BASILEA PHARMACEUTICA AG (SIX: BSLN). Please visit basilea.com https://www.globenewswire.com/Tracker?data=1BJd5k0B7ZURoQl3h57m2kLVYYY50OtTUFW20Mx5h8O6ESlEtIYfDuxOAkyQtSQ-iIm2hEAzsLmT2LQZHeHdpQ== . Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. Derazantinib and its uses are investigational and have not been approved by a regulatory authority for any use. Efficacy and safety have not been established. The information presented should not be construed as a recommendation for use. The relevance of findings in nonclinical/preclinical studies to humans is currently being evaluated. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from www.basilea.com. References 1. FIDES-01: ClinicalTrials.gov identifier: NCT03230318 2. Topline results of cohort 1 of the FIDES-01 study were published on February 10, 2021 (see press release https://www.basilea.com/news/news/basilea-reports-positive-topline-results-from-phase-2-study-fides-01-for-derazantinib-in-fgfr2-gene-fusion-positive-patients-with-bile-duct-cancer-icca ). Interim results of cohort 2 of the FIDES-01 study were published on March 24, 2021 (see press release https://www.basilea.com/news/news/basilea-reports-positive-interim-results-from-phase-2-study-fides-01-for-derazantinib-in-fgfr2-gene-mutation-or-amplification-positive-patients-with-bile-duct-cancer-icca ) 3. Results from the dose-finding part of FIDES-02 were published on February 12, 2021 (see press release https://www.basilea.com/news/news/basilea-reports-derazantinib-pd-l1-checkpoint-inhibitor-combination-results-from-dose-finding-part-of-fides-02-study-in-patients-with-solid-tumors-at-asco-gu-symposium ) 4. T. G. Hall, Y. Yu, S. Eathiraj et al. Preclinical activity of ARQ 087, a novel inhibitor targeting FGFR dysregulation. PLoS ONE 2016, 11 (9), e0162594 5. R. Porta, R. Borea, A. Coelho et al. FGFR a promising druggable target in cancer: Molecular biology and new drugs. Critical Reviews in Oncology/Hematology 2017 (113), 256-267 6. T. Helsten, S. Elkin, E. Arthur et al. The FGFR landscape in cancer: Analysis of 4,853 tumors by next-generation sequencing. Clinical Cancer Research 2016 (22), 259-267 7. P. McSheehy, F. Bachmann, N. Forster-Gross et al. Derazantinib (DZB): A dual FGFR/CSF1R-inhibitor active in PDX-models of urothelial cancer. Molecular Cancer Therapeutics 2019 (18), 12 supplement, pp. LB-C12 8. M. A. Cannarile, M. Weisser, W. Jacob et al. Colony-stimulating factor 1 receptor (CSF1R) inhibitors in cancer therapy. Journal for ImmunoTherapy of Cancer 2017, 5:53 9. Y. Zhu, B. L. Knolhoff, M. A. Meyer et al. CSF1/CSF1R Blockade reprograms tumor-infiltrating macrophages and improves response to T cell checkpoint immunotherapy in pancreatic cancer models. Cancer Research 2014 (74), 5057-5069 10. E. Peranzoni, J. Lemoine, L. Vimeux et al. Macrophages impede CD8 T cells from reaching tumor cells and limit the efficacy of anti--PD-1 treatment. Proceedings of the National Academy of Science of the United States of America 2018 (115), E4041-E4050 11. V. Mazzaferro, B. F. El-Rayes, M. Droz dit Busset et al. Derazantinib (ARQ 087) in advanced or inoperable FGFR2 gene fusion-positive intrahepatic cholangiocarcinoma. British Journal of Cancer 2019 (120), 165-171. ClinicalTrials.gov identifier: NCT01752920 12. FIDES-02: ClinicalTrials.gov identifier: NCT04045613 13. FIDES-03: ClinicalTrials.gov identifier: NCT04604132 14. S. K. Saha, A. X. Zhu, C. S. Fuchs et al. Forty-year trends in cholangiocarcinoma incidence in the U.S.: intrahepatic disease on the rise. The Oncologist 2016 (21), 594-599 15. A. Lamarca, D. H. Palmer, H. S. Wasa et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, controlled trial. Lancet Oncology 2021 (22):690-701 16. B. Dietrich, S. Srinivas. Urothelial carcinoma: the evolving landscape of immunotherapy for patients with advanced disease. Research and reports in urology 2018 (10), 7-16 17. A. O. Siefer-Radtke, A. Necchi, E. Rosenbaum et al. Efficacy of programmed death 1 (PD-1) and programmed death 1 ligand (PD-L1) inhibitors in patients with FGFR mutations and gene fusions: Results from a data analysis of an ongoing phase 2 study of erdafitinib (JNJ-42756493) in patients with advanced urothelial cancer. Journal of Clinical Oncology 2018 (36), supplement, abstract 450 18. Y. Loriot, A. Necchi, S. H. Park et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. New England Journal of Medicine 2019 (381), 338-348 19. F. M Johnston, M. Beckman. Updates on management of gastric cancer. Current Oncology Reports 2019 (21), 67 20. M. Orditura, G. Galizia, V. Sforza et al. Treatment of gastric cancer, World Journal of Gastroenterology 2014 (20), 1635-1649 21. A. Bass, V. Thorsson, I. Shmulevich et al. Comprehensive molecular characterization of gastric adenocarcinoma. Nature 2014 (513), 202-209 Attachment -- Press release (PDF) http://ml-eu.globenewswire.com/Resource/Download/0294fdd6-7ebb-4db1-94ab-ce3165b9b518
(END) Dow Jones Newswires
May 31, 2021 01:15 ET (05:15 GMT)
