Ankündigung • Apr 29
Scancell Holdings plc Receives Fda Fast Track Designation for Iscib1+ in Advanced Melanoma and Provides Data Update from Its Scope Phase 2 Study Scancell Holdings plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead ImmunoBody® iSCIB1+ for the treatment of advanced melanoma. Progression free survival (PFS) has matured positively, reaching 77% at 20 months in the target population. This widens the lead of iSCIB1+ over PFS reported with ipilimumab plus nivolumab alone of 43% at 20 months, now representing a 30+ percentage point improvement over standard of care (SoC). The Fast Track Designation is granted for investigational therapies that show advantage over available treatments, such as superior effectiveness, and provides the process to expedite review of drugs for serious conditions, with the aim of getting effective therapies to patients faster. The designation enables frequent engagement to ensure alignment on development plans, enhance development predictability and support a more efficient path through clinical development. Moreover, Fast Track Designation brings eligibility for Accelerated Approval, Priority Review and Rolling Review. Additional PFS data and early OS data from the Phase 2 SCOPE study are expected in the first half of 2027. The SCOPE study (NCT04079166) is a Phase 2, Multicentre, Open-Label, Study in Advanced Unresectable Melanoma. Patients receiving either Nivolumab plus Ipilimumab or Pembrolizumab as standard of care (SoC) will also be treated with SCIB1 or iSCB1+. The study aims to determine the efficacy and safety of SCIB1 or iSCIB1+ when added to these SoC therapies. Additional endpoints include disease control rate (DCR), duration of response (DOR), progression free survival (PFS), overall survival (OS). Participants receive up to 11 doses of either SCIB1 or iSCIB1+ using the PharmaJet needle-free injection devices. Ankündigung • Jan 26
Scancell Holdings plc Announces Fda Clearance of Ind Application for Global Phase 3 Trial of Iscib1+ in Advanced Melanoma Scancell Holdings plc announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a registrational Phase 3 trial of its iSCIB1+ Immunobody® in advanced melanoma, with progression free survival as the agreed surrogate endpoint. Scancell has completed the 140-patient SCOPE Phase 2, open-label, multi-centre study evaluating ImmunoBody® immunotherapies (SCIB1 and iSCIB1+) in combination with nivolumab plus ipilimumab in previously untreated unresectable stage IIIB/IV melanoma. In addition to demonstrating potentially best-in-class efficacy and durability, from the data analysis have identified a selection marker to enrich the phase 3 trial for responders. Data from the Phase 2 SCOPE trial shows a significant improvement in progression free survival as well as emerging overall survival with iSCIB1+ compared to historic benchmarks. The favourable PFS remains consistent across key subgroups analysed including PD-L1 low, BRAF Wildtype and prior checkpoint inhibitor exposure, who might be expected to have worse outcomes. Ankündigung • Jan 23
Scancell Holdings plc to Report First Half, 2026 Results on Jan 29, 2026 Scancell Holdings plc announced that they will report first half, 2026 results on Jan 29, 2026 Ankündigung • Jan 10
PharmaJet's Needle-Free Injection System Selected to Administer DNA Immunotherapy for Advanced Melanoma in Late-Stage Clinical Development Following Positive Phase 2 Data PharmaJet® announced that its partner Scancell has reported updated Phase 2 clinical data from the SCOPE study in unresectable advanced melanoma. In this study, Scancell's iSCIB1+ immunotherapy was delivered intramuscularly using Stratis, PharmaJet's Needle-free Injection System. Data was presented at the ESMO Immuno-Oncology Congress 2025 on December 11, 2025. Advanced melanoma continues to represent a significant unmet medical need, with five-year survival rates of less than 23% for Stage IV patients, and an estimated 58,000 deaths annually. While immune checkpoint inhibitors have improved outcomes for many patients, approximately half either fail to respond or experience non-durable benefits, underscoring the need for novel therapeutics that extend and deepen clinical responses. Updated Phase 2 data of Scancell's iSCib1+ DNA immunotherapy delivered with PharmaJet's Stratis demonstrated a Progression-Free Survival (PFS) rate of 74% at 16 months, compared to 50% PFS at 11.5 months for standard-of-care checkpoint inhibitor therapy alone. Based on these results, Scancell has indicated plans to initiate a registrational Phase 3 study in the second half of 2026 with its immunotherapy delivered with Stratis, PharmaJet's need. Subject to regulatory outcomes and achievement of clinical endpoints, Scancell has outlined plans to advance iSCIB1+ towards potential commercialization by 2029. Ankündigung • Dec 09
