tambiciclib (SLS009) / GenFleet Therap, SELLAS Life Sciences - LARVOL DELTA

In vitro efficacy of CDK9 inhibitor tambiciclib (SLS009) in ASXL1 mutated colorectal cancer cell lines. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Preclinical • Colorectal Cancer • Oncology • Solid Tumor • ASXL1

SELLAS Life Sciences Announces First Pediatric AML Patient Dosed in the Ongoing Phase 2 Trial of SLS009 r/r AML (GlobeNewswire) - "SELLAS Life Sciences Group, Inc...today announced that the first pediatric AML patient has been dosed in the ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML)....The Phase 2 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 venetoclax and azacitidine at two dose levels, 45 and 60 mg."

Trial status • Acute Myelogenous Leukemia

PIVOT - Received Preliminary Data for Pediatric Acute Lymphoblastic Leukemia (ALL) Patients Derived Xenografts (PDX) (GlobeNewswire) - "The experiment conducted and funded by the National Institute of Health (NIH) through the PIVOT program included 27 patient-derived ALL tumors from pediatric patients. Tumors were xenografted in mice in two groups: vehicle control arm and SLS009 arm. Mice were treated with a fractionated dose once per week for 6 consecutive weeks. The treatment was well tolerated. For all models, median survival was approximately tripled in the SLS009 arm compared to the vehicle control arm. SLS009 demonstrated delayed progression in 25/27 (93%) models and more than 2 times longer time to progression in 15/27 (56%) of ALL models. In addition, there were complete responses (CR) in 2 models, and in one of the two models, CR was maintained after the treatment had been completed until the end of the study (4 months)."

Preclinical • Acute Lymphocytic Leukemia

SELLAS Unveils Breakthrough Preclinical Data Highlighting Efficacy of SLS009 in TP53 Mutated AML at the 2025 AACR Conference (GlobeNewswire) - "Preclinical data suggest that SLS009, a highly selective CDK9 inhibitor, can induce apoptosis downstream of p53 by targeting critical proteins such as MCL-1 and survivin, regardless of p53 status. Immunoblot analysis reveals near-complete removal of these proteins in treated cells within 8 hours of exposure to SLS009. Furthermore, the treatment reduced TP53-mutated leukemia cell populations by up to 97% in combination with azacitidine–venetoclax, and by up to 80% as monotherapy."

Preclinical • Acute Myelogenous Leukemia

SELLAS to Present at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "SELLAS Life Sciences Group...announced that preclinical efficacy of SLS009 in ASXL1 mutated colorectal cancer lines will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting..."

Preclinical • Colorectal Cancer

SELLAS Announces Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 in r/r AML (GlobeNewswire) - P1/2 | N=160 | NCT04588922 | Sponsor: Sellas Life Sciences Group | "8.9 Months Median Overall Survival (mOS) in Patients with AML-Myelodysplasia-Related Changes (AML-MRC) and 8.8 mOS in All Relapsed or Refractory to Venetoclax-Based Regimens Patients; Surpassing Historical Benchmark of 2.5 Months; Overall Response Rate (ORR) of 67% Achieved in Patients with AML-MRC (Target Patient Population of SLS009 in r/r AML) – Exceeding Targeted 20% ORR; Trial Continues with Full Data and FDA Regulatory Path Feedback Expected in 1H 2025."

P2 data • Acute Myelogenous Leukemia

SELLAS Life Sciences Reports Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Reported Positive Overall Survival and Overall Response Rate Data from the Ongoing Phase 2 Trial of SLS009 (Tambiciclib) in r/r AML – Full Data and FDA Regulatory Path Feedback Expected in 1H 2025"

FDA event • P2 data • Acute Myelogenous Leukemia

SELLAS Announces Positive Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL (GlobeNewswire) - PIb/II | N=51 | NCT06375733 | Sponsor: Genfleet Therapeutics (Shanghai) Inc. | "SELLAS Life Sciences...announced data from Phase 2a trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)...The results showed an overall response rate of 67%, more than double the expected overall response rate (ORR) of zanubrutinib alone. Among responders, one achieved complete response (CR), while three had partial response (PR) with target lesion shrinkages of 89%, 78%, and 56%, respectively. As of the last follow-up, after the median of 4.6 (range: 1.4 - 7.4) months follow-up, median overall survival (OS) was not reached, and six out of 9 patients were alive....Genetic data of 6 out of 9 enrolled patients showed that none of the patients carried MYD88 or CD79B mutations predictive of better response to BTK inhibitors."

