Delving into the Latest Updates on Autologous dendritoma vaccine(Oncolix) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Melaxin

Target-

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Malignant melanoma stage IVMelanoma

Originator Organization

Oncolix, Inc.

Active Organization-

Inactive Organization

Oncolix, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Aim: We developed a novel approach to efficiently deliver autologous tumor antigens to the cytoplasm of dendritic cells (DC) using yeast cell wall particles (YCWP). Materials and Methods: Loading of YCWP, leakage of protein from loaded YCWP and cytoplasmic delivery of YCWP content was assessed using fluorescent-tagged experiments. Spectrophotometric analysis compared the epitope-specific T-cell responses following antigen presentation via YCWP versus exogenous loading. The in vivo effectiveness of tumor lysate (TL) particle loaded DC (TLPLDC) vaccine was assessed using murine melanoma models. Results: In fluorescence-tagged experiments, YCWP efficiently delivered antigen to the cytoplasm of DC. TLPLDC loading was more effective than conventional exogenous loading of DC. Finally, in murine melanoma models, TLPLDC outperformed an analogous dendritoma vaccine. Conclusion: The TLPLDC vaccine is commercially scalable and holds the potential of producing personalized vaccines.

01 Apr 2016·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

A phase I/IIa clinical trial in stage IV melanoma of an autologous tumor–dendritic cell fusion (dendritoma) vaccine with low dose interleukin-2

Q2 · MEDICINE

Article

Author: Hardin, Mark O ; Martin, Jonathan ; Schneble, Erika J ; Flores, Madeline ; Wagner, Thomas E ; Yu, Xianzhong ; Greene, Julia M ; Hale, Diane F ; Jackson, Doreen O ; Herbert, Garth S ; Vreeland, Timothy J ; Peoples, George E

BACKGROUNDStage IV melanoma has high mortality, largely unaffected by traditional therapies. Immunotherapy including cytokine therapies and checkpoint inhibitors improves outcomes, but has significant toxicities. In this phase I/IIa trial, we investigated safety and efficacy of a dendritoma vaccine, an active, specific immunotherapy, in stage IV melanoma patients.METHODSAutologous tumor lysate and dendritic cells were fused creating dendritoma vaccines for each patient. Phase I patients were vaccinated every 3 months with IL-2 given for 5 days after initial inoculation. Phase IIa patients were vaccinated every 6 weeks with IL-2 given on days 1, 3 and 5 after initial inoculation. Toxicity and clinical outcomes were assessed.RESULTSTwenty-five patients were enrolled and inoculated. All dendritoma and IL-2 toxicities were CONCLUSIONSThe dendritoma vaccine has minimal toxicity profile with potential clinical benefit. There was OS advantage for NED stage IV patients, those receiving higher number of doses and increased frequency. Based on these results, we initiated a phase IIb trial utilizing improved dendritoma technology in the adjuvant setting for NED stage III/IV melanoma patients.

Oncology ReportsQ3 · MEDICINE

Combined treatment of dendritoma vaccine and low-dose interleukin-2 in stage IV renal cell carcinoma patients induced clinical response: A pilot study

Q3 · MEDICINE

Article

Author: Trocha, Steven ; Bouton-Verville, Hilary ; Sticca, Robert P. ; Holmes, Lillia M. ; Stephenson, Joseph J. ; Wei, Yanzhang C. ; Smith, Sam ; Burgin, Kelly E. ; Williamson, Jane ; Martin, Julie ; Li, Jinhua ; Jakubchak, Susan ; Meyer, Karen ; Evans, Lyndon ; Wagner, Thomas E.

Vaccination using dendritic/tumor cell hybrids represents a novel and promising cancer immunotherapy. We have developed a technology that can instantly purify the hybrids (dendritomas) from the fusion mixture of dendritic cells (DCs) and tumor cells. Our animal studies and a phase I study of stage IV melanoma patients demonstrated that dendritoma vaccination could be conducted without major toxicity and induced tumor cell-specific immunological and clinical responses. In this pilot study, ten stage IV renal cell carcinoma patients were studied. Dendritomas were made from autologous DCs and tumor cells and administered by subcutaneous injection. After initial vaccination, three escalating doses of IL-2 (3, 6, and 9 million units each) were followed within five days. This treatment regimen was tolerated well without severe adverse events directly related to the dendritoma vaccine. Most adverse events were related to IL-2 administration or pre-existing disease. Patient-specific immune responses were evaluated by flow cytometric measurement of interferon-gamma-producing T-cells before and after vaccination in response to stimulation with tumor antigens. Nine out of nine patients eligible for the analysis showed an increase of IFN-gamma-expressing CD4+ T cells after vaccination(s); while five out of eight patients eligible for the analysis showed an increase of IFN-gamma-expressing CD8+ T cells. Clinical responses were documented in 40% of the patients, three with stabilization of disease and one with a partial response documented by a reduction in tumor size. This pilot study demonstrated that dendritoma vaccines could be administered safely to patients with metastatic renal cell carcinoma, while producing both clinical and immunologic evidence of response.

100 Deals associated with Autologous dendritoma vaccine(Oncolix)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Malignant melanoma stage IV	Phase 2	US	Oncolix, Inc.	01 Apr 2008
Melanoma	Phase 2	US	Oncolix, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00671554 (CTgov)	Phase 1/2	Malignant melanoma stage IV	3	Melaxin	dlprzhugyh(lhpqkgpvnj) = ojkqzoxzsr evrbcnvuoa (oklrbaveuf, qmvafhqgax - jjyatdeusg)	-	04 Jun 2014
AACR2013	Not Applicable	Prostatic Cancer	48	Vaccine	atxuijfjze(fndqggwdsu) = gvgxtsaart brggbmawrb (gyfxcnwlsc )	-	15 Apr 2013
AACR2013	Not Applicable	Prostatic Cancer	48	novel autologous immunomodulated vaccine (Control group)	atxuijfjze(fndqggwdsu) = hcdtgrgjmg brggbmawrb (gyfxcnwlsc )	-	15 Apr 2013
ASCO2007	Phase 2	Melanoma	15	Dendritoma vaccination	(rfccbukzue) = ekfsrfplvd cnstwbqlwj (jqswuwvhpi )	Positive	20 Jun 2007