Scancell Updated Phase 2 Data Shows Continued Improvement in Progression Free Survival with iSCIB1+ in Patients with First Line Advanced Melanoma Scancell Holdings plc announced updated positive data from the SCOPE Phase 2 trial of iSCIB1+ in combination with ipilimumab and nivolumab, current standard of care (SoC). A late-breaking abstract on the data has been released, and an additional poster presentation will be made during an oral session at the ESMO Immuno-Oncology Congress 2025 (ESMO IO) conference on 11th December 2025. Results from SCOPE to date have enabled Scancell to select Immunobody iSCIB1+, administered needle-free intramuscularly, for further development in patients with selected human leukocyte antigen (HLA) alleles ("the target population"), representing 80% of melanoma patients. This profile is reflected within Cohort 3 of the SCOPE trial. Updated data in this cohort show progression free survival (PFS) was 74% at 16 months in the target population. This compares favourably to PFS reported with ipilimumab plus nivolumab alone of 50% at 11.5 months. The favourable PFS remains consistent across key subgroups analysed including PD-L1 low, BRAF Wildtype and prior checkpoint inhibitor exposure, who might be expected to have worse outcomes. Cohort 3 comprised a total of 50 patients of which 39 were in the target HLA population, 10 outside the target HLA population and one was non-evaluable due to active brain metastases. Data in this cohort from the non-target population support the use of HLA as a biomarker for a registrational trial, with PFS of 20% at 14 months and overall response rate of 20%, albeit in a small number of patients. Dr Heather Shaw, lead for the Medical Oncology Skin Cancer Service at University College London Hospital, London and principal investigator of the SCOPE trial at Mount Vernon Cancer Centre, said: "iSCIB1+, in combination with checkpoint inhibitors, is showing a significant 24% improvement in PFS over standard of care and more efficacy than the first generation SCIB1. This provides additional confidence in the Immunobody®? being taken forward towards registrational trials. The translational data backing these clinical outcomes is also compelling, showing that iSCIB1+ drives a powerful durable T-cell response." The Company has held positive discussions with the U.S Food and Drug Administration (US FDA) and other regulatory agencies. The feedback received to date supports plans to move to Phase 3 registrational development with iSCIB1+ with alignment on trial design, dose, manufacturing and progression free survival as the expected registrational endpoint. Ankündigung • Oct 03
Scancell Holdings plc, Annual General Meeting, Oct 30, 2025 Scancell Holdings plc, Annual General Meeting, Oct 30, 2025. Location: the offices of cooley uk llp, 22 bishopsgate, ec2n 4bq, london United Kingdom Ankündigung • Sep 04
Scancell Holdings plc to Report Fiscal Year 2025 Results on Sep 11, 2025 Scancell Holdings plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Sep 11, 2025 Ankündigung • Jul 22
Scancell Reports Phase 2 Data Showing Strongly Improved Outcomes in Late-Stage Melanoma with Itst Immunobody® iSCIB1+ Scancell Holdings plc announced further positive data from the ongoing Phase 2 SCOPE trial of SCIB1/iSCIB1+ Immunobody® DNA active immunotherapies in combination with checkpoint inhibitors in patients with advanced unresectable melanoma. The data demonstrates a potential new benchmark for treatment of patients with late-stage melanoma in terms of efficacy, durability, immune responses and safety. This next-generation Immunobody®? iSCIB1+, includes additional epitopes targeting HLA class 1 alleles present in 80% of the population, has improved avidity from Scancell's AvidiMab® platform, and showed equipotency and equal safety compared to SCIB1. iSCIB1+ is efficacious in a wider patient population than SCIB1, 80% compared with 40% for SCIB1 and is therefore the candidate of choice for further development. This rapid development of iSCIB1+ demonstrates the potential of Scancell's technology platforms for continuous product refinement and improvement so as to provide greater benefits for larger numbers of patients. The SCOPE study also provides Scancell with the option of a patient selection biomarker for a future registrational study. Ankündigung • Apr 01
Scancell Holdings plc to Present Clinical Data from the Ongoing Phase 2 Scope Trial of Scib1 at 2025 AACR Annual Meeting Scancell Holdings plc announced clinical data from the ongoing Phase 2 SCOPE trial will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place in Chicago, Illinois on 25-30 April 2025. SCIB1 is a potent, targeted DNA melanoma cancer vaccine, that effectively activates high-avidity T cells, leading to a potent, lasting immune response by creating an immune memory that prevents the cancer from recurring. The SCOPE study (NCT04079166) is a Phase 2, Multicentre Open-Label, Study, investigating SCIB1/iSCIB1+, with double checkpoint inhibitors ("CPIs") in late-stage melanoma. Initial data in 25 patients has shown 84% disease control rate; 80% progression free survival, with 20% complete response rate; and 72% objective response rate. Scancell CMO Nermeen Varawalla will present the SCOPE clinical trial program, preliminary results of cohort 1 and their correlation with T cell responses. These data along with those expected from ongoing study cohorts, 3 & 4 will determine the design for the planned follow-on randomised registration clinical trial. The AACR conference is an internationally recognised annual meeting, bringing together experts to share the latest advances in oncology. Ankündigung • Feb 17