P2a data • Diffuse Large B Cell Lymphoma

Expected Milestones in 2025: SLS009: highly selective CDK9 inhibitor (GlobeNewswire) - "Phase 2 clinical trial in AML: Full topline data from expansion cohorts which include AML-MRC patients with ASXL1 mutation (cohort 4) and mutations and cytogenic changes other than ASXL1 (cohort 5) are expected in 1H 2025; FDA feedback on regulatory path for r/r AML study expected in 1H 2025."

FDA event • P2 data • Acute Myelogenous Leukemia

SELLAS Announces Positive Overall Survival and Overall Response Rate Data from the Phase 2 Trial of SLS009 in r/r AML (GlobeNewswire) - P1/2a | N=160 | NCT04588922 | Sponsor: Sellas Life Sciences Group | "Key Highlights from the updated topline data: As of December 4, 2024, data cutoff, 14 patients were enrolled in Cohort 3 and 14 in Cohort 4 and 5, of which 9 were evaluable at the time of analysis. At latest follow-up, the mOS has not been reached yet but has exceeded 7.7 months in Cohort 3. This is particularly significant as the expected mOS for patients in this setting is typically 2.5 months. In expansion cohorts 4 and 5, in patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation (cohort 4) and mutations and cytogenic changes other than ASXL1 (cohort 5) the ORR was 56% in 9 evaluable for efficacy patients. SLS009 was well-tolerated with no new safety signals observed to date as the regimen remains safe in additional patients enrolled to date."

P2a data • Acute Myelogenous Leukemia

SELLAS Announces Positive Data from Preclinical Studies Indicating ASXL1 Mutations as Predictor of Response to SLS009 in Solid Cancers (GlobeNewswire) - "SELLAS Life Sciences Group, Inc...announced data from preclinical studies identifying ASXL1 mutation as key predictor of SLS009, a highly selective CDK9 inhibitor, response in solid cancers....In CRC MSI-H, ASXL1 mutations were observed in 7/12 (58%) of PDCs, aligning with predicted frequency of ~55%; In NSCLC, ASXL1 mutations occurred in 2/6 (33%) studied cell lines, higher than predicted 2.6%; Overall, in 18 studied solid cancer cell lines, ASXL1 mutations were recorded in 9 cell lines and no ASXL1 mutations were recorded in 9 cell lines which were designated as control; In ASXL1 mutated cell lines, high SLS009 efficacy (IC50 <100 nM) was observed in 6/9 (67%) solid cancer cell lines and in non-ASXL1 mutated cancer high SLS009 efficacy was observed in 0/9 (0%) of studied solid cancer cell lines."

Preclinical • Colorectal Cancer • Microsatellite Instability • Non Small Cell Lung Cancer

Preclinical metabolism and disposition of [14C]GFH009, a novel selective CDK9 inhibitor. (PubMed, Xenobiotica) - "Besides, the major clearance pathway for GFH009 was excretion and the minor one was metabolism.5. GFH009 exhibits favourable drug metabolism and pharmacokinetics (DMPK) properties, which provides valuable insights into the disposition of GFH009 and can be used to guide future clinical studies."

Journal • Preclinical • CDK9

SELLAS Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Pipeline Highlights:...(i) Phase 3 REGAL study in AML:...Based on a detailed analysis of all unblinded data, the IDMC projected that the interim analysis (60 events) will occur in the fourth quarter of 2024; (ii) SLS009:...Additional Phase 2 Cohorts in Venetoclax Combinations in r/r AML Continue Enrollment:...These cohorts are also open for enrollment of certain pediatric patients. Additional topline data updates are expected in the fourth quarter of 2024."

