ExpreS2ion Biotech: Start of a promising year
Clinical study is screening cancer patients
ExpreS2ion Biotechnologies and its partners in Austria have started to screen potential participants with metastatic breast cancer for a first-in-human phase 1 trial of ES2B-C001. Each patient will have five injections of the cancer vaccine candidate ES2B-C001 and safety results will be evaluated after an 18-week treatment period.
Three different doses will be evaluated in up to twenty-seven patients. Management expects the trial to last 18 months including full evaluation of the last treated patient. Principal investigator is Professor Rupert Bartsch at the department of clinical pharmacology, Medical University of Vienna.
First readout possible by year-end
Dosing of the first participant is expected to start in this quarter, a milestone which we believe will be separately released. Interim data from the first cohorts is anticipated within a 40–48-week period, which would suggest a timing around year-end.
As always in these first clinical stages, it will be decisive to follow the recruitment steps of the trial. It was listed as recruiting patients in early January. By starting one clinical center, it may be assumed that the recruitment pace will be slow in the early phase of the trial, but on the other hand the targeted patient population is common. Furthermore, additional sites in Austria have been identified and can be opened if needed.
Potential strength of vaccine approach to cancer
Based on solid preclinical data in mice, management has extrapolated the potential efficacy of ES2B-C001 in humans. The >19 months progression-free survival (PFS) in diseased mice would in a mathematical model, called allometric scaling, translate into an impressive 7-year PFS in humans.
This compares with 18 months PFS with the current standard-of-care with combined antibodies. However, this type of translation of animal data should be used with caution.
Cash position expected to cover first readout
ExpreS2ion ended last year with a cash position of SEK 81m, above our expectation at SEK 70m. This was driven by the received tax credits from the Danish state which we did not anticipate. Cash is expected to last to the first read-out in the second half of this year. Further financing will also be provided by the TO11 warrant in September, which can add up to 0,8 mln new shares.
ExpreS2ion is heading for an exciting start in 2025, which allows us to stick to a fair value of SEK 91 per share. Our main scenario is based on a licensing deal in 2027.