Tivic Health Secures Global Rights to Phase III TLR5 Agonist from Statera Biopharma
Tivic Health Systems, Inc. (Nasdaq: TIVC) has taken a major step toward expanding its therapeutic portfolio by acquiring the exclusive worldwide license rights to Entolimod™, a late-stage Toll-like Receptor 5 (TLR5) agonist, from Statera Biopharma (OTC: STAB). Entolimod is a promising drug candidate aimed at treating acute radiation syndrome (ARS). Additionally, Tivic has secured an exclusive option to license five more indications and clinical applications for Entolimod and its derivative compound, Entalasta™. This move signifies a pivotal transformation for Tivic Health, evolving from a single-product, direct-to-consumer company into a diversified therapeutics company with a robust pipeline of bioelectronic and biologic product candidates.
Strategic Transformation for Tivic Health
Jennifer Ernst, Chief Executive Officer of Tivic Health, emphasized the significance of this acquisition in reshaping the company’s strategic direction. “Today, we have aggressively accelerated Tivic’s strategic transformation from a single-product, direct-to-consumer company to a diversified therapeutics company—one with a growing pipeline of clinically validated product candidates,” said Ernst. “Statera’s TLR5 immunotherapy program strongly complements our work on non-invasive vagus nerve stimulation, positioning us to address immune and autonomic dysregulation—and associated diseases—through both neural and molecular pathways.”
This acquisition marks a significant milestone in Tivic’s expansion strategy, enabling the company to broaden its focus beyond bioelectronic medicine and into the biologics sector. By incorporating immunotherapy into its portfolio, Tivic is poised to address complex medical conditions through innovative therapeutic pathways, combining neural and molecular approaches.
The Science Behind Entolimod and Entalasta
Entolimod, a TLR5 agonist, is an advanced-stage therapeutic candidate with substantial potential in the treatment of acute radiation syndrome (ARS). TLR5 is a critical component of the immune system, playing a key role in initiating protective immune responses. By activating TLR5, Entolimod can stimulate innate immune pathways that mitigate the effects of radiation exposure, ultimately reducing mortality and improving recovery outcomes in affected individuals.
In addition to its potential in ARS treatment, Entolimod and its optimized derivative, Entalasta, have been extensively studied in preclinical and clinical trials. Over forty animal and human trials have been conducted, supported by approximately $140 million in prior investments. These studies have demonstrated the drug’s ability to activate immune pathways, offering potential applications in various therapeutic areas beyond radiation exposure, such as oncology and immunodeficiency disorders.
Market Potential and Industry Impact
The global market for acute radiation syndrome (ARS) treatments is projected to reach $5.2 billion in 2024, with a compound annual growth rate (CAGR) of 5% from 2024 to 2031, according to research firm CoherentMI. Statera Biopharma has been identified as one of the key market leaders in this sector, and the acquisition of Entolimod’s rights positions Tivic Health as a significant player in this growing market.
The FDA has recognized the potential impact of Entolimod by granting it both Fast Track and Orphan Drug designations for the prevention and treatment of ARS. These designations facilitate a streamlined regulatory pathway, increasing the likelihood of accelerated approval and market entry. The Fast Track designation allows for closer communication with the FDA, ensuring a more efficient review process, while the Orphan Drug status provides incentives such as market exclusivity and tax credits for clinical development.
Regulatory Pathway and Future Development
Michael K. Handley, Chief Executive Officer of Statera Biopharma, expressed confidence in Tivic’s ability to advance Entolimod toward regulatory approval. “Based on extensive prior research, development, and numerous clinical trials of Entolimod, this important immunotherapy drug will now be advanced through the final steps toward a BLA (Biologics License Application) filing and potential FDA approval under the skilled execution of the Tivic team,” said Handley. “We believe this agreement has the potential to provide considerable value for both Statera and Tivic shareholders.”
Tivic’s acquisition of Entolimod’s licensing rights aligns with its broader mission to address unmet medical needs through innovative therapeutics. The company plans to work closely with regulatory agencies to complete the final stages of development and secure FDA approval for Entolimod as a treatment for ARS.
Expanding Indications and Future Applications
Beyond ARS, Tivic’s licensing agreement with Statera includes an exclusive option to develop Entolimod and Entalasta for five additional indications. Potential areas of application include oncology, immune system disorders, and infectious diseases, where TLR5 activation could provide significant therapeutic benefits. Given the extensive clinical research and safety profile already established for Entolimod, these additional indications could advance through clinical trials more rapidly than entirely new drug candidates.
Furthermore, the integration of Tivic’s expertise in bioelectronic medicine with its newly acquired biologic assets could lead to novel combination therapies. By leveraging both neural stimulation techniques and molecular therapeutics, Tivic may develop groundbreaking treatments that address complex conditions with a multifaceted approach.
Financial and Strategic Implications
This acquisition reflects Tivic Health’s commitment to growth and innovation in the life sciences sector. By securing global rights to Entolimod, Tivic enhances its competitive position and establishes itself as a leader in immunotherapy and bioelectronic medicine. The financial terms of the agreement have not been disclosed, but the strategic value of the deal is evident in Tivic’s broader transition toward a multi-faceted therapeutics company.
Investors and stakeholders will be closely monitoring Tivic’s progress in advancing Entolimod through the final stages of regulatory approval and exploring additional indications for its use. As the company continues to expand its pipeline and strengthen its position in the therapeutics market, this acquisition represents a significant milestone in its evolution.
