This section highlights FDA-related milestones and regulatory updates for drugs developed by SELLAS Life Sciences Group (SLS).
Over the past two years, SELLAS Life Sciences Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
galinpepimut-S and SLS009. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
galinpepimut-S (GPS) - FDA Regulatory Timeline and Events
galinpepimut-S (GPS) is a drug developed by SELLAS Life Sciences Group for the following indication: Targets the WT1 protein, which is present in an array of tumor types.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- galinpepimut-S (GPS)
- Announced Date:
- March 20, 2025
- Indication:
- Targets the WT1 protein, which is present in an array of tumor types.
Announcement
SELLAS Life Sciences Group provided a corporate update.
AI Summary
SELLAS Life Sciences Group recently shared its 2024 full-year corporate update, outlining key milestones and future plans. The update highlighted a positive outcome from the interim analysis of its pivotal Phase 3 REGAL trial for the GPS therapy in acute myeloid leukemia (AML). The interim results showed encouraging signs of safety and effectiveness, as fewer than half of the patients enrolled had died after a median follow-up of 13.5 months. The final analysis is scheduled once 80 events occur, a milestone that SELLAS anticipates reaching in 2025.
Additionally, the company noted promising topline data expected from its Phase 2 trial of SLS009 (tambiciclib) in relapsed or refractory AML, with full FDA regulatory feedback expected in the first half of 2025. These developments underscore SELLAS’ commitment to advancing innovative AML treatments.
Read Announcement- Drug:
- galinpepimut-S (GPS)
- Announced Date:
- January 23, 2025
- Indication:
- Targets the WT1 protein, which is present in an array of tumor types.
Announcement
SELLAS Life Sciences Group, Inc. announced that Independent Data Monitoring Committee (IDMC) has completed pre-specified interim analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML).
AI Summary
SELLAS Life Sciences Group, Inc. announced that the Independent Data Monitoring Committee (IDMC) has completed the pre-specified interim analysis for the Phase 3 REGAL trial evaluating galinpepimut-S (GPS) in acute myeloid leukemia (AML). This analysis, conducted after reaching 60 death events, showed that GPS exceeded predetermined futility criteria and raised no safety concerns. The IDMC praised the study’s operational excellence and data integrity, and recommended that the trial continue without any modifications. Early data also indicated promising survival outcomes, as fewer than 50% of enrolled patients had died after a median follow-up of 13.5 months, suggesting improvements compared to historical survival rates with conventional therapy. Additionally, 80% of a randomly selected group of REGAL patients demonstrated a specific T-cell immune response to GPS. The final analysis will be performed after reaching 80 events.
Read Announcement- Drug:
- galinpepimut-S (GPS)
- Announced Date:
- December 10, 2024
- Indication:
- Targets the WT1 protein, which is present in an array of tumor types.
Announcement
SELLAS Life Sciences Group, Inc. announced that the pre-specified threshold of 60 events (deaths) has been reached in its ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), triggering the interim analysis to be conducted by the Independent Data Monitoring Committee (IDMC).
AI Summary
SELLAS Life Sciences Group, Inc. announced that the REGAL Phase 3 clinical trial for galinpepimut-S (GPS) in acute myeloid leukemia (AML) has reached a key milestone by meeting the pre-specified threshold of 60 events (deaths). This achievement triggers an interim analysis by the Independent Data Monitoring Committee (IDMC), which will review the current trial data. The analysis will assess efficacy, futility, and safety of GPS in the study. The company stated that reaching this threshold is a significant step in developing new treatment options for AML patients and expressed optimism about the potential of GPS as a promising therapy. The IDMC is scheduled to conduct a detailed review and meet in January 2025 to discuss the results and recommendations from the data collected so far.
Read Announcement- Drug:
- galinpepimut-S (GPS)
- Announced Date:
- June 17, 2024
- Indication:
- Targets the WT1 protein, which is present in an array of tumor types.
