Tivic Health Expands Global License for TLR5 Agonist Entolimod to Include Neutropenia Treatment
Tivic Health Systems, Inc. , a diversified therapeutics company focused on advancing innovative treatment solutions, has made a significant move in expanding its therapeutic pipeline. On March 28, 2025, the company announced that it had exercised its licensing option for the exclusive, worldwide rights to advance Entolimod™, a late-stage immunotherapy program, for a second indication—Neutropenia. This expansion is part of Tivic’s ongoing partnership with Statera Biopharma, Inc., under which Tivic holds exclusive global rights for Entolimod™ as part of a broader strategy to address several critical medical conditions.
Entolimod™: A Promising Immunotherapy for Multiple Indications
Entolimod™ is a Toll-like Receptor 5 (TLR5) agonist, a type of immunotherapy that has garnered attention due to its potential for treating a range of immune system-related conditions. The mechanism of action of Entolimod™ targets TLR5, a class of proteins that play a vital role in the innate immune response. By activating this receptor, Entolimod™ aims to modulate the immune system to enhance the body’s ability to fight infections and other immune challenges.
The decision to pursue Neutropenia as a second indication comes as part of Tivic’s strategy to expand the therapeutic uses of Entolimod™ beyond its initial focus on acute radiation syndrome (ARS). Neutropenia, characterized by abnormally low levels of neutrophils—white blood cells that play a crucial role in the body’s defense against infections—can result from a variety of causes, including chemotherapy, radiation, chronic infections, autoimmune diseases, bone marrow disorders, and even aging. Patients with neutropenia are at increased risk of severe infections, making it a significant clinical concern.
The Neutropenia Market: A Growing Opportunity
According to recent reports from Data Bridge Market Research, the global market for Neutropenia treatments is projected to exceed $20 billion by 2029. This growth is driven by an increasing prevalence of conditions that lead to neutropenia, particularly in cancer patients undergoing chemotherapy and radiation treatments. As such, Neutropenia represents an area of significant unmet need within the global healthcare landscape. Tivic’s licensing of Entolimod™ for Neutropenia represents an opportunity to tap into this growing market while potentially improving patient outcomes in a critical therapeutic area.
Strategic Expansion of Commercial Rights
Tivic Health’s licensing agreement with Statera Biopharma, which originally secured Tivic exclusive rights to Entolimod™ for the treatment of ARS, has now been expanded to include the Neutropenia indication. This move highlights Tivic’s commitment to leveraging its assets across multiple indications, potentially increasing the value of its investment in Entolimod™. In addition to Neutropenia, Tivic retains the option to license additional indications for Entolimod™, including lymphocyte exhaustion, immunosenescence (age-related decline in immune function), and chronic radiation syndrome (CRS)—further expanding the potential applications of this promising immunotherapy.
The TLR5 agonist mechanism of Entolimod™ makes it a unique candidate for a range of immune-related conditions. While the focus has primarily been on ARS, which occurs when individuals are exposed to high doses of radiation, the broader immune-modulating effects of Entolimod™ have opened the door to additional uses. This is particularly important for conditions such as Neutropenia, where immune system modulation could significantly improve patient outcomes by boosting neutrophil production and enhancing the body’s immune response to infections.
Tivic Health’s Commitment to Advancing Immunotherapy
Jennifer Ernst, CEO of Tivic Health, emphasized the company’s strategy in advancing Entolimod™. “As Tivic prepares for commercial-grade manufacturing of Entolimod™, we see the opportunity to leverage that investment across more than one indication,” said Ernst. She highlighted that Entolimod™ and its companion product, Entolasta, have already been the subject of more than 40 animal and human clinical trials, with over $140 million in prior investment. This substantial investment in research and development underscores Tivic’s confidence in the drug’s potential to move through the final stages of the development process toward a biologics license application (BLA) filing with the U.S. Food and Drug Administration (FDA).
Based on the extensive preclinical and clinical data accumulated over the years, Tivic believes that Entolimod™ is well-positioned for approval and commercialization. The company is focused on advancing the immunotherapy through the final stages of clinical trials, with the ultimate goal of securing FDA approval for the drug as a treatment for Neutropenia and other potential indications.
Terms of the License Agreement: A Milestone-Driven Approach
The licensing agreement between Tivic Health and Statera Biopharma is structured to align both companies’ interests around the clinical and commercial success of the Entolimod™ program. Under the terms of the agreement, Tivic holds exclusive worldwide rights to Entolimod™ for Neutropenia and ARS, as well as the option to acquire exclusive rights for additional indications, including lymphocyte exhaustion, immunosenescence, and chronic radiation syndrome.
Future payments under the agreement will be milestone-driven, ensuring that Tivic’s investment is aligned with the progress and success of the Entolimod™ program. These payments will be tied to specific clinical and regulatory milestones, such as advancing through clinical trial phases and receiving regulatory approvals. The milestone-driven structure allows Tivic to strategically manage its investments while maximizing potential returns as Entolimod™ progresses toward commercialization.
This milestone-based approach also provides Tivic with the flexibility to manage the financial risk associated with the development of Entolimod™. By linking payments to specific milestones, Tivic can ensure that resources are allocated efficiently and that both companies remain focused on achieving the shared goal of bringing Entolimod™ to market.
A Strong Future for Entolimod™
Tivic Health’s expanded licensing agreement with Statera Biopharma marks an important step in the company’s growth and its efforts to build a diverse portfolio of innovative therapeutic solutions. The expansion of commercial rights to include Neutropenia not only offers Tivic the opportunity to tap into a substantial market but also strengthens the company’s position as a leader in immunotherapy development.
With more than 40 clinical trials completed, significant investment in research and development, and a pipeline of promising indications, Tivic is well on its way to positioning Entolimod™ as a cornerstone of its therapeutic portfolio. As the company moves forward with the regulatory process and works toward FDA approval, Tivic Health remains committed to leveraging its expertise and resources to bring innovative solutions to patients in need.
As the global healthcare landscape continues to evolve, Tivic’s efforts to expand the applications of Entolimod™ could help address a variety of critical immune system-related conditions, including Neutropenia, ARS, and others. With a focus on improving patient outcomes and addressing unmet medical needs, Tivic Health is poised for success in the rapidly growing immunotherapy market.
In conclusion, Tivic Health’s strategic decision to expand its licensing agreement with Statera Biopharma for the development of Entolimod™ for Neutropenia reflects the company’s commitment to addressing major healthcare challenges. With a proven track record in immunotherapy and an expanding pipeline of therapeutic opportunities, Tivic is positioned to make a significant impact in the fight against immune system disorders. As the company prepares for the next phase of development, the potential for Entolimod™ to transform the treatment landscape for Neutropenia and other indications is both exciting and promising.
