ACE1702 / Acepodia, JW (Cayman) Therap - LARVOL DELTA

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Acepodia Biotech, Inc. | Recruiting ➔ Completed | N=36 ➔ 12

Enrollment change • IO biomarker • Metastases • Trial completion • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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

[VIRTUAL] ACE1702, a first-in-class, off-the-shelf, selected natural killer cell [oNK] product using antibody cell conjugation technology [ACC], with pre-clinical and early clinical activity in HER2 < 3+ tumors (ESMO 2021) - P1 | "In pre-clinical studies, ACE1702 exhibited cancer-specific cytotoxicity and superior potency against low HER2 tumors. Preliminary data in pts showed no CRS, GvHD, or DLTs through doses of 3B cells/cycle and antitumor activity in a HER2 < 3+ tumor. Dose escalation continues up to 15B cells/cycle with updated clinical data to be provided."

Preclinical • Oncology • Salivary Gland Cancer • HER-2 • IFNG • IL10 • IL6

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Acepodia Biotech Inc. | Trial completion date: Jul 2022 ➔ Jun 2024 | Trial primary completion date: Jan 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • IFNG • IL10 • IL2 • IL6 • TNFA

Acepodia Presents Positive Interim Phase 1 Feasibility Data for Antibody Cell Effector Therapy, ACE1702, in Advanced HER2-Positive Tumors (GlobeNewswire) - P1, N=36; NCT04319757; Sponsor: Acepodia Biotech; "These initial data were presented based on eight subjects who received escalating doses of ACE1702 in the range of 0.3 to 9 billion cells per cycle (DL1 and DL4, respectively) over the course of 14 days following a standard low dose lymphodepletion (LD) regimen....One patient with an IHC score of 2+ achieved a partial response at DL3 (3 billion cells per cycle) based on RECIST criteria with no signs of CRS. The patient showed increased serum levels of interferon gamma (IFNγ) (18-fold increase on day 21) and IL-10 (2.6 fold increase on day 14)...There were no severe adverse events (SAE) related to ACE1702. One patient experienced two unrelated SAEs of pulmonary embolism and death due to progressive disease."

P1 data • Breast Cancer • Oncology • Solid Tumor

Acepodia to Present Data from Preclinical and Phase 1 Studies of ACE1702 at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress (GlobeNewswire) - P1, N=36; NCT04319757; Sponsor: Acepodia Biotech; “Acepodia…announced that it will present new interim data from an ongoing Phase 1 study [NCT04319757] evaluating ACE1702, the company’s most advanced therapeutic candidate, in patients with advanced HER2 tumors…Preliminary results from the ongoing clinical trial showed that seven patients treated across the first four dose levels with ACE1702 showed no clinical signs of dose limiting toxicity, such as cytokine release syndrome, neurotoxicity or graft versus host disease."

P1 data • Preclinical • Oncology • Solid Tumor

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Acepodia Biotech Inc.; N=24 ➔ 36

Clinical • Enrollment change • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • IFNG • IL10 • IL2 • IL6 • TNFA

Acepodia Publishes Preclinical Data on Novel Off-the-Shelf Natural Killer Cell Therapy, ACE1702, for HER2-Expressing Solid Tumors Using Antibody-Cell Conjugation Technology in the Journal Cancers (GlobeNewswire) - "In the study, the Company applied its antibody-cell conjugation (ACC) platform to conjugate its oNK cells, which are a unique line of proprietary off-the-shelf NK cells, with an anti-human epidermal growth factor receptor 2 (HER2) antibody trastuzumab. Trastuzumab-conjugated oNK demonstrated its in vitro and in vivo cytotoxicity against HER2-expressing cancer cells and secretion of interferon gamma (IFNγ). Irradiated and cryopreserved trastuzumab-conjugated oNK (ACE1702) retained HER2-specific in vitro and in vivo potency with no tumorigenic potential...'We are expecting data from our Phase 1 clinical study1 of ACE1702 against HER2-expressing solid tumors in the second half of 2021'..."

P1 data • Preclinical • Oncology • Solid Tumor

A Novel off-the-Shelf Trastuzumab-Armed NK Cell Therapy (ACE1702) Using Antibody-Cell-Conjugation Technology. (PubMed, Cancers (Basel)) - "The irradiated and cryopreserved ACE-oNK-HER2, designated as ACE1702, retained superior HER2-specific in vitro and in vivo potency with no tumorigenic potential. In conclusion, this study provides the evidence to support the potential clinical application of ACE1702 as a novel off-the-shelf NK cell therapy against HER2-expressing solid tumors."

