Acepodia is a clinical-stage biotechnology company that uses its proprietary antibody-cell conjugation (ACC) platform technology to produce first-in-class cell treatments. It directly connects tumor-targeting antibodies to various immune cell receptors, enhancing the connection between immune cells and cancer cells, generating highly specific and effective cell therapies without the need for genetic engineering.

Tags

Neoplasms

Immune System Diseases

Hemic and Lymphatic Diseases

γ-δT

Gene therapy

CAR-NK

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	5
Immune System Diseases	2
Hemic and Lymphatic Diseases	2

Top 5 Drug Type	Count

γ-δT	2
CAR-NK	1
Antibody-cell Conjugate (ACC)	1
Gene therapy	1
T-lymphocyte cell therapy	1

Top 5 Target	Count

HER2(Receptor tyrosine-protein kinase erbB-2)	1
EGFR(Epidermal growth factor receptor erbB1)	1
PDL1(Programmed death-ligand 1)	1
CD20(B-lymphocyte antigen CD20)	1
CD19 x CD20	1

Drugs associated with Acepodia Biotechnologies, Ltd.

ACE-1831

Target

CD20

Mechanism

CD20 inhibitors [+2]

Active Org.

Acepodia Biotech, Inc.

Originator Org.

Acepodia Biotech, Inc.

Active Indication

Follicular Lymphoma [+2]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

ACE-2016

Target

EGFR

Mechanism

EGFR antagonists [+2]

Active Org.

Acepodia Biotech, Inc.

Originator Org.

Acepodia Biotech, Inc.

Active Indication

Locally Advanced Malignant Solid Neoplasm [+3]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

ACE-1702

Target

HER2

Mechanism

HER2 antagonists

Active Org.

Acepodia Biotech, Inc. [+1]

Originator Org.

Acepodia Biotech, Inc.

Active Indication

Solid tumor [+4]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Acepodia Biotechnologies, Ltd.

NCT06415487 / Not yet recruitingPhase 1

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).
The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).

Start Date31 May 2024

Sponsor / Collaborator

Acepodia Biotech, Inc.

NCT05653271 / RecruitingPhase 1

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic CD20-conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies

ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of CD20-expressing B-cell malignancies.
The ACE1831-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and efficacy of ACE1831 in patients with CD20-expressing Non-Hodgkin lymphoma.

Start Date21 Jan 2023

Sponsor / Collaborator

Acepodia Biotech, Inc.

NCT04319757 / RecruitingPhase 1

A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.

Start Date19 May 2020

Sponsor / Collaborator

Acepodia Biotech, Inc.

100 Clinical Results associated with Acepodia Biotechnologies, Ltd.

0 Patents (Medical) associated with Acepodia Biotechnologies, Ltd.

Literatures (Medical) associated with Acepodia Biotechnologies, Ltd.

04 Oct 2023·Cancers

A Novel Allogeneic Rituximab-Conjugated Gamma Delta T Cell Therapy for the Treatment of Relapsed/Refractory B-Cell Lymphoma.

Article

Author: Chiang, Yun-Jung ; Yang, Hsiu-Ping ; Chen, Li-Yu ; Chen, Ciao-Syuan ; Kuo, Yi-Chiu ; Leng, Pei-Ju ; Cheng, Zih-Fei ; Lee, Chia-Yun ; Hsiao, Shih-Chia ; Li, Hao-Kang ; Hsiao, Ching-Wen ; Wu, Tai-Sheng ; Yang, Sen-Han ; Tang, Sai-Wen ; Chen, Yu-Ju ; Lin, Yan-Liang

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. Antibody-cell conjugation (ACC) technology, which originated from bio-orthogonal click chemistry, provides an efficient approach for arming immune cells with cancer-targeting antibodies without genetic modification. Here, we applied ACC technology in Vγ9Vδ2 T (γδ2 T) cells to generate a novel off-the-shelf CD20-targeting cell therapy ACE1831 (rituximab-conjugated γδ2 T cells) against relapsed/refractory B-cell lymphoma. ACE1831 exhibited superior cytotoxicity against B-cell lymphoma cells and rituximab-resistant cells compared to γδ2 T cells without rituximab conjugation. The in vivo xenograft study demonstrated that ACE1831 treatment strongly suppressed the aggressive proliferation of B-cell lymphoma and prolonged the survival of tumor-bearing mice with no observed toxicity. Mass spectrometry analysis indicated that cell activation receptors including the TCR complex, integrins and cytokine receptors were conjugated with rituximab. 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.

