July 11, 2024
Member Spotlight: Qpex Biopharma, a Shionogi Group Company

Shionogi’s New Expanded Discovery Lab in San Diego Will Strengthen International Collaborations to Fight Antimicrobial Resistance Worldwide
Shionogi is a Japanese pharmaceutical company with a storied history. Founded in Osaka in the late 1800s, the company is known for its work in advancing research and treatments for infectious diseases and bacterial infections, and pioneering therapies such as cefiderocol and dolutegravir (which are available in the U.S.). Last summer, the company acquired Qpex Biopharma, a San Diego-based company established in 2018 dedicated to developing new therapies to combat antimicrobial resistance (AMR).
During the BIO 2024 convention in June, Shionogi announced its plans to establish its first discovery lab here in the U.S., which will be an expansion of Qpex’s operations in San Diego within the SD Tech by Alexandria campus. The Shionogi Qpex Lab will focus on antimicrobial and pandemic preparedness research and is scheduled to open in early 2025.
The World Health Organization notes that AMR affects millions of patients worldwide and is a critical public health challenge today. In this month’s Member Spotlight featuring Michael Dudley, president and CEO of Qpex Biopharma, we learn more about how this expanded new facility will address unmet needs in the field. We also hear from Michael about what this new influx of international capital means for the region, as well as some exciting future projects.

A rendering of the new Building C facility at the SD Tech by Alexandria mega campus in the Sorrento Mesa area in San Diego where the new Shionogi Qpex facility will be located. Image courtesy of Alexandria Real Estate.
Congratulations on the news of this new expanded research facility in San Diego. Can you speak to why the company selected San Diego as the base for their first discovery lab in the U.S.?
Qpex Biopharma, a Shionogi Group Company, is already open for business in San Diego with an established research facility. The new state-of-the-art discovery laboratory will expand our global infectious disease and antimicrobial research operations in the U.S.
The location of this facility in the U.S., and in San Diego in particular, will connect Shionogi and Qpex to expertise and innovation occurring in laboratories of private biotech companies, research institutes and universities. It also supports our collaborations with U.S. government entities, such as the Biomedical Advanced Research and Development Authority (BARDA). Furthermore, San Diego is in the Pacific time zone, which facilitates collaboration between Qpex researchers and colleagues from Shionogi who are based in Japan.
How will this influx of international investment and capital benefit the industry in our region, and in California?
First, our expanded presence will provide an opportunity to further develop our company’s partnership network with researchers in both the public and private sectors.
In addition, Qpex has a strong team of scientists who have been together for more than a quarter of a century. We will be adding new research and clinical scientists and support personnel positions to our core team of researchers in the U.S. and Japan. In addition, as a Shionogi Group Company, Qpex is part of a larger network of scientists, which allows scientists from Japan to come work in the U.S. and vice versa, further enhancing our capabilities and collaboration.
Finally, Qpex and Shionogi will also train the next generation of scientists and leaders in the discovery of new treatments for infectious diseases.
In a recent interview with GEN Edge you mentioned that AMR (antimicrobial resistance) is an escalating issue. How critical is this issue? How will the new expanded facility contribute to the necessary research to address it?
Infectious diseases have substantial health and economic costs and are becoming difficult to treat.1,2 There are hundreds of known bacterial and fungal pathogens, including antibiotic resistant bacteria that are considered priority for development of new treatments by the WHO.3,4,5 Unfortunately, the antibiotic R&D pipeline has continued to decline due to insufficient investment needed to develop new treatments.6,7
It’s important that we appropriately reward innovative treatments to support continued investment which brings new, needed therapies to patients worldwide. In contrast to many companies that have left the space, Shionogi and Qpex have demonstrated sustained success over decades with innovation and commercialization of products in infectious diseases, including antivirals and antibiotics. In fact, the senior team at Qpex was involved in regulatory approvals for four anti-infective products during the last decade.
