Modi-1 / ISA Pharma, Scancell - LARVOL DELTA

ModiFY: Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer (clinicaltrials.gov) - P1/2 | N=168 | Recruiting | Sponsor: Scancell Ltd | Trial completion date: Jun 2026 ➔ Jul 2027

Trial completion date • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • High Grade Serous Ovarian Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • PD-L1

Scancell’s Modi-1 Moditope Vaccine Achieves Early Clinical Validation in Head and Neck Cancer (Scancell Press Release) - P1/2a | N=144 | ModiFY (NCT05329532) | Sponsor: Scancell Ltd | "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."

P2a data • Squamous Cell Carcinoma of Head and Neck

Results for the Year Ended 30 April 2024 (Scancell Press Release) - "SCIB1/ iSCIB1+ (SCOPE trial): Full cohort data with SCIB1 and iSCIB1+ expected in Q4 2024 and H1 2025 respectively. Phase 2/3 registration study in advanced melanoma planned to begin in 2025 supported by strategic guidance from international key opinion leaders. Modi-1 (ModiFY trial): Modi-1 completed dose escalation and safety cohorts of the Phase 1/2 ModiFY trial and continues in the expansion cohorts....RCC cohort dosing has commenced with early clinical read-out expected in H1 2025."

New P2/3 trial • P2 data • Trial status • Genito-urinary Cancer • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

Isolation and characterisation of TCRs that recognise Citrullinated and Homocitrullinated post translationally modified peptides (CIMT 2024) - "We are currently running A Phase 1/2, Multicentre, Open-Label Study of Modi-1 in Patients with Breast, Head and Neck, Ovarian, or Renal Cancer (The ModiFY Study) study...Our own data in preclinical mouse models have shown that T cells that recognise post translational modified peptides induce tumour regression. Our data demonstrates the successful isolation of post translational-specific TCRs, these TCRs can be used to provide cancer therapy as either a cellular therapy or in a soluble T cell bispecific format."

IO biomarker • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • CD4 • CD8 • IFNG • VIM

Scancell receives approval to expand ModiFY cancer trial (Proactiveinvestors) - "Scancell Holdings PLC...has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) to expand its ModiFY trial to include 44 new patients with untreated renal cell carcinoma, a form of kidney cancer. They will receive Scancell's Modi-1 cancer vaccine combined with two checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo).... This expansion also aims to see if the combination can work better together, or synergistically, as shown in Scancell's previous studies."

Trial status • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Clinical Update on the DC Targeting Melanoma Vaccine, SCIB1 and The Modi-1 Vaccine Targeting Citrullination (IO-SUMMIT EUROPE 2024) - "SCIB1 a DC targeting DNA vaccine gives at impressive 85% response rate in combination with ipilimumab and nivolumab in advanced melanoma. Citrullination occurs in stressed tumor cells and makes an excellent target for a universal cancer vaccine. Modi-1 targeting citrullination is currently in phase II clinical trial"

Clinical • Melanoma • Oncology • Solid Tumor

Scancell to present at the Annual Immuno-Oncology Summit Europe (Scancell Press Release) - "Scancell Holdings plc...announces that it will be presenting at the 8th Immuno-Oncology Summit Europe 2024....'I am pleased to be invited to share this exciting data on SCIB1, Scancell’s ‘off the shelf’ ImmunoBody cancer vaccine, which has demonstrated positive efficacy data from the Phase 2 SCOPE trial for advanced unresectable melanoma. I am also looking forward to presenting early data from patients receiving Modi-1 as a monotherapy in range of hard-to-treat solid tumours, which has shown good T cell responses, safety and tolerability'."

P1/2 data • P2 data • Melanoma

Clinical Update on the DC Targeting Melanoma Vaccine, SCIB1 and The Modi-1 Vaccine Targeting Citrullination (IO-SUMMIT EUROPE 2024) - "SCIB1 a DC targeting DNA vaccine gives at impressive 85% response rate in combination with ipilimumab and nivolumab in advanced melanoma. Citrullination occurs in stressed tumor cells and makes an excellent target for a universal cancer vaccine. Modi-1 targeting citrullination is currently in phase II clinical trial"

Clinical • Melanoma • Oncology • Solid Tumor

Scancell raises GBP12 million in total from fundraise (Morningstar UK) - "Scancell Holdings PLC on Tuesday said it has raised GBP11.9 million in total, from an open offer, placing, and subscription of shares....On Tuesday, it has raised GBP1.2 million through an open offer of 11.1 million shares....'The funds raised today will further drive the company's progress with its lead programmes, including SCIB1, which recently demonstrated an unprecedented objective response rate of 85% in patients with unresectable melanoma in initial data from the Scope study, and Modi-1 through its next clinical steps...'"

