Delving into the Latest Updates on Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.) with Synapse

Overview

Basic Info

Drug Type

Shared antigen vaccine, Therapeutic vaccine

Synonyms

Cancer vaccine DCVex NY-ESO-1, DCVex/NY-ESO-1 cancer vaccine

+ [3]

Target

NY-ESO-1

Action

inhibitors, stimulants

Mechanism

CD8B inhibitors(CD8b molecule inhibitors), NY-ESO-1 inhibitors(Cancer/testis antigen 1 inhibitors), Immunostimulants

Therapeutic Areas

NeoplasmsRespiratory DiseasesSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Non-Small Cell Lung CancerSarcomaUnresectable Melanoma

Originator Organization

Immune Design Corp.

Active Organization-

Inactive Organization

Merck Sharp & Dohme Corp.

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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This phase I trial studies how well autologous NY-ESO-1-specific CD8-positive T lymphocytes (modified T lymphocytes [T cells]), chemotherapy, and aldesleukin with or without dendritic cell-targeting lentiviral vector ID-LV305 (LV305) and immunotherapeutic combination product CMB305 (CMB305) work in treating participants with sarcoma that has spread to other places in the body (advanced) or that has come back (recurrent). Modified T cells used in this study are taken from participants, are changed in a laboratory, and may "kill" some types of tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide may help the body get ready to receive the modified T cells. Interleukins, such as aldesleukin, are proteins made by white blood cells and other cells in the body and may help regulate immune response. LV305 and CMB305 may help stimulate the immune system. Giving modified T cells, chemotherapy, aldesleukin, LV305, and CMB305 may work better in treating participants with sarcoma.

Start Date13 Sep 2018

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT02122861

/ CompletedPhase 1

A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.

Start Date30 May 2014

Sponsor / Collaborator

Immune Design Corp.

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100 Clinical Results associated with Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.)

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100 Translational Medicine associated with Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.)

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100 Patents (Medical) associated with Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.)

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5

Literatures (Medical) associated with Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.)

01 Jan 2020·OncoImmunologyQ2 · MEDICINE

A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

Q2 · MEDICINE

ArticleOA

Author: Sankhala, Kamalesh K. ; Kenney, Richard T. ; Chen, Michael ; Kim, Joseph W. ; Chawla, Sant P. ; Morris, John C. ; Kim-Schulze, Seunghee ; Lu, Hailing ; Yishak, Mahlet ; Block, Matthew S. ; Jones, Robin L. ; Do, Khanh ; Gnjatic, Sacha ; Yakovich, Adam ; Druta, Mihaela ; Ter Meulen, Jan ; Hwu, Patrick ; Bohac, Chet ; Tuballes, Kevin ; Somaiah, Neeta ; Pollack, Seth M.

Preclinical data suggest that a "prime-boost" vaccine regimen using a target-expressing lentiviral vector for priming, followed by a recombinant protein boost, may be effective against cancer; however, this strategy has not been evaluated in a clinical setting. CMB305 is a prime-boost vaccine designed to induce a broad anti-NY-ESO-1 immune response. It is composed of LV305, which is an NY-ESO-1 expressing lentiviral vector, and G305, a recombinant adjuvanted NY-ESO-1 protein. This multicenter phase 1b, first-in-human trial evaluated CMB305 in patients with NY-ESO-1 expressing solid tumors. Safety was examined in a 3 + 3 dose-escalation design, followed by an expansion with CMB305 alone or in a combination with either oral metronomic cyclophosphamide or intratumoral injections of a toll-like receptor agonist (glucopyranosyl lipid A). Of the 79 patients who enrolled, 81.0% had sarcomas, 86.1% had metastatic disease, and 57.0% had progressive disease at study entry. The most common adverse events were fatigue (34.2%), nausea (26.6%), and injection-site pain (24.1%). In patients with soft tissue sarcomas, a disease control rate of 61.9% and an overall survival of 26.2 months (95% CI, 22.1-NA) were observed. CMB305 induced anti-NY-ESO-1 antibody and T-cell responses in 62.9% and 47.4% of patients, respectively. This is the first trial to test a prime-boost vaccine regimen in patients with advanced cancer. This approach is feasible, can be delivered safely, and with evidence of immune response as well as suggestion of clinical benefit.

01 Oct 2019·Clinical Cancer ResearchQ1 · MEDICINE

First-in-Class, First-in-Human Study Evaluating LV305, a Dendritic-Cell Tropic Lentiviral Vector, in Sarcoma and Other Solid Tumors Expressing NY-ESO-1

Q1 · MEDICINE

Article

Author: Shapiro, Geoffrey I. ; Chen, Michael ; Block, Matthew S. ; Lu, Hailing ; Bohac, Chet ; Kim, Joseph W. ; Pollack, Seth M. ; Eder, Joseph P. ; Gnjatic, Sacha ; Hwu, Patrick ; Jones, Robin L. ; Hsu, Frank J. ; Somaiah, Neeta ; Do, Khanh T. ; ter Meulen, Jan H.

