Aurinia Submits IND Application to US Food & Drug Administration for AUR 200

• AUR200, a potent recombinant fusion protein, has a clinically validated MOA with a high affinity for targeting both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand)
• Upon FDA clearance of the IND, AUR 200 will be studied in a Phase 1 first-in-human trial in healthy volunteers, marking a significant advancement for Aurinia’s emerging autoimmune pipeline

ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases. Upon receiving FDA clearance to proceed with proposed research, Aurinia plans to initiate a Phase 1 study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of AUR200 in healthy volunteers.

AUR200 is a highly potent and specific Fc-fusion protein containing a modified B cell maturation antigen (BCMA), for enhanced binding to both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). BAFF and APRIL play important roles in regulating B-cell survival and differentiation.

“Our IND submission for AUR200 is an important step forward for Aurinia’s pipeline and our mission to change the trajectory of autoimmune disease. Dual inhibition of BAFF and APRIL is a clinically validated mechanism which has demonstrated great potential in the treatment of autoimmune diseases such as IgA nephropathy and systemic lupus erythematosus. We are encouraged by AUR200’s unique profile and pre-clinical activity and look forward to sharing further data and updates once our clinical research program begins,” said Volker Knappertz, M.D., Executive Vice-President, Research & Development, Aurinia.

In animal data presented at the annual American College of Rheumatology Convergence 2022, AUR200 dosed therapeutically reduced several markers of disease activity and improved overall survival in a mouse model of lupus. AUR200 was also well-tolerated in both mice and cynomolgus monkeys, with no adverse effects. These data highlight the potential utility for AUR200 in the treatment of autoimmune diseases.

Aurinia acquired AUR200 as part of a strategy to diversify its development pipeline and leverage existing R&D capabilities to advance innovative therapeutic solutions to help people living with autoimmune diseases.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations with high unmet medical needs that are impacted by autoimmune, kidney and rare diseases. In January 2021, the Company introduced LUPKYNIS^® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in Edmonton, Alberta, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.

Reference

Morales S, Cross J, Huizinga R. AUR200: An Improved BAFF/APRIL Inhibitor with Increased Potency and Safety for the Treatment of B Cell-Mediated Diseases [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/aur200-an-improved-baff-april-inhibitor-with-increased-potency-and-safety-for-the-treatment-of-b-cell-mediated-diseases/. Accessed December 6, 2023.