Financing • Melanoma • Oncology • Skin Cancer • Solid Tumor

Results for the Year Ended 30 April 2023 (Scancell Press Release) - "SCIB1 (SCOPE trial)....Recruitment in the second stage is expected to be complete by the end of 2023 with data available in H1 2024 and a clear potential development pathway; iSCIB1+ cohort could be added to SCOPE trial if the protocol amendment is approved by the MHRA with early data with iSCIB1+ available in H1 2024....Early clinical data with Modi-1 expected to be available in 2024."

P1 data • Trial status • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Melanoma • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Scancell to present at the 2023 World Vaccine Congress Europe (Scancell Press Release) - "Scancell Holdings plc...today announces Professor Lindy Durrant, Chief Executive Officer and Chief Scientific Officer of Scancell, will be presenting at the 2023 World Vaccine Congress Europe, taking place on 17-19 October in Barcelona, Spain."

Clinical • Melanoma • Oncology

Clinical update on the DC targeting melanoma vaccine, SCIB1 and the Modi-1 vaccine targeting citrullination (WVCE 2023) - No abstract available

Clinical • Melanoma • Oncology • Solid Tumor

Scancell 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 Press Release) - "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."

Commercial • New P2/3 trial • P1/2 data • Melanoma • Ovarian Serous Adenocarcinoma • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Scancell passes 'important milestone' with cancer trial expansion (Proactiveinvestors) - "Scancell Holdings PLC...has announced the expansion of its Modi-1 trial in combination with checkpoint inhibitors (CPI) for patients with renal or head and neck cancer. This decision follows the successful completion of Cohort 4, where the higher dose Modi-1 in combination with CPI was found to be well-tolerated with no safety concerns. The safety review committee has approved the inclusion of two new cohorts, with 21 patients to be recruited into each group....In addition to the cohort expansion, recruitment into the neoadjuvant arm of the Modi-1 trial, again in combination with CPI, has been approved. This study will enrol 30 patients who will be randomly selected at diagnosis to receive either two doses of Modi-1 three weeks apart or two doses of Modi-1 plus one dose of CPI."

Trial status • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Scancell focuses on development of two critical cancer fighting assets (Proactiveinvestors) - "Scancell Holdings PLC...has told investors it is tightening its focus on two critical assets, SCIB1 and Modi-1, following promising results from ongoing trials....The Phase 2 SCOPE trial on SCIB1 or iSCIB1+ in metastatic melanoma patients is making good headway, the company noted, with 73% of the required number of patients having so far received SCIB1 to date and initial topline data readout from this arm of the study is due in the fourth quarter of 2023. Scancell said it intends to launch a similar trial with iSCIB1+ before 2023 ends. It also noted that positive data from iSCIB1+ could trigger a rapid clinical development programme by the second half of 2024, creating a pathway to a potential deal."

New trial • P2 data • Trial status • Breast Cancer • Chronic Cluster Headache • Genito-urinary Cancer • Gynecologic Cancers • Kidney Cancer • Melanoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Triple Negative Breast Cancer

Modi-1, anti-citrullinated neoepitope vaccine, alone and combined with checkpoint inhibitors in patients with head and neck, breast, renal, and ovarian cancers: ModiFy phase I/II basket clinical trial—Report after completion of monotherapy dose-finding. (ASCO 2023) - P1/2 | "Modi-1 is well tolerated, and the early monotherapy efficacy data are encouraging. Safety and early efficacy data are supportive of further development of combination with CPI. Clinical trial information: NCT05329532."

Checkpoint inhibition • Clinical • Monotherapy • P1/2 data • Anemia • Breast Cancer • Fatigue • Genito-urinary Cancer • Head and Neck Cancer • Hematological Disorders • Immunology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD4 • VIM

Scancell to present ModiFY Phase 1/2 cancer vaccine clinical trial protocol and early efficacy data at the American Society of Clinical Oncology Meeting (Scancell Press Release) - "Scancell Holdings plc...announces it will present a poster...at the American Society of Clinical Oncology Meeting (ASCO) 2023 Annual Meeting taking place at McCormick Place, Chicago, US between 2-6 June 2023. The poster, being presented by Dr Robert Miller, Medical Director, describes the protocol and presents the results after completion of the monotherapy dose-finding and provides an update on patients recruited into the monotherapy dose expansion cohorts and into the checkpoint inhibitor (CPI) combination dose-finding cohort."