AbstractPurpose:LV305 is a modified, third-generation, nonreplicating, integration-deficient lentivirus-based vector designed to selectively transduce dendritic cells in vivo. LV305 induces expression of the New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) cancer testis antigen in dendritic cells, promoting immune responses against NY-ESO-1–expressing tumors. This phase I study evaluated the safety, immunogenicity, and preliminary efficacy of LV305 in patients with sarcoma or other solid tumors.Patients and Methods:Adults with previously treated, advanced, NY-ESO-1–positive solid tumors and limited tumor burden were eligible. LV305 was administered every 3 weeks by intradermal injection in four dose cohorts (Cohort 1: 108 vector genomes (vg) x 3 doses; Cohorts 1A, 2, and 3: 108 vg, 109 vg, 1010 vg x 4 doses).Results:Thirty-nine patients were enrolled: 3 patients each in Cohorts 1, 1A, and 2, and 30 patients in Cohort 3. No dose-limiting toxicities were observed. Tumor types included sarcoma (n = 24), ovarian (n = 8), melanoma (n = 6), and lung cancer (n = 1). All treatment-related adverse events were grade 1 or 2. Common treatment-related adverse events were fatigue (49%), injection site reactions (46%), and myalgia (21%). The disease control rate was 56.4% in all patients and 62.5% in sarcoma patients. One patient with synovial sarcoma achieved a partial response lasting >36 months. Anti–NY-ESO-1-specific CD4+ and/or CD8+ T cells were induced in 57% of evaluable sarcoma patients. Induction of an anti–NY-ESO-1 immune response was associated with improved 1-year survival in an exploratory analysis.Conclusions:This first-in-class, first-in-human study of LV305 demonstrated a favorable safety profile, induction of antigen-specific responses, and potential clinical activity in patients with advanced cancer.

01 Oct 2017·Journal of ImmunotherapyQ4 · MEDICINE

First-in-Human Treatment With a Dendritic Cell-targeting Lentiviral Vector-expressing NY-ESO-1, LV305, Induces Deep, Durable Response in Refractory Metastatic Synovial Sarcoma Patient

Q4 · MEDICINE

Article

Author: Jones, Robin L. ; Gnjatic, Sacha ; O’Malley, Ryan B. ; Lu, Hailing ; ter Meulen, Jan ; Pollack, Seth M. ; Somaiah, Neeta ; Hsu, Frank J.

Effective induction of antitumor T cells is a pivotal goal of cancer immunotherapy. To this end, lentiviral vectors (LV) are uniquely poised to directly prime CD8 T-cell responses via transduction of dendritic cells in vivo and have shown promise as active cancer therapeutics in preclinical tumor models. However, until now, significant barriers related to production and regulation have prevented their widespread use in the clinic. We developed LV305, a dendritic cell-targeting, integration-deficient, replication incompetent LV from the ZVex platform, encoding the full-length cancer-testis antigen NY-ESO-1. LV305 is currently being evaluated in phase 1 and 2 trials in metastatic recurrent cancer patients with NY-ESO-1 positive solid tumors as a single agent and in combination with anti-PD-L1. Here we report on the first patient treated with LV305, a young woman with metastatic, recurrent, therapy-refractive NY-ESO-1+ synovial sarcoma. The patient developed a robust NY-ESO-1-specific CD4+ and CD8+ T-cell response after 3 intradermal injections with LV305, and subsequently over 85% disease regression that is continuing for >2.5 years posttherapy. No adverse events >grade 2 occurred. This case demonstrates that LV305 can be safely administered and has the potential to induce a significant clinical benefit and immunologic response in a patient with advanced stage cancer.

100 Deals associated with Cancer vaccine DCVex NY-ESO-1(Immune Design Corp.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 1	United States	Merck Sharp & Dohme Corp.	30 May 2014
Sarcoma	Phase 1	United States	Merck Sharp & Dohme Corp.	30 May 2014
Unresectable Melanoma	Phase 1	United States	Merck Sharp & Dohme Corp.	30 May 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03520959 (IMDZ-04-1702, CTgov)	Phase 3	Soft Tissue Sarcoma \| Synovial Sarcoma	1	LV305-matching placebo (Placebo)	qgvrfpegto(lfhzstigcw) = ftweemncns elljfbcxty (uceodfxqnz, ltarkmcywg - tcfnhfsjht) View more	-	16 Apr 2020
				G305+LV305 (CMB305)	svbkvqjcyo(ngzmidizpd) = xgpdwimuna vxwodkdewg (vvfytrqvgz, ofnuanbbkr - wxprbxcyfo) View more
ASCO2017	Phase 1	Neoplasms	62	CMB305	mrpjxqmuul(zimmlttoto) = vkfcecrnor qveuiwyxqu (dconiwopeg ) View more	-	30 May 2017
				LV305	mrpjxqmuul(zimmlttoto) = niihgnzdea qveuiwyxqu (dconiwopeg ) View more
NCT02122861 (ASCO2016)	Phase 1	Sarcoma \| Neoplasms	27	LV305	(ichhlxkgdm) = no DLT or SAEs were observed in the 12 sarcoma patients; all related AEs were grade 1/2 ujzxukdece (xggecvkdch ) View more	Positive	20 May 2016