- Announced Phase 2a study of SLS009 in r/r AML Showing 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20% and 100% Response Rate in Patients with Identified Biomarkers -
- Completed Enrollment in Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia; Steering Committee Guided Interim Analysis May Be Imminent; IDMC Scheduled in Late April-
- Phase 1b/2 Study of SLS009 in Relapsed/Refractory Peripheral T-cell Lymphoma Patients Ongoing with Top-line Data Expected in First Half 2024
- First Patient Dosed in Phase 1b/2 Study of SLS009 in Combination with Brukinsa® (Zanubrutinib, BTK Inhibitor) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
“We are off to a strong start this year highlighted by progress in our late-stage pipeline, strong data from Phase 2a study of SLS009 in r/r AML, completing enrollment in Phase 3 REGAL study, positive feedback from the
Recent Highlights:
Completed enrollment in Phase 3 REGAL study: Reached planned enrollment of patients in
Phase 3 REGAL study in AML:
Reported data from the Phase 2a Study of SLS009 in Relapsed/Refractory AML Patients: A total of 21 patients were enrolled in the study as of
Received
Presented Phase 1 Data in AML at the 2024
Publication in Oncotarget: The preclinical data published revealed the underlying mechanisms of action behind the anti-proliferative effects of SLS009, a highly selective CDK9 small molecule inhibitor, in various hematologic malignancies. The publication, entitled, “The pharmacodynamic and mechanistic foundation for the antineoplastic effects of GFH009, a potent and highly selective CDK9 inhibitor for the treatment of hematologic malignancies”, is available online.
Fast Track Designation: The
2024 Milestones:
Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
- Phase 3 REGAL study in AML: Anticipated interim analysis of the ongoing global Phase 3 registrational clinical trial (the REGAL study) of GPS in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients) in 1H 2024. Final analysis expected to occur by the end of 2024.
SLS009: highly selective CDK9 inhibitor
- Phase 2a clinical trial in r/r AML: Additional data expected in 1H 2024. Initially planned enrollment of approximately 20 patients has been completed and additional patients continue to enroll. Confirmation of safety and further exploration of efficacy in additional patients will be combined with additional biomarkers related data to enable us to plan for further development.
- Phase 1b/2 clinical trial in r/r PTCL: Enrollment started in
December 2023 . Thirty-one sites are active for recruiting and approximately 10 more sites will be initiated. Interim analysis is planned after 20-25 patients are enrolled and have undergone initial follow-up which is projected to occur in 1H 2024. The interim efficacy data will be discussed with regulatory agencies to decide on the continuation of the trial as a pivotal registrational study that would enroll approximately 70-75 additional patients. This study is fully funded by the Company’s partner for SLS009,GenFleet Therapeutics (Shanghai), Inc. (“GenFleet”), and is being conducted inChina . - Phase 1b/2 clinical trial in combination with BTK inhibitor, Brukinsa® (zanubrutinib), in r/r DLBCL: Genfleet entered into a clinical trial collaboration and supply agreement with
BeiGene Switzerland GmbH and the first patient dosed inMarch 2024 . The trial is an open-label single-arm multicenter Phase 1b/2 trial to be conducted in two parts. In the Phase 1b portion, 6-18 patients will be enrolled and in the Phase 2 portion, approximately 45 patients will be enrolled. This study is being conducted inChina and is funded by GenFleet. - 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.
2023 Highlights:
Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
- Positive immunobiological and clinical data from the completed Phase 1/2 clinical trial of GPS in combination with Keytruda® (pembrolizumab) in WT1+ platinum-resistant advanced ovarian cancer was presented at the
International Gynecologic Cancer Society 2023 annual global meeting inNovember 2023 . - The Company reported positive follow-up immune response and survival data in the fourth quarter of 2023 for the completed Phase 1 clinical trial of GPS combined with Opdivo® (nivolumab) in advanced malignant pleural mesothelioma.
- In the fourth quarter of 2023, the Company announced that it had concluded a Type C meeting with the
U.S. Food and Drug Administration (FDA) regarding the Company’s Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (BLA) for GPS.SELLAS had submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans. The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance.
SLS009: highly selective CDK9 inhibitor
- The Phase 1 clinical trial for patients with AML and lymphomas was completed in 2023. For patients with AML, SLS009 demonstrated a favorable tolerability profile with no dose limiting toxicities. Anti-tumor activity and clinical responses across dose levels were observed, indicating a broad therapeutic index. Meaningful cell killing activity, defined as ≥50% reduction in blasts in the bone marrow, was observed at several dose levels. A durable complete remission (CR) with no minimal residual disease (MRD) was observed in one patient with AML who had failed prior venetoclax plus azacytidine (aza/ven) therapy. The patient achieved CR three months after the treatment that lasted 8 months and continues to be alive 12 months following commencement of treatment per last follow-up. The recommended Phase 2 dose for patients with AML was established at 60 mg. For the patients with lymphomas, no off-target safety issues were observed at any dose level and responses were observed across dose levels with a 14.7% clinical response rate overall, 35.3% overall disease control rate, and 36.4% clinical response rate for patients with PTCL. The recommended Phase 2 dose for patients with lymphomas was established at 100 mg administered as a once weekly infusion.
- In the second quarter of 2023, the Company announced the dosing of the first patient (45 mg) in an open-label, single-arm, multi-center Phase 2a study that is designed to evaluate safety, tolerability, and efficacy at two dose levels of SLS009 (once weekly 45 mg or 60 mg) in combination with aza/ven in patients with AML. Enrollment in the 45 mg cohort was completed in the fourth quarter of 2023. Also in the fourth quarter of 2023, the Company announced the dosing of the first patients in the 60 mg dose cohort. The patients in the 60 mg dose cohort will be dosed with 60 mg once per week or 30 mg twice per week.
- Early topline data from the Phase 2a study in patients with AML dosed at the 45 mg level (n=9) include one patient with a CR and significant anti-leukemic effects (≥50% decrease in bone marrow blasts) were observed in five out of six assessable patients with no significant safety issues to date.
- In the fourth quarter of 2023, the Company announced the dosing of the first patient in a Phase Ib/II open-label, single-arm trial in r/r PTCL which will enroll up to 95 patients to evaluate safety and efficacy and, based on results, may serve as a registrational study. This study is fully funded by the Company’s partner for SLS009,
GenFleet Therapeutics (Shanghai), Inc. , and is being conducted inChina . - The Company received the following regulatory designations from the FDA for SLS009 in 2023:
- Orphan Drug Designation (ODD) for the treatment of AML
- ODD for the treatment of PTCL
- Fast Track Designation for the treatment of r/r PTCL
Financial Results for the Full Year 2023:
R&D Expenses: Research and development expenses for the year ended
G&A Expenses: General and administrative expenses for the year ended
Net Loss: The net loss was
Cash Position: As of
About
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program and the timing for achievement of milestones. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting
Investor Contact
Managing Director
SELLAS@lifesciadvisors.com
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
Year Ended | |||||||||
2023 | 2022 | ||||||||
Licensing revenue | $ | — | $ | 1,000 | |||||
Operating expenses: | |||||||||
Cost of licensing revenue | — | 100 | |||||||
Research and development | 24,007 | 20,268 | |||||||
General and administrative | 13,862 | 12,582 | |||||||
Acquired in-process research and development | — | 10,000 | |||||||
Total operating expenses | 37,869 | 42,950 | |||||||
Loss from operations | (37,869 | ) | (41,950 | ) | |||||
Non-operating income: | |||||||||
Change in fair value of warrant liability | 4 | 36 | |||||||
Change in fair value of contingent consideration | — | 296 | |||||||
Interest income | 525 | 317 | |||||||
Total non-operating income | 529 | 649 | |||||||
Net loss | $ | (37,340 | ) | $ | (41,301 | ) | |||
Per share information: | |||||||||
Net loss per common share, basic and diluted | $ | (1.34 | ) | $ | (2.13 | ) | |||
Weighted average common shares outstanding, basic and diluted | 27,777,111 | 19,395,709 |
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
2023 | 2022 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 2,530 | $ | 17,125 | |||
Restricted cash and cash equivalents | 100 | 100 | |||||
Prepaid expenses and other current assets | 542 | 531 | |||||
Total current assets | 3,172 | 17,756 | |||||
Operating lease right-of-use assets | 858 | 874 | |||||
1,914 | 1,914 | ||||||
Deposits and other assets | 275 | 399 | |||||
Total assets | $ | 6,219 | $ | 20,943 | |||
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,639 | $ | 3,357 | |||
Accrued expenses and other current liabilities | 7,650 | 6,286 | |||||
Operating lease liabilities | 446 | 372 | |||||
Acquired in-process research and development payable | — | 5,500 | |||||
Total current liabilities | 13,735 | 15,515 | |||||
Operating lease liabilities, non-current | 460 | 573 | |||||
Warrant liability | — | 4 | |||||
Total liabilities | 14,195 | 16,092 | |||||
Commitments and contingencies | |||||||
Stockholders’ (deficit) equity: | |||||||
Preferred stock, | — | — | |||||
Common stock, | 3 | 2 | |||||
Additional paid-in capital | 209,265 | 184,753 | |||||
Accumulated deficit | (217,244 | ) | (179,904 | ) | |||
Total stockholders’ (deficit) equity | (7,976 | ) | 4,851 | ||||
Total liabilities and stockholders’ (deficit) equity | $ | 6,219 | $ | 20,943 |
Source:
2024 GlobeNewswire, Inc., source