A Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab (The SCOPE Study)

The purpose of this study is to find out if two new treatment cancer vaccines called SCIB1 and iSCIB1+ can be used safely when added to nivolumab (Opdivo) with ipilimumab (Yervoy), or SCIB1 with pembrolizumab (Keytruda). Pembrolizumab or nivolumab with ipilimumab are standard treatments approved for patients with advanced melanoma (skin cancer).
The study will also look to see if SCIB1 or iSCIB1+ can increase the likelihood that melanoma patients will respond to the standard treatments, and also if SCIB1 and iSCIB1+ can help to make those responses last longer. SCIB1 and iSCIB1+ are considered experimental. SCIB1 has been given to melanoma patients in an earlier study. It was generally well-tolerated, and researchers saw some signs that it may help to stimulate the immune system, which is a way in which the body can fight the cancer. iSCIB1+ is similar to SCIB1 but might benefit more patients with melanoma.

Start Date19 Aug 2019

Sponsor / Collaborator

Scancell Ltd.

EUCTR2018-002844-10-GB / Unknown statusPhase 2

A Phase 2, Multicenter, Open-Label Study of SCIB1 in Patients with Advanced Unresectable Melanoma Receiving Pembrolizumab - SCIB1 in melanoma patients receiving pembrolizumab SCIB1-002

Start Date24 Jan 2019

Sponsor / Collaborator

Scancell Ltd.

NCT01138410 / TerminatedPhase 1/2

A Phase I/II Trial of SCIB1, a DNA Immunotherapy, in the Treatment of Patients With Malignant Melanoma

The study is an investigation of a novel immunotherapy, SCIB1, for the treatment of melanoma. SCIB1 is a solution of plasmid DNA molecules which will express a modified antibody in human cells. The antibody modifications are designed to stimulate the patient's immune T cells to have a strong and specific reaction against melanoma cells which should then be eliminated. SCIB1 is injected into muscle using a device which simultaneously delivers an electrical impulse to enhance the transfer of SCIB1 into muscle cells. The trial will assess the safety and tolerability of SCIB1, the safety and performance of the injection device and the immunological effects of SCIB1. This is the first study of SCIB1 in humans and the trial has two parts, in the first part the dose will be escalated to determine a safe and tolerable level up to a maximum of 8 mg per dose. In the second part patients will receive the dose determined in the first part. Patients will have stage III or IV melanoma, be HLA type A2 and have a life expectancy of at least three months. All patients will receive 5 injections of SCIB1 over 5.5 months. At the discretion of the investigator, patients may continue to receive SCIB1 at 3-6 month intervals for 5 years. The study will be conducted at major cancer centres in the UK only and is expected to last for seven years. Patients will be followed up for five years after they have completed the trial.

Start Date01 May 2010

Sponsor / Collaborator

Scancell Ltd.

100 Clinical Results associated with Melanoma vaccine TRP2 gp100(Scancell Ltd.)

100 Translational Medicine associated with Melanoma vaccine TRP2 gp100(Scancell Ltd.)

100 Patents (Medical) associated with Melanoma vaccine TRP2 gp100(Scancell Ltd.)

Literatures (Medical) associated with Melanoma vaccine TRP2 gp100(Scancell Ltd.)

01 Oct 2021·Immunology & Cell Biology

Helicase antigen (HAGE)‐derived vaccines induce immunity to HAGE and ImmunoBody®‐HAGE DNA vaccine delays the growth and metastasis of HAGE‐expressing tumors in vivo

Article

Author: Metheringham, Rachael ; Pearson, Joshua ; Durrant, Lindy ; McArdle, Stephanie E ; Pockley, A Graham ; Nagarajan, Divya ; Brentville, Victoria