Scancell Holdings plc to Present Translational Data from the Phase 2 Ongoing SCIB1 at the 2025 AACR IO Conference Scancell Holdings plc announced translational data from the SCOPE trial demonstrating SCIB1 combined with nivolumab and ipilimumab will be presented during a poster session at the AACR IO conference, taking place in Los Angeles, California on 23-26 February 2025. SCIB1, a DNA plasmid melanoma cancer vaccine, is the lead product from the Company's ImmunoBody®? DNA Vaccine platform, which uses the body's immune system to identify, attack and destroy tumours. The SCOPE Study (NCT04079166) is a Phase 2, Multicentre Open-Label, Study, investigating SCIB1 with double checkpoint inhibitors ("CPIs") in late-stage melanoma. So far, 25 patients in cohort 1, receiving SCIB1 in combination with ipilimumab and nivolumab, have shown 84% disease control rate, 80% progression free survival and 20% complete response rate. The translational data that will be presented demonstrates functional vaccine specific T cell responses for patients enrolled in cohort 1 (SCIB1 plus ipilimumab and nIVolumab). This data supports the latest findings from the Phase 2 Scope trial, evaluating SCIB1 in combination with CPIs. Ankündigung • Jan 23
Scancell Holdings plc to Report First Half, 2025 Results on Jan 30, 2025 Scancell Holdings plc announced that they will report first half, 2025 results on Jan 30, 2025 Ankündigung • Jan 09
Scancell's Modi-1 Moditope® Vaccine Achieves Early Clinical Validation in Head and Neck Cancer Scancell Holdings plc has achieved significant clinical and commercial milestones in its ModiFY study. Modi-1, the lead vaccine from Scancell's Moditope® platform, is being investigated in the open-label Phase 2a dose expansion ModiFY study. This trial evaluates the safety, tolerability, and preliminary efficacy of Modi-1 in combination with checkpoint inhibitors (CPIs) in patients with renal and head and neck cancers. The cohort investigating HPV negative head and neck squamous cell carcinoma (SCCHN) was designed to determine if the overall objective response rate (ORR) in patients could be improved by combining Modi-1 Moditope® in combination with standard of care single agent checkpoint inhibitor pembrolizumab. Three of the seven evaluable patients that have received immunisation with Modi-1 Moditope® combined with a checkpoint inhibitor have demonstrated a partial response as determined by RECIST 1.1 tumour assessment at their 25-week scan. This equates to an ORR of 43% compared to historical ORRs of 19% for Pembrolizumab and 13% for nivolumab. In view of the significant improvement in response rate and the good safety and tolerability, this study is well positioned to continue enrolment into Simon stage 2. These encouraging early results will be further verified upon completion of this HPV (-) SCCHN Modi-1 Moditope ® + CPI cohort, after a total of up to 21 patients have been vaccinated. In addition, there is investigator interest to evaluate Modi-1Moditope® in the neoadjuvant setting for this indication. The commercial positioning of Modi-1 Moditope® has been further strengthened through approval by the U.S. Patent and Trademark Office (USPTO) for a patent for Moditope® and successful formulation development. The patent from the USPTO will add to the protection of the Company's pipeline of Moditope® vaccines for the treatment of cancer, which has already been granted by the European Patent Office, along with China, Japan and Australia. Ankündigung • Dec 10
Scancell Holdings plc has completed a Follow-on Equity Offering in the amount of £1 million. Scancell Holdings plc has completed a Follow-on Equity Offering in the amount of £1 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 9,523,809
Price\Range: £0.105 Ankündigung • Nov 19
Scancell Holdings plc Announces Further Positive Data from the Ongoing SCOPE Trial of SCIB1 with Double CPIs for Advanced Melanoma Scancell Holdings plc announced that 25 patients in cohort 1, receiving SCIB1 in combination with ipilimumab and nivolumab, have reached the 25-week landmark point of the SCOPE trial. These patients are showing progression free survival (PFS) of 80% at 6 months, with 5 (20%) complete responders (CR). 21 of 25 patients (84%) have shown disease control (stable disease or tumour regression, DCR). 18 out of 25 patients have shown a clinical response which is an objective response rate (ORR) of 72%, with many patients continuing to show tumour shrinkage over time. These responses have been verified in all patients with further scans at 19 and 25 weeks. These results compare favourably with reported outcomes from the double checkpoints alone, namely PFS of 65%, CR of 16%, DCR of 58% and ORR of 48%, respectively. The PFS and accumulating number of complete responders indicates that the combination of SCIB1 with double checkpoints gives sustained and durable responses which are improved when compared to double checkpoints alone. To date, cohort 1 of the SCOPE trial has recruited42/43 patients, and it is anticipated that all of these patients will reach week 25 during first half of 2025. Cohort 2, investigatingSCIB1 in combination with pembrolizumab, has recruited 9/43 patients and cohort3, investigating the next generation, iSCIB1+in combination with ipilimumab and nivolumab has recruited 33/43 patients. The iSCIB1+ cohort has predominantly recruited the non-HLA.A2 matched patients as these patients are being enrolled in cohort 1. Once recruitment in cohort 1 is complete, HLA. A2 patients will be recruited to complete cohort 3 to give a representative sample of the advanced melanoma patient population. It is anticipated that all cohort 3 patients will reach week 25 during second half of 2025. This will allow to select the best vaccine for its planned phase 2/3 randomized, adapted registration trial. Ankündigung • Oct 01
