Scandion Oncologys vd: “Our clinical study and partnering strategy are jointly progressing”
Scandion Oncologys bokslutskommuniké för 2023 fokuserar på det faktum att bolaget på ett år har levererat flera omgångar positiva data från fas IIa-studien CORIST. BioStock har talat med vd Francois Martelet för att få hans syn på hur SCO-101 ska positioneras ur ett kliniskt och marknadsmässigt perspektiv.
Scandion Oncology utvecklar first-in-class-läkemedel för behandling av cancerformer som är resistenta mot nuvarande behandlingsalternativ. Huvudkandidaten SCO-101 utvärderas för närvarande i fas II- och Ib-studierna CORIST och PANTAX. Förhoppningen är att förbättra behandlingen av kemoterapiresistent metastaserad kolorektalcancer (mCRC) och bukspottkörtelcancer, där resistens uppstår i så många som nio av tio patienter.
I CORIST-studien ges patienterna SCO-101 i kombination med cellgiftsbehandlingen FOLFIRI, som för närvarande är standardbehandlingen vid mCRC.
Positiva data
I slutet av januari i år meddelade Scandion positiva topline-resultat från den pågående tredje delen av fas II-studien CORIST i kolorektalcancer med SCO-101. Dessa data visade en tumörreduktion som stödjer kombinationen med kemoterapin FOLFIRI, en väsentligt ökad progressionsfri överlevnad, en hög klinisk nytta samt konsekvent säkerhet och tolerabilitet.
Resultaten bekräftar dessutom tidigare data som rapporterats i de två första delarna av studien. Efter att 21 av 25 patienter nu har utvärderats, så har medianvärdet för progressionsfri överlevnad (PFS) ökat till 4,6 månader. Det är en tydlig förbättring jämfört med medianvärdet för PFS på 2,0 månader som sågs i den andra delen av studien.
Den kliniska nyttan ökar över tid
Den senaste analysen av top line-data visar också att Clinical Benefit Rate (CBR) ökade till 76 procent efter åtta veckors behandling – en ökning från 46 procent från del två av CORIST. En av patienterna uppvisade en markant tumörreduktion (partiell respons) på över 30 procent. Sammantaget tyder detta på en potentiell minskning eller stabilisering av tumören och en ihållande och ökad nytta av kombinationsbehandlingen ju längre patienterna står på behandling med SCO-101. Behandlingen var säker och tolererades väl.
Läs en intervju med Scandions CMO Lars Damstrup om den senaste batchen av data här: Scandion rapporterar positiva resultat från del tre av CORIST. (2 feb 2024)
»We have already established contacts with potential partners and discussions are ongoing, and we expect market interest to increase as we execute on our strategy with SCO-101. We have a good understanding of what these potential partners are looking for and continuing our progression toward our phase IIb randomized study is key right now« – Francois Martelet, vd Scandion Oncology
Vd kommenterar
BioStock kontaktade Scandions vd Francois Martelet för att få veta mer om bolagets planer för att ta SCO-101 vidare ur ett kliniskt, men även affärs- och partnerskapsmässigt perspektiv.
Francois, considering the recent positive developments in the CORIST study, how do you anticipate leveraging these results to explore new partnership opportunities?
– We clearly started 2024 in a strong position thanks to the positive CORIST Part 3 trial data, combined with the first two parts or the trial. The solid data support the mechanism of action of our lead compound SCO-101 reinforces the strategy that we developed together with our advisors – to first optimize the doze of the anti-cancer agent irinotecan in combination with SCO-101 before progressing to the randomized Phase IIb trial.
– We developed our clinical development plan together with our advisors, but also with supportive feedback from potential pharma partners during the project. Business development activities and partner discussions are absolutely part of our strategy. We have already established contacts with potential partners and discussions are ongoing, and we expect market interest to increase as we execute on our strategy with SCO-101. We have a good understanding of what these potential partners are looking for and continuing our progression toward our phase IIb randomized study is key right now.
What steps are being taken to attract potential institutional investors who share an interest in advancing SCO-101?
– We know there is a tremendous unmet patient need for the treatment of drug resistant metastatic colorectal cancer (mCRC). And we are also confident in the potential of SCO-101. Scandion took a lot of time discussing the market potential with our scientific advisors and potential partners to home in on the best development path for SCO-101. Like with any life science company, our goal is to communicate the market and scientific potential.
– We have had positive data up to this point and we need to prove to the market that SCO-101 truly works and that is done by delivering actual data. The case has gotten stronger each time we release data. I trust potential institutional investors will appreciate all the data produced so far and our strategy to advance the program.
How does SCO-101 differentiate itself in the competitive oncology landscape?
– First, Scandion Oncology is a targeted therapy company working on drug resistance, and we are one of few companies working with efflux pump inhibition, which is an innovative mechanism of action. This is import in terms of how we stand out in the market.
– The recent CORIST part 3 positive data leverage our bio-modulating mechanism of action of our lead compound SCO-101 through our ACBG2 and UGT1A1 targets. This dual mechanism of action is critical for those patients with other cancer and other diseases that are resistant to treatment. SCO-101 has a unique dual-targeting mechanism of action, selectively targeting the protein ABCG2 and the enzyme UGT1A1 simultaneously. In this way, it aims to maximize therapeutic efficacy of chemotherapy in colorectal cancer while minimizing the risk of resistance development.
How does Scandion Oncology plan to navigate regulatory pathways and reimbursement challenges to ensure widespread access to SCO-101?
– A key part to Scandion’s development strategy is having a good understanding of what regulators in Europe and the US would be looking for in terms of trial design. We have always worked closely with our experienced scientific advisory board and other advisors to map out our best path forward to market approval. We are still progressing toward our phase IIb randomized study, so it is a bit early to talk about reimbursement strategy. We have positive data telling us SCO-101 works so now it is time to execute on the rest of our development plan.
Finally, what milestones do you anticipate within the coming year?
– We have several value inflection points for 2024. The first will be the CORIST part 3 PK and safety data, which should reinforce the positive recent part 3 topline results release earlier this year. We will also release the final results for the Phase 1b PANTAX trial. Later in the second half of the year we will have the final data from part 3 of CORIST. What is critical for our strategy now is advancing CORIST toward the Phase IIb randomized trial. The first step in doing that will be optimizing the dose of the anti-cancer agent irinotecan in combination with SCO-101.
– The goal is to establish the maximum tolerated dose of SCO-101at 250 mg with an increasing dose of irinotecan. Up to 12 patients in this smaller CORIST part 3 testing will be divided into two groups. Once this is complete, Scandion will be ready for the randomized phase IIb/III study, a move that will put us in a strong market position. We have a clear plan. Now it is time to execute.
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