MedPath

Bizaxofusp

Generic Name
Bizaxofusp
Drug Type
Biotech
CAS Number
1236019-35-4
Unique Ingredient Identifier
FRY3MOL2QU

Medicenna to Present MDNA11 ABILITY-1 Trial Update and Novel MDNA113 Data at AACR 2025

• Medicenna Therapeutics will present interim results from its Phase 1/2 ABILITY-1 trial of MDNA11, the only long-acting 'beta-enhanced not-alpha' IL-2 super-agonist in clinical development for advanced solid tumors. • The company will also showcase preclinical data on MDNA113, a first-in-class tumor-targeted and tumor-activated bifunctional anti-PD1-IL2 Superkine designed to enhance therapeutic efficacy. • Both presentations will take place at the American Association for Cancer Research Annual Meeting in Chicago from April 25-30, 2025, highlighting Medicenna's expanding immunotherapy pipeline.

Pipeline Advances in Head and Neck Cancer Treatment: Over 100 Drugs in Development for 2025

• DelveInsight's latest report reveals a robust pipeline with over 80 companies developing 100+ drug candidates for head and neck cancer, highlighting significant research momentum in this therapeutic area. • Key late-stage candidates include Debiopharm/Merck's xevinapant, GlaxoSmithKline's dostarlimab, and QBiotics' tigilanol tiglate, each employing novel mechanisms to potentially improve outcomes for patients with limited treatment options. • Multiple clinical trials are underway testing innovative approaches including IAP inhibitors, immune checkpoint blockers, and oncolytic therapies, with several Phase III studies expected to deliver results that could reshape treatment paradigms.

Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval

• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries. • Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages. • Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.

Medicenna Reports 78% Disease Control Rate for MDNA11-KEYTRUDA Combination in Advanced Cancer Trial

• Medicenna's ABILITY-1 trial demonstrates promising results with a 78% disease control rate in the MDNA11-KEYTRUDA combination arm, including complete and partial responses in advanced cancer patients. • The company's MDNA11 monotherapy showed significant efficacy with a 30% objective response rate in checkpoint-resistant patients, highlighting its potential as a standalone treatment. • With $30 million in cash reserves, Medicenna is well-positioned to advance its clinical programs through mid-2026, including completion of MDNA11 trials and development of novel immunotherapy MDNA113.

Medicenna's MDNA11 Shows Promise in Advanced Solid Tumors: Updated Phase 1/2 Data

• Medicenna's MDNA11, an IL-2 Superkine, demonstrates single-agent activity in patients with advanced solid tumors in an ongoing Phase 1/2 ABILITY-1 study. • The ABILITY-1 study evaluates MDNA11 both as a monotherapy and in combination with pembrolizumab for various advanced or metastatic solid tumors. • Updated clinical data, including safety and efficacy results, were presented at the 2024 Immunotherapy Bridge Conference on December 5, 2024. • MDNA11 is engineered to preferentially activate immune effector cells, potentially overcoming limitations of previous IL-2 therapies.

Medicenna Presents Preclinical Data on IL-2 Super-Antagonist MDNA209 and Anti-PD1-IL-2 BiSKIT MDNA113

• Medicenna's MDNA209, an IL-2 super-antagonist, demonstrated a 400% increase in overall survival in an animal model of graft versus host disease (GvHD), suggesting potential in autoimmune disease treatment. • MDNA113, a tumor-targeted anti-PD1-IL-2 BiSKIT, showed enhanced efficacy in mice with IL-13Rα2-overexpressing tumors, indicating promise for treating immunologically 'cold' tumors like pancreatic and ovarian cancers. • The BiSKIT approach of MDNA113 allows for conditional activation in the tumor microenvironment, potentially improving safety and efficacy compared to traditional anti-PD1 therapies. • These preclinical findings validate Medicenna's IL-2 Superkine platform and its potential to develop transformative medicines for both cancer and autoimmune diseases.
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