AbstractThe management of patients with triple‐negative breast cancer (TNBC) continues to pose a significant clinical challenge. Less than 30% of women with metastatic TNBC survive 5 years, despite adjuvant chemotherapy and the initial higher rates of clinical response that can be achieved with neoadjuvant chemotherapy. ImmunoBody is a plasmid DNA designed to encode a human antibody molecule with complementarity‐determining regions engineered to express cytotoxic and helper T‐cell epitopes derived from the cancer antigen of interest. The helicase antigen (HAGE) is a cancer testis antigen, which is expressed in TNBC. Herein, we have identified a 30‐amino‐acid‐long HAGE‐derived sequence containing human leukocyte antigen (HLA)‐A2‐ and HLA‐DR1‐restricted epitopes and demonstrated that the use of this sequence as a peptide (with CpG/incomplete Freund's adjuvant) or incorporated into an ImmunoBody vaccine can generate specific interferon‐γ‐secreting splenocytes in HHDII+DR1+ mice. T‐cell responses elicited by the ImmunoBody‐HAGE vaccine were superior to peptide immunization. Moreover, splenocytes from ImmunoBody‐HAGE‐vaccinated mice stimulated in vitro could recognize HAGE+ tumor cells and the human TNBC cell line MDA‐MB‐231. More importantly, the growth of implanted HHDII+DR1+HAGE+Luc+ B16 cells.

03 Jun 2018·OncoImmunologyQ2 · MEDICINE

Targeting gp100 and TRP-2 with a DNA vaccine: Incorporating T cell epitopes with a human IgG1 antibody induces potent T cell responses that are associated with favourable clinical outcome in a phase I/II trial

Q2 · MEDICINE

ArticleOA

Author: Brentville, Victoria A. ; Ottensmeier, Christian H. ; Machado, Lee ; Durrant, Lindy G. ; Pandha, Hardev ; Villasanti, Naty ; Hadjimichael, Efthymios ; Daniels, Ian ; Metheringham, Rachael L. ; Patel, Poulam M. ; Elsheikh, Somaia ; Plummer, Ruth ; Gijon, Mohamed ; Hannaman, Drew ; Adams, Sally E. ; Lorigan, Paul ; Mulatero, Clive ; Cunnell, Michelle

A DNA vaccine, SCIB1, incorporating two CD8 and two CD4 epitopes from TRP-2/gp100 was evaluated in patients with metastatic melanoma. Each patient received SCIB1 via intramuscular injection with electroporation. The trial was designed to find the safest dose of SCIB1 which induced immune/clinical responses in patients with or without tumour. Fifteen patients with tumor received SCIB1 doses of 0.4-8 mg whilst 20 fully-resected patients received 2-8 mg doses. Twelve patients elected to continue immunization every 3 months for up to 39 months. SCIB1 induced dose-dependent T cell responses in 88% of patients with no serious adverse effects or dose limiting toxicities. The intensity of the T cell responses was significantly higher in patients receiving 4 mg doses without tumor when compared to those with tumor (p < 0.01). In contrast, patients with tumor showed a significantly higher response to the 8 mg dose than the 4 mg dose (p < 0.03) but there was no significant difference in the patients without tumor. One of 15 patients with measurable disease showed an objective tumor response and 7/15 showed stable disease. 5/20 fully-resected patients have experienced disease recurrence but all remained alive at the cut-off date with a median observation time of 37 months. A positive clinical outcome was associated with MHC-I and MHC-II expression on tumors prior to therapy (p = 0.027). We conclude that SCIB1 is well tolerated and stimulates potent T cell responses in melanoma patients. It deserves further evaluation as a single agent adjuvant therapy or in combination with checkpoint inhibitors in advanced disease.

13 Dec 2016·Oncotarget

SCIB1, a huIgG1 antibody DNA vaccination, combined with PD-1 blockade induced efficient therapy of poorly immunogenic tumors

Article

Author: Yagita, Hideo ; Metheringham, Rachael L. ; Cook, Katherine W. ; Brentville, Victoria A. ; Xue, Wei ; Symonds, Peter ; Durrant, Lindy G.

PURPOSEWe have previously shown that supraoptimal signaling of high avidity T cells leads to high expression of PD-1 and inhibition of proliferation. This study was designed to see if this effect could be mitigated by combining a vaccine that stimulates high avidity T cells with PD-1 blockade.EXPERIMENTAL DESIGNWe investigated the anti-tumor effect of a huIgG1 antibody DNA vaccine (SCIB1) and PD-1 blockade.RESULTSVaccination of HLA-DR4 transgenic mice with SCIB1 induced high frequency and avidity T cell responses that resulted in survival (40%) of mice with established B16F1-DR4 tumors. SCIB1 vaccination was associated with increased infiltration of CD4 and CD8 T cells within the tumor but was also associated with upregulation of PD-L1 within the tumor environment. PD-1 blockade also resulted in increased CD8 T cell infiltration and an anti-tumor response with 50% of mice showing long term survival. In line with our hypothesis that PD-1/PD-L1 signaling results in inhibition of proliferation of high avidity T cells at the tumor site, the combination of PD-1 blockade with vaccination, enhanced the number and proliferation of the CD8 tumor infiltrate. This resulted in a potent anti-tumor response with 80% survival of the mice.CONCLUSIONSThere is a benefit in combining PD-1 blockade with vaccines that induce high avidity T cell responses and in particular with SCIB1.