Announcement
SELLAS Life Sciences Group, Inc. announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC).
AI Summary
SELLAS Life Sciences Group, Inc. shared positive news about its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML). The Independent Data Monitoring Committee (IDMC) carefully reviewed unblinded data from the trial and found no safety or futility concerns. As a result, the committee recommended that the trial continue without any modifications. They also projected that a key interim analysis, based on 60 events, should take place by the fourth quarter of 2024.
This encouraging review strengthens confidence in GPS as a promising treatment option for AML patients. The ongoing trial focuses on evaluating the overall survival of patients who have achieved complete remission after undergoing second-line salvage therapy, marking a significant step forward in AML treatment research.
Read Announcement- Drug:
- galinpepimut-S (GPS)
- Announced Date:
- June 17, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Targets the WT1 protein, which is present in an array of tumor types.
Announcement
SELLAS Life Sciences Group, Inc announced that Interim Analysis Anticipated by Q4 2024 .
AI Summary
SELLAS Life Sciences Group, Inc. recently shared promising news regarding its Phase 3 REGAL clinical trial for the treatment of acute myeloid leukemia (AML). An Independent Data Monitoring Committee (IDMC) reviewed the trial data and recommended that the study continue without any changes. The committee did not raise any safety or futility concerns after a thorough assessment of the unblinded data. Importantly, the IDMC has projected with high confidence that the interim analysis, which will be based on 60 events, is expected to occur by the fourth quarter of 2024. This milestone is a key indicator of progress for the trial and adds optimism about the potential of the investigational treatment, galinpepimut-S (GPS), as a safe and effective option for AML patients. The next steps in this ongoing trial are highly anticipated as the data is reviewed further.
Read Announcement
SLS009 - FDA Regulatory Timeline and Events
SLS009 is a drug developed by SELLAS Life Sciences Group for the following indication: For Treatment of Acute Myeloid Leukemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SLS009
- Announced Date:
- June 2, 2025
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, announced preclinical efficacy of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer lines.
AI Summary
SELLAS Life Sciences Group recently announced promising preclinical data for its CDK9 inhibitor, SLS009 (tambiciclib), in ASXL1 mutated colorectal cancer cell lines. In studies highlighted at the 2025 ASCO Annual Meeting, SLS009 showed strong anti-cancer activity, particularly in cell lines with ASXL1 mutations. The research demonstrated that 50% of ASXL1 mutant cell lines achieved an IC50 below 100 nM, while no wild-type lines reached this level of efficacy. Notably, cell lines with ASXL1 frameshift mutations had a 75% response rate, and those with mutations in the 637-638 protein region all responded to treatment. These effective concentrations were significantly lower than levels considered safe in patients, suggesting a broad therapeutic window.
These findings provide a strong rationale for further developing SLS009 as a targeted therapy for patients with ASXL1 mutated cancers, potentially improving patient selection and treatment outcomes.
Read Announcement- Drug:
- SLS009
- Announced Date:
- May 15, 2025
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, Inc. 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).
AI Summary
SELLAS Life Sciences Group, Inc. announced a major milestone in its ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor designed for relapsed/refractory acute myeloid leukemia (r/r AML). The company has now dosed its first pediatric AML patient, marking an important step to address the treatment challenges faced by young patients suffering from aggressive blood cancers. The trial is exploring SLS009’s safety, tolerability, and effectiveness, especially when used in combination with established therapies like venetoclax and azacitidine. With limited options available for pediatric patients with difficult-to-treat AML, this development reflects SELLAS’ commitment to filling a significant unmet need. This positive step may lead to improved treatment options for vulnerable pediatric AML patients.
Read Announcement- Drug:
- SLS009
- Announced Date:
- April 28, 2025
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, announced that preclinical efficacy of SLS009 in TP53 mutated Acute Myeloid Leukemia (AML) cells are being presented in a poster session at the American Association for Cancer Research (AACR) taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL.
