In connection with the procurement of contract manufacturer for the active protein in the chlamydia vaccine candidate, Eurocine Vaccines AB (“Eurocine Vaccines” or the “Company”) has, already at this stage, decided to develop a manufacturing method, which is suitable for the manufacture of vaccines on an industrial scale. In connection with the decision, the Company has updated the time plan.
The decision to develop an industrial method for the manufacture of the vaccine at an early stage means that the investment in future work, such as toxicological studies and all clinical studies in phases 1-3, will be carried out with a fully representative active protein from the outset. After proof of concept, the Company intends to out-license the chlamydia vaccine candidate to a vaccine company that will take over the responsibility for the further clinical program and market launch.
The manufacturing method can thus be qualified and quality assured well ahead of future upscaling and commercialization, which in turn significantly reduces the risk at out-licensing and technology transfer to a commercial manufacturing facility.
The new time plan for the chlamydia vaccine candidate reads as follows:
|Quarter I||Start of process development with contract developer|
|Quarter I||Results from the ongoing preclinical study|
|Quarter I – IV||Development of the manufacturing process for the active protein|
|Quarter IV||Manufacture of pilot batch of the active protein|
|Quarter IV||Start of toxicological study|
|Quarter I||Upscaling of the manufacturing process|
|Quarter II||Manufacture of study products for clinical study|
|Quarter III||Toxicological study reported|
|Quarter III||Clinical trial application to the relevant medical agency|
|Quarter IV||Initiate the first clinical study with the chlamydia vaccine candidate|
In parallel with the chlamydia project, several activities are taking place, both to expand the portfolio and to initiate collaborations, such as the evaluation of Endocine™ in a veterinary application, as earlier communicated.
This information is such information that Eurocine Vaccines AB (publ) is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the agency of the contact person set out above, for publication on 30 December 2020.