Clinical protocol • P1/2 data • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Modi-1, anti-citrullinated neoepitope vaccine alone and combined with checkpoint inhibitors in patients with head and neck, breast, renal and ovarian carcinoma: protocol for the ModiFY phase I/II basket clinical Ttial (AACR 2023) - P1/2 | "These patients are randomized 1:1 to receive either Modi-1 alone or Modi-1+ pembrolizumab. A total of 21/138 patients have been treated to date. ClinicalTrials.gov NCT05329532"

Checkpoint inhibition • Clinical • P1/2 data • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD4 • IFNG • VIM

Encouraging early efficacy data from monotherapy part of ModiFY Phase 1/2 clinical trial (Scancell Press Release) - P1/2 | N=144 | ModiFY (NCT05329532) | "Data from patients receiving the Modi-1 cancer vaccine as a monotherapy showed that it was safe and well tolerated and demonstrated encouraging early efficacy in a head and neck cancer patient and in other hard-to-treat cancers such as high grade serous ovarian carcinoma (HGSOC) and triple negative breast cancer (TNBC)....So far, initial clinical responses have been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one has had a confirmed partial response and seven patients have stable disease, despitehaving progressive disease prior to enrolment in the study. As no dose limiting toxicities were observed in the monotherapy dose escalation cohorts, patients continue to be enrolled into both the ongoing monotherapy expansion cohorts and the CPI combination dose escalation cohorts during H1 2023."

P1/2 data • Trial status • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

"UK's @scancellpharma 's Moditope platform generates CD4 T cell response to stress-induced post-translational modifications. Modi-1 currently in phase I/II trial targeting citrullinated peptides (NCT05329532), Modi-2 preclincial targeting homocitrullinated peptides." (@Bermudashorts2)

P1/2 data • CD4

First patient dosed in the expansion phase of the monotherapy arms of ModiFY (Scancell Press Release) - "Scancell Holdings plc...announces that the first patient in the expansion phase of the monotherapy arms in the multicentre Phase 1 Modi-1 clinical trial (ModiFY) has been enrolled and dosed. In addition, Cohort 3 of ModiFY is now open for recruitment in combination with a checkpoint inhibitor (CPI). Expansion into the monotherapy arms and the start of combination dosing follows review of the safety data from the Cohort 2 patients by the Safety Review Board....The ModiFY study is a first-in-human clinical trial, with Modi-1, the first candidate from Scancell’s Moditope^® platform, being administered alone or in combination with CPIs in patients with head and neck, triple negative breast and renal tumours and as a monotherapy in patients with ovarian cancer, where there are no approved CPI therapies....The Company expects further safety and immunogenicity data to be available in H 2022 and early efficacy data in 2023."

P1/2 data • Trial status • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

First patient dosed in Scancell’s clinical trial for multiple cancers (PharmaTimes) - "Scancell...has announced the enrolment and treatment of the first patient in its multicentre Modi-1 clinical trial (ModiFY) at Imperial College London, Hammersmith Hospital...The study is a first-in-human clinical trial in patients with triple negative breast, ovarian, head and neck and renal cancer....Scancell expects early safety and immunogenicity data to be available later in 2022 and efficacy data in 2023."

P1/2 data • Trial status • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

ISA Pharmaceuticals announce new trial testing technology for cancers (PharmaTimes) - "A clinical trial of Amplivant – an adjuvant technology to boost immune response to cancer therapy –has started. ISA Pharmaceuticals’ novel technology is being tested in a multicentre clinical trial which is also testing the Moditop vaccine, Modi-1....The first-in-human clinical trial brings Modi-1 to patients with triple negative breast cancer, ovarian cancer, head and neck cancer and renal cancer using the Amplivant adjuvant technology to boost immune response to the therapy."

New trial • Breast Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

ModiFY: Modi-1 in Breast, Head and Neck, Ovarian, or Renal Cancer (clinicaltrials.gov) - P1/2 | N=144 | Recruiting | Sponsor: Scancell Ltd

New P1/2 trial • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • IFNG • PD-L1