Clinical Trials
12
6 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
4
33.3%
Available
1
8.3%
Completed
3
25.0%
Not yet recruiting
2
16.7%
Recruiting
1
8.3%
Unknown
1
8.3%
No approval data available
- Sellas Life Sciences' experimental immunotherapy galinpepimut-S is predicted to fail to prolong survival versus standard treatment in acute myeloid leukemia patients in second remission. - The event-driven Phase 3 REGAL study has already been delayed by nearly a year, which raises significant doubts about the efficacy of the Sellas treatment. - The prediction, published in a subscriber-only biotech newsletter, anticipates a negative outcome for REGAL, though the timing of that outcome remains unknown.
- Sellas Life Sciences' Phase 3 Regal trial of Galinpepimut-S (GPS) in acute myeloid leukemia has recorded 78 of the 80 events required to trigger final analysis, placing the company near a pivotal readout. - The trial will be deemed successful if GPS achieves median overall survival of 12.6 months versus eight months for the control arm, potentially supporting a biologics license application to the FDA. - CEO Angelos Stergiou called the delay in reaching the final event "a profoundly positive signal," suggesting patients may be living longer than projected. - Sellas is separately advancing SLS009, having enrolled 28 of a planned 80 patients in a Phase 2 trial in newly diagnosed AML, with initial results expected in the fourth quarter of 2026.
- Sellas Life Sciences' Phase 3 REGAL study of galinpepimut-S in AML is nearing final analysis with 78 of 80 required events reported, while updated executive severance agreements fuel acquisition speculation. - Moderna highlighted progress across oncology, autoimmune, and rare disease programs at its Science Day, including mRNA-2808, an investigational T-cell engager for multiple myeloma. - AbCellera Biologics secured a research collaboration with Jazz Pharmaceuticals for multispecific T-cell engager antibodies targeting gastrointestinal cancers, with $56 million in upfront funding for the first two programs.
- SELLAS Life Sciences presented positive Phase 2 data showing SLS009 in combination with azacitidine and venetoclax achieved a 46% overall response rate in heavily-pretreated relapsed/refractory AML patients who had previously failed venetoclax-based therapy. - The study demonstrated particularly strong outcomes in patients with limited prior therapy, achieving a 58% response rate and median overall survival not yet reached, compared to historical benchmarks of approximately 2.5 months. - SLS009 showed encouraging activity in patients with poor prognostic mutations including ASXL1 and TP53, with response rates of 48% and 57% respectively, while maintaining a favorable safety profile with no dose-limiting toxicities observed. - The company plans to expand the study to evaluate SLS009 plus AZA/VEN in newly diagnosed AML patients with high-risk features, with enrollment expected to begin in Q1 2026.
- SELLAS Life Sciences announced the immediate exercise of warrants for approximately $31 million in gross proceeds to fund its late-stage cancer therapy development programs. - The company is developing GPS, a WT1-targeting therapy licensed from Memorial Sloan Kettering, and SLS009, a potentially first-in-class CDK9 inhibitor for acute myeloid leukemia. - SELLAS will host a virtual R&D Day on October 29, 2025, featuring key opinion leaders to discuss unmet medical needs in acute myeloid leukemia treatment. - SLS009 has demonstrated high response rates in AML patients with unfavorable prognostic factors, including ASXL1 mutations associated with poor prognosis.
- SELLAS Life Sciences will present preclinical data showing SLS009 significantly prolonged survival in T-cell prolymphocytic leukemia models, with monotherapy achieving 7.4 weeks survival versus 4.4 weeks for venetoclax alone. - The company's Phase 2 study of SLS009 combined with azacitidine and venetoclax in relapsed/refractory AML with MDS-related changes will be presented at the ASH Annual Meeting in December 2025. - SLS009 demonstrated meaningful single-agent activity and enhanced venetoclax efficacy in patient-derived xenograft models, while maintaining favorable tolerability profiles. - Additional preclinical research reveals SLS009's cytotoxic effects against AML cell lines with leukemia-driving mutations, providing mechanistic support for addressing BCL-2 inhibition resistance.
- SELLAS Life Sciences will host a virtual R&D Day on October 29, 2025, featuring key opinion leaders discussing acute myeloid leukemia treatment advances and unmet medical needs. - The company will present an overview of its ongoing Phase 3 REGAL trial of galinpepimut-S (GPS), with results expected by year-end for AML patients in complete second remission. - SELLAS will provide updates on SLS009, a highly selective CDK9 inhibitor showing high response rates in AML patients with unfavorable prognostic factors, with a new frontline study planned for Q1 2026.
- Schrödinger has terminated development of its CDC7 inhibitor SGR-2921 after two patient deaths in a Phase I trial for relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndromes. - The drug showed early evidence of monotherapy activity but was considered to have contributed to the patient deaths, making further development difficult to pursue. - The company's stock dropped 17.5% following the announcement, though Schrödinger maintains other oncology programs including SGR-1505 and SGR-3515. - The decision highlights ongoing safety challenges in blood cancer drug development, with limited therapeutic options remaining for relapsed/refractory AML patients.
- The Independent Data Monitoring Committee completed a pre-specified analysis of SELLAS' Phase 3 REGAL trial and recommended continuing the study without modification, finding no safety concerns. - The trial enrolled 126 AML patients who achieved complete remission following second-line salvage therapy, with final analysis expected by year-end upon occurrence of 80 events. - Galinpepimut-S targets the WT1 protein and represents a potential therapeutic advance for acute myeloid leukemia patients in complete remission after salvage therapy. - The positive IDMC recommendation validates the risk-benefit profile of GPS and supports continued evaluation under the current study protocol.
- Phase 2a trial demonstrates promising 67% overall response rate for tambiciclib plus zanubrutinib combination in relapsed/refractory DLBCL patients, including one complete response. - The combination therapy showed particularly strong efficacy in ABC DLBCL subtype patients, achieving an 83% disease control rate with 4 responses and 1 stable disease out of 6 patients. - Safety profile reveals grade 3 or higher adverse effects in 55.6% of patients, while genetic analysis indicates efficacy independent of MYD88 or CD79B mutations.
