Formation Bio has announced it has acquired worldwide rights—excluding Greater China—to LNK01006, a next-generation, CNS-penetrant, highly selective TYK2 inhibitor, from Lynk Pharmaceuticals. The asset will be developed under Formation Bio’s newly launched subsidiary, Bleecker Bio.

 

LNK01006 recently cleared the FDA’s IND to start first-in-human studies in the U.S. Formation Bio plans to kick off a Phase 1 trial in the first half of 2026, signaling momentum in building its portfolio of high-potential, clinical-stage assets.

 

LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure, offering a potential path to modulate immune responses in autoimmune and inflammatory diseases. Its unique pharmacologic profile could open doors to indications where central or compartmentalized immune pathways are critical.

 

“This asset represents a prime example of what we call our 'Known In New' strategy of applying validated mechanisms to novel areas of high unmet need,” said David Steinberg, Chief Business Officer at Formation Bio. “Leveraging world class human expertise, robust clinical data sets, and homegrown, state-of-the-art AI tools, we've developed deeply grounded hypotheses around novel therapeutic applications of clinically derisked asset classes.”

 

LNK01006 showcases the company’s medicinal chemistry expertise, with a scaffold optimized for target selectivity, metabolic stability, and CNS penetration.

 

“We are excited to partner with Formation Bio to advance LNK01006 into the clinic,” said Zhao-Kui Wan, CEO of Lynk Pharmaceuticals. “Formation Bio's experienced clinical development team and AI-enabled capabilities provide the ideal environment to translate this compound's scientific potential into meaningful patient impact.”

 

Under the agreement, Lynk Pharmaceuticals will receive a minority equity stake in Bleecker Bio, an upfront payment, and up to $605 million in development, regulatory, and commercial milestones, plus tiered royalties on future sales. New York-based Pacific Bridge NY is a minority co-investor in Bleecker Bio.

 

Formation Bio’s model integrates capital, technology, and development infrastructure to accelerate promising programs in-house. Its approach combines deep therapeutic expertise, dedicated teams, and a proprietary AI platform that streamlines asset sourcing, clinical execution, and commercialization—all aimed at boosting speed, efficiency, and probability of success.