Scancell Holdings plc, Annual General Meeting, Oct 25, 2024 Scancell Holdings plc, Annual General Meeting, Oct 25, 2024. Location: the offices of cooley uk llp, 22 bishopsgate, ec2n 4bq, london United Kingdom Ankündigung • Sep 18
Scancell Holdings plc to Report Fiscal Year 2024 Results on Sep 24, 2024 Scancell Holdings plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Sep 24, 2024 Ankündigung • Jul 24
Scancell Holdings plc Announces That A Group of Medical Oncologists in the Field of Melanoma Treatment Reviewed and Strengthened Scancell's Plan for A Phase 2/3 Registration Study Following Completion of the Ongoing Scope Study Scancell Holdings plc announced that a group of leading medical oncologists in the field of melanoma treatment reviewed and strengthened Scancell's plan for a Phase 2/3 registration study following completion of the ongoing SCOPE study. Scancell's plans to conduct an adaptive randomised controlled Phase 2/3 SCOPE-2 trial is supported by a panel of experts. The study is expected to have an early interim analysis of Overall Response Rate (ORR) based on a blinded independent centralised review of CT/MRI scans before advancing to the Phase 3 component where the primary endpoint of progression-free survival will be analysed at a predetermined landmark. Scancell continues to recruit to the SCOPE study, which includes patients treated with SCIB1 as well as iSCIB1+. 32/43 patients have been recruited into the SCIB1 cohort and 22/43 into the iSCIB1+ cohort, with clinical results expected in fourth quarter of 2024 and first quarter of 2025, respectively. Ankündigung • Jul 10
Scancell Holdings plc Appoints Florian Reinaud to the Board Scancell Holdings plc announced that Dr Florian Reinaud, aged 50, of Redmile Group, LLC has been appointed as a Non-Executive Director to Scancell's Board of Directors. Florian is a highly accomplished life sciences professional who brings over 20 years of leadership and investment experience across established pharmaceutical companies, start-ups and healthcare investment organisations. He is currently on the investment team at Redmile, an investment firm that focuses on the healthcare sector. Florian began his career as a medical doctor in the NHS before moving to Schroders Salomon Smith Barney, Citigroup's European investment banking arm, working as an equity analyst covering the pan-European medtech and healthcar e services. He then transitioned to the healthcare team at Apax Partners in Paris, advising on and executing venture and late-stage investments. Following his time at Apax, Partners, Florian became the first CFO of Paris-based DBV technologies, a biopharmaceutical specialising in allergy diagnosis and treatment, and then went on to serve as Partner at CDC Innovation Capital, a French venture capital firm focused on investments in healthcare services, for six years. He later co-founded and served as CEO of Concilio, a medical concierge service, for six years, before joining Redmile. Florian holds a BA (hons) in Physiology from Oxford University, as well as a medical degree from Imperial College London School of Medicine. Current Directorships: Sensome SAS, Sensorion SA, Hansa Biopharma AB. Previous Directorships (last 5 years): Concilio. Ankündigung • Mar 15
Scancell Holdings plc Appoints Sath Nirmalananthan to the Board Scancell Holdings plc announced that Sath Nirmalananthan, Chief Financial Officer, has been appointed to the Company's Board of Directors (the "Board") with immediate effect. Sath was appointed as the Company's Chief Financial Officer on 29 August 2023, having previously served as Chief Financial Officer for Europe, Middle-East and Africa at Prenetics. He brings more than 15 years' experience in the healthcare sector, and has held roles at FTSE and NASDAQ listed companies, including Reckitt and BTG. Prior to this Sath held positions in investment banking at Nomura, and at KPMG. Sath is a qualified Chartered Accountant and a member of the Institute of Chartered Accountants in England and Wales (ICAEW), and sits as a Non-Executive member of the audit committee at The Institute of Cancer Research (ICR). He was awarded a BSc in Pharmacology from King's College, London. Full name and age: Sathijeevan Nirmalananthan, aged 38. Current Directorships: PNSN Company Limited. Previous Directorships (last 5 years): Oxsed Limited, DNA Fit Limited, DNA Sport Limited, DNAFIT Life Sciences Limited, Prenetics EMEA Limited, Prenetics Consumer Healthcare Limited, Duo Doc Limited, Norse Medica Limited and SP Care Holdings Limited. Ankündigung • Feb 05
Scancell Holdings plc Directorate and Executive Changes Changes Scancell Holdings plc announced that Dr. Sally Adams is retiring as an Executive Director of the Board and as Chief Development Officer. Dr. Callum Scotthasbeen appointed as the new Head of Development, effective immediately, and Sally will remain with the Company part time for 6 months to ensure a smooth and effective transition of responsibilities. Dr. Scott brings over 15 years of experience in vaccine research and development. Previously, he held the role of Technical Transfer & Formulation Development Manager at UK biotech firm Allergy Therapeutics (AIM:AGY) where he led all CMC (Chemistry, Manufacturing and Controls)/product development activities relating to their VLP Peanut project through Phases 1-3 including IND approvals. Dr. Scott holds a PhD in Molecular Microbiology and a BSc in Biochemistry, both from Heriot-Watt University. Ankündigung • Jan 26
