Scancell to present ModiFY Phase 1/2 cancer vaccine clinical trial protocol and early efficacy data at the American Association for Cancer Research Annual Meeting
pharmafile | April 18, 2023 | News story | Business Services |
Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces it will today present a poster entitled “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 trial” at the American Association for Cancer Research (AACR) 2023 Annual Meeting taking place at the Orange County Convention Center in Orlando, Florida, US between 14-19 April 2023.
The poster being presented by Fayaz Master, Head of Clinical Operations, describes the protocol and introduces the concept of citrullination as a good target for cancer vaccines. This is exemplified by presenting the results reported by the Company on 21 February on the ModiFY trial. This is a first-in-human Phase 1/2 basket trial investigating the use of Modi-1, the first candidate from Scancell’s Moditope® platform, to treat four different types of cancer: high grade serous ovarian carcinoma (HGSOC), triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (SCCHN) and renal cell carcinoma (RCC).
The poster, which includes data up until the date of the poster acceptance by AACR, concludes that Modi-1 is well tolerated and that the early efficacy data from the monotherapy arm of the trial is encouraging. Safety and early efficacy data are supportive of the current ongoing sub-studies with Modi-1 in combination with standard of care checkpoint inhibitor (CPI) therapy. Over 20 patients had been vaccinated with Modi-1 and all had skin reactions at the injection sites consistent with a delayed-type hypersensitivity (DTH) reaction indicative of a T cell response. Initial clinical responses had been assessed in 14 patients reaching the first imaging evaluation timepoint at week 8. Of these patients, one had a confirmed partial response and seven patients had had stable disease, despite having progressive disease prior to enrolment in the study.
The ModiFY study is ongoing and recruiting patients into the Phase 2a sub-study investigating Modi-1 monotherapy in dose expansion cohorts. In tandem, patients are being screened for treatment with Modi-1 in combination with standard of care CPI therapy. The safety, efficacy and immunology of Modi-1 will continue to be evaluated in up to 138 cancer patients within the master protocol.
The title, timing and location of the poster presentation are as follows:
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Abstract |
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Poster presentation title |
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 trial |
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Session title |
Phase I and First-in-Human Clinical Trials in Progress |
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Session date and time |
13:30 – 17:30 ET, 18 April 2023 |
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Location |
Orange County Convention Center, Section 46, Poster Board Number 19 |
Copies of the poster will be available on Scancell’s website following the conference at: https://www.scancell.co.uk/vaccine-publications