14 Apr 2023·Cancer Research

Abstract LB089: ACE2016: an off-the-shelf EGFR-targeting γδ2 T cell therapy against EGFR-expressing solid tumors

Author: Lee, Chia-Yun ; Leng, Pei-Ru ; Li, Hao-Kang ; Wu, Tai-Sheng ; Cheng, Zih-Fei ; Tang, Sai-Wen ; Lin, Yan-Liang ; Kuo, Yi-Chiu ; Hsiao, Shih-Chia

AbstractIntroduction: CAR-αβT therapies have been shown to improve clinical outcomes in hematological malignancies; however, solid tumors still remain as challenges to CAR-αβT therapies due to tumor microenvironment, limited tumor infiltration or antigen escape. Previous research findings indicate γδ2 T cells are involved in tumor surveillance by responding to phosphoantigen overexpressed by most of cancers. The antibody cell conjugation (ACC) technology has the advantage to link cancer-targeting antibodies on cell surface of immune cells without genetic modification. This study applies ACC technology to generate an off-the-shelf EGFR-targeting γδ2 T cell therapy ACE2016, and presents the promising potency of ACE2016 against EGFR-expressing cancer cells.Methods: γδ2 T cells were expanded from healthy donor PBMCs and αβ T cell population were depleted. Both γδ2 T cells and αEGFR were covalently conjugated to selected DNA aptamers that enable DNA hybridization to generate EGFR-targeting γδ2 T cells, ACE2016. The characteristics and antibody conjugation of ACE2016 was evaluated by flow cytometry, and in vitro cytotoxicity and in vivo anti-tumor potency was investigated using luminescence-based cytotoxicity assay and the orthotopical model with EGFR-expressing cancer cells, respectively.Results: ACE2016 showed nearly 100 % of αEGFR antibody conjugation and exhibited EGFR-specific binding activity. These features conferred ACE2016 with enhanced in vitro cytotoxicity against EGFR-expressing cancer cells compared to unconjugated γδ2 T cells, while ACE2016 and γδ2 T cells showed no significant difference of anti-tumor potency against EGFR-negative cancer cells. Further characterization studies demonstrated that co-cultured with target cells significantly activated ACE2016 along with enhanced degranulation and cytokine production without measurable IL-6 secretion. Moreover, ACE2016 suppressed EGFR-expressing breast cancer cells in vivo in the orthotopic xenograft model without weight loss or toxicological observations.Conclusion: ACE2016, an EGFR-targeting γδ2 T cell product, was successfully generated as an effective off-the-shelf treatment for EGFR-expressing solid tumors. This study provides the evidence for the in vitro and in vivo efficacy of ACE2016 against EGFR-expressing cancer cells to support the clinical application against EGFR-expressing tumors.Citation Format: Hao-Kang Li, Tai-Sheng Wu, Pei-Ru Leng, Yi-Chiu Kuo, Zih-Fei Cheng, Chia-Yun Lee, Yan-Liang Lin, Sai-Wen Tang, Shih-Chia Hsiao. ACE2016: an off-the-shelf EGFR-targeting γδ2 T cell therapy against EGFR-expressing solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr LB089.

