ACE2016 / Acepodia - LARVOL DELTA

AcePodia Biotech, Inc. Announces IND Approval by Taiwan Food and Drug Administration for Investigational Product ACE2016 [Google translation] (Zonebourse) - "AcePodia Biotech, Inc. announced that on February 17, 2025, it received notification from the Taiwan Food and Drug Administration (TFDA) approving the Phase I clinical trial for the investigational product ACE2016. Trial Design Name: A Phase 1, multicenter study evaluating the safety and efficacy of ACE2016, an allogeneic Gamma Delta T-cell (gdT) therapy conjugated to anti-EGFR, in adult subjects with locally advanced or metastatic solid tumors expressing epidermal growth factor receptor (EGFR)."

New P1 trial • Oncology • Solid Tumor

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Acepodia Biotech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • IL2

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

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Acepodia Biotech, Inc.

Metastases • New P1 trial • Oncology • Solid Tumor • IL2

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

IND • New P1 trial • 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

ACE2016: an off-the-shelf EGFR-targeting γδ2 T cell therapy against EGFR-expressing solid tumors (AACR 2023) - "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."

Late-breaking abstract • Breast Cancer • Hematological Malignancies • Oncology • Solid Tumor • IL6

Acepodia to Present Preclinical Data of Gamma Delta T cell Therapy Candidate, ACE2016, an off-the-shelf EGFR-targeting γδ2 T cell therapy against EGFR-expressing solid tumors (PRNewswire) - "Acepodia...announced the upcoming poster presentation of new preclinical data for ACE2016, a gamma delta-2 T cell therapy designed to target EGFR expressing solid tumors. The company will present this data at the American Association for Cancer Research (AACR) annual meeting in Orlando, Florida, April 14-19, 2023. The poster presentation will showcase data demonstrating the in vitro and in vivo efficacy of ACE2016 against EGFR-expressing cancer cells which warrant investigation of potential clinical application in EGFR-expressing tumors."

Preclinical • Oncology • Solid Tumor • EGFR