Scancell Holdings plc to Report First Half, 2024 Results on Jan 30, 2024 Scancell Holdings plc announced that they will report first half, 2024 results on Jan 30, 2024 Ankündigung • Jan 18
Scancell Holdings plc Announces Update on SCOPE Trial Scancell Holdings plc announced that following further discussions with the Medicines and Healthcare products Regulatory Agency (MHRA), it has now received approval to add a third cohort to the SCOPE trial. This cohort will recruit 43 advanced unresectable melanoma patients who will receive i SCIB1 + with doublet therapy, consisting of ipilimumab (Yervoy®) plus nivolumab (Opdivo®). iSCIB1+ is a modified version of SCIB1 developed using Scancell's AvidiMab® platform to enhance its potency compared to SCIB1 and gives 15 years of extended patent protection. iSCIB1+ also includes additional melanoma-specific epitopes so it has the potential to be effective in a broader patient population beyond the 40% of patients with the tissue type treatable with SCIB1, where treatment is HLA dependent. Exceptional results from the first 13 patients receiving SCIB1 in the ongoing SCOPE trial, with an objective response rate of 85%, indicate a high probability of success in this cohort which should complete in second quarter 2024. Recruitment into the iSCIB1+ cohort is expected to be complete by the end of second quarter 2024, with early data expected in third quarter 2024. The results from these SCIB1 and iSCIB1+ cohorts, administered in combination with doublet therapy, will enable the Company to make a data-led decision regarding initiation of a randomised Phase 2/3 adapted registration programme in patients with unresectable melanoma, which represents a potential $1.5 billion per annum market. The Phase 2 part of the adapted trial is anticipated to take 18 months, with the potential to generate attractive licensing opportunities. Ankündigung • Dec 20
Scancell Holdings plc has completed a Follow-on Equity Offering in the amount of £11.897217 million. Scancell Holdings plc has completed a Follow-on Equity Offering in the amount of £11.897217 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 96,292,367
Price\Range: £0.11
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 727,274
Price\Range: £0.11
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 11,136,877
Price\Range: £0.11
Transaction Features: Rights Offering; Subsequent Direct Listing Ankündigung • Dec 02
Scancell Holdings plc has filed a Follow-on Equity Offering in the amount of £12.672161 million. Scancell Holdings plc has filed a Follow-on Equity Offering in the amount of £12.672161 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 96,292,367
Price\Range: £0.11
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 727,274
Price\Range: £0.11
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 18,181,818
Price\Range: £0.11
Transaction Features: Rights Offering; Subsequent Direct Listing Ankündigung • Nov 01
Scancell Holdings plc, Annual General Meeting, Nov 29, 2023 Scancell Holdings plc, Annual General Meeting, Nov 29, 2023, at 14:00 Coordinated Universal Time. Location: offices of Cooley (UK) LLP at 22 Bishopsgate, London EC2N 4BQ London United Kingdom Agenda: To consider Reports and Financial Statements; to consider Appointment and remuneration of Auditors; to consider Election of Director; to consider Re-election of Directors; to consider Permission for the Directors to allot further shares; to consider Renewal of the power to dis-apply pre-emption rights; to consider Authority to buy back up to 10% of the Company's issued share capital; to consider other business matters. Ankündigung • Oct 05
Scancell Holdings plc to Report Q4, 2023 Results on Oct 12, 2023 Scancell Holdings plc announced that they will report Q4, 2023 results on Oct 12, 2023 Ankündigung • Sep 29
Pharmajet Partner, Scancell, Announces Positive Data from the First Stage of Its Phase 2 Trial of Advanced Melanoma Dna Vaccine Delivered Needle-Free PharmaJet® 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. 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. Ankündigung • Sep 20
Scancell Holdings plc Announces Positive Data from the First Stage in its Phase 2 Scope Trial with SCIB1 Cancer Vaccine Delivered by Needle Free Injection for Advanced Melanoma Scancell Holdings plc announced positive data from the first stage in its Phase 2 SCOPE trial, investigating SCIB1 in combination with checkpoint inhibitors (CPIs) in advanced melanoma. Initial data from 11 patients showed an 82% objective response rate (ORR) to treatment, which is better than 70% ORR that the trial was configured to show. The Phase 2 SCOPE trial was designed to determine if the ORR in patients with unresectable metastatic melanoma could be improved in combination with CPIs. The concept is that the vaccine induces new, or boosts existing, immune responses which are subsequently protected in the tumour environment by the CPIs. During the first stage of the SCOPE trial patients received SCIB1 via a needle-free device in combination with the most efficacious treatment currently available, namely the CPIs nivolumab and ipilimumab. The first milestone in the SCOPE trial was to achieve responses in more than 8 out of 15 patients which would suggest that SCIB1 in combination with doublet CPI therapy might meaningfully improve current outcomes for these patients.16 stage IV metastatic patients have received this combination. To date, 11 of these study patients have reached 