15 Jun 2022·Cancer Research

Abstract 5573: ACE1831: A novel allogeneic αCD20-conjugated Vδ2 gamma delta T product for non-Hodgkin’s lymphoma

Author: Graef, Thorsten ; Yang, Sen-Han ; Lin, Yan-Liang ; Li, Hao-Kang ; Hsiao, Sonny ; Tang, Sai-Wen ; Cheng, Zih-Fei ; Lee, Chia-Yun ; Ou, Yi-Hung ; Wu, Tai-Sheng ; Hsiao, Ching-Wen ; Yang, Hsiu-Ping

AbstractIntroduction Autologous CAR-T has improved clinical outcomes in hematological malignancies; however need remains to improve the toxicities, relapse rates, treatment delays and costs. ACE1831 is a novel, off-the-shelf Antibody Conjugated Effector cell therapy with aCD20 linked to gd T cells by selective proprietary DNA aptamers to activation receptors without genetic modification. Data for in vitro/in vivo pre-clinical studies are presented.Methods γδ T cells were expanded from healthy donor PBMCs by cytokine stimulation and αβ T cell depletion. Both γδ T cells and αCD20 were covalently linked to selected DNA aptamers that enable conjugation, and cryopreserved. ACE1831 was evaluated for phenotype and antibody conjugation by flow cytometry, cytotoxicity and cytokine production by 4-hour co-culture with CD20+ Raji cells, and for in vivo anti-tumor activity and weight loss using SCID-Beige mice inoculated IV with 1 x 105 Raji cells, 4 doses of 1 x 107 ACE1831 on days 0, 3, 7, 10, and monitored for 123 days. All studies used cryopreserved ACE1831.Results gd T cells of ACE1831 were expanded >10,000 fold with >95% viability, >85% Vδ2 purity, and <0.03% αβ T cell impurity. γδ T cells expressed high levels of CD56, CD16, NKG2D and CD69 and low levels of PD-1 and KIRs. Following αCD20 conjugation and cryopreservation, ACE1831 drug product batches retained >90% viability and cytotoxicity against CD20+ Raji cells. In the presence of cell growth media, about 30% and 10% of αCD20 were retained on the cell surface at 24 and 48 hours, respectively, and at 24 and 48 hours, ACE1831 elicited 100% and 85% specific lysis against Raji cells. At 72 hours, specific lysis was 35%; however, in combination with obinutuzumab (1,000 ng/mL), ACE1831 provided 95% specific lysis against Raji cells. Co-cultured with Raji cells, ACE1831 produced 10 times more IFNγ and TNFα than unconjugated γδ T cells, but no measurable IL-6. When co-cultured with allogeneic PBMCs, ACE1831 showed no cytotoxicity towards PBMCs and the mixture showed no increase in IFNγ, TNFα, GM-CSF, IL-2, IL-4, IL-8, IL-6, and IL-10 levels compared to the PBMCs only group. ACE1831 showed persistence in vivo for >14 days after a single dose of 1 x 107 AC1831 in non-tumor inoculated SCID-Beige mice. Tumor inoculated mice treated with 4 doses of ACE1831 survived 123 days without weight loss or tumor relapse based on bioluminescence and necropsy, while mice treated with γδ T survived <40 days due to tumor progression.Conclusion ACE1831, a aCD20-armed allogeneic γδ T cell product, represents a novel approach for off-the-shelf treatment for B cell malignancies. 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.Citation Format: Tai-Sheng Wu, Hao-Kang Li, Ching-Wen Hsiao, Yi-Hung Ou, Zih-Fei Cheng, Hsiu-Ping Yang, Sen-Han Yang, Chia-Yun Lee, Yan-Liang Lin, Thorsten Graef, Sai-Wen Tang, Sonny Hsiao. ACE1831: A novel allogeneic αCD20-conjugated Vδ2 gamma delta T product for non-Hodgkin’s lymphoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5573.

News (Medical) associated with Acepodia Biotechnologies, Ltd.

