On August 19, 2022, Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it has now received approvals from authorities and ethical committees in Denmark and Germany for the next parts of the ongoing CORIST phase II-trial (Press release, Scandion Oncology, AUG 19, 2022, View Source,c3615707 [SID1234618499]). The trial studies Scandion’s lead compound SCO-101 as a combination treatment in patients with metastatic colorectal cancer (mCRC). Thus, the development of SCO-101 can continue as planned and communicated in connection with Scandion’s recently completed rights issue.
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Part 1 of the CORIST trial has been completed and part 2 is currently ongoing with topline data expected to be communicated during the third quarter of 2022. To ensure a seamless continuation of the trial, parts 3 and 4 have been planned, and part 3 is ready to start independently of part 2. Patient recruitment in part 3 is expected to commence during the third quarter of 2022, and topline results from CORIST part 3 are expected most likely within the third quarter of 2023.
CORIST part 3 represents an expansion of the development program, in order to best exploit SCO-101’s potential in mCRC. As described in connection with the rights issue the expansion is expected to approximately double the commercial potential of SCO-101 in this indication.
The trial is expanded by adding a new schedule for combining SCO-101 and chemotherapy (FOLFIRI), which will be evaluated in patients with both RAS wild-type and RAS mutated tumors. The expansion was done through an amendment of the ongoing trial, making it possible to initiate the expansion while finalizing part 2, thereby keeping the momentum in the trial and utilizing already activated trial sites.
"We are pleased to have received formal approvals so swiftly and thereby be able to advance the CORIST trial as soon as practically possible. The expansion of the trial will greatly enhance both the medical and commercial potential of SCO-101 and we are delighted to be able to invest in maximizing the value of this compound to the benefit of patients, physicians and Scandion", says Bo Rode Hansen, President & CEO of Scandion.
The CORIST trial is also carried out in Spain. Parts 3 and 4 of the trial are expected to recruit patients here as well as in Denmark and Germany pending one outstanding approval in Spain.