This new discovery laboratory along with our combined expertise—including decades of successful infectious disease R&D—provides for an increased potential for public/private partnerships and collaborations that will enable us to accelerate our efforts to develop new antibiotic treatments to address current and emerging health threats.
Together … we have the capabilities and the capacity to face the known public health crises of today and to prepare for the impact future pathogens may have on society.
Since AMR is a niche field of study, are there any current challenges in finding talent as you’re looking to expand your workforce for the lab’s opening next year?
San Diego has a rich talent pool of scientists from existing companies as well as academic and research institutions. The existing ecosystem of biotech companies, combined with leading academic and research institutes in San Diego provide for an excellent recruiting environment for us.
Our research and clinical scientists are driven. They recognize the importance of discovering and developing new antibiotics that provide foundational support for all areas of human medicine. In addition, our team is committed to developing novel antibiotics that change the way we manage difficult-to-treat infections.
Qpex has two new antibiotics in its pipeline under development—S-743229 and S-649228— compounds that target infections in patients with limited antibiotic treatment options. The company recently received a $10 million award from BARDA to advance these therapies. What is some other exciting company news you can share?
Qpex’s current partnership with BARDA is advancing xeruborbactam-based products S-649228 (cefiderocol + xeruborbactam IV) and S-743229 (ceftibuten oral + xeruborbactam oral prodrug). The development of these compounds in Qpex’s portfolio is funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, BARDA, under OTA number HHSO100201600026C. To date, BARDA has awarded $92 million and provided technical support. If all options are awarded, the agreement would provide up to $132 million in support for the development of a portfolio of new antibiotics to fight drug-resistant gram-negative infections.
We are grateful for our successful and longstanding contract with BARDA and partnership with other government agencies, whose support in addressing the global and growing threat of antimicrobial resistance and infectious diseases has been unparalleled.
In the near term, Qpex is focused on xeruborbactam; from a larger Shionogi perspective, we are open to all forms of collaboration. We believe that an expanded footprint in the U.S. will allow for greater collaboration and information sharing with external partners—both public and private—and enable faster future discoveries and potentially expand Shionogi’s pipeline.
What excites you the most about the life science industry in San Diego, and California as a whole, today?
This is a landmark opportunity to build upon the excellent track record of our organizations in discovering innovative antimicrobial drugs and bringing them to patients. Together, with our government and academic partners, we have the capabilities and the capacity to face the known public health crises of today and to prepare for the impact future pathogens may have on society.
References:
1. O’Neill J. The Review on Antimicrobial Resistance. 2016. Accessed April 30, 2024. Available at: https://amr-review.org/
2. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55.
3. Bartlett, A., Padfield, D., Lear, L., Bendall, R., & Vos, M. (2022a). A comprehensive list of bacterial pathogens infecting humans. Microbiology, 168(12). https://doi.org/10.1099/mic.0.001269
4. About Fungal Diseases. The Centers for Disease Control. Accessed May 24, 2024. Available at: https://www.cdc.gov/fungal/about/index.html#:~:text=There%20are%20nearly%201%2D5,risk%20for%20most%20fungal%20infections
5. WHO Bacterial Priority Pathogens List, 2024. Accessed May 24, 2024. Available at: https://iris.who.int/bitstream/handle/10665/376776/9789240093461-eng.pdf?sequence=1
6. Dheman D, Mahoney N, Cox E.C, Farley J.J, Amini T, Lanthier M.L. An Analysis of Antibacterial Drug Development Trends in the United States, 1980–2019, Clinical Infectious Diseases, 73(11): e4444-e4450. December 2021. https://doi.org/10.1093/cid/ciaa859
7. Lack of innovation set to undermine antibiotic performance and health gains. The World Health Organization. Accessed June 24, 2024. Available at: https://www.who.int/news/item/22-06-2022-22-06-2022-lack-of-innovation-set-to-undermine-antibiotic-performance-and-health-gains
