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Clinical Trial News

Regeneron Expands Patent Protection for Aflibercept with New Formulation Patent Against Amgen

  • Regeneron filed a new patent infringement complaint against Amgen on June 17, 2025, asserting U.S. Patent No. 12,331,099 covering a stable liquid ophthalmic formulation without buffer requirements.
  • The Patent Trial and Appeal Board denied inter partes review petitions from Samsung Bioepis and Formycon challenging Regeneron's earlier aflibercept patent, citing substantial investment in parallel district court proceedings.
  • Amgen's biosimilar PAVBLU launched commercially in November 2024 after the Federal Circuit denied Regeneron's preliminary injunction motion on a separate patent covering buffered formulations.

GH Research Submits IND Hold Response to FDA for Depression Treatment GH001 Ahead of Schedule

  • GH Research PLC submitted its complete response to the FDA's clinical hold on GH001 ahead of schedule in June 2025, addressing regulatory concerns with comprehensive data and completed toxicology studies.
  • The company's lead candidate GH001 is formulated for mebufotenin administration via proprietary inhalation for treatment-resistant depression (TRD).
  • Phase 2b trial results showed GH001 met its primary endpoint with a statistically significant MADRS reduction of -15.5 points compared to placebo on Day 8 (p<0.0001).
  • The company believes GH001 has potential to transform current TRD treatment approaches based on observed clinical activity.

Cereno Scientific Secures 100 MSEK Financing to Advance HDAC Inhibitor Pipeline for Rare Cardiovascular and Pulmonary Diseases

Rare Disease
  • Cereno Scientific secured 100 MSEK through loan financing agreements with existing and new investors to advance its HDAC inhibitor portfolio targeting rare cardiovascular and pulmonary diseases.
  • The funding will support Phase IIb trial initiation for CS1 in pulmonary arterial hypertension and Phase II development for CS014 in idiopathic pulmonary fibrosis.
  • The company's lead candidate CS1 demonstrated favorable safety profile and positive clinical efficacy parameters in a completed Phase IIa trial for PAH patients.
  • The financing structure includes a new 25 MSEK loan, 50 MSEK advance payment, and 25 MSEK convertible conversion, providing runway to reach key clinical milestones.

Aurobindo Pharma Secures Multiple FDA Approvals for Generic Drug Portfolio Expansion

Drug Approval
  • Aurobindo Pharma Limited has received FDA approval for multiple generic drug formulations, including critical medications for cardiovascular, neurological, and gastrointestinal conditions.
  • The company's recent approvals include AB-rated generic equivalents to major brand-name drugs such as Eliquis, Pradaxa, Chantix, and Nexium, expanding access to affordable treatment options.
  • These FDA approvals represent significant additions to Aurobindo's generic drug portfolio, covering therapeutic areas from anticoagulation to smoking cessation and acid reflux management.

Candid Therapeutics Doses First Patients with Novel T-Cell Engagers for Autoimmune Diseases

  • Candid Therapeutics has dosed the first patients with its two lead T-cell engager therapies, cizutamig (BCMA TCE) and CND261 (CD20 TCE), in patients with refractory rheumatoid arthritis and systemic sclerosis.
  • The company has launched clinical studies across five autoimmune diseases including IgA nephropathy, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis.
  • Both T-cell engagers have been well tolerated with early signs of promising clinical response and disease improvement in initial patients.
  • Candid launched in 2024 with $370 million in financing and aims to establish T-cell engagers as the largest therapeutic class in autoimmune diseases, potentially surpassing TNF inhibitors like Humira.

Dutch Court Upholds Xtandi Patent Protection, Blocking Generic Enzalutamide Launch Until 2028

  • The District Court The Hague dismissed nullity suits from Accord Healthcare and Sandoz against Xtandi's basic patent EP 1 893 196 and its Dutch SPC, maintaining protection until June 2028.
  • Generic companies challenged the patent's priority claims, arguing the lead compound RD 162 was previously published, but the court rejected their arguments.
  • The ruling continues Astellas and University of California's successful European defense of Xtandi patents, following similar victories in the UK and Germany.
  • Appeals remain pending in the UK regarding the same patent, while Dutch appeals are expected as generic companies previously appealed a related formulation patent decision.

Terumo BCT Unveils Automated CAR-T Manufacturing Platform Delivering 12 Billion Cells in 7-8 Days

CAR-T
  • Terumo BCT has developed a new automated workflow that consolidates T cell activation, viral transduction, and expansion into a single platform, streamlining CAR-T manufacturing significantly.
  • The protocol demonstrates the ability to produce over 12 billion CAR-T cells in just 7 to 8 days with doubled transduction efficiency compared to manual methods.
  • The integrated 3-in-1 approach uses serum-free culture conditions and closed-system design to reduce contamination risks while supporting generation of crucial T cell subtypes including memory cells.
  • The workflow is currently under evaluation by cell therapy developers and is expected to shorten production timelines, lower costs, and expand patient access to CAR-T treatments.

Lomond Therapeutics Receives FDA Clearance for Phase 1 Trial of Lonitoclax in Relapsed/Refractory AML

Targeted Therapy
  • Lomond Therapeutics announced FDA clearance of its IND application for lonitoclax, a selective BCL-2 inhibitor designed to address safety limitations of venetoclax.
  • The Phase 1 multicenter study will evaluate lonitoclax in combination with azacitidine in up to 60 patients with relapsed/refractory acute myeloid leukemia.
  • Preclinical data demonstrate lonitoclax has minimal immunosuppressive activity and improved safety profile compared to venetoclax, with synergistic activity when combined with other AML therapies.
  • The trial is planned to initiate in the third quarter of 2025 across multiple investigative sites, marking the company's third U.S. IND clearance.

Bio-Thera Solutions Receives Positive CHMP Opinion for Ustekinumab Biosimilar USYMRO

Monoclonal Antibody
  • The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions' biosimilar referencing Stelara.
  • The positive recommendation was based on comprehensive analytical, non-clinical and clinical data demonstrating biosimilarity through Phase 1 and Phase 3 studies in healthy volunteers and severe plaque psoriasis patients.
  • Bio-Thera partnered with Gedeon Richter in October 2024 for commercialization rights in the EU, UK and Switzerland following potential European Commission approval.
  • USYMRO targets IL-12 and IL-23 pathways involved in chronic inflammatory conditions including psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

Moleculin Biotech Raises $5.9 Million to Advance Annamycin Through Phase 3 AML Trial

Oncology
  • Moleculin Biotech completed a $5.9 million public offering to fund advancement of its lead drug candidate Annamycin through clinical development.
  • The company is conducting the MIRACLE Phase 3 trial evaluating Annamycin combined with cytarabine for relapsed or refractory acute myeloid leukemia.
  • Annamycin is designed as a next-generation anthracycline that avoids multidrug resistance and lacks the cardiotoxicity of current anthracyclines.
  • The funding will also support development of the company's broader pipeline including WP1066 for brain tumors and WP1122 for viral infections.

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