Journal • Graft versus Host Disease • Immunology • Inflammation • Oncology • Solid Tumor • IFNG

Acepodia to Present at the 6th Annual Innate Killer Summit (GlobeNewswire) - “Acepodia…announced that Sonny Hsiao, Ph.D., chief exectuvie officer and co-founder of Acepodia will deliver a keynote clinical data presentation of preclinical and interim clinical data from studies of the Company’s lead clinical natural killer (NK) cell therapy candidate, ACE1702, during the virtual 6th Annual Innate Killer Summit being held March 23-25, 2021. A second presentation on scalable cell therapy manufacturing strategy will also be given at the conference by Acepodia senior research scientist, Sylvia Lee, M.S.”

Clinical data • Preclinical • Oncology

Acepodia Completes $47 Million Series B Financing to Advance Pipeline of Allogeneic Cell Therapy Candidates (GlobeNewswire) - “Acepodia…announced the closing of its $47 million Series B financing. The funding will be used to advance the company’s lead off-the-shelf natural killer (NK) cell therapy candidate, ACE1702, through clinical development in solid tumors, and to advance its preclinical NK and gamma delta T cell therapy pipeline into the clinic. Acepodia anticipates completing IND-enabling studies for two additional pipeline products in 2021.”

Financing • New trial • Oncology • Solid Tumor

Acepodia to Present Late-breaking Poster Presentation Supporting the Potential of its NK Cell Therapy in Solid Tumors at The Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting (GlobeNewswire) - "ACE1702 displayed higher cytotoxicity against multiple HER2-expressing cancer cell lines compared to the leading anti-HER2 antibody, trastuzumab, and its derived antibody-drug conjugate, trastuzumab emtansine (T-DM1)....ACE1702 retained cytotoxic activity under hypoxic and metabolic conditions similar to the immunosuppressive tumor microenvironment."

Preclinical • Oncology • Solid Tumor

[VIRTUAL] A potent and off-the-shelf oNK cell therapy product targets HER2+ cancer cells and resists suppressive tumor microenvironment (SITC 2020) - "Conclusions Here we introduced a novel trastuzumab-modified oNK cell product with enhanced specificity against myriad types of HER2+ cancers. Selective conjugation of trastuzumab with membrane proteins contributing to NK activation conferred ACE1702 with enhanced cytotoxicity even in the suppressive tumor microenvironment."

Biomarker • Late-breaking abstract • Tumor microenvironment • Oncology • Ovarian Cancer • Solid Tumor • HER-2

[VIRTUAL] A potent and off-the-shelf oNK cell therapy product targets HER2+ cancer cells and resists suppressive tumor microenvironment (SITC 2020) - "Conclusions Here we introduced a novel trastuzumab-modified oNK cell product with enhanced specificity against myriad types of HER2+ cancers. Selective conjugation of trastuzumab with membrane proteins contributing to NK activation conferred ACE1702 with enhanced cytotoxicity even in the suppressive tumor microenvironment."

Biomarker • Late-breaking abstract • Tumor microenvironment • Oncology • Ovarian Cancer • Solid Tumor • HER-2

Acepodia to Deliver Late-breaking Poster Presentation at The Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting (GlobeNewswire) - "Acepodia...announced that Howard Li, Ph.D., Preclinical Research Scientist, will present a late-breaking virtual poster at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting...Presentation Title: A potent and off-the-shelf oNK cell therapy product targets HER2+ cancer cells and resists suppressive tumor microenvironment....Additional information on the ACE1702 study is available at clinicaltrials.gov (NCT04319757)"

Clinical data • Oncology • Solid Tumor

Acepodia to Present at the 7th Annual China Healthcare Summit (GlobeNewswire) - "The presentation will outline the progress of Acepodia’s Phase 1 clinical trial of lead candidate ACE1702, a unique natural killer (NK) cell therapy, which is being evaluated in a phase 1 clinical trial in HER2-expressing solid tumors, and preclinical data highlighting the potential of its CD20 targeting NK cell therapy candidate, ACE1655 for the treatment of B-cell malignancies....In addition, Acepodia will provide an update on the progress of ACE1655 in hematological malignancies, supporting a future investigational new drug application (IND)."

Clinical • P1 data • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Acepodia Initiates a Phase 1 Clinical Trial Evaluating Allogeneic NK Cell Therapy ACE1702 for Treatment of Solid Tumors (GlobeNewswire) - "Acepodia…announced that it has dosed the first patient in its Phase 1 open-label, dose escalation study of ACE1702, a natural killer cell (NK cell) therapy being developed as a treatment for HER2-expressing solid tumors. The first patient was dosed at The University of Texas MD Anderson Cancer Center in Houston, Texas…The study is expected to enroll 12 to 24 patients at multiple leading oncology sites in the United States, including Peninsula Cancer Institute in Newport News, Virginia...'Now, 45 days after the first patient received repeat doses of ACE1702, we are very encouraged that there were no adverse events , including no graft versus host disease or cytokine release syndrome which have been observed with other cell therapy approaches.'"

