ExpreS2ions huvudkandidat, bröstcancervaccinet ES2B-C001, fortsätter att avancera i sin kliniska fas I-studie. Under det fjärde kvartalet gav den oberoende säkerhetskommittén (DSMB) grönt ljus att gå vidare till nästa doskohort, baserat på positiva säkerhetsdata. Bolaget har rapporterat tidiga men uppmuntrande data kring immunogenicitet, som visar läkemedelsspecifika immunsvar vid dosnivån 50-μg. ExpreS2ion ligger fortsatt i fas för att slutföra doseskaleringen i fas Ia runt mitten av 2026, med en planerad expansion till fas Ib mot slutet av 2026.
Betydande milstolpar inom infektionssjukdomar
Utöver onkologin har ExpreS2ion uppnått flera stora milstolpar inom sin portfölj för infektionssjukdomar, vilket validerar mångsidigheten hos ExpreS2-plattformen. En framträdande händelse under kvartalet var tecknandet av ett slutgiltigt licensavtal med Serum Institute of India, som omfattar två Oxford-ledda vaccinkandidater mot blodstadiet av malaria (RH5.1 och R78C).
Dessutom har VICI-Disease-programmet för ett Nipahvirusvaccin tagit viktiga steg mot att bli redo för kliniska studier. Efter ett slutgiltigt antigenval och framsteg inom processutvecklingen, utsåg ExpreS2ion nyligen Northway Biotech till sin kontraktstillverkare (CDMO) för den kommande GMP-produktionsfasen.
Finansiell ställning och vd-kommentarer
Under Q4 inbringade inlösen av teckningsoptioner av serie TO11 en bruttolikvid om cirka 10,4 Mkr, vilket stärkte bolagets finansiella flexibilitet. Vid utgången av 2025 uppgick likvida medel (kassan) till 48 Mkr.
BioStock kontaktade vd Bent U. Frandsen för att få en djupare inblick i portföljens framsteg och förväntningarna på det kommande året.
You recently received a DSMB recommendation to proceed to the next dose cohort for ES2B-C001. How significant are the early immunogenicity observations you have seen so far in this first-in-human oncology setting?
– Based on the data currently available, five out of six evaluable patients have demonstrated a drug-specific immune response, defined as an increase from baseline in anti-HER2 lambda light-chain antibody titers following treatment with ES2B-C001. This is encouraging, and we are pleased to progress on the back of these early data.
The licensing agreement with the Serum Institute of India is a major milestone for your malaria programmes. What does this partnership mean for ExpreS2ion from a long-term commercial perspective?
– Following the closing of the licensing transaction we have been in a technology transfer phase, so SII can take the two malaria cell lines derived from our S2 cells into their manufacturing process. It’s a big step that SII is now going to initiate production of RH5.1 and R78C antigens by application of ExpreS2ion’s technology. The broader the application of our ExpreS2 platform the better we think from a long-term commercial perspective.
With Northway Biotech now selected for the GMP manufacturing of the Nipah virus vaccine, what does the expected timeline look like for advancing this candidate into clinical evaluation?
– We are on track with the development plan work packages that will pave the way for producing Nipah virus antigen under Good Manufacturing Practice (GMP). Following technology transfer and setup at Northway Biotech, we expect them to supply material for GLP toxicology studies and a GMP-compliant clinical batch before the end of 2026. Together, these activities will support submission of the IND and potential entry into the clinic in 2027.
Considering your year-end cash position of SEK 48 million and the recent TO11 capital injection, how do you view your financial runway in relation to the clinical milestones planned for 2026?
– As of 31 December 2025, we had approximately SEK 48 million in cash, and the TO11 warrant exercise further strengthened our balance sheet. Based on our current operating plan, this supports operations towards the next phase I clinical milestones and interim readouts planned for 2026. As previously communicated, additional funding will be required to complete phase Ia and support further development.
As we move further into 2026, what are the most critical value-inflection points across your proprietary and partnered pipeline that investors should keep an eye out for?
– For ES2B-C001, our lead breast cancer program, the key milestones in 2026 are continued progress in the Phase I dose escalation study, with interim safety and immunogenicity updates, as well as the potential for early exploratory observations on clinical activity as the dataset matures. In our partnered portfolio, we expect further clinical readouts from the Oxford-led malaria trials, and advancement of the Nipah vaccine program into GMP manufacturing and IND-enabling activities under the VICI consortium. Together, these represent important development steps across both oncology and infectious diseases.
Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från.
