Telitacicept

RemeGen and Vor Bio have reported a phase 3 trial win for telitacicept in IgA nephropathy. It is the second phase 3 success for the therapy in the last two weeks, with the other coming in Sjögren’s disease. 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.”

Plus, news about Nykode, Therna Biosciences, Fosun, Sitala Bio, Catalyst Pharmaceuticals and Lupin: 🔎 Lilly’s Verzenio improves survival in early breast cancer: In the seven-year analysis of the monarchE trial, two years of treatment with Verzenio on top of endocrine therapy as an adjuvant therapy improved survival compared to endocrine therapy alone. The massive study enrolled over 5,000 patients with HR+, HER2-, node-positive early breast cancer at high risk of recurrence. Lilly kept details under wraps, saying the data will be shared at a future medical meeting. Verzenio was first approved in this indication in 2021 with an expanded label in 2023. — Lei Lei Wu 📝 RemeGen gets another Phase 3 win: This time, the Chinese biotech’s drug telitacicept succeeded in an IgA nephropathy trial, and it plans to ask Chinese drug authorities for approval. In the Phase 3 study, telitacicept cut a kidney function measure known as 24-hour UPCR by 55% at 9 months compared to placebo. The news was announced by its Cambridge-based partner Vor Bio, which holds rights to the drug outside China, Hong Kong, Macau and Taiwan. Vor Bio’s shares $VOR fell 3% Wednesday morning. Earlier in August, RemeGen’s drug also passed a Sjögren’s study . If approved, the Sjögren’s indication would mark telitacicept’s fourth indication, while IgA nephropathy would be its fifth in China. — Lei Lei Wu 🔭 Nykode seeks to re-partner cancer vaccine: The Oslo-based biotech said that it’s seeking to attract potential partners for its individualized neoantigen cancer vaccine VB10.NEO, and will make a limited investment in the program moving forward. Genentech dropped its deal with Nykode over the experimental cancer vaccine at the start of this year. — Lei Lei Wu 💰 Therna Biosciences lands $10M: The RNA medicines startup emerged with a seed round from AIX Ventures, Pear VC and Fusion Fund to work on an AI-driven platform. It was founded by UCSF and Arc Institute investigator Hani Goodarzi. San Francisco-based Therna is led by co-founder and CEO Nazli Azimi, who previously founded Bioniz Therapeutics. — Kyle LaHucik 🤝 Fosun does another Western deal: The Shanghai biotech is licensing an inflammatory disease drug candidate to Sitala Bio. The UK biotech is backed by Forbion and OrbiMed, according to the websites of the investors. Fierce Biotech reported on the deal on Tuesday, noting it’s worth up to $670 million. Fosun did a lung disease licensing deal with Expedition Therapeutics earlier this month. — Kyle LaHucik 🖊️ Catalyst Pharmaceuticals settles patent dispute with Lupin: The US biotech has inked an agreement with India’s Lupin over a generic version of Catalyst’s treatment, called Firdapse, for Lambert-Eaton myasthenic syndrome. Under the terms of the settlement, Lupin can’t market its generic drug until Feb. 25, 2035. Catalyst reached a similar agreement with Teva in January. — Ayisha Sharma