ACE1831 / Acepodia - LARVOL DELTA

A Phase 1, Open-Label, Multicenter Study of Treatment with ACE1831, Comprised of Allogeneic Gamma Delta T Cells Conjugated to an Anti-CD-20 Antibody, in Patients (Pts) with B-Cell Relapsed/Refractory Non-Hodgkin's Lymphoma (R/R NHL) (ASH 2024) - P1 | "Pts with R/R NHL who had received ≥ 2 prior lines of therapy receive a single infusion of ACE1831 (w/w/o obinutuzumab) following lymphodepletion with cyclophosphamide and fludarabine. Anti-drug antibody responses to ACE1831 were monitored by flow cytometry analysis in four pts during the DLT period with Day -5 levels as baseline and there were no increases of anti-ACE1831 antibodies observed.ConclusionsPreliminary data in 5 pts showed no DLTs, ACE1831-related SAEs, as well as no CRS, ICANS, or GvHD in single dose of 0.3B cells in 5 pts. Dose escalation will continue including 0.6 and 1B cells, with updated clinical data to be provided.Clinical trial identificationNCT05653271"

Clinical • IO biomarker • P1 data • Anemia • Diffuse Large B Cell Lymphoma • Fatigue • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CXCL8 • IFNG • IL10 • IL2 • IL6 • TNFA

Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE1831 in IgG4-Related Disease (PRNewswire) - "Acepodia (6976:TT)...announced today that it has received U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for the company's lead candidate ACE 1831 in IgG4-related disease (IgG4-RD), a multi-organ, fibro-inflammatory autoimmune condition."

IND • Immunology

Acepodia Enters Strategic Clinical Collaboration with Pfizer to Accelerate Development of Antibody-Cell Conjugation-Based Cell Therapies... (PRNewswire) - "Acepodia...announced today that it has entered a strategic clinical collaboration with Pfizer Ignite to support the development of its therapies in autoimmune diseases. Pfizer Ignite is an end-to-end offering that leverages Pfizer's significant resources, scale, and expertise, alongside a proven track record in the development of breakthroughs, to support biotechs seeking to accelerate their innovations from preclinical R&D through the development lifecycle. Under this new agreement, Pfizer Ignite will provide strategic guidance and resources to Acepodia as the company develops its cell therapies for oncology and autoimmune diseases....Acepodia's lead clinical candidate, ACE1831, is currently being evaluated in a Phase 1 first-in-human clinical trial for patients with non-Hodgkin's lymphoma....Pfizer Ignite will also provide strategic advisory support for Acepodia's ongoing clinical programs, ACE1831 in NHL and ACE2016 in solid tumors."

Licensing / partnership • Non-Hodgkin’s Lymphoma • Solid Tumor

Acepodia Announces Preliminary Clinical Data From Phase 1 Clinical Trial of ACE1831, First-Ever Anti-CD20 Antibody Conjugated Allogenic Gamma Delta T Cell Therapy for Non-Hodgkins Lymphoma (PRNewswire) - P1 | N=42 | NCT05653271 | Sponsor: Acepodia Biotech, Inc. | "Acepodia...today announced preliminary data from its Phase 1 dose escalation clinical trial of ACE1831, an anti-CD20 antibody conjugated allogeneic gamma delta T cell therapy being evaluated in patients with non-Hodgkin's lymphoma (NHL)...One out of five patients demonstrated complete response (CR) and three out of five patients experienced disease stabilization (SD) with single dose of ACE1831 at the lowest dose level. Among those patients, one CR and two SD patients were previously treated with CD19 CAR-T...The lowest dose of ACE1831 was well tolerated with no ACE1831-related serious adverse events or dose limiting toxicities. Dose escalation is ongoing...The multi-center trial is expected to enroll up to 42 patients in the United States and Taiwan."

P1 data • Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Novel Allogeneic Rituximab-Conjugated Gamma Delta T Cell Therapy for the Treatment of Relapsed/Refractory B-Cell Lymphoma. (PubMed, Cancers (Basel)) - "Chimeric antigen receptor T cell (CAR-T) therapy has been applied in the treatment of B-cell lymphoma; however, CAR-T manufacturing requires virus- or non-virus-based genetic modification, which causes high manufacturing costs and potential safety concerns. Intriguingly, the antigen recognition of the ACC-linked antibody/receptor complex stimulated NFAT activation and contributed to ACE1831-mediated cytotoxicity against CD20-expressing cancer cells. This study elucidates the role of the ACC-linked antibody/receptor complex in cytotoxicity and supports the potential of ACE1831 as an off-the-shelf γδ2 cell therapy against relapsed/refractory B-cell lymphoma."