08 May 2024

·www.prnewswire.com

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

First dosing dohort was completed with complete response and disease stabilization identified at three months at the lowest dose level in the Phase 1 study No ACE1831-related serious adverse events, including GvHD, neurotoxicity, high-grade CRS or dose limiting toxicities were observed Results shared during a fireside chat hosted by William Blair & Company on May 7th, 2024. An archived recording will be available for 7 days following the event at . ALAMEDA, Calif. and TAIPEI, May 8, 2024 /PRNewswire/ -- Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms to address gaps in cancer care, 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). Key Results From Preliminary Clinical Data 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. Durability of clinical response was observed for three months after a single dose of ACE1831. The lowest dose of ACE1831 was well tolerated with no ACE1831-related serious adverse events or dose limiting toxicities. Dose escalation is ongoing. ACE1831 is Acepodia's first cell therapy to enter clinical development from its proprietary ACC platform, which uses biorthogonal chemistry to conjugate gamma delta 2 (γδ2) T cells with antibodies targeting CD20. The platform, based on the pioneering work of 2022 Nobel Prize laureate Dr. Carolyn Bertozzi that applied click chemistry to living systems, creates an off-the-shelf, non genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxity and other side effects associated with CAR-T cell therapies. The preliminary data demonstrates that ACE1831 activates both an innate and adaptive immune response by direct killing of tumor cells, tumor opsonization, and recruitment of T cells through cytokine secretion, and may therefore generate a more comprehensive immune response than standard CAR-T cell therapies. "This ongoing trial is the first to demonstrate potential clinical benefit to patients using biorthogonal chemistry and opens the door to a powerful, new approach for cell therapy that overcomes limitations of current CAR-T cell therapies and is more accessible to patients," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "We are encouraged to see a robust and durable effect after a single treatment at the lowest dose, and remain focused on the continued development of this first-of-its kind treatment option." The first-in-human, phase 1 trial is an open-label, dose escalation study that aims to evaluate the safety and tolerability, pharmacokinetics, and efficacy of ACE1831 in patients with relapsed/refractory non-Hodgkin's lymphoma. The multi-center trial is expected to enroll up to 42 patients in the United States and Taiwan. About ACE1831 ACE1831 is an off-the-shelf gamma delta T cell therapy candidate developed from Acepodia's proprietary ACC platform. ACE1831 targets CD20-expressing hematological cancers using anti-CD20 antibody conjugated gamma delta T cells. Taking advantage of the high expression of NK cell activating receptors of the gamma delta T cells to scavenge the malignant blood cells, ACE1831 has demonstrated in models enhanced cytotoxicity against cancer cells both in vitro and in vivo. ACE1831 is currently being evaluated in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin's lymphoma. About Acepodia Acepodia is a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune cells, such as natural killer and gamma delta T cells to create novel ACE therapies, which have increased binding strength against tumors that express low levels of tumor antigens. Acepodia is made up of seasoned leaders and scientific experts dedicated to advancing its robust pipeline of ACE therapies with the potential to bring innovative, effective, and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information, visit and follow Acepodia on Twitter and LinkedIn. SOURCE Acepodia Inc.

Cell TherapyPhase 1ImmunotherapyClinical Result

15 Feb 2024

·www.pharmaceutical-technology.com

FDA maps out process for sponsors to charge for drugs in clinical trials

The FDA released a draft guidance, answering questions on charging for investigational drugs under an IND. Credit: Vi_L via Getty Images The US Food and Drug Administration (FDA) published a final guidance on how sponsors can charge for new drugs under an investigational new drug application (IND) during clinical trials or in expanded access programs. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will recieve your mail in sometime.So, please check your email to download the Report. Go deeper with GlobalData Reports NPVM: FCR-001 Reports NPVM: FLT190 Premium Insights The gold standard of business intelligence. Find out more The new guidance replaces a previous one issued in June 2016. If a sponsor wants to charge a trial participant for an investigational drug, the issued guidance provides a blueprint for the logistics involved in getting approvals for the same while ensuring it does not worsen any financial burden on participants. The updated document also outlines how this may work in a blinded, controlled clinical trial without compromising the study’s blind. In those cases, the FDA advised sponsors to seek out the appropriate review division in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) or get advice from the appropriate review office in the Center for Biologics Evaluation and Research (CBER) on how to maintain the blind. While the FDA allows sponsors to charge for a drug in a study after an authorisation, in terms of expanded access use, the agency mandates sponsors to give reasonable evidence that the charging would not interfere with drug development and provide documentation to justify this approach is consistent with current requirements. The FDA also made it clear that sponsors must also show that the clinical trial would not be possible without asking for the costs to be incurred due to the extraordinary cost of the drug and providing the paperwork to support its calculation for cost recovery. The FDA lists potential reasons for extraordinary drug costs as “manufacturing complexity, scarcity of a natural resource, the large quantity of the drug needed (e.g., based on the size or duration of the trial), or some combination of these or other extraordinary circumstances.” The agency clarified that the “extraordinary” status of these costs would be assessed relative to the size of financial position of a company. The FDA accepts several INDs every month in a bid to allow clinical research. Recently, the agency approved an IND from Veru for a Phase IIb trial investigating its GLP-1 RA-associated muscle loss drug Ostarine. This month, the agency also approved an IND for Acepodia’s solid tumour trial . The agency currently has a pre-IND consultation program in which sponsors can discuss any questions and concerns about the IND process with the FDA. See Also: FDA fast tracks Diamyd’s immunotherapy for managing type 1 diabetes Japan’s FY 2024 pricing reform expected to favour new listed innovative drugs Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. 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Phase 2

