Regulatory
13 May 2024

Scandion confirms positive final Phase Ib data from PANTAX trial with SCO-101

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Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, today announces final data from the PANTAX phase Ib trial confirming the good safety profile of SCO-101 and showing good signs of efficacy in hard-to-treat pancreatic cancer.

The open-label PANTAX phase Ib international multi-center trial has evaluated Scandion’s lead compound SCO-101 in combination with standard of care chemotherapies gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. The majority of the 22 enrolled patients in the study were heavily pretreated and, in those patients, no other active treatment options were available. The data documents long survival in patients with metastatic pancreatic cancer.

We are encouraged by the positive overall survival data for this hard-to-treat refractory patient population, confirming the top-line results presented last year. These promising data supports the continued development of SCO-101”, says Lars Damstrup, Chief Medical Officer of Scandion.

Overall findings include:

  • The maximal tolerated dose (MTD) was established at 200 mg SCO-101 and presented at ESMO 2023
  • PK data demonstrated that the exposure of SCO-101 was in line with the expectations
  • 15 patients were evaluable for response and 1 had a PR resulting in an ORR of 6.7%
  • Amongst the 15 evaluable patients CBR was 53% (1 PR and 7 SD)
  • Progression-free survival (PFS) was 2.5 months and overall survival (OS) was 9.5 months. Both are in line with historical data for the same patient population

These final data add to the topline results from PANTAX announced in March and October 2023 1,2 which confirmed the safety and tolerability of SCO-101 in combination with chemotherapy Gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer.

Evaluation of MTD was the primary endpoint and was found to be 200 mg SCO-101. The clinically meaningful OS of 9.5 months in this very hard to treat malignancy is important as OS is the gold standard in oncology trials and an important regulatory endpoint. Another secondary endpoint in the trial was Progression Free Survival (PFS) and the median was 2.5 months. For both the ORR, OS and PFS the data from the PANTAX are in line with historical data, 3,4,.

References:
1 https://storage.mfn.se/8a2b68af-9360-4e9f-b1cd-255284eb4fa1/clinical-safety-data-from-the-pantax-trial-is-presented-at-esmo-congress-2023.pdf

2 https://scandiononcology.com/mfn_news/scandion-oncology-successfully-completes-the-dose-finding-with-lead-compound-sco-101-in-advanced-pancreatic-cancer-patients-pantax-phase-ib-trial/

3 https://europepmc.org/article/pmc/4651133

4 https://pubmed.ncbi.nlm.nih.gov/31146420/

For further information please contact:
Johnny Stilou, CFO
Phone: +45 2960 3532
E-mail: jos@scandiononcology.com

This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on May 13, 2024, at 07.00 CET.

About Scandion Oncology

Scandion Oncology (Scandion) is a clinical-stage biotech company using an innovative drug efflux pump inhibition technique with biomodulation capabilities on ABCG2 and UGT1A1 targets to revert drug resistance.

Drug resistance remains a massive problem in cancer treatment and in the development of new medicines. Scandion’s lead compound SCO-101 is currently studying metastatic colorectal cancer (mCRC) in its Phase 2 CORIST trial, while the PANTAX Phase 1 program is developing SCO-101 for pancreatic cancer.

Scandion is based in Copenhagen and is listed on Nasdaq First North Growth Market Sweden (ticker: SCOL). Västra Hamnen Corporate Finance is the Company's certified advisor on Nasdaq First North Growth Market.

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