Scinai Immunotherapeutics Supports Serpin Pharma’s Phase 2 Clinical Trial with CDMO Services

• Scinai Immunotherapeutics supported Serpin Pharma’s Phase 2 clinical trial in Germany and Israel through tailored CDMO services.

• The collaboration included aseptic filling, stability testing, and analytical method development for SP16, a novel peptide therapy.

Scinai Immunotherapeutics Ltd. has provided contract manufacturing support to U.S.-based biopharmaceutical company Serpin Pharma for a Phase 2 clinical trial of its lead candidate, SP16. The study was conducted across Germany and Israel, marking the first time an international client used Scinai’s CDMO services.

SP16 is a novel peptide drug derived from human alpha-1-antitrypsin. It targets the LRP1 receptor to modulate immune responses and is being investigated for multiple inflammatory conditions, including acute myocardial infarction, chemotherapy-induced peripheral neuropathy, and acute kidney injury.

Scinai’s involvement included bulk formulation, aseptic filling, stability studies, analytical release method development, and preparation of documentation aligned with international regulatory requirements. The CDMO said its work spanned all aspects necessary to enable clinical supply.

Serpin Pharma’s CEO, Dr. Cohava Gelber, commented on the partnership, stating: “We appreciated Scinai’s dedication, customised approach, and high level of professionalism and expertise throughout the project.”