Enrollment status • P2 data • P3 data • Acute Myelogenous Leukemia

SELLAS Life Sciences to Present at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2024 (GlobeNewswire) - P1/2 | N=160 | NCT04588922 | Sponsor: Sellas Life Sciences Group | "Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure; 50% Response Rate at the Selected Dose Level of 30 mg Twice a Week (BIW); 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.5 Months vs. <2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg BIW Median OS Not Reached."

P2a data • Acute Myelogenous Leukemia

SELLAS Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Phase 3 REGAL study in AML:...Based on a detailed analysis of all unblinded data, the IDMC projects that the interim analysis (60 events) will occur by the fourth quarter of 2024....SLS009: highly selective and specific CDK9 inhibitor:...Additional Phase 2 Cohorts in Venetoclax Combinations in r/r AML Opened for Enrollment: Development of SLS009 continued with the opening of two new cohorts - AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients."

Enrollment status • P3 data • Acute Myelogenous Leukemia

SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas (GlobeNewswire) - "SELLAS Life Sciences Group...announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL)."

Orphan drug • Peripheral T-cell Lymphoma

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia (GlobeNewswire) - "SELLAS Life Sciences Group, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute myeloid leukemia (AML)....'We look forward to continued SLS009 development and enrolling pediatric AML patients in our Phase 2 clinical trial.'"

Enrollment status • FDA event • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia (GlobeNewswire) - "SELLAS Life Sciences Group, Inc...announced that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML)....'We look forward to working closely with the EMA and the FDA to advance SLS009 clinical development and ultimately deliver it to the patients who need it most. To that end, we remain on track to share further data around SLS009 in the third quarter of this year.'...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."

Orphan drug • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: Sellas Life Sciences Group | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Combination therapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia (GlobeNewswire) - "SELLAS Life Sciences Group, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute lymphoblastic leukemia (ALL)."

FDA event • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology

SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML (GlobeNewswire) - P1/2a | N=160 | NCT04588922 | Sponsor: Sellas Life Sciences Group | "SELLAS Life Sciences...announced the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009...in relapsed/refractory acute myeloid leukemia (r/r AML)...Initial Data...The overall response rate was 29.6% in all evaluable patients, and across all SLS009 doses, with the highest response rate of 50% observed at the dosing regimen of 30 mg BIW...A 100% overall response rate (CR/CRi/MLFS) was achieved in patients with ASXL1 mutations in the 30 mg BIW cohort to date....Based on the preliminary findings from this Phase 2a trial, the trial has been expanded to include two additional cohorts consisting of dosing at 30 mg BIW. One cohort will enroll AML patients with ASXL1 mutations and the other AML patients with myelodysplasia-related molecular mutations other than ASXL1. Study enrollment continues and additional updates and data are expected in Q3."

Enrollment closed • P2a data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

SELLAS Life Sciences Reports First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "SLS009: National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024."

Clinical data • Oncology • Solid Tumor

SELLAS Announces Positive Phase 2 Preliminary Data of SLS009 in r/r AML Achieving a 100% Response Rate in Patients with ASXL1 Mutation At the Optimal Dose Level (GlobeNewswire) - P1/2a | N=135 | NCT04588922 | Sponsor: Genfleet Therapeutics | "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....SELLAS intends to initiate discussions with the U.S. Food and Drug Administration (FDA) about the potential for an accelerated approval pathway with SLS009 in the ASXL1 molecularly defined r/r AML population as well as in patients harboring this mutation in other indications....Study Enrollment Ongoing at 30mg BIW Dose of SLS009 with Expansion Cohort of ASXL1 Mutation Patients; Updates Expected in Q3 2024."

FDA event • P2a data • Trial status • Acute Myelogenous Leukemia

A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL (clinicaltrials.gov) - P1/2 | N=51 | Recruiting | Sponsor: Zhejiang Genfleet Therapeutics Co., Ltd.

Combination therapy • New P1/2 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "SLS009: highly selective CDK9 inhibitor:...PIVOT program with the National Cancer Institute (NCI) in multiple pediatric cancer indications continues. Initial safety and efficacy data are expected to be reported throughout 2H 2024."

Preclinical • Oncology