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

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Target

5T4

Mechanism

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

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Renal Cell Carcinoma

Inactive Indication

Castration-Resistant Prostatic CancerColorectal CancerFallopian Tube Carcinoma+ [6]

Originator Organization

Oxford Biomedica Plc

Active Organization

University of Cardiff

Wales Cancer Research CentreStartup

University College London

Inactive Organization

Oxford Biomedica Plc

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. There will be a concurrent open-label 1:1 randomisation to compare daily TAF/FTC (week 0-26) to daily TDF/FTC (weeks 0-26) as pre-exposure prophylaxis.
The study aims to randomise up to 1668 eligible adults (18-40 years) through collaborating clinical research centres in 4 countries (Mozambique; South Africa; Tanzania; and Uganda). Each participant will be followed for a minimum of 74 weeks after enrolment.
The trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis.
The PrEP component will determine whether the effectiveness of TAF/FTC is unacceptably lower than the effectiveness of TDF/FTC.

Start Date15 Dec 2020

Sponsor / Collaborator

EuroVacc Foundation

[+10]

NCT02390063 / CompletedPhase 1IIT

A Randomized Phase I Study to Determine the Safety and Immunogenicity of ChAd-MVA Vaccination Compared to MVA Alone With and Without Low Dose Cyclophosphamide in Low and Intermediate Risk Localised Prostate Cancer

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]

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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88

Literatures (Medical) associated with OXB-301

10 Aug 2024·BMC Surgery

Opioid-free anesthesia with esketamine-dexmedetomidine versus opioid-based anesthesia with propofol-remifentanil in shoulder arthroscopy: a randomized controlled trial.

Article

Author: Qian, Weisheng ; Yang, Nan ; Yan, Cong ; Zhang, Geqing ; Qian, Bin ; Xue, Zhouya ; Liu, Xiang ; Liu, Yi

BACKGROUND:

OFA (Opioid-free anesthesia) has the potential to reduce the occurrence of opioid-related adverse events and enhance postoperative recovery. Our research aimed to investigate whether OFA, combining esketamine and dexmedetomidine, could serve as an alternative protocol to traditional OBA (opioid-based anesthesia) in shoulder arthroscopy, particularly in terms of reducing PONV (postoperative nausea and vomiting).

METHODS:

A total of 60 patients treated with shoulder arthroscopy from September 2021 to September 2022 were recruited. Patients were randomly assigned to the OBA group (n = 30) and OFA group (n = 30), receiving propofol-remifentanil TIVA (total intravenous anesthesia) and esketamine-dexmedetomidine intravenous anesthesia, respectively. Both groups received ultrasound-guided ISBPB(interscalene brachial plexus block)for postoperative analgesia.

RESULTS:

The incidence of PONV on the first postoperative day in the ward (13.3% vs. 40%, P < 0.05) was significantly lower in the OFA group than in the OBA group. Moreover, the severity of PONV was less severe in the OFA group than in the OBA group in PACU (post-anesthesia care unit) (0 [0, 0] vs. 0 [0, 3], P<0.05 ) and in the ward 24 h postoperatively ( 0 [0, 0] vs. 0 [0, 2.25], P<0.05). Additionally, the OFA group experienced a significantly shorter length of stay in the PACU compared to the OBA group (39.4 ± 6.76 min vs. 48.7 ± 7.90 min, P < 0.001).

CONCLUSIONS:

Compared to the OBA with propofol-remifentanil, the OFA with esketamine- dexmedetomidine proved to be feasible for shoulder arthroscopy, resulting in a reduced incidence of PONV and a shorter duration of stay in the PACU.

TRIAL REGISTRATION:

The Chinese Clinical Trial Registry (No: ChiCTR2100047355), 12/06/2021.

01 Aug 2024·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

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

Article

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

Background:

Immunotherapy 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.

Objective:

To assess the effectiveness and safety of MVA-5T4 as treatment for asymptomatic relapsed ovarian cancer.

Methods:

TRIOC 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.

Results:

A 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),

Conclusion:

MVA-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 number:

NCT01556841 .

01 Jul 2024·Journal of Anaesthesiology Clinical Pharmacology

Feasibility of opioid-free anesthesia in laparoscopic radical prostatectomy: A retrospective, quasi-experimental study

Article

Author: Bijelic, Lana ; García, Marta ; Tejedor, Ana

Abstract:

Background and Aims::

Opioid-free anesthesia (OFA) provides adequate analgesia minimizing opioids. OFA has not been evaluated in laparoscopic radical prostatectomy (LRP). Our aim was to evaluate OFA feasibility and its effectiveness in LRP.