AI Summary
SELLAS Life Sciences Group announced that preclinical data showing the efficacy of its CDK9 inhibitor, SLS009, in TP53 mutated Acute Myeloid Leukemia (AML) cells is now being highlighted at this year’s AACR meeting. The poster session, held at McCormick Place Convention Center in Chicago, Illinois from April 25th to 30th, presents data where SLS009 induced rapid apoptosis of AML cells by targeting key proteins like MCL-1 and survivin. Notably, in combination with azacitidine–venetoclax, SLS009 reduced TP53-mutated leukemia cell populations by up to 97%, while showing significant efficacy as a monotherapy. These findings offer promising hope for patients with TP53-mutated AML, a group that traditionally experiences poor outcomes even with aggressive treatments. This work underscores SELLAS’ ongoing commitment to improving therapeutic options for difficult-to-treat cancer populations.
Read Announcement- Drug:
- SLS009
- Announced Date:
- April 8, 2025
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, announced Cohort 3 data from the ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).
AI Summary
SELLAS Life Sciences Group has released promising Cohort 3 data from its ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in patients with relapsed/refractory acute myeloid leukemia (r/r AML). The trial focused on patients who had failed previous venetoclax-based regimens. Results showed that patients receiving SLS009 achieved a median overall survival (mOS) of 8.8 months, a significant improvement over the historical benchmark of 2.5 months. In particular, patients with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) reached an mOS of 8.9 months and an impressive overall response rate (ORR) of 67%, far exceeding the 20% ORR target.
The company noted that SLS009 was well-tolerated with no new safety issues, and these strong efficacy signals support the potential of this therapy to transform treatment outcomes for AML patients. Further data analysis and FDA pathway feedback are expected in the first half of 2025.
Read Announcement- Drug:
- SLS009
- Announced Date:
- February 20, 2025
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, 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).
AI Summary
SELLAS Life Sciences Group announced encouraging results from its Phase 2a trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL). In this trial conducted in China, SLS009 was given in combination with the BTK inhibitor zanubrutinib. The combination achieved a 67% overall response rate, more than double that expected with zanubrutinib alone, and an 83% disease control rate in patients with the aggressive non-GCB (ABC) subtype of DLBCL. One patient reached complete response and several others showed substantial partial responses with significant tumor shrinkage. With a median follow-up of 4.6 months, the median overall survival was not yet reached, and 67% of patients were still alive. These findings support the potential of SLS009 to improve treatment outcomes for patients facing this challenging lymphoma.
Read Announcement- Drug:
- SLS009
- Announced Date:
- December 9, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group announced additional data from the expansion cohorts in the Phase 2 trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).
AI Summary
SELLAS Life Sciences Group announced encouraging new data from the expansion cohorts in its Phase 2 trial for SLS009, a highly selective CDK9 inhibitor in relapsed/refractory acute myeloid leukemia (r/r AML). In the 30 mg twice-weekly cohort, which focuses on patients previously treated with venetoclax-based regimens, the median overall survival has not yet been reached but already exceeds 7.7 months, a significant improvement over the expected 2.5 months in this patient group.
Additionally, expansion cohorts in patients with AML exhibiting myelodysplasia-related changes showed an overall response rate of 56%, well above the preset threshold of 33%. These results highlight the potential of SLS009 to offer a transformative treatment option for a heavily pretreated and underserved patient population.
Read Announcement- Drug:
- SLS009
- Announced Date:
- November 27, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
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.
