공시 • May 16
Vor Biopharma Announces Publication of Interim Analysis of Teligan Phase 3 Trial of Telitacicept in Iga Nephropathy Vor Bio announced that results from the Phase 3 TELIGAN trial evaluating telitacicept in IgA nephropathy in China sponsored by its collaborator, RemeGen Co. Ltd., were published in The New England Journal of Medicine (NEJM). The publication reports results from a prespecified interim analysis of the ongoing Phase 3 TELIGAN trial, a multicenter, randomized, double-blind, placebo-controlled trial conducted at 72 sites in China evaluating telitacicept in adults with biopsy-proven IgA nephropathy and persistent proteinuria despite optimized supportive care. The study met its primary endpoint, demonstrating a statistically significant reduction in proteinuria at week 39. Patients treated with telitacicept achieved a 58.9% reduction from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR), compared with an 8.8% reduction for placebo, representing a 55.0% relative difference between groups. Estimated glomerular filtration rate (eGFR) remained stable with telitacicept, with a mean percentage change from baseline of -1.0% compared with -7.7% for placebo at week 39. A confirmed decline in eGFR of =30% occurred in 6.3% of telitacicept-treated patients compared with 27.0% of placebo-treated patients. At week 39, 61.0% of telitacicept-treated patients achieved a UPCR below 0.8 compared with 19.5% of placebo-treated patients. Reductions in proteinuria were observed consistently across prespecified patient subgroups, including baseline kidney function, proteinuria level, and use of SGLT2 inhibitors. Telitacicept treatment was associated with reductions in circulating CD19+ B cells and serum immunoglobulin levels, including a 60.6% mean reduction in serum IgA levels. Safety findings were generally consistent with previous studies of telitacicept. Most adverse events were mild to moderate in severity. Serious adverse events occurred less frequently with telitacicept than placebo (2.5% vs. 8.2%). The most common adverse events associated with telitacicept included upper respiratory tract infection, injection-site reactions, and reductions in immunoglobulin levels. Telitacicept is a novel recombinant fusion protein designed to treat autoimmune diseases through dual inhibition of BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). Additional regulatory filings in China are underway, including biologics license applications for primary Sjögren’s disease (SjD) and IgA nephropathy (IgAN). Vor Bio is advancing telitacicept in global Phase 3 trials in gMG and SjD to support potential regulatory approvals in the United States, Europe, and Japan. 공시 • Apr 28
Vor Biopharma Inc., Annual General Meeting, Jun 11, 2026 Vor Biopharma Inc., Annual General Meeting, Jun 11, 2026. Location: meetnow.global/mpc7qxv., United States 공시 • Mar 30
Vor Bio Doses First Patient in Global Phase 3 UPSTREAM SjD Registrational Trial of Telitacicept in Primary Sjögren’s Disease Vor Bio announced the dosing of the first patient in UPSTREAM SjD, a global, randomized, double-blind, placebo-controlled Phase 3 trial evaluating telitacicept in adult patients with active primary Sjögren’s disease (SjD), formerly known as Sjögren's syndrome. First and only dual BAFF/APRIL inhibitor in primary Sjögren’s disease, one of the largest autoimmune diseases without an approved therapy. In late 2025, RemeGen presented results from a Phase 3 trial conducted in China with telitacicept in the same indication that demonstrated potential best-in-disease activity, with statistically significant and clinically meaningful improvements in both ESSDAI and ESSPRI, the two key, validated EULAR measurements used to assess patient disease burden. These prior results provide important clinical support for dual BAFF/APRIL inhibition as a therapeutic strategy in this disease. UPSTREAM SjD will evaluate the efficacy and safety of telitacicept administered subcutaneously with a pre-filled syringe compared to placebo in approximately 250 adult patients with active primary SjD. The primary endpoint is the change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score at Week 48. The trial is expected to enroll patients who meet the 2016 ACR/EULAR classification criteria for primary SjD and have active disease as defined by an ESSDAI score =5. Key secondary endpoints in the UPSTREAM SjD trial will evaluate the effect of telitacicept at Week 48 across systemic disease activity, glandular function, and patient-reported symptoms. Sjögren’s disease is a chronic autoimmune condition in which overactive B cells drive inflammation, damaging moisture-producing glands and, in many cases, other organs throughout the body. Hallmark symptoms include dry eyes and dry mouth, alongside fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system. About one-third of patients develop significant extraglandular involvement, and the disease carries an elevated lymphoma risk, often leading to substantial impairment in daily life. One of the most common rheumatic autoimmune diseases, Sjögren’s remains underdiagnosed, with roughly half of cases unrecognized and women comprising the vast majority of patients. Despite its prevalence and burden, no approved systemic disease-modifying therapies exist; current care focuses on symptom management with incomplete relief. Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). Additional regulatory filings in China are underway, including biologics license applications for primary Sjögren’s disease (SjD) and IgA nephropathy (IgAN). Vor Bio is advancing global development programs across major autoimmune indications, including a global Phase 3 trial in gMG and SjD to support potential regulatory approvals in the United States, Europe, and Japan. 공시 • Mar 27
Vor Biopharma Inc. announced that it expects to receive $74.999996 million in funding from TCG Crossover Management, LLC Vor Biopharma Inc. announced that it has entered into a Securities Purchase Agreement with entities affiliated with TCGX, TCG Crossover Fund II, L.P. for 2,669,039 shares, TCG Crossover Fund III, L.P. for 2,669,039 shares pursuant to which the Company, in a private placement, agreed to issue and sell to the Investors an aggregate of 5,338,078 common shares at a price per Share of $14.05 for gross proceeds of $74,999,995.9 on March 26, 2026. The Purchase Agreement contains customary representations and warranties of the Company, on the one hand, and the Investors, on the other hand, and customary conditions to closing. The closing of the Private Placement is expected to occur on March 30, 2026, subject to customary closing conditions. Upon the closing of the Private Placement, the Company will have 54,185,582 shares of common stock outstanding. The Shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act. Each Investor has represented that it is a “qualified institutional buyer,” under the Securities Act or an institutional “accredited investor” (as defined in Rule 501(a) under the Securities Act), 공시 • Jan 03
Vor Biopharma Inc. Announces Separation of Qing Zuraw as Chief Development Officer, Effective December 31, 2025 On December 31, 2025, Vor Biopharma Inc. (the “Company”) entered into a separation agreement (the “Separation Agreement”) with Dr. Qing Zuraw, the Company’s Chief Development Officer, as a result of Dr. Zuraw’s decision to pursue other opportunities. Pursuant to the Separation Agreement, Dr. Zuraw’s employment with the Company ended on December 31, 2025. The Company anticipates entering into a consulting arrangement with Dr. Zuraw pursuant to which Dr. Zuraw will provide consulting services to assist in the transition during the first quarter of 2026.