Bora Biologics to Support DotBio’s Novel Antibody Against Cancer Targets
Bora said it will be involved in stages ranging from chemistry, manufacturing, and controls strategy through to clinical development.
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Bora Biologics, a division of contract development and manufacturing organization (CDMO) Bora Pharmaceuticals, said in a press release on Jan. 9, 2025 that it will be supporting Singapore-based biopharmaceutical company DotBio in the development and manufacturing of what DotBio considers its lead asset, DB007, a novel, tri-specific antibody (1).
DotBio, which specializes in next-generation antibody therapies, is developing DB007 for use against undisclosed cancer targets, according to the release. Its existing portfolio includes the out-licensed JS207 program, which is now in clinical trials, and multiple, multi-specific antibody candidates that are currently in preclinical development.
Bobby Sheng, chairman and CEO of Bora Group, noted in the release that Bora Biologics’ support would be originating from its 48,400-square-foot center of excellence in Zhubei, Taiwan (1).
This news comes shortly before Bora Biologics’ planned merger with Tanvex BioPharma, another Taiwan-based company, which is expected to happen in the first quarter of 2025 (1).
“Bora Biologics offers a tailored development and manufacturing plan that provides end-to-end support for our client’s development programs,” Sheng said. “With operations up and running in Zhubei, Bora’s team of experts are ready to deliver high-yield processes together with the sophisticated program management capabilities necessary to successfully develop even the most challenging molecules.”
In the press release, Bora said its support of DB007 would range from its chemistry, manufacturing, and controls strategy, through to clinical development (1).
“We chose Bora Biologics as our development partner because of its expertise in early-phase biologics development and solid track record in high-yield manufacturing of multi-specific antibody molecules,” Ignacio Asial, PhD, founder and CEO of DotBio, said in the release. “Bora’s early-clinical manufacturing facilities in Taiwan align perfectly with our current IND [investigational new drug]-development stage, while their large-scale, commercial-stage manufacturing and fill-and-finish facilities in the United States will support our goal to treat patients globally. I am thrilled to be working hand in hand with one of the best CDMO partners in Asia.”
Bora, which was founded in 2007 in Taiwan, made news in 2024 when it expanded its North American footprint by purchasing an 87,000-square-foot sterile manufacturing facility in Baltimore, Md., a site previously owned by Emergent BioSolutions (2). That transaction, for approximately $30 million, followed Bora’s acquisition earlier in 2024 of Minnesota-based generics manufacturer Upsher-Smith Laboratories, which further deepened Bora’s reach within the United States.
The company’s Zhubei facility, meanwhile, specializes in providing early-stage discovery research support, lead candidate screening, and both in-vitro and biochemical/physical assays (1). Other services provided by the facility, primarily for research purposes, include preparation and purification of complex and other recombinant proteins, and monoclonal, bispecific, and multi-specific antibodies.
Bora said its track record of more than 70 batches produced in its Taiwan manufacturing plant has a 100% success rate continuously since 2014 (1).
References
1. Bora Pharmaceuticals. Bora Biologics Announces Strategic Collaboration to Accelerate Key CMC Development of DotBio’s Tri-Specific Antibody to Treat Cancer. Press Release. Jan. 9, 2025.
2. Bora Pharmaceuticals. Bora Pharmaceuticals Expands North American Footprint with Agreement to Acquire First Sterile Manufacturing Facility. Press Release. June 20, 2024.
