The majority of all treatments for patients with metastatic cancer fail. This is mainly because the cancer cells are resistant already when the cancer diagnosis is confirmed, or because resistance arises during treatment. Scandion Oncology The goal is to combat cancer cells' resistance to current cancer treatments.
Clinical studies are proceeding according to plan
Scandion is currently evaluating the lead candidate SCO-101 in phase II and Ib studies CHORUS and PANTAXThese studies are focused on chemotherapy-resistant metastatic colon cancer (mCRC) and pancreatic cancer, respectively – two diseases where drug resistance affects 9 out of 10 patients.
Earlier this year, the company expanded its pipeline with the blood cancer form acute myeloid leukemia (AML), where drug resistance affects over half of patients. In April, the company was strengthened by a scientific study that points to the need for new treatments that address drug resistance in AML. Read moreScandion expects to be able to present preclinical data in H2, 2023.
In the phase II CORIST study, patients are given SCO-101 together with FOLFIRI, i.e. today's standard of care for mCRC. All patients participating in this clinical trial have previously demonstrated resistance to FOLFIRI.
Phase II study CORIST
The first part of the Phase II CORIST trial was able to establish a safe dose of SCO-101 with FOLFIRI and was successfully completed with positive interim results in June 2021. The second part has enrolled 25 patients and is focusing on safety and efficacy. Topline data from the end of Q3, 2022 confirmed the safety and tolerability of SCO-101, with some tumor reductions observed. Read more here.
Based on these results, CORIST Part 3 is designed to optimize the dosing of SCO-101 and chemotherapy to maximize efficacy in patients with mCRC. The goal is to achieve a tumor reduction of 30 percent, thereby proving the efficacy of the treatment concept.
The company expects to be able to present data from the ongoing study in H2, 2023. Depending on how the study turns out, the company may plan part 4 of CORIST, a clinical proof-of-concept study.
Phase Ib study PANTAX
The PANTAX study aims to determine a safe dose of SCO-101 in combination with standard-of-care chemotherapies nab-paclitaxel and gemcitabine in patients with inoperable or metastatic pancreatic cancer. The company initiated the Phase Ib dose study in 2020, and in August 2022, the dosage was increased to higher levels than expected. This extended the study to H1, 2023. This spring, the maximum tolerated dose of SCO-101 was identified, 200 milligrams, in combination with standard-of-care. Read more.
Presentation of topline results from PANTAX will take place at European Society for Medical Oncology (ESMO) Congress in October and a full analysis can probably be expected in the first half of 2024. This analysis will form the basis for further developments in pancreatic cancer and/or other indications.
In summary, Scandion Oncology has dosed SCO-101 at higher doses than expected, demonstrating good tolerability, while achieving the goal of identifying the maximum tolerated dose of the candidate. It also provides a good basis for the company to further analyze and develop SCO-101 as a combination therapy.
Strengthened patent protection
Scandion Oncology's Q2 report shows that the company has also extended its financial sustainability after savings, which means that the business is financed until the second half of 2024.
In July, the company secured an upcoming patent approval in the EU covering the solid crystalline forms of SCO-101, which includes the form of the substance that Scandion expects to commercialize. The patent, if finally approved, will be valid until 2042, thereby extending the potential commercial exclusivity period for SCO-101.
At the same time, the patent enables expanded development of SCO-101 into new indications and drug combinations, and can strengthen the company in future partner discussions. Last but not least, it also potentially reduces the company's overall development risk by adding acute myeloid leukemia (AML) to its preclinical pipeline.
Comments from the CEO
In a comment to BioStock, he says Scandions CEO, Francois Martelet, MD:
"Scandion had a good second quarter of 2023 in which we continued to seamlessly execute our strategy and plans. We maintained strong momentum in the CORIST trial, reduced internal and external costs to extend our cash runway and significantly enhanced the patent protection of SCO-101, our lead compound. Further, we continued the pre-clinical research in Acute Myeloid Leukemia (AML). All in all, it was another quarter with strong operational execution in which we right-sized the company and made several efforts to de-risk our development pipeline.”