aims to Treat Relapsed/Refractory Non-Hodgkin Lymphoma, which has already demonstrated potent cancer cell-killing potential in both in vivo and in vitro models. This candidate drug is currently in Phase 1 clinical trials.

As a relatively niche cell therapy, most companies are still in the preclinical research stage for γδT, and only six companies abroad have entered clinical trials.The fastest among them is TC BioPharm, whose first off-the-shelf, unmodified allogeneic γδT cell product, OmnImmune, is currently in Phase 2b/3 clinical trials.Previously, the CR rate in the Phase 1b/2a clinical data for this candidate therapy treating AML was 50%. Companies such as ImCheck Therapeutics, IN8bio, CytoMed, Gadeta, and Adicet Bio are mainly in Phase 1 clinical trials.

In China,Legend Biotech, PersonGen, JiDeKangMin, SenLang Biotech, RuiChuang Biotech, Letu Life Technology, QingHui LianNuo, Shanghai Cell Therapy GroupA number of companies, includingChina-based RC1012 (DNT Cell Therapy) from Zhongrui Chuangsheng and LB2013 from Legend Biotech have entered Phase 1 clinical trials.。At the beginning of this year, the IND application for the "γδ-T Cell Injection" developed by Acepodia was officially accepted by the CDE.And last year,Clinical Trial Officially Launched by Letu LifeTech to Evaluate Allogeneic γδT Cell Infusion for Improving Immune Function in Advanced Cancer Patients。

In terms of indications,Most of the γδT cell therapies under research are targeting hematological tumors., such as TC BioPharm's OmnImmune for AML, Gadeta's GDT002 for MM, and Adicet Bio's ADI-001 for NHL, etc. For γδT cell therapies that differ from CAR-T in the peptide chain of the T-cell receptor, targeting hematologic malignancies is the first step of exploration. However,Some companies have also expanded the indications to solid tumors with a much larger patient population., such as IN8bio's INB-200 for the treatment of glioblastoma, and PersonGen’s UTAA06 for the treatment of solid tumors. Additionally,Acepodia Also Advances with a γδT Cell Therapy for Autoimmune Diseases. Meanwhile, Acepodia alsoCombining γδT Technology with TCR-T Technology for the Development of γδ-TCR Cell Therapy, launched the third-generation γδT cell platform, which has broad future application potential.