Journal • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Yushibo two new drugs have made progress [Google translation] (money.udn.com) - "The CEO Xiao Shijia said yesterday (1) that Yushibo uses antibody cell linking (ACC) and immune cells to contain γδ2T cells are the two core technology platforms, and two new allogeneic cell drugs have entered the first phase of clinical trials. Among them, ACE1831, a new drug for lymphoma, will see 30-50% complete data before the end of next year; ACE1702, a solid tumor drug, will have more chances next year Entered the second clinical phase....ACE1702 is developed for the treatment of HER2-positive solid tumors. Currently, it has been approved for phase I clinical trials in Taiwan and the United States, and is expected to enter phase II clinical trials next year."

New P2 trial • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Acepodia Secures $100 Million Series D Financing to Advance (PRNewswire) - "Acepodia...announced a $100 million Series D financing led by Digital Mobile Venture with participation from additional existing investors. The funds will be used to progress the company's pipeline of enhanced cell therapies for solid tumors and hematologic cancers, including ACE1831 and ACE2016."

Financing • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Acepodia Announces First Patient Dosed in Phase 1 Clinical Trial of ACE1831, an Anti-CD20 Armed Allogeneic Gamma Delta T-cell Therapy in Development to Treat Patients with Non-Hodgkin's Lymphoma (PRNewswire) - "Acepodia...today announced that the first patient has been dosed with ACE1831 in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin's lymphoma."

Trial status • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Yushibo's allogeneic cell drug ACE1831 has been approved by TFDA for Phase I clinical trials in Taiwan [Google translation] (money.udn.com) - "Yushibo Biotech announced...that the off-the-shelf anti-CD20 allogeneic gamma delta T cell drug ACE1831 developed by the company has been approved by the Food and Drug Administration (TFDA) of the Taiwan Ministry of Health and Welfare. Phase 1 clinical trials will be conducted in Taiwan....This clinical trial aims to evaluate the safety and tolerability of ACE1831 cell therapy in the treatment of non-Hodgkin's lymphoma with CD20 expression."

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Acepodia Biotech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: Acepodia Biotech, Inc.

New P1 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Application of Antibody-Cell Conjugation Technology in a Novel Off-the-shelf CD20-targeting Gamma Delta T Cell Therapy ACE1831 (SITC 2022) - "DNA linker-1 and linker-2 were conjugated to γδ T cells and Rituximab, respectively. ACE1831 will be evaluated in clinical trials for relapsed/refractory B cell lymphomas. Ethics Approval SCID-Beige mice were purchased and housed under the regulation of the Institutional Animal Care and Use Committee (IACUC) of the contract research organizations."

Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IFNG • IL6 • TNFA

Acepodia to Present Preclinical Data on its Gamma Delta T cell Therapy Candidate, ACE1831, at 2022 SITC Annual Meeting (PRNewswire) - "Acepodia...announced the upcoming poster presentation of new preclinical data for ACE1831, a gamma delta 2 T cell therapy being developed as a treatment for non-Hodgkin's lymphoma. The company will present this data at the 37th annual meeting of the Society for Immunotherapy of Cancer (SITC), being held in Boston, MA, from November 8 to 12, 2022. The poster presentation will showcase data demonstrating that ACE1831 is able to target cancer cells, overcome tumor defenses, and deliver a potent, cancer-killing cellular payload...'we look forward to advancing our ACE1831 into phase 1 clinical study in 2022'."

New P1 trial • Preclinical • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic gamma delta T-cell Therapy Candidate to Treat Patients with non-Hodgkin's Lymphoma (PRNewswire) - "Acepodia...announced that it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate a Phase 1, first-in-human, multi-center clinical study of its ACE1831 in patients with non-Hodgkin's lymphoma....'We look forward to advancing ACE1831 into its first clinical trial'."

IND • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ACE1831: A novel allogeneic αCD20-conjugated Vδ2 gamma delta T product for non-Hodgkin’s lymphoma (AACR 2022) - "At 72 hours, specific lysis was 35%; however, in combination with obinutuzumab (1,000 ng/mL), ACE1831 provided 95% specific lysis against Raji cells. Specifically, this product candidate can offer high levels of anti-tumor activity that is extended with soluble antibody using native Fc receptor expression, and may have a low risk of GvHD and IL-6 related toxicity. These data support future clinical studies in this setting."

IO biomarker • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD69 • CSF2 • CXCL8 • IFNG • IL10 • IL2 • IL4 • IL6 • NCAM1 • NKG2D • PD-1 • TNFA

Acepodia Presents Data on its Allogeneic Natural Killer-Like Gamma-Delta T Cell Therapy, ACE1831, in Development for Hematological Cancers (GlobeNewswire) - "In an in vivo model, ACE1831 showed prolonged survival compared to the treatment group utilizing the same antibody and effector cells separately; ACE1831 triggers the release of interferon gamma but not interleukin-6 while engaging the target tumor cells in the in vivo model, which shows that ACE1831 may activate the immune system without the risk of cytokine release syndrome."

Cytokine release syndrome • Preclinical • Hematological Malignancies • Oncology