Material and Methods::

A quasi-experimental retrospective study of 55 adult patients undergoing LRP was performed from September 2020 until December 20223. Predefined protocols for either opioid-based anesthesia (OBA; with continuous remifentanil infusion) or OFA (continuous lidocaine, dexmedetomidine, and ketamine infusion) were followed. In both groups, wound infiltration was performed before skin incision. Primary outcome was postoperative pain management (numerical rating scale [NRS]) in the first 24 postoperative hours. Secondary outcomes were opioid consumption, start to sitting and ambulation, postoperative complications, and length of hospital stay.

Results::

OFA protocol patients had better median pain scores during movement at 1, 18 and 24 h, that is, 1 (interquartile range [IQR] 0–3) versus 2.5 (IQR 0–4), P = 0.047; 0 (IQR 0–1) versus 1 (IQR 0–2), P = 0.017; and 0 (IQR 0–0.25) versus 1 (IQR 0–2), P = 0.013, respectively. At 6 and 12 h, there were no statistically significant differences, that is, 0.5 (IQR 0–2) versus 1 (IQR 0–2), P = 0.908 and 1 (IQR 0–2) versus 0.5 (IQR 0–2), P = 0.929, respectively. Lower morphine requirements were recorded in the first 18 and 24 postoperative hours, that is, 0 (IQR 0–0) versus 1 (IQR 0–2.75) mg, P = 0.028 and 0 (IQR 0–2) versus 1.5 (IQR 0–3) mg, P = 0.012, respectively. Start to sitting and ambulation occurred earlier in the OFA group (P = 0.030 and P = 0.002, respectively). Linear regression showed that ambulation was independently associated with the analgesic technique (P = 0.034). Only one patient had postoperative nausea and vomiting (PONV) and belonged to the OBA group. There was no difference in total complications or the length of stay.

Conclusion::

In this study, OFA strategy was found to be safe, feasible, and provided adequate analgesia, minimizing the use of postoperative opioids, and was independently associated with earlier ambulation.

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
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	US	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	FR	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	DE	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	IL	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	PL	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	RO	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	RU	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	ES	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	UA	Oxford Biomedica Plc	01 Sep 2006
Metastatic Clear Cell Renal Cell Carcinoma	Phase 3	GB	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	gjlbjobyao(slbrsjryxe) = dofmfoxazg wxbssvtpyc (uynjyuamoh ) View more	Negative	17 May 2024
				Placebo	gjlbjobyao(slbrsjryxe) = suvszfrdjn wxbssvtpyc (uynjyuamoh ) View more
EUCTR2011-001836-44-GB (TRIOC-A, ESMO2020)	Phase 2	Recurrent ovarian cancer	94	MVA-5T4 vaccine	wfyvfgleae(qrburnebid) = hkilnsesxj nodjcyhroc (pmlrjwvjoq ) View more	Negative	17 Sep 2020
				Placebo	wfyvfgleae(qrburnebid) = zmbtthgucp nodjcyhroc (pmlrjwvjoq ) View more
NCT01194960 (Pubmed \| Cancer Immunol Immunother)	Phase 2	Castration-Resistant Prostatic Cancer	25	TroVax plus docetaxelTroVax plus docetaxel	lbvdczzdbd(oephonsgyw) = ddrpayysyn gtwryysncq (marurceyrw )	-	01 Sep 2013
				docetaxel alone	lbvdczzdbd(oephonsgyw) = recqnzlaog gtwryysncq (marurceyrw )
ASCO2013	Phase 2	Kidney Neoplasms	50	MVA-5T4 alone	mpcmhjstjs(rwqukytwnu) = zsqqtiyziz buzsouegbv (stvmcplfuj ) View more	-	20 May 2013
NCT00397345 (Pubmed \| Clin Cancer Res)	Phase 3	Kidney Neoplasms First line	733	MVA-5T4	qixuxripqn(ecldmvhunh) = The magnitude of the 5T4-specific antibody response induced by vaccination with MVA-5T4 was associated with enhanced patient survival ufwetkzicg (dzxqwlskua )	Negative	15 Nov 2010
				Placebo
ASCO2008	Phase 2	Kidney Neoplasms	25	TroVax[T] + low dose interleukin-2 (IL-2)	fuqqvlcoxz(ajmbmmgyob) = exnxxnjqoa lxrahmqbls (emrkudijuz ) View more	-	20 May 2008
ASCO2008	Phase 2	Kidney Neoplasms First line	11	TroVax plus IFN-α	ohujzbtbwj(ivqtcqwvvr) = fswkzqzjrd mjarabkray (oujjnatqio )	-	20 May 2008
ASCO2007	Not Applicable	Metastatic Renal Cell Carcinoma	41	MVA 5T4 alone	mjmlkmeevp(gpyeqpcupz) = fudzfprijq ioejigtebz (xnnlbcdivh )	-	20 Jun 2007