Krakow, Poland – 16 May 2019 – Selvita today announced that abstracts regarding Phase 1/2 study of SEL24/MEN1703 accepted for poster presentations at the 2019 American Society of Clinical Oncology (ASCO) annual meeting and 24th Annual European Hematology Association (EHA) Congress are now available online.
The poster entitled “CLI24-001: First-in-human study of SEL24/MEN1703, an oral dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia” (abstract #256995) will be presented at the 2019 ASCO Annual Meeting (Presenting Author: Farhad Ravandi-Kashani, M.D., of the University of Texas MD Anderson Cancer Center, on June 3, from 8:00 – 11:00 a.m. (ET)).
2019 ASCO Annual Meeting will take place in Chicago from May 31 to June 4, 2019.
The second poster, entitled “CLI24-001: First-in-human study of SEL24/MEN1703, an oral dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia”, (abstract PF281) will be presented during the 24th EHA Congress, on June 14, from 5:30 – 7:00 p.m. (CET).
24th Congress of EHA will take place in Amsterdam, Netherlands, June 13 to 16, 2019.
The CLI24-001 study was initiated in March 2017 and is the first clinical trial testing a dual PIM/FLT3-ITD inhibitor, potentially active in acute myeloid leukemia (AML) regardless of FLT3 status and able to overcome FLT3 inhibitor resistance.
The aim of the study is to determine the recommended Phase 2 dose (RP2D), the pharmacokinetic profile and the single agent activity of SEL24/MEN1703 in relapsed/refractory or newly diagnosed AML patients (excluding acute promyelocytic leukemia (APL) patients) not suitable for chemotherapy treatment.
According to the information published in the EHA abstract, as of January 8, 2019 (data cutoff), n=17 patients were treated and the study is completing the dose escalation part of a two-part, first-in-human study in patients with relapsed/refractory or newly diagnosed non-promyelocytic AML not suitable for chemotherapy.
The second part of the study, a cohort expansion at the recommended Phase 2 dose (RP2D) is planned to confirm the safety profile and assess single agent activity.
According to the information in the EHA Congress abstract provided by the sponsor Menarini Ricerche SpA, in the recommended dose expansion part, the study (currently running at five U.S. sites) will be expanded to approximately 40 sites in the U.S. and EU.
Additional information on the Phase 1/2 study, which is being conducted by Selvita’s partner Menarini Group, is available at https://clinicaltrials.gov/ct2/show/NCT03008187.
About the 2019 ASCO Annual Meeting
With over 40,000 attendees the ASCO Annual Meeting is one of the largest educational and scientific events in the oncology community. The five-day event provides a venue for physicians and scientists to present research results to a global audience of oncology professionals. ASCO offers a robust program designed to teach, engage, and bring the oncology field together.
About the 24th EHA Congress
The Annual Congress of EHA is a flagship meeting held in a major European city every June—a significant meeting place for hematologists from every area of specialization. Annual congresses encompass the entire spectrum of hematological studies, where over 11,000 participants who share passion for this field, can learn about the latest findings and innovations.
Selvita is developing novel small molecule therapies that address emerging targets in oncology with industry-leading research expertise supported by a research services division. Pipeline candidates apply diverse mechanisms directed at kinases, synthetic lethality pathways, immuno-oncology pathways and other cancer-related targets. SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia. SEL120 is a CDK8 kinase inhibitor with potential for development in indications including hematological malignancies and solid tumors. Selvita is headquartered in Krakow with offices in the U.S. and U.K. In March 2019, Selvita announced the intent to split its oncology development and research services divisions into separate companies.