China biotech RemeGen and its new U.S. partner Vor Bio are on a roll with their first-in-class autoimmune treatment telitacicept.
Two weeks after RemeGen revealed the success of a China phase 3 trial of telitacicept in Sjögren’s disease, the companies have reported another late-stage win for the injected treatment, this time in IgA nephropathy (IgAN).
In Stage A of a phase 3 study of 318 adult patients in China who had received standard therapy, telitacicept achieved its primary endpoint, showing a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared to placebo, Vor reported.
UPCR, which is a measure of kidney damage obtained through a urine sample, is a globally recognized regulatory marker in IgAN. High levels of protein (proteinuria) indicate kidney disease progression in patients with the condition.
The FDA has approved other IgAN drugs—like Novartis’ Vanrafia—using the same UPCR metric.
RemeGen said it plans to reveal full results of the trial at an upcoming medical conference and will submit a Biologics License Application (BLA) to regulators in China. Two weeks ago, the company said it would submit a BLA for telitacicept in Sjögren’s disease.
RemeGen gained its first approval for telitacicept in China for systemic lupus erythematosus (SLE) in 2021. That was followed by nods in China for rheumatoid arthritis (RA) and generalized myasthenia gravis (gMG).
In June of this year, Vor Bio paid $45 million upfront to acquire ex-China rights to telitacicept. The deal also includes an initial payment of $80 million in warrants that grant a RemeGen subsidiary roughly a 23% stake in Vor. Long-term, potential clinical and commercial milestones could earn RemeGen up to $4.1 billion from the deal.
The licensing deal marked a major reversal for Vor, which had said in May that it was winding down its existing clinical and manufacturing operations and eliminating 95% of its workforce. Vor had been developing two lead cell therapy assets in acute myeloid leukemia and cited a “challenging fundraising environment” as the rationale behind its pivot.
The companies tout the dual action of telitacicept, targeting two cell-signaling molecules for B-lymphocyte development—B lymphocyte stimulator (BlyS) and A proliferation-inducing ligand (APRIL).
“By directly targeting the upstream drivers of IgAN and stopping the downstream signaling that fuels disease progression, telitacicept has the potential to modify the disease at its core, potentially leading to deeper, more durable responses and long-term kidney preservation for patients,” said Jean-Paul Kress, M.D., Vor’s CEO and chairman, in an Aug. 27 release. “Taken together, these data reinforce our conviction that telitacicept is a pipeline-in-a-product with the potential to deliver a best-in-class profile across multiple autoimmune diseases.”