AI Summary
SELLAS Life Sciences Group, Inc. recently announced promising preclinical data identifying the ASXL1 mutation as a key predictor of response to SLS009, their highly selective CDK9 inhibitor, in solid cancers. In the study, cell lines with ASXL1 mutations showed a high efficacy rate, with 67% achieving an IC50 below 100 nM, compared to no response in non-mutated lines. This finding was observed in solid cancers such as colorectal cancer (CRC MSI-H) and non-small cell lung cancer (NSCLC), in addition to previous evidence from hematologic malignancies. The results support the idea that ASXL1 mutations can serve as an important biomarker to select patients who are more likely to benefit from SLS009, potentially leading to more targeted and effective cancer clinical trials. These innovative insights pave the way for tailored treatment strategies in solid tumors with ASXL1 mutations.
Read Announcement- Drug:
- SLS009
- Announced Date:
- August 6, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
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).,
AI Summary
SELLAS Life Sciences Group announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation for SLS009. This designation is for a novel, highly selective CDK9 inhibitor intended for the treatment of relapsed/refractory peripheral T-cell lymphomas (PTCL), a serious and aggressive type of lymphoma with few treatment options.
The designation recognizes the potential of SLS009 to provide a significant benefit to patients suffering from this life-threatening condition. Early clinical trial results have shown that SLS009 is well-tolerated and has demonstrated promising response rates in patients with PTCL. This milestone from the EMA reinforces the company's ongoing commitment to developing new and effective therapies for patients with difficult-to-treat cancers. The achievement underscores SELLAS’ expertise in regulatory affairs and its focus on advancing innovative treatments for cancer.
Read Announcement- Drug:
- SLS009
- Announced Date:
- July 16, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, Inc. 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).
AI Summary
SELLAS Life Sciences Group recently announced that the U.S. Food and Drug Administration granted Rare Pediatric Disease Designation to SLS009 for the treatment of pediatric acute myeloid leukemia (AML). SLS009 is a highly selective CDK9 inhibitor designed to target AML in children—a disease known for its poor outcomes and limited treatment options.
This designation recognizes the potential of SLS009 to address serious and life-threatening challenges in pediatric AML, including cases with treatment-resistant mutations. Furthermore, if SLS009 receives marketing approval, SELLAS may qualify for a Priority Review Voucher, which can be transferred or sold to another company and has an estimated market value of around $100 million. The company is actively enrolling pediatric AML patients in its ongoing Phase 2 clinical trial to further evaluate the drug’s safety and effectiveness.
Read Announcement- Drug:
- SLS009
- Announced Date:
- July 8, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
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).
AI Summary
SELLAS Life Sciences Group, Inc. announced that the European Commission granted Orphan Drug Designation (ODD) for its drug candidate SLS009 after receiving a positive opinion from the European Medicines Agency (EMA). SLS009 is a novel, highly selective CDK9 inhibitor designed for the treatment of acute myeloid leukemia (AML), a rare and aggressive form of blood cancer.
This designation offers SELLAS important regulatory and financial benefits, such as a 10-year marketing exclusivity period in the European Union, reduced protocol assistance fees, and streamlined access to centralized marketing authorization. By obtaining ODD, SELLAS strengthens its commitment to developing innovative treatments that could provide significant benefits for AML patients. The company plans to further advance SLS009’s clinical evaluation and is preparing to share additional data in the near future.
Read Announcement- Drug:
- SLS009
- Announced Date:
- June 24, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, Inc. 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).
AI Summary
SELLAS Life Sciences Group recently announced that the FDA has granted Rare Pediatric Disease Designation (RPDD) for its drug candidate SLS009, a highly selective CDK9 inhibitor, aimed at treating pediatric acute lymphoblastic leukemia (ALL), the most common cancer in children. This designation highlights the serious nature and unmet medical needs associated with childhood ALL, which affects fewer than 200,000 patients in the United States. The RPDD status can help expedite the clinical development of SLS009, and upon successful marketing approval, SELLAS may receive a Priority Review Voucher. This voucher might be used to speed up future drug reviews or sold to generate significant revenue. With a strong focus on improving therapeutic options for pediatric patients, SELLAS is committed to advancing SLS009 to potentially offer a safer and more effective treatment for children battling ALL.
