deuterated S-avadomide (SP-3164) / Salarius - LARVOL DELTA

Salarius Pharmaceuticals and Decoy Therapeutics Announce Definitive Merger Agreement (GlobeNewswire) - "Salarius Pharmaceuticals, Inc...and Decoy Therapeutics, Inc...announce the signing of a definitive agreement under which Decoy Therapeutics will merge with a wholly-owned subsidiary of Salarius Pharmaceuticals, subject to the closing conditions set forth in the definitive agreement. The newly formed company will be named Decoy Therapeutics....In addition, the combined company intends to incorporate Salarius’ oral small molecule protein degrader SP-3164 into a highly targeted peptide-based proteolysis targeting chimeras (PROTACS) drug candidate."

Commercial • Oncology

Salarius Pharmaceuticals Issued U.S. Patent for Next-Generation Targeted Protein Degraders (GlobeNewswire) - "Salarius Pharmaceuticals, Inc...announces that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,773,080...This patent covers the composition of matter for novel molecular glue degraders and expires in mid-2039....Targeted protein degradation (TPD) utilizes the body’s own degradation system to promote the selective elimination of disease-causing proteins. This newly issued patent expands and extends protection of Salarius’ TPD pipeline, which is led by SP-3164..."

Patent • Oncology

Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Salarius Pharmaceuticals, LLC | Trial completion date: Aug 2026 ➔ Aug 2027 | Initiation date: Aug 2023 ➔ Mar 2024

Trial completion date • Trial initiation date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Salarius Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides a Business Update (GlobeNewswire) - "Salarius Pharmaceuticals...today reported financial results for the three and six months ended June 30, 2023 and provided a business update...Cash and cash equivalents were $11.5 million as of June 30, 2023, compared with $12.1 million as of December 31, 2022...Research and development expenses declined to $2.4 million for the second quarter of 2023 from $2.9 million for the second quarter of 2022, primarily due to lower spending on seclidemstat offset by higher spending on SP-3164. Spending associated with seclidemstat and SP-3164 for the second quarter of 2023 was $1.1 million and $1.3 million, respectively, compared with $2.1 million and $0.8 million, respectively, for the second quarter of 2022."

Commercial • Ewing Sarcoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Solid Tumor

Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Salarius Pharmaceuticals, LLC

New P1 trial • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Salarius Pharmaceuticals Receives FDA Clearance of SP-3164 Investigational New Drug Application to Begin a Phase 1 Clinical Trial in Relapsed/Refractory Non-Hodgkin Lymphoma Patients (GlobeNewswire) - "Salarius Pharmaceuticals, Inc...announces U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug (IND) application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). Salarius expects to begin treating patients in the dose-escalation portion of the trial in the second half of 2023 to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics...'We now plan to enroll NHL patients in the dose-escalation portion of the clinical trial and will then focus on patients with diffuse large B-cell lymphoma (DLBCL) in the second portion of the trial.'"

IND • New P1 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A NOVEL CEREBLON-BINDING MOLECULAR GLUE, SP-3164, SHOWS PRECLINICAL ACTIVITY IN NON-HODGKIN LYMPHOMAS (EHA 2023) - "To date, the majority of CRBN-binding molecular glues, including lenalidomide, pomalidomide, and avadomide, are glutarimides with an unstable chiral center that results in interconversion between the desired, active ( S )-enantiomer and the inactive ( R )-enantiomer...Additionally, we showed SP-3164's potent activity in an in vivo DLBCL model as a single agent and in combination with rituximab...In addition, the combination of SP-3164 with venetoclax (50 mg/kg QD PO, 5 on/2 off) resulted in more significant TGI than either SP-3164 or venetoclax alone (Figure)... SP-3164 is a novel, orally available, CRBN-binding molecular glue with potent immunomodulatory activity andattractive therapeutic properties in NHL models, including FL. Further assessment of SP-3164's potential as a treatment for NHLs is warranted and a clinical trial is planned to start in 2023. Non-Hodgkin's lymphoma, Immunomodulation, B cell lymphoma"

