Zenas BioPharma (USA) LLC

Zenas BioPharma and Royalty Pharma announced a $300 million funding partnership to advance obexelimab development for IgG4-Related Disease and other autoimmune conditions.

• The FDA has approved Amgen's UPLIZNA (inebilizumab-cdon) as the first and only targeted treatment specifically for IgG4-related disease, following positive results from the Phase III MITIGATE trial. • The MITIGATE trial demonstrated an 87% reduction in disease flare risk compared to placebo, with the study enrolling 135 adults across 80 sites in 22 countries. • Multiple companies including Sanofi and Zenas BioPharma are advancing a robust pipeline of approximately 10 therapies for IgG4-related disease, potentially transforming treatment options for this rare inflammatory condition.

Novo Nordisk undergoes significant executive restructuring following the departure of EVP Camilla Sylvest, with rare disease leader Ludovic Helfgott taking over expanded commercial strategy responsibilities.

• Zenas Biopharma has initiated MoonStone, a Phase 2 clinical trial evaluating obexelimab, a unique B-cell targeting therapy administered weekly via subcutaneous injection in relapsing multiple sclerosis patients. • The trial will enroll 93 participants across 40+ sites globally, targeting adults aged 18-60 with relapsing-remitting MS or active secondary progressive MS, with results expected in Q3 2025. • Unlike current B-cell therapies, obexelimab targets CD19 and FcgammaRIIb proteins to reduce B-cell activity without depleting them, potentially offering a broader therapeutic approach than existing CD20-targeting treatments.

• Several companies are actively developing novel therapies for IgG4-Related Disease (IgG4-RD), a chronic immune-mediated condition, with promising clinical trial results. • Amgen's Phase III MITIGATE trial of UPLIZNA (inebilizumab-cdon) demonstrated an 87% reduction in flare risk compared to placebo in IgG4-RD patients. • Zenas BioPharma's Phase III INDIGO trial is evaluating obexelimab in patients with active IgG4-RD, with targeted enrollment completed across multiple global sites.

• Zenas BioPharma has completed targeted enrollment for its Phase 3 INDIGO trial evaluating obexelimab in patients with Immunoglobulin G4-Related Disease (IgG4-RD). • The INDIGO trial is the largest clinical trial ever conducted for IgG4-RD, a chronic fibro-inflammatory disease affecting multiple organ systems. • Topline results from the Phase 3 INDIGO trial are expected to be reported by the end of 2025, marking a key milestone for Zenas BioPharma. • Obexelimab, a bifunctional monoclonal antibody, aims to inhibit B cell activity without depletion, offering a novel approach to treating IgG4-RD.

• Bicara Therapeutics raised $315 million to fund a pivotal trial of ficerafusp alfa for head and neck squamous cell carcinoma (HNSCC). • Zenas Biopharma secured $225 million to advance obexelimab, a bifunctional antibody, through Phase 3 trials for IgG4-related disease and Phase 2 trials for multiple sclerosis, lupus, and wAIHA. • MBX Biosciences garnered $163 million to support clinical trials of MBX 2109 for chronic hypoparathyroidism and MBX 1416 for post-bariatric hypoglycemia.

• Bicara Therapeutics leads the IPO surge with a $315 million raise for its cancer therapeutics program, marking the third-largest biotech IPO of 2024. • Zenas BioPharma successfully raised $225 million to advance its immunology pipeline, while MBX Biosciences secured $163 million for endocrine and metabolic disease research. • The triple IPO event represents a significant milestone in 2024's biotech market, though overall IPO activity remains below pre-pandemic levels with 18 biotechs going public this year.

• Candid Therapeutics launched with $370 million in funding to develop bispecific T-cell engagers for autoimmune diseases, acquiring two private biotechs, Vignette Bio and TRC 2004. • The company's pipeline includes two T-cell engagers, targeting BCMA and CD20, which have completed Phase 1 testing in cancer and are slated for autoimmune clinical trials next year. • Candid aims to offer a more commercially viable and convenient alternative to cell therapies for autoimmune diseases, leveraging the potential of bispecific antibodies. • CEO Ken Song believes T-cell engagers represent a transformative approach, citing encouraging case reports and growing industry interest in the field.

• Bicara Therapeutics plans a $200 million IPO to advance ficerafusp alfa, a bifunctional antibody targeting EGFR and TGF-β for solid tumors. • Zenas BioPharma also seeks $200 million through an IPO to support obexelimab, a CD19 and FcγRIIb targeting antibody in Phase 3 for IgG4-RD. • Both companies anticipate using the IPO proceeds to fund clinical trials and further develop their respective pipelines of novel therapeutics. • The IPOs reflect continued investor interest in innovative biotech companies developing targeted therapies for cancer and autoimmune diseases.