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Noticias de ZBIO
Eventos de ZBIO
Zenas BioPharma Announces New IgG4-RD Data
Zenas BioPharma announced new obexelimab data in immunoglobulin G4-related disease, or IgG4-RD, presented at the 6th International Symposium on IgG4-Related Disease, held October 8-10 in Cambridge, Massachusetts. The presentations included longer-term flare protection and safety data from the Phase 3 INDIGO open-label extension, initial findings from an associated vaccine response sub-study, and an analysis of glucocorticoid-associated toxicity from the randomized, controlled period of INDIGO. Participants who completed the 52-week randomized, controlled period of the Phase 3 INDIGO study could enter the open-label extension and receive 250 mg obexelimab subcutaneously once weekly. The open-label extension evaluated longer-term flare protection and safety of continued obexelimab treatment in patients with IgG4-RD. The 12-month probability of remaining flare-free was 0.93 based upon investigator- and adjudication committee-confirmed flares requiring rescue therapy, and 0.87 based upon investigator-determined flares requiring rescue therapy, with five patients pending adjudication at the time of the data cutoff. The median and mean cumulative glucocorticoid rescue doses were 0 mg and 105 mg, respectively. Adverse event rates were comparable to or lower than those observed during the randomized, controlled period. This Phase 3 INDIGO trial sub-analysis evaluated glucocorticoid-associated toxicity in patients with IgG4-RD using the Glucocorticoid Toxicity Index, or GTI. Obexelimab significantly reduced cumulative glucocorticoid toxicity versus placebo at week 52. Fewer patients receiving obexelimab reached clinical thresholds for cumulative glucocorticoid toxicity versus placebo. Initial analyses from the ongoing sub-study of the INDIGO open-label extension assessed immune responses to vaccination during a planned treatment-free window. In addition, the preservation of pre-existing influenza and SARS-COV-2 immunity following long-term obexelimab exposure was evaluated. Vaccination during the treatment-free window resulted in seroimmunity to influenza in 6 of 7 participants and seroimmunity to COVID-19 in 4 of 4 participants. No disease flares were observed during the treatment-free vaccination window, lasting an average of 34.6 days. Participants maintained pre-existing markers of immunity following long-term obexelimab treatment.
Zenas BioPharma Files to Sell 7.0M Shares of Common Stock
Zenas BioPharma files to sell 7.0M shares of common stock for holders
Jennifer Fox to Transition to Strategic Advisor Role
The company announced that Jennifer Fox will transition from her current role as CFO and chief business officer to serve in a new role as strategic advisor to the board chair effective September 30. Joe Farmer, president and COO, will serve as principal financial officer and principal accounting officer until the appointment of a CFO.
Zenas Reports Q2 Revenue of $1M, Below Consensus of $15M
Reports Q2 revenue $1M, consensus $15M. "2026 continues to be a transformative year for Zenas, highlighted by FDA acceptance of the obexelimab BLA for the treatment of IgG4-RD, with a PDUFA date of May 27, 2027. Our expanding team is actively preparing for the potential commercialization of our first product," said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. "The strength of the Phase 3 INDIGO data for obexelimab in IgG4-RD was underscored by its selection as an oral presentation at EULAR and simultaneous publication in the New England Journal of Medicine. Beyond IgG4-RD, we are on track to report Phase 2 topline data for obexelimab in SLE and initial Phase 1 data for ZB021 by year-end. We continue to execute across our portfolio and make meaningful progress toward our vision of becoming a fully integrated, global development and commercial-stage biopharmaceutical company that brings impactful treatments to patients living with autoimmune and chronic inflammatory diseases."
Zenas BioPharma Submits BLA for Obexelimab to FDA
Zenas BioPharma announced the submission of its biologics license application, or BLA, to the FDA for obexelimab in Immunoglobulin G4-Related Disease. IgG4-RD is a debilitating chronic fibro-inflammatory disease affecting multiple organ systems, often resulting in irreversible tissue damage and organ failure. Obexelimab, an investigational therapy, is a bifunctional monoclonal antibody designed to bind both CD19 and FcgRIIb to inhibit B cell function. The BLA submission is supported by the results of the Phase 3 INDIGO registrational trial of obexelimab for the treatment of IgG4-RD. In INDIGO, obexelimab met the primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period. Obexelimab also met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints and was generally well tolerated. Data from the INDIGO trial will be presented during an oral session at the European Alliance of Associations for Rheumatology 2026 Congress in London, UK, on June 4.
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