TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

Salarius Pharmaceuticals Granted FDA Approval for Investigational New Drug (IND) Application SP-3164, Commences Phase 1 Clinical Trial for Relapsed/Refractory Non-Hodgkin Lymphoma Patients

Wednesday, July 12, 2023

Salarius Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, has received FDA clearance for its investigational new drug (IND) application for SP-3164. This clearance allows Salarius to proceed with a Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL). The trial aims to evaluate the safety, clinical activity, pharmacokinetics, and pharmacodynamics of SP-3164. Patient enrollment for the dose-escalation portion of the trial is expected to begin in the second half of 2023.

Salarius President and CEO, David Arthur, expressed the significance of the FDA clearance, highlighting the company's commitment to providing new treatment options for patients. The initial phase of the trial will focus on NHL patients, with subsequent attention given to those with diffuse large B-cell lymphoma (DLBCL).

Non-Hodgkin lymphoma is a prevalent cancer, accounting for a significant percentage of all cancer cases in the United States. DLBCL, a subtype of NHL, is particularly common in Western countries.

The trial will also explore the potential of a gene signature in predicting patient response to SP-3164. Previous research with similar agents has indicated that patients with a specific gene signature may have a higher likelihood of positive responses to SP-3164 treatment.

David Arthur further emphasized the potential impact of SP-3164, considering the expected number of new NHL cases and related fatalities in the United States. He also highlighted the success of first-generation targeted protein degraders (TPDs) and expressed optimism that SP-3164, as a next-generation TPD, can build upon that success.

SP-3164 is an oral, next-generation molecular glue developed using Salarius' proprietary technology platform. It stabilizes the preferred form of avadomide, a compound that has demonstrated promising clinical efficacy in NHL and other hematologic malignancies. Salarius holds a composition-of-matter patent for SP-3164 in the United States and select countries worldwide.

Encouraging preclinical data for SP-3164 have been presented at various scientific conferences, demonstrating its activity in lymphoma models and its potential as a cancer treatment.

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit