Zenas BioPharma (USA) LLC

FDA Approves First Targeted Therapy for IgG4-Related Disease: Amgen's UPLIZNA

10 days ago

• 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.

UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease, Reducing Flare Risk by 87%

2 months ago

• The FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with IgG4-related disease, a chronic immune-mediated inflammatory condition that can cause permanent organ damage. • In the pivotal MITIGATE trial, UPLIZNA demonstrated an 87% reduction in flare risk compared to placebo and allowed nearly 60% of patients to achieve corticosteroid-free, flare-free complete remission. • The approval marks Amgen's expanding leadership in CD19-directed B-cell depletion therapies across multiple autoimmune diseases, including NMOSD, IgG4-RD, and potentially generalized myasthenia gravis.

Sanofi Acquires Dren Bio's Novel B-Cell Depleter for $600 Million, Expanding Immunology Pipeline

2 months ago

• Sanofi has agreed to acquire Dren Bio's DR-0201, a first-in-class bispecific myeloid cell engager that induces deep B-cell depletion, for an upfront payment of $600 million. • DR-0201 works by targeting CD20 and engaging tissue-resident myeloid cells, potentially resetting the immune system in patients with refractory B-cell mediated autoimmune diseases like lupus. • The acquisition strengthens Sanofi's immunology portfolio and includes potential future payments of $1.3 billion upon achievement of development and launch milestones, with transaction expected to close in Q2 2025.

Ascentage Pharma's IPO Funds Global Expansion of Cancer Therapies

4 months ago

• Ascentage Pharma raised $126.4 million in a U.S. IPO to support late-stage clinical development of olverembatinib and lisaftoclax, aimed at treating CML and CLL, respectively. • Olverembatinib, already approved in China for CML, is undergoing Phase 3 trials in the U.S., Canada, Australia, and China, with plans for an FDA submission in 2026. • Lisaftoclax, a Bcl-2 inhibitor, is under regulatory review in China for advanced CLL/SLL, with potential to compete with AbbVie and Genentech's Venclexta. • Takeda Pharmaceuticals holds an option to license olverembatinib outside of Greater China and Russia, potentially bringing Ascentage up to $1.2 billion in milestone payments.

IgG4-Related Disease: Clinical Trials Update and Emerging Therapies

6 months ago

• 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.

Xenon Pharmaceuticals Advances Azetukalner Program for Epilepsy and MDD

6 months ago

• Xenon Pharmaceuticals is progressing its Phase 3 epilepsy program with azetukalner, anticipating topline data from the X-TOLE2 study in the second half of 2025. • The company plans to initiate the X-NOVA2 Phase 3 trial for azetukalner in major depressive disorder (MDD) by the end of the year, expanding its therapeutic focus. • Xenon is expanding its ion channel portfolio, with multiple candidates advancing towards IND filings in 2025, targeting Kv7, Nav1.7, and Nav1.1. • Long-term data from the X-TOLE open-label extension study of azetukalner in focal onset seizures will be presented at the American Epilepsy Society (AES) annual meeting.

Zenas BioPharma Completes Enrollment in Phase 3 IgG4-RD Trial of Obexelimab

6 months ago

• 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, Zenas, and MBX Bio Launch IPOs, Raising $703M for Clinical Trials

8 months ago

• 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.

Three Biotech Firms Secure $700M in Major IPO Wave, Signaling Market Momentum

8 months ago

• 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 Launches with $370M to Advance Bispecific T-Cell Engagers for Autoimmune Diseases

8 months ago

• 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.

NeOnc Technologies Pursues Direct Listing with Intranasal Glioblastoma Therapy

8 months ago

• NeOnc Technologies is pursuing a direct listing after withdrawing its IPO plans, aiming to fund development of NEO100, an intranasal drug for glioblastoma. • NEO100 leverages cranial nerves to bypass the blood-brain barrier, delivering perillyl alcohol (POH) directly to brain tumors, showing promise in early trials. • A Phase 1 study demonstrated NEO100's safety and tolerability, with some patients showing extended survival, particularly those with IDH1 mutations. • NeOnc's Phase 2a trial is ongoing, focusing on patients with IDH1 mutations, with preliminary data expected in mid-2025, as the company explores novel drug delivery methods.

Bicara Therapeutics and Zenas BioPharma Aim for $200 Million IPOs

8 months ago

• 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.