Sonoma Biotherapeutics, an immune tolerance company focused on the development of novel regulatory T cell (Treg) therapies for autoimmune and inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase 1 study of SBT115301 in healthy participants. SBT115301 is a biologic designed to eliminate highly activated effector T cells (Teff) that are dominant in autoimmune and inflammatory disease.
“This IND clearance is an important milestone as we move our programs into clinical development, including the SBT115301 program, which is a key piece of our therapeutic strategy,” said Jeff Bluestone, Ph.D., Co-Founder and CEO of Sonoma Biotherapeutics. “We aim to restore immune tolerance with therapies that impact both sides of the immune balance— combining engineered Treg cell therapies with a biologic that can deplete and inactivate Teff cells. Our combinatorial approach holds the potential to transform the way we treat autoimmune and inflammatory diseases.”
Sonoma Biotherapeutics is pioneering Treg cell therapies alone and in combination with a Teff modulating therapy. The loss of immune system balance is correlated with Treg-resistant Teff cells. SBT115301 is a CD2-binding fusion protein that resets the microenvironment by selectively depleting and inactivating these Teff cells at the site of disease. As a combination therapy, SBT115301 is designed to pre-condition patients for optimal treatment with Treg cell therapies.
About Sonoma Biotherapeutics
Sonoma Biotherapeutics is an immune tolerance company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases driven by an imbalanced immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted Treg cell therapies designed to induce durable immune tolerance to treat and prevent autoimmune and inflammatory diseases. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information visit www.sonomabio.com and follow on Twitter and LinkedIn.
Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat serious immuno-inflammatory diseases with significant unmet medical needs, today announced favorable results from the Company’s Phase 1 clinical program for VLX-1005, a novel 12-LOX inhibitor being developed for the treatment and prevention of heparin-induced thrombocytopenia and thrombosis (HIT). Veralox also announced that VLX-1005 has been awarded Fast Track Designation by the U.S. Food and Drug Administration (FDA).
“Completion of our Phase 1 study for VLX-1005 together with announcement of Fast Track Designation for this program represent important milestones that reflect the new levels of momentum we are achieving with our clinical strategy at Veralox,” said Michael Hanna, Chief Medical Officer at Veralox. “We look forward to continuing our development of VLX-1005 to address the underlying pathology of HIT, a disease that has not seen innovation in available therapies in over 20 years.”
Veralox completed a Phase 1a study consisting of a single ascending dose (SAD) portion and a multiple ascending dose (MAD) portion that was designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of VLX-1005. In this study VLX-1005 was found to be well tolerated with no reports of serious adverse events (SAEs), dose-limiting toxicities (DLTs) or discontinuations; adverse events (AEs) were infrequent and mild. Data analyses revealed dose linear increases in key PK metrics approaching dose proportionality with no upper limits on tolerability to the maximum dose tested.
Veralox also completed a Phase 1b drug-drug interaction (DDI) study of VLX-1005 in conjunction with argatroban, an anticoagulant that is approved for the treatment of HIT in the U.S. This study was designed to evaluate the effects of coadministration of VLX-1005 and argatroban on subject safety and on a range of exploratory biomarkers. The study showed that co-administration of VLX-1005 with argatroban was well tolerated with no SAEs; AEs were infrequent and mild. Preliminary analysis of the PK and PD (as measured by APTT) data revealed no evidence of DDI.
The FDA granted Fast Track designation for the VLX-1005 program on May 27, 2022, following an End-of-Phase 1 meeting with the Agency. The company will use the results of the successful Phase 1 studies as well as the standards inherent in Fast Track designation and previously announced Orphan Drug designation to finalize the design of the planned Phase 2 clinical program for VLX-1005 in HIT.
VERALOX Therapeutics Inc. (https://veralox.com/) is the clinical leader in developing first-in-class therapeutics targeting 12-lipoxygenase, pioneering a new class of therapies that treat the underlying pathologies of serious immune-inflammatory diseases with unmet medical needs. The company’s lead candidate, VLX-1005, is in development for the treatment of patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for type 1 diabetes and other immune-mediated and inflammatory diseases.