Preclinical • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Immune Modulation • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Targeted Protein Degradation • CRBN • IKZF1 • TNFA

Salarius Pharmaceuticals Presents SP-3164 Targeted Protein Degrader Preclinical Data at the European Hematology Association 2023 Hybrid Congress (GlobeNewswire) - "Salarius Pharmaceuticals, Inc...announces the presentation of a poster related to the company’s novel molecular glue, SP-3164, at the European Hematology Association 2023 Hybrid Conference, which was held in Frankfurt, Germany and virtually June 8-11, 2023....Potent degradation of Ikaros and Aiolos (I/A) in peripheral blood mononuclear cells (PBMC) within 2 hours of dosing, which increased in a dose- and time-dependent manner over 24 hours. SP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment. In addition to having direct antitumor effects, SP-3164 also induces an anticancer immunomodulatory effect as demonstrated through the induction of cytokine secretion in human T cells following treatment."

Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Salarius Pharmaceuticals Reports No Adverse Safety Signals from Two Good Laboratory Practice Toxicology Studies with its Targeted Protein Degrader SP-3164 (GlobeNewswire) - "Salarius Pharmaceuticals...announces the completion of two Good Laboratory Practice (GLP) toxicology studies with its targeted protein degrader SP-3164, with no unexpected safety findings during the course of either study. These GLP toxicology reports will be included in the Investigational New Drug (IND) application the company plans to submit to the U.S. Food and Drug Administration (FDA) in the second quarter of 2023....Salarius held a pre-IND meeting with the FDA in May 2022 and is in the process of completing activities that will allow it to commence a Phase 1 study in the second half of this year."

IND • New P1 trial • Preclinical • Oncology

SP-3164, a novel molecular glue degrader with activity in preclinical models of multiple myeloma (AACR 2023) - "Cereblon (CRBN)-binding Ikaros and Aiolos (I/A) protein degraders (i.e., lenalidomide (LEN) and pomalidomide (POM)) have had great success in treating MM. In vivo, SP-3164 has superior single agent and combination activity compared to approved molecular glues. These data support the continued development as a novel therapy in MM."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • CRBN • IKZF1

SP-3164, a novel ikaros and aiolos molecular glue degrader with preclinical activity in non-Hodgkin lymphomas (AACR 2023) - "Lenalidomide (LEN), a molecular glue degrader, is approved for treatment of diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and other NHLs. SP-3164 is a novel, orally available, CRBN-binding molecular glue with desirable therapeutic properties and significant anticancer activity in NHL models. Further assessment of SP-3164’s potential as a treatment for NHLs is warranted and a clinical trial is planned to start in 2023."

Preclinical • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRBN • IKZF1

Salarius Pharmaceuticals Presents Compelling Data in Two SP-3164 Targeted Protein Degrader Posters at the American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Salarius Pharmaceuticals...announced the presentation of two posters related to the company’s novel molecular glue, SP-3164, at the American Association for Cancer Research (AACR) Annual Meeting. Both abstracts highlight preclinical findings with SP-3164, with one focused on non-Hodgkin lymphoma (NHL) and the other on multiple myeloma (MM)."

Preclinical • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Salarius Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Targeted protein degrader SP-3164 on track for IND submission in first half of 2023 with clinical trial to begin in second half of 2023."

IND • New trial • Oncology

Salarius Pharmaceuticals Announces Two Abstracts Accepted for Presentation at the American Association for Cancer Research Annual Meeting (GlobeNewswire) - "The other abstract, titled 'SP-3164, a novel molecular glue degrader with activity in preclinical models of multiple myeloma,' concludes that SP-3164 is a potent cereblon-binding molecular glue with the ability to rapidly degrade cancer-promoting proteins and induce cell death in multiple myeloma cell lines. In multiple myeloma animal models, SP-3164 has superior single agent and combination treatment activity compared to approved molecular glues."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Salarius Pharmaceuticals Announces Two Abstracts Accepted for Presentation at the American Association for Cancer Research Annual Meeting (GlobeNewswire) - "One abstract is titled 'SP-3164, a novel Ikaros and Aiolos molecular glue degrader with preclinical activity in non-Hodgkin lymphomas,' and concludes that SP-3164 is a novel, orally available, cereblon-binding molecular glue with attractive therapeutic properties and significant anticancer activity in NHL cell line and animal models. Further assessment of SP-3164’s potential as a treatment for NHLs is warranted and a clinical trial is planned to start in 2023."

