Micreos Pharmaceuticals Partners with Northway Biotech for Scalable cGMP Manufacturing of Engineered Endolysin Therapy

• Micreos Pharmaceuticals AG has partnered with Northway Biotech to develop scalable cGMP production processes for its investigational biologic therapeutic, MEndoB.

• The collaboration will focus on process development, analytical validation, and regulatory compliance to support clinical trials.

Micreos Pharmaceuticals AG has entered into a strategic partnership with Northway Biotech, a Contract Development and Manufacturing Organization (CDMO), to advance the cGMP manufacturing of its biologic therapeutic, MEndoB. The investigational drug, a first-in-class dual-active domain targeted medicine, is set to enter clinical trials in the coming months for the treatment of atopic dermatitis.

The partnership will leverage Northway Biotech’s expertise in biologics manufacturing to develop a scalable production process for Micreos’ engineered endolysin technology. The collaboration includes process development, analytical method validation, cell bank manufacturing, and technology scale-up for cGMP Drug Substance generation. Additionally, both companies will ensure compliance with regulatory requirements by preparing IND/IMPD supporting documentation.

Matt Regan, CEO of Micreos, commented: “This partnership with Northway Biotech marks a significant milestone for Micreos as we advance our engineered endolysins into scalable therapeutics for clinical trials.” He highlighted the potential impact of targeted medicines in dermatology and oncology, particularly in conditions such as atopic dermatitisand cutaneous T-cell lymphoma.

Northway Biotech aims to accelerate Micreos’ clinical development timeline by delivering cGMP drug substance material by late summer 2024. Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, stated: “We are honored to contribute to Micreos’ innovative engineered endolysin therapies.”