Read Announcement- Drug:
- SLS009
- Announced Date:
- June 10, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, Inc. Additional Update Expected in Q3 2024 -
AI Summary
SELLAS Life Sciences Group, Inc. recently announced key progress in its Phase 2a trial of SLS009 for relapsed/refractory acute myeloid leukemia (AML). The study enrolled 30 patients ahead of schedule and showed encouraging results with overall response rates exceeding expectations. Notably, a 100% response rate was observed in patients with ASXL1 mutations in the 30 mg twice-a-week dosing group, and a median overall survival of 5.4 months was achieved in the 45 mg once-a-week safety cohort, surpassing the standard care benchmark of 2.5 months.
The trial is now expanding to include two additional cohorts aimed at patients with ASXL1 mutations and other myelodysplasia-related molecular mutations. SELLAS plans to provide further updates and additional data from these expansion cohorts in Q3 2024, reflecting ongoing efforts to address the unmet needs of AML patients.
Read Announcement- Drug:
- SLS009
- Announced Date:
- June 10, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, Inc. announced the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).
AI Summary
SELLAS Life Sciences Group, Inc. announced that enrollment has been completed for the initial portion of its ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in patients with relapsed/refractory acute myeloid leukemia (r/r AML). The trial has shown positive initial results, with efficacy outcomes far exceeding the target overall response rate of 20% and a median overall survival of 3 months. In the study, patients who received 45 mg once a week showed a median overall survival of 5.4 months compared to an expected 2.5 months with the standard of care. Response rates differed by dosing regimen, reaching 33% for a 60 mg once‐a‐week cohort and 50% in the 30 mg twice‐a‐week group. These promising outcomes, coupled with a well-tolerated safety profile, offer hope for a new treatment option for this challenging patient population.
Read Announcement- Drug:
- SLS009
- Announced Date:
- May 1, 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, Inc. announces the preliminary data from Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) and successful filing of a provisional patent application around the ASXL1 mutation and SLS009, including all CDK9 inhibitor drugs
AI Summary
SELLAS Life Sciences Group, Inc. has announced promising preliminary data from its Phase 2a trial of SLS009, a highly selective CDK9 inhibitor designed for relapsed/refractory acute myeloid leukemia (r/r AML). Early results show a 100% overall response rate in patients with the ASXL1 mutation in the 30 mg twice-weekly group, with overall anti-leukemic activity observed in 62% of patients across all dose levels. These findings suggest that SLS009 could address the unmet need for targeted therapies in AML patients with the ASXL1 mutation, which is typically linked to poor outcomes with standard treatments.
In addition, SELLAS has filed a provisional patent application covering the ASXL1 mutation and SLS009, along with all CDK9 inhibitor drugs. This move may support a potential accelerated approval pathway with the FDA for this defined patient population.
Read Announcement- Drug:
- SLS009
- Announced Date:
- May 1, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For Treatment of Acute Myeloid Leukemia
Announcement
SELLAS Life Sciences Group, Inc Study Enrollment Ongoing at 30mg BIW Dose of SLS009 with Expansion Cohort of ASXL1 Mutation Patients; Updates Expected in Q3 2024 –
AI Summary
SELLAS Life Sciences Group, Inc. announced that its Phase 2a trial of SLS009 is actively enrolling patients at the 30 mg twice-weekly dose. The study now includes an expansion cohort focusing on patients with the ASXL1 mutation, a common alteration in acute myeloid leukemia (AML) and other cancers that often lead to poor outcomes with current treatments.
Preliminary data has shown very promising anti-leukemic activity and strong safety profiles in this cohort. Notably, patients with ASXL1 mutations have exhibited a 100% overall response rate so far, suggesting that SLS009 may be particularly effective for this subgroup. These encouraging results support further discussions with the FDA regarding a potential accelerated approval pathway. Updates on the trial progress and additional results are expected in Q3 2024.
Read Announcement
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