Mike Dudley
Michael N. Dudley, PharmD, President and CEO of Qpex Biopharma

SAN DIEGO—Shionogi plans to create its first discovery lab in the United States, with a focus on antimicrobial and pandemic preparedness research as well as the development of infectious disease treatments.

The Shionogi Qpex Lab will be established through Shionogi’s wholly-owned subsidiary Qpex Biopharma within the SD Tech by Alexandria campus, located in the city’s Sorrento Valley section.

Qpex already occupies some 20,000 square feet at the campus, which is owned and managed by Alexandria Real Estate Equities, a publicly traded real estate investment trust (REIT) that is the largest and longest-tenured owner, operator, and developer specializing in life science mega-campuses.

The new lab will be around the same size and occupy the top floor of SD Tech by Alexandria’s Building C, which is being completed and is expected to be ready for occupancy in early 2025.

Qpex says its presence in San Diego is just one reason why the lab is being built here. Another is the city’s location in the Pacific time zone, which facilitates collaboration between Qpex researchers and colleagues from Shionogi who are based in Japan. Plus, the region’s critical mass of universities, research institutions, and companies has made San Diego a leader in advancing antibiotics from lab research to human clinical trials.

“There’s a talent pool here in San Diego and an ecosystem that really has been supportive as we have brought these products forward over the last decade,” Michael N. Dudley, PharmD, president and CEO of Qpex, told GEN in an interview during the Biotechnology Innovation Organization (BIO) International Convention, which is being held at the San Diego Convention Center. “There’s a real, very vibrant and effective ecosystem here for antibiotic discovery that works well.”

Part of that ecosystem is Qpex’s senior leadership, which has worked together for more than a quarter-century, during which time they completed regulatory reviews and secured approvals for four antibiotic drugs. Much of the team worked at Rempex Pharmaceuticals, which was acquired by The Medicines Co. in 2013 for up to $474 million.

Five years later in 2018, The Medicines Co. sold its preclinical-stage anti-infective assets to Qpex, which was spun out with $33 million in Series A financing to advance the development of a class of drugs called boronic acid beta-lactamase inhibitors.

During its first three years of operation, Qpex advanced three products to investigational new drug (IND) applications. Two of the three are designed to neutralize a resistance mechanism that’s responsible for bacteria being resistant to many classes of drugs that are used in hospitals.

Qpex’s infectious disease expertise and resulting clinical-phase portfolio of treatments compelled Osaka, Japan-based Shionogi to acquire the company through a subsidiary last year for $100 million upfront, plus up to $40 million tied to achieving regulatory and development milestones.

Shionogi is one of the few biopharma giants to focus on developing antibiotics and infectious disease drugs, with a heritage of developing anti-infective treatments for HIV, influenza, and COVID-19 stretching back to the 1950s.

Partnership opportunity

Shionogi and Qpex say the expanded U.S. presence represented by the new lab will offer an opportunity to further develop the companies’ network of partnerships with researchers in industry, government, and academia.

“In the field of antibiotic research and development, addressing the escalating issue of antimicrobial resistance (AMR) is a critical challenge. Qpex has been very effective in research and development within this area, having created many beneficial compounds to date,” Shogo Nishijima, a corporate planning executive with Shionogi who was previously a researcher and manager focused on manufacturing methods for active pharmaceutical ingredients, said on the company’s website April 16.

Qpex’s lead program is based on xeruborbactam, an ultra-broad-spectrum beta-lactamase inhibitor discovered by the company’s scientists. Xeruborbactam is under development in combination with IV beta-lactam as OMNIvance®, which has completed Phase I, while a xeruborbactam prodrug is being developed with oral beta-lactam as ORAvance™, now in Phase I.

Just last week, the Biomedical Advanced Research and Development Authority (BARDA) agreed to support development of xeruborbactam by exercising a $10 million option to advance the company’s antibiotic clinical development program. The option was awarded under Qpex’s existing contract with BARDA, which provides up to $132 million to advance development of the company’s portfolio of therapies (Other Transaction Authority number HHSO100201600026C).

BARDA—part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services—is funding development of the candidates in Qpex’s portfolio, in whole or in part depending on the drug.

Qpex has close to 20 staffers now in San Diego—a number that the company expects will rise to 30 by year’s end. The new hires are expected to have expertise in small molecule drugs—including medicinal chemistry, biology, pharmacology, and structural modeling—as well as clinical development, plus personnel to support operations of the labs. General and administrative functions are handled by Shionogi’s U.S. offices in the New York City suburb of Florham Park, NJ.

The cost of the new lab has not been disclosed.

Shionogi first announced plans for the new lab Tuesday at BIO, during a panel discussion that brought together leaders from industry and public health agencies.

Shionogi’s John Keller, PhD, senior executive officer, senior vice president, R&D supervisory unit, was joined on the panel by Gary Disbrow, PhD, deputy assistant secretary, director of BARDA; Paul Friedrichs, MD, a retired U.S. Army major general who is now deputy assistant to the President, Inaugural Director of the White House Office of Pandemic Preparedness and Response Policy; and Stephen Schondelmeyer, PharmD, PhD, professor and Century Mortar Club Endowed Chair in Pharmaceutical Management and Economics, University of Minnesota College of Pharmacy, and co-principal investigator of the Resilient Drug Supply Project at the Center for Infectious Disease Research and Policy (CIDRAP).

Phyllis Arthur, executive vice president & head, healthcare policy and programs for BIO, moderated the panel.

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