13 weeks and been evaluated at radiological imaging and nine have already shown an objective response, equating to an ORR of 82% with no increase in toxicity. At this time point the reduction in tumour volume was 31%-94%. Four patients reaching the 25 weeks imaging evaluation and two reaching the 37 weeks evaluation have shown a 69%-94% and a 87%-94% reduction in total tumour burden, respectively. This compares to an ORR of 50% reported in patients just receiving this doublet CPI therapy in the real world setting with a progression free survival time of 11.5 months. The SCOPE trial has now successfully transitioned into the second stage,which willrecruit a further 27 patients (for a total of 43). The aim is to achieve at least 18 further responses (that is 27 responses in total) which would statistically demonstrate that SCIB1, in combination with doublet therapy, exceeds currently achievable ORRs. Recruitment is expected to be complete by the end of 2023 with data available in first half of 2024. Based upon the first 11 patients there is a greater than 90% probability that the second phase will also be successful. If validated in the second stage of the SCOPE trial this will provide confidence to initiate a randomised phase 2/3 adapted registration programme in patients with unresectable melanoma which represents a potential $1.5 billion per annum market. The Phase 2 part of the adapted trial should take 18 months and will likely generate significant partner interest. In addition to SCIB1, Scancell expects significant results from its other programmes in 2024 including top-line Modi-1 CPI combination data and attractive out-licensing opportunities from the GlyMab® and AvidiMab® platforms. Ankündigung • Sep 14
Scancell Holdings plc Provides an Update on Its Two Ongoing Phase 1/2 Clinical Trials with Lead Cancer Vaccine Assets SCIB1/iSCIB-1+ and Modi-1 Scancell Holdings plc provided an update on its two ongoing Phase 1/2 clinical trials with lead cancer vaccine assets SCIB1/iSCIB-1+ and Modi-1. Encouraging data from these open label studies provides validation for the Company's decision to concentrate its strategic focus and resources on these two assets. SCIB1/iSCIB1+: The open-label, Phase 2 single arm SCOPE trial is investigating the safety and tolerability of using SCIB1/iSCIB1+, the company's lead ImmunoBody® cancer vaccine, in combination with checkpoint inhibitors in patients with advanced melanoma. The current trial is designed to determine whether any clinical effect is unlikely to be due to checkpoints alone based on the rate of clinical responses in each cohort, that is, with either a single or double checkpoint combination. The trial is progressing well, with 73% of the required number of patients receiving SCIB1 in combination with two checkpoint inhibitors (ipilimumab and nivolumab) recruited to date. The company expects the initial topline data readout from this double checkpoint arm of the study in fourth quarter 2023. Following the data readout, Scancell intends to initiate a similar double checkpoint cohort with iSCIB1+ before the end of the year. iSCIB1+ has a number of competitive advantages, with potentially increased potency due to modifications to the product using Scancell's propriety AvidiMab ® platform, and an extended patent life to 2039. iSCIB1+ is able to be used by a broader patient population because it incorporates more melanoma-specific epitopes. If positive, data generated by iSCIB1+ could lead to the initiation of a potential, rapid clinical development programme in second half 2024. An adapted registration trial could yield Phase 2 data within 2 years and would provide the company with a pathway to a potential deal. The Phase 3 data could be complete within the following 3 years. Modi-1: Modi-1 is the first vaccine based on Scancell's Moditope® platform. Recruitment is progressing well in the ModiFY open-label Phase 2a dose expansion study investigating the safety, tolerability and preliminary efficacy of Modi-1 as a monotherapy and in combination with checkpoint inhibitors in patients with ovarian, triple negative breast, renal and head and neck cancers. The cohort of 16 ovarian cancer patients receiving Modi-1 has now been fully recruited. All patients had failed on previous treatments and their disease was actively progressing when they entered the study. Following treatment with Modi-1 44% of patients achieved stable disease for at least 8 weeks, with some patients experiencing a longer duration of disease stability for 4 months or more. Four patients are still ongoing in this cohort. The number of patients who have experienced long periods of stable disease following monotherapy with Modi-1 is encouraging in this difficult to treat cancer and the Company believes that combination therapy with checkpoint inhibitors, which are not currently approved for the treatment of ovarian cancer, could further improve outcomes for this patient group. Evaluation of Modi-1 plus checkpoint inhibitors in other tumour types in the ongoing Phase 1/2 study, will provide supporting data for this proposed combination use. Ankündigung • Sep 08