Enrollment open • P1 data • Oncology • Solid Tumor

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Acepodia Biotech Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Acepodia and JW Therapeutics Enter into Option and License Agreement for Off-the-shelf NK Cell Therapies (GlobeNewswire) - "Acepodia…and JW Therapeutics…have announced a collaboration to develop and commercialize ACE1702 and ACE1655, two of Acepodia’s cell therapy candidates for the treatment of solid tumors and hematologic malignancies, respectively, in Mainland China, Hong Kong, and Macau. Acepodia will receive upfront and milestone payments in addition to royalties on sales."

Licensing / partnership • Hematological Malignancies • Oncology • Solid Tumor

[VIRTUAL] ACE1702: A potent and off-the-shelf oNK cell therapy product (AACR-II 2020) - "In this work, we develop a NK cell therapy product ACE1702, a novel NK cell line oNK conjugated with Trastuzumab, and assess its potency against HER2+ solid tumors.MethodsoNK cells, a fluorescence-activated cell sorting (FACS) isolated CD16+ population sorted from NK-92 cells, was covalently conjugated with monoclonal antibody Trastuzumab after sublethal irradiation by our patented antibody-cell conjugates (ACCTM) platform to become our cryopreserved final product ACE1702 compliant with current good manufacturing practice (cGMP). Furthermore, in vivo results in human ovarian cancer cell line SK-OV-3-bearing xenograft mouse model supported the in vitro observations. Compared to other immunotherapeutic strategies such as antibody-drug conjugate, allogeneic NK and chimeric antigen receptor (CAR) modification, ACCTM platform underscores its power in compatibility with diverse antibodies, ease for mass production compliant with good manufacturing practice and affordability to..."

IO Biomarker • Breast Cancer • Gynecologic Cancers • HER2 Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2

Acepodia Presents Preclinical Data on its Lead NK Cell Therapy Candidate ACE1702 at 2020 AACR Virtual Meeting II (GlobeNewswire) - "ACE1702 demonstrates cytotoxicity against multiple cancerous cell lines expressing HER2 at varying levels. ACE1702 demonstrates elevated levels of intracellular IFNγ compared to control oNK cells in the presence of human ovarian cancer cells (SK-OV-3 cells), indicative of enhanced engagement and cytotoxicity by activated oNK cells upon contact with tumor cells."

Preclinical • Oncology • Solid Tumor

Acepodia provides corporate update and unveils new preclinical allogeneic NK cell therapy pipeline candidates at BIO Digital 2020 (GlobeNewswire) - "Dr. Hsiao will present an overview of the company’s proprietary oNK cells, and lead candidate ACE1702. Dr. Hsiao will also provide insight into new initiatives the company is taking to expand its cell therapy portfolio, including data from preclinical studies of ACE1755…preclinical studies of ACE1975 and ACE1708, ACC-oNK cell therapy candidates for treatment of solid tumors and hematological malignancies targeting CD70 and PD-L1, respectively… ACE1702 and initiated its first US clinical trial site in the third quarter of 2020 with an expected data readout by the end of 2020…Acepodia expects IND clearance by the FDA for ACE1755 in the first quarter of 2021…Acepodia expects to initiate Phase 1 clinical trials of ACE1975 in 2021….ACE1708…IND clearance anticipated in 2021."

IND • New P1 trial • New trial • Preclinical • Oncology • Solid Tumor

[VIRTUAL] Acepodia Biotech, Inc. (BIO 2020) - "Several off-the-shelf allogeneic cell therapies in Acepodia pipeline are developing for both solid and hematological malignancies, including the lead HER2 targeting drug candidate, ACE1702. The phase 1 study of ACE1702 for patients with HER2 positive solid tumors is ongoing now in US."

Hematological Malignancies • Oncology • HER-2

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Acepodia Biotech Inc.

Clinical • New P1 trial

Acepodia announces FDA clearance of IND for its NK cell therapy drug candidate ACE1702 to treat patients with HER2-expressing solid tumors (GlobeNewswire) - "Acepodia....announced it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate a Phase 1 clinical study of its natural killer (NK) cell therapy and lead drug candidate ACE1702 in patients with HER2-expressing solid tumors."

IND