- The Company Filed IP Protection Related to the ASXL1 Mutation, a Highly Prevalent Gene Mutation in Myeloid Malignancies and Solid Tumors With Significant Market Potential –
- 100% Overall Response Rate in Patients with ASXL1 Mutation in the SLS009 30mg BIW Cohort to Date, All Patients Alive: Further Support for Potential Accelerated Approval Pathway in Defined Patient Population –
- SLS009 Exhibits Strong Anti-Leukemic Activity in 62% of Patients with a Favorable Safety Profile Across All Dose Levels and 67% in the 30 mg BIW Cohort –
- Study Enrollment Ongoing at 30mg BIW Dose of SLS009 with Expansion Cohort of ASXL1 Mutation Patients; Updates Expected in Q3 2024 –
“These early clinical results are very promising and could open up a new avenue in the treatment of AML and potentially beyond,” said
Study highlights:
- As of
April 19, 2024 data cutoff, a 57% overall response rate has been achieved thus far, in the selected optimal dose regimen of 30 mg BIW, far surpassing the targeted 20% rate. - 4/4 (100%) r/r AML patients with ASXL1 truncating mutations at the selected dose level achieved an overall response (CR/CRi/MLFS) and are alive.
- 5/8 (63%) of r/r AML patients, across all dose levels, with ASXL1 truncating mutations treated with SLS009 achieved an overall response.
- A review of the mutational status of the patient in the Phase 1 trial with SLS009 monotherapy,
who achieved a CR lasting 8+ months, revealed that the patient also harbored an ASXL1 mutation. - The ASXL1 mutation is found in both hematological malignancies as well as solid tumors.
- All patients in the study are diagnosed with AML refractory to or relapsed after venetoclax-containing regimens. Enrollment and treatment will be focused on the participants in the expansion cohort receiving 30 mg BIW dose and diagnosed with the ASXL1 mutation.
“The remarkable responses achieved in patients with the ASXL1 mutation underscores the transformative potential of SLS009 in addressing the unmet medical needs of AML but also targeting colorectal cancer, and other tumor types with this alteration,” said
The Phase 2a clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with aza/ven at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The target response rate at the optimal dose level is 20% with a target median survival over 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.
About ASXL1
ASXL1 mutations are associated with poor prognosis in all myeloid diseases, owing to the reduced response to the current treatment options. In AML, ASXL1 mutations were an unfavorable prognostic factor as regards survival, with a significantly lower complete response rate. In MDS, ASXL1 mutations are independently associated with worse overall survival, as well as AML transformation. The tables below demonstrate ASXL mutation frequency across hematologic malignancies and solid cancers.
ASXL1 mutations in Hematologic Malignancies with ASXL1m Frequency ≥5%
Condition | ASXL1m Frequency | US Condition Incidence | |
AML (Acute Myeloid Leukemia) | 20% | 20,800 | |
MDS (Myelodysplastic Syndrome) | 20% | 10,000 | |
MPN (Myeloproliferative Neoplasms) | 10% | 20,000 | |
CMML (Chronic Myelomonocytic Leukemia) | 43% | 1,100 | |
Total | 51,900 |
ASXL1 in Solid Cancers with ASXL1m Frequency ≥5%
Condition | ASXL1m Frequency | US Condition Incidence | |
CRC MSI-high (Colorectal Cancer with High Microsatellite Instability) | 55% | 22,500 | |
Cervical Ca. (invasive) | 5% | 13,800 | |
Liver Ca. | 10% | 42,400 | |
Total | 78,700 |
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Investor Contact
Managing Director
SELLAS@lifesciadvisors.com
Source:
2024 GlobeNewswire, Inc., source