Delving into the Latest Updates on ADCV-01 with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, Dendritic cell vaccine

Synonyms

Autologous dendritic cell vaccine

Target-

Action

stimulants

Mechanism

Immunostimulants, T lymphocytes stimulants

Therapeutic Areas

NeoplasmsNervous System DiseasesOther Diseases

Active Indication

Glioblastoma Multiforme

Inactive Indication-

Originator Organization

Ever Supreme Bio Technology Co., Ltd.

Active Organization

Ever Supreme Bio Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Autologous dendritic-cell vaccine therapy combined with systemic therapy may be of benefit in patients with metastatic renal cell cancer undergoing cytoreductive nephrectomy according to results from the large ADAPT trial. Combined retrospective analysis and correlative immunology research revealed that patients receiving everolimus may have derived a greater benefit. The currently enrolling phase 2 CoImmune trial is designed to test this hypothesis in patients undergoing cytoreductive nephrectomy and systemic therapy.

15 Feb 2022·Clinical Cancer ResearchQ1 · MEDICINE

A Phase I Study of Autologous Dendritic Cell Vaccine Pulsed with Allogeneic Stem-like Cell Line Lysate in Patients with Newly Diagnosed or Recurrent Glioblastoma

Q1 · MEDICINE

Article

Author: Phuphanich, Surasak ; Omofoye, Oluwaseun A. ; Yu, John S. ; Kim, Sungjin ; Wang, Hongqiang ; Shiao, Stephen L. ; Mazer, Mia ; Patil, Chirag G. ; Tighiouart, Mourad ; Rudnick, Jeremy D. ; Ganaway, Toni ; Hu, Jethro L. ; Chu, Ray M. ; Wang, Rongfu ; Black, Keith L.

AbstractPurpose:Glioblastoma (GBM) is a heterogeneous malignancy with multiple subpopulations of cancer cells present within any tumor. We present the results of a phase I clinical trial using an autologous dendritic cell (DC) vaccine pulsed with lysate derived from a GBM stem-like cell line.Patients and Methods:Patients with newly diagnosed and recurrent GBM were enrolled as separate cohorts. Eligibility criteria included a qualifying surgical resection or minimal tumor size, ≤ 4-mg dexamethasone daily dose, and Karnofsky score ≥70. Vaccine treatment consisted of two phases: an induction phase with vaccine given weekly for 4 weeks, and a maintenance phase with vaccines administered every 8 weeks until depletion of supply or disease progression. Patients with newly diagnosed GBM also received standard-of-care radiation and temozolomide. The primary objective for this open-label, single-institution trial was to assess the safety and tolerability of the autologous DC vaccine.Results:For the 11 patients with newly diagnosed GBM, median progression-free survival (PFS) was 8.75 months, and median overall survival was 20.36 months. For the 25 patients with recurrent GBM, median PFS was 3.23 months, 6-month PFS was 24%, and median survival was 11.97 months. A subset of patients developed a cytotoxic T-cell response as determined by an IFNγ ELISpot assay.Conclusions:In this trial, treatment of newly diagnosed and recurrent GBM with autologous DC vaccine pulsed with lysate derived from an allogeneic stem-like cell line was safe and well tolerated. Clinical outcomes add to the body of evidence suggesting that immunotherapy plays a role in the treatment of GBM.

01 Dec 2018·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

Randomized phase II trial of autologous dendritic cell vaccines versus autologous tumor cell vaccines in metastatic melanoma: 5-year follow up and additional analyses

Q2 · MEDICINE

ArticleOA

Author: Cornforth, Andrew N ; Depriest, Carol ; McClay, Edward F ; Nistor, Gabriel I ; Amatruda, Thomas T ; Dillman, Robert O

BACKGROUNDDespite improved survival following checkpoint inhibitors, there is still a potential role for anti-cancer therapeutic vaccines. Because of biological heterogeneity and neoantigens resulting from each patient's mutanome, autologous tumor may be the best source of tumor-associated antigens (TAA) for vaccines. Ex vivo loading of autologous dendritic cells with TAA may be associated with superior clinical outcome compared to injecting irradiated autologous tumor cells. We conducted a randomized phase II trial to compare autologous tumor cell vaccines (TCV) and autologous dendritic cell vaccines (DCV) loaded with autologous TAA.METHODSShort-term autologous tumor cell lines were established from metastatic tumor. Vaccines were admixed with 500 micrograms of GM-CSF and injected weekly for 3 weeks, then at weeks 8, 12,16, 20, and 24. The primary endpoint was overall survival. Secondary objectives were identification of adverse events, and results of delayed type hypersensitivity (DTH) reactions to intradermal tumor cell injections.RESULTSForty-two patients were randomized. All were followed from randomization until death or for five years; none were lost to follow-up. DCV was associated with longer survival: median 43.4 versus 20.5 months (95% CI, 18.6 to > 60 versus 9.3 to 32.3 months) and a 70% reduction in the risk of death (hazard ratio = 0.304, p = 0.0053, 95% CI, 0.131 to 0.702). Tumor DTH reactions were neither prognostic nor predictive. The most common treatment-related adverse events were mild to moderate local injection site reactions and flu-like symptoms; but grade 2 treatment-related adverse events were more frequent with TCV. Serum marker analyses at week-0 and week-4 showed that serum markers were similar at baseline in each arm, but differed after vaccination.CONCLUSIONSThis is the only human clinical trial comparing DCV and TCV as platforms for autologous TAA presentation. DCV was associated with minimal toxicity and long-term survival in patients with metastatic melanoma. DTH to autologous tumor cells was neither prognostic for survival nor predictive of benefit for either vaccine.TRIAL REGISTRATIONClinical trials.gov NCT00948480 retrospectively registered 28 July 2009.

100 Deals associated with ADCV-01

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