Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) told investors it enrolled and treated the first patient with its Modi-1 vaccine as part of a multi-centre clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer.
Modi-1, which is the first candidate in the company’s Moditope platform, will be administered alone or in combination with a checkpoint inhibitor (CPI).
With up to 108 patients recruited, the initial part of the trial aims to assess the safety and immunogenicity of two citrullinated vimentin peptides and, if there are no significant side effects, a citrullinated enolase peptide will be added.
Early safety and immunogenicity data are expected to be available in the second half of 2022 and efficacy data in 2023, the company reiterated.
In addition, the effect of Modi-1 in promoting T-cell infiltration into the tumour in a neoadjuvant cohort will be assessed in a further cohort of 30 patients with head and neck cancer, with patients treated with Modi-1 with or without CPI, prior to their first surgical resection.
Modi-1 is a vaccine composed of a combination of three peptides from two target antigens, with the peptides linked to Amplivant, which the company said is a potent adjuvant that in preclinical models has shown it enhances immune response between tenfold and a hundredfold.
This results in highly efficient tumour clearance and protection against tumour recurrence.
Amplivant is the subject of a worldwide licensing and collaboration agreement between Scancell and ISA Pharmaceuticals, which will manufacture, develop and commercialise Amplivant-Modi-1 conjugate therapy.
“This is the first time we have taken a product from our Moditope platform into cancer patients and it is a highly significant milestone for the company,” said chief executive Prof Lindy Durrant.
“We are optimistic about the broad clinical utility of Modi-1 and, following safety assessments in the first few cohorts of patients, we intend to rapidly recruit patients across all four cancers."
Dr David Pinato, medical oncologist and principal investigator at Imperial College London, Hammersmith Hospital, said the rationale of treating patients with Moditope “is scientifically attractive, and in clinical practice was very straightforward to administer to our first patient”.
“The study will address many important clinical questions in patients where there is an unmet need.”