Biopharmaceutical companies continue to hunt for new immunology drugs that bring patients the same benefit as injectable antibody medicines, but in the form of more convenient daily pills. Coultreon Biopharma has more fuel for this chase from $125 million that the startup will use to advance its lead program to mid-stage clinical development.
Coultreon is the new name for Onco3R Therapeutics, a Leuven, Belgium-based startup formed last year with assets acquired from Galapagos. Onco3R aimed to develop these small molecules for autoimmune disease and cancer. As Coultreon, the new company name announced Tuesday, the startup is narrowing its focus to immunology and metabolic disease.
Before Galapagos’s ill-fated foray into cancer cell therapy, immunology was its focus. The company’s search for new mechanisms of action in immunology led to a novel class of targets called salt-inducible kinases (SIK), a family of enzymes that regulate immune and metabolic responses. In its 2022 annual report, Galapagos said SIK inhibition could reduce the production of pro-inflammatory signaling proteins while also enhancing production of immunoregulatory mediators.
“This unique mechanism-of-action offers the potential to restore the immune balance that is typically out of balance in autoimmune diseases, and differentiate product candidates from existing therapies that predominantly act by suppressing the immune system,” Galapagos said in the report.
Lead Coultreon program COL-5671 (formerly O3R-5671) is a SIK3 inhibitor that was the most advanced molecule from Galapagos’s SIK research. Coultreon describes this molecule as selective to SIK3, avoiding the toxicities that can come from also hitting the SIK1 and SIK2 receptors. Preclinical research showed this drug inhibited the release of two inflammatory cytokines, TNFα and IL-23. The drug also promoted the release of the immunomodulatory cytokine IL-10.
TNFα inhibition is the mechanism of action of blockbuster biologic drugs such as AbbVie’s Humira, Amgen’s Enbrel, and Johnson & Johnson’s Remicade. All three products have approvals in multiple immunological indications, but each must be administered via a needle in the arm.
Preliminary Phase 1 results for COL-5671 in healthy volunteers were presented in February during the European Crohn’s and Colitis Organization meeting in Stockholm. Coultreon reported its drug showed the ability to inhibit TNFα “as efficiently as monoclonal antibodies.” For the 15 mg dose, the third highest of four doses evaluated to date in the study, Coultreon reported the drug led to sustained TNFα inhibition. At 24 hours, this inhibition remained higher than 90%.
The company said the human data along with the preclinical research show COL-5671 has the potential to treat a variety of autoimmune diseases. In the Tuesday financing announcement, Coultreon said it aims to advance this molecule to Phase 2 testing in psoriasis and ulcerative colitis; proof of concept data are expected next year.
Coultreon acquired COL-5671 and other small molecule assets from Galapagos last year. Per terms of that deal, Galapagos participated in the startup’s seed financing with a €20 million (about $23.4 million) loan that would convert to equity in the company’s next financing round, according to Galapagos regulatory filings.
Sofinnova Investments led Coultreon’s new financing, a Series A round. Forbion and Novo Holdings are the co-leads. Other investors include Galapagos, Regeneron Ventures, Balyasny Asset Management, Luma Group, Samsara BioCapital, Longwood Fund, and Finchley Healthcare Ventures. Coultreon is led by CEO Pierre Raboisson, who previously served as head of discovery and preclinical development at Galapagos.
“This financing marks a major inflection point for our company,” Raboisson said in a prepared statement. “With the support of this top-tier syndicate, we are well positioned to advance our SIK program, while unlocking the broader potential of our pipeline.”
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