05 Feb 2024

·www.prnewswire.com

Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE2016, a First-in-Class Allogeneic Anti-EGFR Cell Therapy

ACE2016 Is an Allogeneic Gamma Delta 2 (γδ2) T Cell Therapy Targeting the Epidermal Growth Factor Receptor (EGFR) in Patients With Solid Tumors. Phase 1 Clinical Study Expected to Begin in H2 2024. ALAMEDA, Calif. and TAIPEI, Feb. 4, 2024 /PRNewswire/ -- Acepodia (6976:TT), a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms to address gaps in cancer care, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 (γδ2) T cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors. This clearance enables Acepodia to initiate a Phase 1, first-in-human trial evaluating the safety, tolerability and pharmacodynamics of ACE2016 in adults with locally advanced or metastatic EGFR-expressing solid tumors. Acepodia expects to begin the trial in the coming months and treat the first patient in the second half of 2024. "This milestone is a key step as we advance our pipeline of next generation cell therapies and explore the potential of our novel Antibody-Cell Conjugation (ACC) technology in solid tumors, which remain to be unmet medical needs in the cell therapy field," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "The rapid progression of obtaining the third IND approval within 18 months highlights the team's remarkable efficiency and dedication to advancing innovative programs swiftly. With our third program in the clinic, we are proud to continue progressing the field of cell therapy with the goal of delivering powerful, accessible treatments for patients through a first-of-its-kind approach." About ACE2016 ACE2016 is an off-the-shelf γδ2 T cell therapy candidate developed from Acepodia's proprietary ACC platform. ACE2016 targets EGFR-expressing solid tumors through antibody conjugated γδ2 T cells that target tumors driven by the cancer-causing EGFR gene. Leveraging the advantages of ACC technology and Acepodia's proprietary γδ2 T cell platform, ACE2016 has shown promising cytotoxicity against several EGFR-expressing cancers in various pre-clinical study models. The Phase 1 trial will evaluate the safety, tolerability and pharmacodynamics of ACE2016 in patients with locally advanced or metastatic EGFR-expressing solid tumors. The trial is expected to dose its first patient in the second half of 2024. About Acepodia Acepodia is a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune cells, such as natural killer and gamma delta T cells to create novel ACE therapies, which have increased binding strength against tumors that express low levels of tumor antigens. Acepodia is made up of seasoned leaders and scientific experts dedicated to advancing its robust pipeline of ACE therapies with the potential to bring innovative, effective, and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information, visit and follow Acepodia on Twitter and LinkedIn. SOURCE Acepodia Inc.

Cell TherapyINDPhase 1Immunotherapy

100 Deals associated with Acepodia Biotechnologies, Ltd.

100 Translational Medicine associated with Acepodia Biotechnologies, Ltd.

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Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Phase 1 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

ACE-2016 ( EGFR )	Locally Advanced Malignant Solid Neoplasm More	Phase 1
ACE-1831 ( CD20 )	Follicular Lymphoma More	Phase 1
ACE-1702 ( HER2 )	HER2-positive gastric cancer More	Phase 1
ACE1755 ( CD19 x CD20 )	B-Cell Lymphoma More	Preclinical
ACE-1708 ( PDL1 )	Neoplasms More	Discovery

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