Pfizer Exits TYK2 Inhibitor Race, Sells Mid-Stage Inflammatory Drug Portfolio to New Biotech Startup

Compiled and Translated by | Tom Li

Recent reports indicate that Pfizer appears to be exiting the competition in the TYK2 inhibitor market. Following extensive research into lead inhibitors for inflammatory diseases, Pfizer recently announced that it is preparing to sell its portfolio to a newly established company in exchange for a 25% stake in the startup.

In terms of competitors, Bristol Myers Squibb has achieved leading progress in the TYK2 field, advancing the candidate drug deucravacitinib through clinical trials. Although deucravacitinib recently faced a regulatory setback for ulcerative colitis, positive trial results indicate that this TYK2 inhibitor holds the potential to deliver biologic-like efficacy in an oral formulation. Notably, Pfizer's positioning at the time was to directly challenge Bristol Myers Squibb's deucravacitinib.

However, Pfizer recently disclosed that it is considering selling its TYK2 assets. In announcing this move, Dr. Albert Bourla, Chief Executive Officer of Pfizer, told investors that Pfizer has granted "an exclusive license to a newly formed company established in partnership with a collaborator that has a strong track record in developing late-stage inflammation and immunology medicines." The transaction covers two Phase 2 drug candidates: brepocitinib and PF-06826647.

Brepocitinib (PF-06700841) is an oral tyrosine kinase 2 (TYK2)/Janus kinase 1 (JAK1) inhibitor. PF-06826647 is a TYK2 inhibitor currently in Phase 2 studies for the treatment of psoriasis and hidradenitis suppurativa (HS). Upon completion of the transaction, the new company will be responsible for future development decisions regarding both candidate drugs; however, Pfizer retains the opportunity to benefit from the candidates' success by holding a 25% equity stake in the startup and retaining commercial rights in certain U.S. markets. Bourla stated that the transaction will "enable the allocation of resources to advance the development of brepocitinib and TYK2, while allowing Pfizer to focus on diversifying its pipeline."

SVB Leerink analysts had previously noted that Pfizer’s brepocitinib would struggle to outperform deucravacitinib’s Phase II results, and that the company lagged behind Bristol Myers Squibb by approximately two years in this space. This transaction inevitably recalls Pfizer’s prior transfers of drug candidates to Cerevel Therapeutics and SpringWorks Therapeutics, even though TYK2, as a member of the JAK family, covers distinct therapeutic areas. Bourla stated that the divestiture of the TYK2 asset is part of Pfizer’s broader pursuit of “various options to advance additional JAK inhibitor assets.”

Against the backdrop of the FDA issuing successive safety warnings and raising concerns regarding JAK inhibitors, the CEO stated that Pfizer continues to believe in the importance of this class of drugs for "appropriate patients with inflammatory diseases." In addition to divesting certain assets, Pfizer has also removed PF-06952229, a solid tumor candidate, and PF-06842874, a pulmonary arterial hypertension candidate, from its list of actively developed R&D projects.

Source: Pfizer sells midphase inflammatory drugs to mystery startup, exiting race against Bristol Myers