News (Medical) associated with Melanoma vaccine TRP2 gp100(Scancell Ltd.)

28 Sep 2023

·www.biospace.com

PharmaJet Partner, Scancell, Announces Positive Data from the First Stage of its Phase 2 Trial of Advanced Melanoma DNA Vaccine delivered Needle-free

SCOPE trial surpasses its first milestone with an 82% response rate. Needle-free delivery is favored by patients. If confirmed in a larger cohort, these data could result in significantly improved care for melanoma patients. GOLDEN, Colo.--(BUSINESS WIRE)-- PharmaJet®, a company that engineers precision delivery systems that overcome the challenges of vaccines and pharmaceuticals delivery, today announced that its partner, Scancell, has received positive data from the first stage in its Phase 2 clinical study for treatment of patients with unresectable advanced melanoma. The vaccine is delivered by needle-free injection with the PharmaJet Stratis® System, which patients prefer over needle and syringe delivery. Historically, the prognosis of patients with unresectable stage III and IV melanoma, when surgery is not an option, has been poor: Median overall survival is only 6.2 months1. Scancell’s immunotherapy platform aims to improve on this prognosis using the body’s immune system to identify, attack and destroy tumors. The first stage in the Phase 2 study trial investigated whether the combination of SCIB1 treatment and checkpoint inhibitors (nivolumab and ipilimumab) resulted in an improvement in patient objective response rate (ORR) to treatment. Initial data from 11 patients showed an 82% ORR, which is better than the 70% ORR that the trial was configured to show and significantly better than previous studies that indicated a maximum 50% response rate. The treatment was delivered needle-free using PharmaJet’s precision delivery system. Prof Lindy Durrant, Chief Executive Officer of Scancell commented, “We are excited by these highly impressive results for SCIB1 combined with the doublet CPI therapy. PharmaJet has been a great partner and their Stratis system is easy to use. We chose the system because it initially worked well with our COVID vaccine and administration was well received by study participants. It is now efficiently delivering our SCIB1 vaccine, and the patients really appreciate a needle free delivery. The data from this study adds to the growing evidence of modern needle-free administration technology being an enabling delivery platform that can enhance plasmid DNA vaccine immune response.” Recruitment is underway for the second stage of the trial, with expected results during the first half of 2024. Based upon the first 11 patients, there is a greater than 90% probability that the second stage will also be successful. Chris Cappello, President and CEO, PharmaJet commented, “We are pleased to be partnering with Scancell as they move forward with the second phase of the Phase 2 trial. In addition to increasing patient acceptance, our partners have published data showing improved immunogenicity with DNA vaccines.” For more information about PharmaJet visit . Refer to Instructions for Use to ensure safe injections and to review risks. 1 About PharmaJet The PharmaJet vision is to enable greater access to life-saving vaccines and pharmaceuticals globally. We are committed to helping our partners realize their research and commercialization goals while making an impact on public health. PharmaJet Precision Delivery Systems™ provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. They are both commercially available for global immunization programs. For more information visit . Follow us on LinkedIn. About Scancell Scancell is a clinical stage biopharmaceutical company that is leveraging its proprietary research, built up over many years of studying the human adaptive immune system, to generate novel medicines to treat significant unmet needs in cancer and infectious disease. The Company is building a pipeline of innovative products by utilising its four technology platforms: Moditope® and ImmunoBody® for vaccines and GlyMab® and AvidiMab® for antibodies. Adaptive immune responses include antibodies and T cells (CD4 and CD8), both of which can recognise damaged or infected cells. In order to destroy such cancerous or infected cells, Scancell uses either vaccines to induce immune responses or monoclonal antibodies (mAbs) to redirect immune cells or drugs. The Company’s unique approach is that its innovative products target modifications of proteins and lipids. For the vaccines (Moditope® and ImmunoBody®) this includes citrullination and homocitrullination of proteins, whereas its mAb portfolio targets glycans or sugars that are added onto proteins and / or lipids (GlyMab®) or enhances the potency of antibodies and their ability to directly kill tumour cells (AvidiMab®). For further information about Scancell, please visit:

