By Rich Soll Senior Advisor, Strategic Initiatives, WuXi AppTec (@richsollwx) and the WuXi Content Team

Founded only in 2015 and currently running with merely 17 members, South Korea-based Bridge Biotherapeutics has brought two molecular compounds forward to early clinical stages, with more programs being generated in its robust pipeline. Its founder and CEO James Jungkue Lee would rather describe Bridge as a “virtual company”, and attributes its remarkable progress to, in addition to a strong and efficient team, choosing the right compounds and targets, and equally important, responsive enabling partners, including WuXi AppTec.

A 25-year industry veteran, Lee’s motivation to better “bridge the bench-to-bedside gap” is founded in his conviction of delivering valuable therapy options to improve the quality of patient’s lives.  According to Lee “patients are not people very far from us, and they are actually our neighbors, or maybe even closer.”

Despite scientific advances over the last two decades, translation of research findings from academic and research institutes into products valued by patients still face difficulties. “What I wanted to achieve is finding novel science from academic institutes and biotech companies and develop those compounds globally,” Lee explains.

“Bridge Biotherapeutics is a clinical stage biotech, which focuses on developing novel compounds addressing unmet medical needs worldwide,” Lee commented.  “I had my eyes on BBT-401, the company’s in-licensed first compound.  The in vivo data of the compound was compelling, worthy for consideration as a promising candidate molecule. BBT-401 targets Pellino-1, a very novel target implicated in ulcerative colitis.”

“The compound is designed to be locally acting in the GI tract only, which means it doesn’t have any systemic exposure and thus has high safety”, declared Lee. “So that’s its basic differentiator from others. The company set up a lab in Houston mainly to facilitate its collaboration with Dr. Shao-Cong Sun at the MD Anderson Cancer Center in the US. Dr. Sun has been one of the leading investigators in Pellino-1.”

The company initiated clinical development of BBT-401 first in the US, and then trying to push its clinical trial in China as well along with its partner company, Daewoong. “They showed a really strong initiative of developing their clinical and commercial capability in Asian territories including Korea, China and Japan and that strategy pitched very well with us for BBT-401, so we decided to let Daewoong develop it in China in a timely manner, and in a coordinated way with our initiative in the US,” says Lee, who considers China as an important global market for its huge potential, not only for the market itself, but as a good place for a clinical development.

The company’s second product, BBT-877, is a candidate with potential to treat idiopathic pulmonary fibrosis, a life-threatening disease with a median overall survival of two to three years.  BBT-877 is the best-in-class autotaxin inhibitor. Lee noticed the compound’s good safety profile and reasonable efficacy, and decided to in-license it from a Korean biotech company.

“As a small biotech company we cannot pursue indications of large population like diabetes or other primary care types of diseases. So we wanted to focus on specialty care, which addresses well defined medical needs,” Lee says.

This special approach has brought about encouraging results, notably, BBT-877 gained an orphan drug designation from the FDA in January 2019. Lee is confident that it has the potential to be a best-in-class product from safety and efficacy perspectives.

In addition to these two products, Bridge Biotherapeutics is building a differentiated pipeline that has not yet been disclosed.  Domestic investors in South Korea are eager to invest in biotech companies in recent years. Thus, the $55M that has been raised to date is based on the strength of the company’s story and its compelling pipeline.

“The first two rounds of fund raising were primarily to advance research of the company’s first two compounds from technical study up to Phase 1, while series C, closed quite recently and raising $27.2 million, which will be used to take those two compounds further up to end of Phase 1 or Phase 2a,” Lee commented.

Lee expects his company to get the first human POC data for BBT-401 and also complete the Phase 1 clinical trial for BBT-877 in the second half of this year. With all these fast-progressing programs and the emerging pipelines, the company has maintained a rather limited size in terms of headcount – fourteen in South Korea and three in the United States.

What makes this group unique, however, is their strong professional backgrounds and industry-seasoned experiences. Most of its scientists have more than ten years of experience in drug discovery and development, and some of them have worked with global pharma companies before.

To get all necessary work done, they “virtually” operated the company from the very beginning— seeking externalized solutions and collaborating globally with enabling and responsive partners like WuXi AppTec. For BBT-401, the company started collaboration with WuXi initially for process development, clinical API supply, GLP-tox and then drug product supplies.

“WuXi has been supporting us in such a great way that we could complete the first GLP dosing to first human dosing in just nine months,” proclaimed Lee. “WuXi certainly demonstrated excellent technological caliber and I was impressed by WuXi’s responsiveness to clients’ needs.”

He recalls that in the BBT-877 case, his company faced great challenges as they had to follow a tight timeline for supplying drug products and also needed a very solid comprehensive pre-formulation study.  To meet the needs of Bridge Biotherapeutics, WuXi conducted the procedures— preparing drug product manufacturing, completing pre-formulation, and screening formulation product—in parallel.

“They don’t want to sit and wait. The WuXi AppTec team has been really engaging and jumped in to solve those problems together with us,” proclaimed Lee.  “We almost feel like they are our internal team. We consider WuXi AppTec not only as a passive server, but a truly enabling partner for us.”

With all those efforts, Bridge Biotherapeutics was able to make it to the first attempt at human dosing for BBT-877 clinical development just in eight months.

As CEO of the company, Lee has set long-term objectives for the company. “We’re hoping to have one of our compounds— BBT-401 or BBT-877— at end of submission or FDA approval in five years. That’s the biggest goal,” says Lee, noting that the company will also seek to strengthen its clinical development capability both in the US and China, and would like to open their eyes to some Asian regions like Japan and China, instead of merely South Korea, in search for scientific assets that has potential for in licensing.

He also plans to continue virtually operating the company on the development side, and relies on collaboration with partners.  “Choosing the right partner is really, really critical for our success.  From that end, we are very lucky to have been working with WuXi AppTec,” he points out.

Lee concludes that over the last five years, he has observed a really great ecosystem and growing opportunities in Asia in terms of science, collaboration network and investment, which have given him great confidence in the industry’s further growth.