Preclinical • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Salarius Pharmaceuticals Presents SP-3164 Preclinical Data at the Inaugural Molecular Glue Drug Development Summit (GlobeNewswire) - "Salarius Pharmaceuticals...announces the presentation of preclinical data showing SP-3164’s activity in non-Hodgkin’s lymphoma (NHL) animal models. In a model of diffuse large B-cell lymphoma, SP-3164 exhibited synergistic activity with the approved anti-CD20 drug rituximab, resulting in the complete elimination of tumors in 50% of treated mice. The combination also performed significantly better than the approved regimen, lenalidomide and rituximab. These data were presented by Aundrietta Duncan, Ph.D., Salarius’ director of non-clinical development, at the inaugural Molecular Glue Drug Development Summit."

Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Salarius Pharmaceuticals to Present SP-3164 Targeted Protein Degrader Preclinical Data at the Inaugural Molecular Glue Drug Development Summit (GlobeNewswire) - "Salarius Pharmaceuticals...announces that Aundrietta Duncan, Ph.D., director of non-clinical development, will present SP-3164 preclinical data and discuss program progress at the inaugural Molecular Glue Drug Development Summit being held on January 24-26, 2023 in Boston....Dr. Duncan will present in vivo data demonstrating the activity of SP-3164 therapeutic activity in cancer models and in vitro data demonstrating SP-3164’s mechanism of action. She also will discuss the overall progress of SP-3164 development....Company planning to submit an Investigational New Drug application to the U.S. Food and Drug Administration and begin a Phase 1 trial in 2023."

IND • Preclinical • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Salarius Pharmaceuticals Announces Issuance of New U.S. Patent for Next-Generation Targeted Protein Degraders (GlobeNewswire) - "Salarius Pharmaceuticals, Inc...announces that on December 27, 2022 the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,535,603, titled 'Deuterium-enriched Piperidinonyl-oxoisoindolinyl Acetamides and Methods of Treating Medical Disorders Using Same.' The issued claims cover the composition of matter for novel molecular glue degraders including Salarius’ preclinical cereblon-binding compound, SP-3204, through September 2037....The newly issued patent is based on the molecular glue eragidomide (CC-90009) that is known to target the degradation of GSPT1, a protein that is highly expressed in numerous cancers, including hematologic and solid tumors...SP-3204 is our second novel molecular glue following SP-3164, our lead molecular glue that is expected to enter the clinic later this year."

New trial • Patent • Hematological Malignancies • Oncology • Solid Tumor

SP-3164, a Novel Cereblon-Binding Protein Degrader, Shows Activity in Preclinical Lymphoma Models (ASH 2022) - "Background: Targeted protein degradation (TPD) is attracting significant interest given the success of early protein degraders, e.g., lenalidomide and pomalidomide, and TPD's potential advantages over other therapeutic approaches. SP-3164 is a novel, CRBN-binding molecular glue with potential attractive therapeutic properties compared to the racemate, avadomide, and to lenalidomide. SP-3164 showed increased IKZF1 degradation efficiency compared to other molecular glues and significant anti-cancer activity as a monotherapy in an in vivo lymphoma mouse xenograft model. Future studies will evaluate SP-3164 efficacy and direct potential combinations to support clinical development of SP-3164 in DLBCL and other non-Hodgkin's lymphomas."

Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Targeted Protein Degradation • CRBN • IKZF1 • IKZF3 • IL17RB

Salarius Pharmaceuticals Presents SP-3164 Data Demonstrating Activity in Preclinical Lymphoma Models at the American Society of Hematology Annual Meeting (GlobeNewswire) - "Salarius Pharmaceuticals...announces that yesterday Daniela Santiesteban, Ph.D., Salarius’ director of targeted protein degradation development, presented positive SP-3164 preclinical data at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition underway in New Orleans and virtually....SP-3164 resulted in complete regressions in 50% of mice when treated in combination with rituximab in a DLBCL mouse model and performed significantly better than the approved regimen of lenalidomide (Revlimid®) and rituximab.... This, along with the data presented at ASH showing compelling SP-3164 activity in lymphoma models, supports SP-3164’s potential in NHL for the clinical trial planned for 2023."

New P1 trial • Preclinical • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Salarius Pharmaceuticals to Hold Conference Call to Discuss Recent Clinical and Preclinical Data on Lead Programs, Including Presentations at ASH (GlobeNewswire) - "New preclinical data with Salarius’ targeted protein degrader SP-3164 being presented at ASH will also be reviewed, along with previously announced SP-3164 preclinical data that was presented at the 5th Annual Targeted Protein Degradation Conference."

Preclinical • Oncology

Salarius Pharmaceuticals Presents Favorable Preclinical Data on SP-3164 at the 5th Annual Targeted Protein Degradation Conference (GlobeNewswire) - "In in vitro studies, SP-3164 has shown potent cereblon binding, efficient degradation of neosubstrates and induction of cell death in both lymphoma and multiple myeloma cells. In in vivo studies, SP-3164 has shown minimal to no interconversion of the preferred S-enantiomer into the unwanted R-enantiomer, indicating successful stabilization....'We are looking forward to providing additional preclinical information at the upcoming American Society of Hematology annual meeting later this year, completing our Investigational New Drug (IND)-enabling studies, submitting the SP-3164 IND to the U.S. Food and Drug Administration in the first half of 2023 and beginning clinical trials shortly thereafter,' Mr. Arthur added."

IND • Preclinical • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology

Salarius Pharmaceuticals Announces Two Presentations at the 2022 American Society of Hematology Annual Meeting (GlobeNewswire) - "Salarius Pharmaceuticals...announced that two abstracts related to the company’s compounds have been accepted for presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 10-13, 2022....'SP-3164 showed increased IKZF1 degradation efficiency compared with other molecular glues and significant anti-cancer activity as a monotherapy in an in vivo lymphoma mouse xenograft model'....MD Anderson Cancer Center’s abstract...concludes that in the six patients for whom data are generated, the combination of seclidemstat with azacitidine 'seems safe at the current dose levels and shows signs of potential activity. Further enrollment and follow up continues to further explore this combination'."

P1/2 data • Preclinical • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology

Salarius Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Advanced plans for filing an Investigational New Drug (IND) application in 1H23 after completing the pre-Investigational New Drug meeting process with the U.S. Food and Drug Administration...Net loss for the second quarter of 2022 was $4.7 million, or $0.09 per share, compared with a net loss of $3.1 million, or $0.07 per share, for the second quarter of 2021. The increase in net loss was due to higher operating expenses, including development spending on SP-3164, our targeted protein degradation technologies purchased in January 2022."

Commercial • IND • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor

Salarius Pharmaceuticals Completes SP-3164 Pre-Investigational New Drug Meeting Process with the U.S. Food and Drug Administration (GlobeNewswire) - "Salarius Pharmaceuticals...announced the successful completion of its pre-IND (Investigational New Drug) meeting process with the U.S. Food and Drug Administration (FDA) for SP-3164....Salarius is developing SP-3164 as a potential treatment for hematological cancers and solid tumors....Salarius is planning to submit an IND in 2023 and, upon receiving IND activation from the FDA, initiate the first clinical trial that same year."

FDA event • IND • Hematological Malignancies • Multiple Myeloma • Oncology