Delving into the Latest Updates on OXB-301 with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

5T4 cancer vaccine, Modified vaccinia Ankara 5T4, OBA 1 cancer vaccine

+ [7]

Target

5T4

Action

modulators, stimulants

Mechanism

5T4 modulators(Trophoblast glycoprotein modulators), T lymphocytes stimulants

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Renal Cell Carcinoma

Inactive Indication

Castration-Resistant Prostatic CancerColorectal Liver MetastasesFallopian Tube Carcinoma+ [8]

Originator Organization

Oxford Biomedica Plc

Active Organization

University of Cardiff

Wales Cancer Research Centre

University College London

Inactive Organization

Oxford Biomedica Plc

License Organization

Oxford Biomedica Plc

Sanofi

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This is a clinical trial of a new treatment for prostate cancer that is a type of vaccine that could be a new way to treat cancer. A vaccine that could alert the immune system to the presence of cancer cells in the body may enable the immune system to target and kill those cells effectively. This vaccine is intended to work by making the immune system kill cells that have a special protein (called 5T4) that is present on the surface of cancer cells. The vaccine is made up of two recombinant viruses ("ChAdOx1" and "MVA") that have been designed to produce the 5T4 protein and have been modified so that they are weakened and cannot reproduce themselves within the body like normal viruses. Once injected into the body, these viruses make the 5T4 protein and help the body's immune system to learn to target this protein and destroy cancer cells.
This is a first-in-human study to evaluate the safety and immunogenicity of ChAdOx1.5T4-MVA.5T4 vaccination regime. It is evaluated in neo-adjuvant setting in low and intermediate risk localised prostate cancer patients who have either decided to have their prostate removed or are stable on active surveillance.

Start Date01 Jun 2015

Sponsor / Collaborator

University of Oxford

NCT01556841

/ CompletedPhase 2IIT

A Phase II Study to Assess the Activity of TroVax® (MVA-5T4) Versus Placebo in Patients With Relapsed Asymptomatic Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The purpose of this trial is to assess the effectiveness of TroVax® compared to placebo in extending the time to progression in patients with asymptomatic relapsed platinum resistant ovarian, fallopian tube or primary peritoneal cancer.The trial will also look at overall survival times and quality of life.

Start Date01 Nov 2013

Sponsor / Collaborator

University College London

[+2]

NCT01194960

/ TerminatedPhase 2

A Randomized Phase II Study to Assess the Activity of TroVax® (MVA-5T4) Plus Docetaxel Versus Docetaxel Alone in Subjects With Progressive Hormone Refractory Prostate Cancer

Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses, thus leading to a more effective therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression free survival (PFS) of subjects with HRPC.

Start Date01 Aug 2010

Sponsor / Collaborator

Oxford Biomedica Plc

[+1]

100 Clinical Results associated with OXB-301

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100 Translational Medicine associated with OXB-301

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100 Patents (Medical) associated with OXB-301

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40

Literatures (Medical) associated with OXB-301

01 Aug 2024·International Journal of Gynecologic Cancer

A randomized phase II trial to examine modified vaccinia Ankara-5T4 vaccine in patients with relapsed asymptomatic ovarian cancer (TRIOC)

Article

Author: Hackshaw, Allan ; Wilson, William ; McNeish, Iain A ; Sunshine, Sunny ; Ngai, Yen ; Michael, Agnieszka ; Blount, Daniel ; Nicum, Shibani ; Pandha, Hardev ; Stylianou, Laura ; Ledermann, Jonathan ; Gwyther, Stephen ; Harrop, Richard ; Lord, Rosemary ; Annels, Nicola

BackgroundImmunotherapy directed at 5T4 tumor antigen may delay the need for further chemotherapy. An attenuated modified vaccinia Ankara virus containing the gene encoding for 5T4 (MVA-5T4) was studied in asymptomatic relapsed ovarian cancer.ObjectiveTo assess the effectiveness and safety of MVA-5T4 as treatment for asymptomatic relapsed ovarian cancer.MethodsTRIOC was a phase II randomized (1:1), placebo-controlled, double-blind multicenter study. The primary aim was to assess the effectiveness and safety of MVA-5T4 as a treatment for asymptomatic patients with relapsed ovarian cancer. Eligible patients had International Federation of Gynecology and Obstetrics (FIGO) stage IC1–III or IVA epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, Eastern Cooperative Oncology Group (ECOG) 0–1, with relapse defined by a rise in CA-125 to twice the upper limit of normal or low-volume disease on CT scan. The primary endpoint was disease progression (including deaths from ovarian cancer) at 25 weeks. Following a brief suspension, the trial restarted as a single-arm study. The revised single-arm design required 45 evaluable patients treated with MVA-5T4 to detect a 25-week progression rate of 50%, assuming an expected 70% rate without MVA-5T4; 85% power with one-sided 5% significance.ResultsA total of 94 eligible patients were recruited, median age was 65 years (range 42–82), median follow-up 34 months (range 2–46). Overall, 59 patients received MVA-5T4 and 35 patients received placebo. The median number of MVA-5T4 injections received was 7 (range 0–9), compared with a median of 6 (range 1–12) for patients receiving placebo. Median progression-free survival was the same in both arms (3.0 months). The 25-week progression rate was similar in both arms: 80.0% for patients treated with MVA-5T4 and 85.7% for those receiving placebo (risk difference −5.7%, 95% CI −21.4% to 10.0%). Median time to clinical intervention was improved with MVA-5T4: 7.6 months (range 6.7–9.5) vs 5.6 (range 4.9–7.6),ConclusionMVA-5T4 vaccination in patients with asymptomatic relapse was well-tolerated but did not improve the progression rate at 25 weeks. The majority of patients who received MVA-5T4 had clinical intervention later than those assigned to placebo.Trial registration numberNCT01556841 .