Phase 2VaccineClinical ResultImmunotherapy

19 Sep 2023

·www.fiercebiotech.com

Scancell enjoys stock bounce on back of phase 2 snapshot for DNA cancer vaccine

Patients received the cancer vaccine, dubbed SCIB1, via a needle-free device. It’s been a good week for Scancell’s shareholders, as investors seized on early data from the biotech's phase 2 cancer vaccine trial to send its stock up 20%. Preliminary data from the first stage of the study showed that the DNA vaccine, dubbed SCIB1, produced an 82% response rate across 11 patients with advanced melanoma when given in combination with checkpoint inhibitors. This exceeded the 70% milestone for objective response rate (ORR) set by the Oxford, U.K.-based company for the trial, according to a release (PDF). The aim of the study was to see whether the vaccine could either induce new, or boost existing, immune responses. These responses could then be protected in the tumor environment by checkpoint inhibitors—in this case Bristol Myers Squibb’s Opdivo and Yervoy. Patients received SCIB1 via a needle-free device. Of the nine patients who have shown a response with radiological imaging at a 13-week evaluation, the reduction in tumor volume ranged from 31%-94%, the biotech said. The company is aiming to beat the 50% ORR of the Opdivo-Yervoy combo alone. “Previous studies indicated that a response rate of 50% was the best that could be achieved in the real world setting for patients with unresectable metastatic melanoma, as no other combination had improved on the response rates for doublet CPI alone,” Scancell CEO Lindy Durrant said in the release. “Confirmation of this data in a larger cohort could make a significant impact on melanoma patient survival, especially as melanoma is now one of the most common cancers in young women.” While it’s still early days for the study, the results appeared to be enough to get investors excited, sending the biotech’s stock up 20%. But even coming after a similar stock bump on Monday, the company’s share price is still only sitting at 15 pence as of 2:15 p.m. U.K. time on the London Stock Exchange’s AIM submarket. In total, the SCOPE trial is expected to recruit 87 participants. Around three-quarters of participants had been recruited as of July, with Scancell suggesting at the time that initial top-line data are likely to read out in the final quarter (PDF) of the year. The company has another cancer vaccine, dubbed Modi-1, in a phase 2 dose-expansion trial as a monotherapy and in combination with checkpoint inhibitors. The study in ovarian, triple negative breast, renal, and head and neck cancers is due to read out next year.

Phase 2VaccineClinical ResultImmunotherapy

100 Deals associated with Melanoma vaccine TRP2 gp100(Scancell Ltd.)

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 2	GB	Scancell Ltd.	01 May 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04079166 (SCOPE, ASCO2024) Manual	Phase 2	Melanoma First line	23	SCIB1 + nivolumab + ipilimumab	(uilgbqtqtw) = vvmbygpvua juvgldugou (hrrzrcikiq ) View more	Positive	24 May 2024
SCOPE (AACR2024) Manual	Phase 2	Unresectable Melanoma	19	SCIB1 + nivolumab + ipilimumab	(syocdmhzbt) = oprmajymaw xayonqspvd (vsyczknyku )	Positive	05 Apr 2024
NCT04079166 (SCOPE, SITC2023)	Phase 2	Unresectable Melanoma	16	SCIB1 + nivolumab + ipilimumab	iomwxeclfc(roltowwptl) = vuxzkketug vzzcccendl (zvpjzxpzcf )	Positive	31 Oct 2023
NCT04079166 (SCOPE, Corporate Publications) Manual	Phase 2	Melanoma	11	SCIB1	(fidufheqit) = hidlvbycna ypgwgesvng (szuftodspu )	Positive	19 Sep 2023
NCT01138410 (Pubmed \| Oncoimmunology) Manual	Phase 1/2	Metastatic melanoma	35	SCIB 1	(ybddcocjgi) = laujbgauyh umkqglnymm (qdiqnpkrck ) View more	Positive	22 Feb 2018
NCT01138410 (ASCO2014)	Phase 1	Melanoma	25	ImmunoBody (SCIB1)	qkfrjygeam(hvmgtxsvfj) = strong expression of PD.L1 on the tumor cells lrdarcbkxy (myojjtqtcg ) View more	-	20 May 2014

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Melanoma vaccine TRP2 gp100(Scancell Ltd.)

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