Scancell Holdings plc Announces Appointment of Dr Mandeep Sehmi as Head of Business Development Scancell Holdings plc announced the appointment of Dr Mandeep Sehmi as Head of Business Development, effective immediately. Mandeep Sehmi brings more than 10 years of experience in business development and has previously held roles at leading UK biotech companies including at Abcam, where she managed and developed the cancer and metabolism portfolios, Cancer Research Technology, focussing on antibody out licensing, and Isogenica, where she was involved in deals for their antibody platform, including a multi-target deal with BioNTech. Mandeep joins Scancell from ImaginAb where she held the role of Director of Business Development and worked on a number of out-licensing opportunities for their lead asset with biotech and pharma in Immuno-oncology for cell therapies, vaccines and therapeutic antibodies. She holds a PhD in Cell and Molecular Biology and a Master's degree in Molecular Pathology and Toxicology from the University of Leicester, UK. Ankündigung • Aug 29
Scancell Appoints Sath Nirmalananthan as CFO Scancell Holdings plc announces the appointment of Sath Nirmalananthan as Chief Financial Officer (CFO), with immediate effect. Sath Nirmalananthan is an experienced finance professional with over 15 years experience across healthcare in FTSE and NASDAQ listed companies, investment banking and audit. Before joining Scancell, Sath was Chief Financial Officer for Europe, Middle-East and Africa at Prenetics, a leading genomics-driven health sciences company. Prior to that, Sath worked at Reckitt where he was Finance Director for Group Reporting and subsequently for eCommerce in Reckitt's Health Division. Sath has also held senior positions at BTG plc, a specialty pharmaceutical company, including Director of Group Reporting and Director of FP&A of interventional oncology. Earlier in his career, he was an equity research analyst in the healthcare team at Nomura and prior to that an auditor at KPMG. Sath earned a BSc in Pharmacology from King's College, London, UK and holds an ACA (ICAEW), Chartered Accountant qualification. Sath is also a Non-Executive member of the audit committee at The Institute of Cancer Research (ICR). Ankündigung • Jul 12
Scancell Holdings plc Provides an Update on Its Two Ongoing Phase 1/2 Clinical Trials with Lead Cancer Vaccine Assets Scib1/Iscib-1+ and Modi-1 Scancell Holdings plc provided an update on its two ongoing Phase 1/2 clinical trials with lead cancer vaccine assets SCIB1/iSCIB-1+ and Modi-1. Encouraging data from these open label studies provides validation for the Company's decision to concentrate its strategic focus and resources on these two assets. The open-label, Phase 2 single arm SCOPE trial is investigating the safety and tolerability of using SCIB1/iSCIB1+, Scancell's lead ImmunoBody® cancer vaccine, in combination with checkpoint inhibitors in patients with advanced melanoma. The current trial is designed to determine whether any clinical effect is unlikely to be due to checkpoints alone based on the rate of clinical responses in each cohort, i.e., with either a single or double checkpoint combination. The trial is progressing well, with 73% of the required number of patients receiving SCIB1 in combination with two checkpoint inhibitors (ipilimumab and nivolumab) recruited to date. Scancell expects the initial topline data readout from this double checkpoint arm of the study in Fourth Quarter 2023. Following the data readout, Scancell intends to initiate a similar double checkpoint cohort with iSCIB1+ before the end of the year. iSCIB1+ has a number of competitive advantages, with potentially increased potency due to modifications to the product using Scancell's propriety AvidiMab® platform, and an extended patent life to 2039. iSCIB1+ is able to be used by a broader patient population because it incorporates more melanoma-specific epitopes. If positive, data generated by iSCIB1+ could lead to the initiation of a potential, rapid clinical development programme in H2 2024. An adapted registration trial could yield Phase 2 data within 2 years and would provide the Company with a pathway to a potential deal. The Phase 3 data could be complete within the following 3 years. Modi-1 is the first vaccine based on Scancell's Moditope® platform. Recruitment is progressing well in the ModiFY open-label Phase 2a dose expansion study investigating the safety, tolerability and preliminary efficacy of Modi-1 as a monotherapy and in combination with checkpoint inhibitors in patients with ovarian, triple negative breast, renal and head and neck cancers. The cohort of 16 ovarian cancer patients receiving Modi-1 has now been fully recruited. All patients had failed on previous treatments and their disease was actively progressing when they entered the study. Following treatment with Modi-1 44% of patients achieved stable disease for at least 8 weeks, with some patients experiencing a longer duration of disease stability for 4 months or more. Four patients are still ongoing in this cohort. The number of patients who have experienced long periods of stable disease following monotherapy with Modi-1 is encouraging in this difficult to treat cancer and the Company believes that combination therapy with checkpoint inhibitors, which are not currently approved for the treatment of ovarian cancer, could further improve outcomes for this patient group. Evaluation of Modi-1 plus checkpoint inhibitors in other tumour types in the ongoing Phase 1/2 study, will provide supporting data for this proposed combination use. In the other monotherapy cancer cohorts, a total of eight patients have received full dose Modi-1: One TNBC patient remains on trial with stable disease beyond 8 weeks and One head and neck patient achieved