02 Dec 2018·OncoImmunologyQ2 · MEDICINE

A single centre phase II trial to assess the immunological activity of TroVax® plus pemetrexed/cisplatin in patients with malignant pleural mesothelioma – the SKOPOS trial

Q2 · MEDICINE

ArticleOA

Author: Harrop, Richard ; Griffiths, Gareth O ; Casbard, Angela C ; Tabi, Zsuzsanna ; Katona, Lajos ; Al-Taei, Saly ; Lester, Jason F ; Attanoos, Richard L

Vaccines in combination with chemotherapy have been shown to be safe in different tumor types. We investigated the immunological activity of the TroVax® vaccine in combination with pemetrexed-cisplatin chemotherapy in malignant pleural mesothelioma (MPM). In this first line, open-label, single-arm, phase 2 study, patients with locally advanced or metastatic MPM were enrolled. Eligible patients received up to 9 intramuscular injections of TroVax®, starting two weeks before chemotherapy and continuing at regular intervals during and after chemotherapy to 24 weeks. The primary endpoint was the induction of cellular or humoral anti-5T4 immune response (defined as a doubling of either response at any of six follow-up time points), with a target response rate of 64%. Of 27 patients, enrolled between Feb 2013-Dec 2014, 23 (85%) received at least three doses of TroVax® and one cycle of chemotherapy and were included in the per-protocol analysis (PPA). 22/23 patients (95.6%) developed humoral or cellular immune response to 5T4. Thus, the study reached its primary endpoint. Disease control was observed in 87% of patients (partial response: 17.4%, stable disease: 69.6%). The median progression-free survival was 6.8 months and median overall survival 10.9 months. Treatment-related adverse events were comparable to those observed in patients with chemotherapy alone. Translational immunology studies revealed a circulating baseline immune signature that was significantly associated with long-term (>20 months in n = 8/23, 34.8%) survival. In this phase 2 trial, TroVax® with pemetrexed-cisplatin chemotherapy showed robust immune activity, acceptable safety and tolerability to warrant further investigation in a phase 3 setting.

01 Jan 2015·The International Journal of Biological Markers

Clinical outcomes model in renal cell cancer patients treated with modified vaccinia Ankara plus tumor-associated antigen 5T4

Article

Author: Peng, Hui ; Xiong, Youxin ; Mohlere, Virginia ; Amato, Robert J.

Aims We developed an outcomes model to select patients for renal cell cancer vaccine immunotherapy. Materials and methods We examined clinical data from 2 phase II studies of modified vaccinia Ankara as vector to express 5T4 (MVA-5T4), calculated progression-free survival (PFS) and overall survival (OS), and created risk groups based on the number of factors involved. Results Median OS was 12.4 months; median PFS was 3.6 months. Significant factors (p<0.05) included neutrophils (both), bone metastases (OS), ECOG performance status (OS), lactate dehydrogenase levels (both), prior therapy with tyrosine kinase inhibitors plus immunotherapy (OS), Fuhrman grade (OS), and 5T4-specific ELISPOT response (PFS). By group, median OS was not reached in patients with favorable risk (censored at cutoff), was 13.7 months in those with intermediate risk and 4.0 months in those with poor risk. Conclusions Further validation of this model will identify the patients most likely to respond to MVA-5T4 and provide a framework for outcomes models for other vaccine therapies.

100 Deals associated with OXB-301

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Renal Cell Carcinoma	Phase 3	-	University of Cardiff	-
Renal Cell Carcinoma	Phase 3	-	Wales Cancer Research Centre	-
Renal Cell Carcinoma	Phase 3	-	University College London	-
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	United States	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	Russia	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	Spain	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	Ukraine	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	United Kingdom	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	Germany	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 2	Israel	Oxford Biomedica Plc	01 Sep 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01556841 (TRIOC, Pubmed) Manual	Phase 2	Recurrent ovarian cancer	94	MVA-5T4 vaccine	(epaxqlsdho) = qwfjofrdge vjwtzvyxzn (hegwrfcweb ) View more	Negative	17 May 2024
NCT01556841 (TRIOC, Pubmed) Manual	Phase 2	Recurrent ovarian cancer	94	modified vaccinia Ankara-5T4 vaccine (Placebo)	(epaxqlsdho) = dvukhrvwlt vjwtzvyxzn (hegwrfcweb ) View more	Negative	17 May 2024
EUCTR2011-001836-44-GB (TRIOC-A, ESMO2020)	Phase 2	Recurrent ovarian cancer	94	MVA-5T4 vaccine	iwcucjmluu(wxjmhimxuy) = tofhxhtflp thteuinxqo (kxzceqxyyo ) View more	Negative	17 Sep 2020
EUCTR2011-001836-44-GB (TRIOC-A, ESMO2020)	Phase 2	Recurrent ovarian cancer	94	Placebo	iwcucjmluu(wxjmhimxuy) = zbhxkgespt thteuinxqo (kxzceqxyyo ) View more	Negative	17 Sep 2020
ASCO2008	Phase 2	Kidney Neoplasms	25	TroVax[T] + low dose interleukin-2 (IL-2)	(kpnimugdkz) = nwbaqzywwh ynvgsedbey (bxfaxkbnmz ) View more	-	20 May 2008
ASCO2008	Phase 2	Kidney Neoplasms First line	11	TroVax plus IFN-α	(ydxosdfsrc) = osgoobetmd vktycfdejp (yfcowpvljg )	-	20 May 2008