Founded in 2020, Xentria’s core mission is to forge a novel collaborative ecosystem aimed at addressing critical unmet clinical needs. Xentria harnesses its extensive internal experience and established networks across the pharmaceutical industry and academia to tackle the inherent risks of pharmaceutical innovation head-on. This proactive approach allows Xentria to transform challenging drug targets into viable and promising clinical programs, offering hope to patients where treatment options are limited.
Validating Xentria’s Innovative Model with XTMAB-16
Xentria’s collaborative model has been successfully validated through the development of XTMAB-16, an anti-tumor necrosis factor alpha (TNF-α) monoclonal antibody. Currently undergoing clinical trials, XTMAB-16 shows significant potential as a treatment for pulmonary sarcoidosis, a rare inflammatory disease (Fig. 1). While similar molecule types have indicated promise for this condition, corticosteroids remain the standard, yet suboptimal, approved treatment. The long-term use of corticosteroids is often associated with debilitating side effects and a reduced quality of life, underscoring the urgent need for better therapeutic alternatives like XTMAB-16, developed through Xentria’s strategic approach.
Fig. 1 | Mechanism of action of Xentria’s XTMAB-16. XTMAB-16, developed by Xentria, is designed to target and inhibit pro-inflammatory cytokines, crucial in reducing the activation of inflammatory pathways implicated in pulmonary sarcoidosis. This targeted approach is central to Xentria’s innovative drug development strategy.
Addressing the complexities of sarcoidosis drug trials, which have historically faced challenges due to the disease’s variable presentation and have led to industry disinvestment, Xentria adopted a collaborative, evidence-driven strategy. Working closely with leading key opinion leaders, patient advocacy groups, and global scientists, Xentria designed an innovative clinical trial for pulmonary sarcoidosis. This patient-centric approach considered critical physiological and quality-of-life outcomes, aligning trial endpoints with what is most meaningful to both patients and their healthcare providers, ensuring that Xentria’s development process is deeply rooted in patient needs.
To further refine the clinical trial design and account for the heterogeneity of sarcoidosis, Xentria employed advanced scientific strategies, including bio-simulation modeling. This novel approach simulated the predicted distribution of XTMAB-16 at various doses to reach pulmonary granulomas, the hallmark of sarcoidosis. These simulations were instrumental in reinforcing the scientific rationale behind XTMAB-16 and identifying potentially safe and effective dosage ranges for clinical investigation. Xentria’s team detailed this innovative modeling approach in a publication in Frontiers in Pharmacology, showcasing Xentria’s commitment to scientific rigor and transparency.
By integrating in vitro model data with findings from the first-in-human clinical trial of XTMAB-16, Xentria developed a population pharmacokinetic model. This model allowed for the assessment of pharmacokinetic variability sources and effectively guided decisions regarding optimal dose levels and administration frequency. Notably, this project marked a pioneering application of bio-simulation modeling to influence dosing strategy in a sarcoidosis trial. This innovative step significantly de-risked subsequent development phases and established a translational framework for determining safe and effective doses for patients, highlighting Xentria’s leadership in applying cutting-edge technologies.
Xentria also prioritized a deep understanding of the sarcoidosis patient journey, ensuring that the patient voice was central to the drug development process from the outset. Considerations of racial, gender, and socioeconomic disparities were integral to the design of future XTMAB-16 trials. Xentria strived to implement equitable and inclusive trial criteria and develop a trial design that minimizes burden on both patients and researchers. Furthermore, diversity and inclusion were key factors in Xentria’s selection of strategic partners for the XTMAB-16 trials, reflecting Xentria’s commitment to ethical and patient-focused drug development.
Currently, Xentria is focused on completing patient enrollment for the pulmonary sarcoidosis studies. Simultaneously, the company continues its active engagement with patient communities and regulatory bodies, and is pursuing new scientific collaborations to further support the development of XTMAB-16 for sarcoidosis, underscoring Xentria’s long-term dedication to this therapeutic area.
Xentria Forges New Partnerships to Expand Impact
The XTMAB-16 project culminated in a significant commercialization licensing agreement for the North American market with Meitheal Pharmaceuticals in 2023. This agreement validates Xentria’s capability to advance complex R&D programs to crucial value inflection points. Building on this success, Xentria is actively seeking new partnerships that align with its mission to collaborate with like-minded researchers. The goal is to accelerate the development of early-stage drug candidates that have the potential to be life-changing, reinforcing Xentria’s position as a pivotal player in biotech innovation.
Xentria is particularly interested in co-development partnerships that will expand its pipeline and broaden the availability of accessible treatment options for patients with significant unmet needs. Xentria welcomes collaborations with researchers holding preclinical or clinical-stage assets, as well as those seeking to progress investigational products to subsequent phases of drug development. By fostering these strategic alliances, Xentria aims to amplify its impact on the pharmaceutical industry and patient care.
As Xentria’s portfolio of projects grows, the company is committed to supporting the expansion and maturation of its partners, alongside the burgeoning life sciences sector in its home city of Chicago. Through these collaborative endeavors, Xentria and its partners will continue to pursue their shared objective: to tackle formidable challenges in drug development, synergizing knowledge and resources to create patient-centric R&D programs. These programs are designed to address major unmet medical needs and drive significant advancements for all stakeholders in the healthcare ecosystem, with Xentria at the forefront of this collaborative movement.
[ ](https://partnerships.nature.com/product/nature-research-custom-media/)[ ](http://www.xentria.com)XTMAB-16 is currently investigational; its safety and efficacy for its intended uses are yet to be fully established.
References
- Offman, E. et al. Front. Pharmacol. 14, 1066454 (2023).
Article PubMed Google Scholar - Licensing Agreement to Commercialize XTMAB-16 in Sarcoidosis | XENTRIA & Meitheal Pharmaceuticals Announce Exclusive Licensing Agreement for XTMAB-16 In North America. https://xentria.com/news/11 (2023).