a partial response and remains on study at week 37. Additionally, Scancell has recruited a fourth cohort of three patients receiving full dose Modi-1 in combination with the checkpoint inhibitor nivolumab. Subject to a safety committee review meeting scheduled to take place in August, this cohort will be expanded to 21 patients in both head and neck and renal cancer. Preliminary topline data from these cohorts is expected to be reported in 2024. Scancell has developed a novel technology platform for producing monoclonal antibodies that recognise glycans with high specificity and affinity. The platform has generated revenues and the antibodies continue to yield compelling results which have led to a new 6-month evaluation by a leading Biotech company. Additional in-house data has illustrated the potential of antibodies as chimeric antigen receptor T cell (CART) therapies providing the data for a deal with a cell therapy company. These results along with updates on SCIB1 and Modi-1 will be presented at the AACR-CIMT meeting in Milan in September 2023. Due to the company increasing focus on its two clinical assets, Scancell is fully funded to 2H 2024 including the near-term data inflection points and near-term cohort expansions outlined above. Ankündigung • Feb 13
Scancell Holdings plc Announces Positive Response in Covidity Trial Scancell Holdings plc announces preliminary immunogenicity data from its Phase 1 COVIDITY clinical trial which was conducted at the University of Cape Town (UCT) Lung Institute in South Africa. The objectives of the trial were to assess the safety and immunogenicity of two vaccine candidates, SCOV1 and SCOV2, in healthy, vaccine-naïve subjects, prior to testing the candidates as a booster in SARS-CoV-2 pre-infected or pre-vaccinated volunteers. SCOV1 and SCOV2 are both plasmid DNA vaccines based on the Company's ImmunoBody® technology and incorporate its AvidiMab® modifications to further enhance the immune responses induced following vaccination. The data from the Phase 1 COVIDITY trial showed that neutralising antibodies were induced as well as T cell responses to both the receptor binding domain (RBD) of the spike protein and the nucleocapsid antigen (NCAP). In vaccine-naïve subjects, the seroconversion rate (the level of detectable antibodies in the blood due to vaccination) was 67% following SCOV1/SCOV2 vaccination, with a broad reactivity against multiple COVID-19 variants, including the currently dominant Omicron variant. These positive results demonstrate that SCOV1 and SCOV2, delivered via PharmaJet's needle-free injection device, induce immune responses in naïve participants. Additionally, a single dose of SCOV2 boosted broad responses in previously exposed subjects. As previously disclosed, the Board of Scancell have decided not to take this vaccine forward in house due to the large size of later stage trials and the competitive Covid-19 landscape, however the positive data for COVIDITY demonstrates the validation of the vaccine platform, including AvidiMab®. As a result, the Company will now seek a partner to progress the COVIDITY vaccine programme. In addition, the success of the vaccine administration using PharmaJet's needle-free injection devices in the COVIDITY trial provides rationale for the Company to further incorporate the device in future trials. Ankündigung • Feb 01
Scancell Holdings plc Announces Executive Changes Scancell Holdings plc announces the appointment of Dr. Jean-Michel Cosséry, as Non-Executive Chairman of the Board of Directors with immediate effect. As previously announced, Dr. John Chiplin who has served as Chairman since 2016, will step down following Jean-Michel's appointment.Jean-Michel will seek to drive Scancell's strategy for clinical progress and commercial development of its novel immunotherapy vaccine and antibody platforms. Jean-Michel brings to Scancell over 25 years of experience in the pharmaceutical and biotechnology industries and a sustained global track record of success in commercial operations as well as in capital raising, US and European public offerings, business development and M&A. Jean-Michel was Vice President for North America Oncology at Eli Lilly, with responsibility for commercialisation of the company's oncology portfolio. Preceding this US-based position, he was Vice President and Managing Director of the Eli Lilly's European Northern Hub, where he was Chair of the Eli Lilly UK Board and a member of Lilly European Executive Committee. Prior to this Jean-Michel served as VP and Chief Marketing Officer at GE Healthcare's Global Headquarters. Following his retirement from Eli Lilly in 2018, Jean-Michel has served on the board ofKymabuntil their acquisition by Sanofi. He was also a member of the Immunocore board prior to the company's Nasdaq listing. Jean-Michel currently serves on the boards of Malin PLC, Exact Therapeutics AS, Eracal Therapeutics and Sophia Genetics SA.He has also been Chair of The American Pharmaceutical Group in the UK, as well as a board member of the Association of British Pharmaceutical Industry. Jean-Michel holds an MBA from the Rotterdam School of Management (Erasmus University), The Netherlands, as well as a PharmD and a PhD in Nuclear Chemistry and Neurobiology from University Paris, France. Ankündigung • Jan 18
Scancell Holdings plc to Report First Half, 2023 Results on Jan 25, 2023 Scancell Holdings plc announced that they will report first half, 2023 results on Jan 25, 2023