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EMA Validates Marketing Applications for HLX14 Denosumab Biosimilar in Osteoporosis Treatment

Monoclonal Antibody
  • The European Medicines Agency has validated marketing authorization applications for HLX14, an investigational biosimilar to denosumab (Prolia/Xgeva) developed by Shanghai Henlius Biotech and Organon for osteoporosis treatment.
  • The applications are supported by positive phase 3 trial data showing HLX14 met both primary efficacy and pharmacodynamic endpoints when compared to reference denosumab in postmenopausal women with osteoporosis.
  • With an estimated 32 million Europeans aged 50 or above having osteoporosis in 2019, including 25.5 million women, this biosimilar could provide expanded treatment access for this significant patient population.

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture

NCT05352516Active, Not RecruitingPhase 3
Shanghai Henlius Biotech
Posted 6/17/2022

Blackstone Launches Uniquity Bio with $300M to Advance Anti-TSLP Therapy for Asthma and COPD

Monoclonal Antibody
  • Blackstone Life Sciences has launched Uniquity Bio with up to $300 million in funding to develop solrikitug, a monoclonal antibody targeting TSLP for immune and inflammatory conditions.
  • The company will begin Phase 2 clinical trials in chronic obstructive pulmonary disease and asthma within the next month, targeting diseases that affect millions globally.
  • Solrikitug was in-licensed from Merck and is positioned as a highly potent anti-TSLP antibody that could address significant unmet medical needs in respiratory and gastrointestinal indications.
  • The global immunology market is projected to grow from $98 billion in 2023 to $257 billion in 2032, highlighting the commercial potential of this therapeutic area.

Outlook Therapeutics Advances ONS-5010 Toward Potential First Approved Ophthalmic Bevacizumab for Retinal Diseases

Monoclonal Antibody
  • Outlook Therapeutics received a positive opinion from the European Medicines Agency's CHMP for ONS-5010/LYTENAVA™ (bevacizumab gamma) for wet AMD treatment, with European Commission decision expected in Q2 2024.
  • The company has submitted a Marketing Authorization Application in the UK and is progressing with the NORSE EIGHT clinical trial in the US, with over 30% of subjects enrolled and topline results expected in Q4 2024.
  • If approved, ONS-5010 would be the first authorized ophthalmic formulation of bevacizumab for treating retinal diseases, potentially launching in the EU and UK in early 2025 and in the US later that year.

IDT Australia Secures Victorian Government Grant to Establish Nation's First Commercial ADC Manufacturing Facility

Monoclonal AntibodyOncology
  • IDT Australia has been awarded a Victorian government grant to establish Australia's first current good manufacturing practice antibody-drug-conjugate manufacturing facility in Boronia.
  • The $3.8 million facility will position Victoria at the forefront of Australia's sovereign capability to manufacture cutting-edge oncological drugs that precisely target cancer cells.
  • The global ADC market is projected to reach $140-211 billion over the next 15 years, with expectations to displace 30-50% of the traditional chemotherapy market.
  • IDT Australia has already secured key partnerships including a master services agreement with Japanese pharmaceutical supplier Nagase & Co, Ltd for ADC component development.

Fresenius Kabi Launches First Actemra® Biosimilar in U.S. Market as Biosimilar Landscape Expands

Drug ApprovalOncologyMonoclonal Antibody
• Fresenius Kabi has launched Tyenne® (tocilizumab-aazg), the first biosimilar of Actemra® to enter the U.S. market, following FDA approval in March 2024 for both intravenous and subcutaneous formulations.
• Accord BioPharma received FDA approval for Hercessi™ (trastuzumab-strf), becoming the sixth Herceptin® biosimilar approved in the U.S., while Xbrane's Xlucane™ (ranibizumab) received a Complete Response Letter from the FDA.
• The expanding biosimilar market continues to challenge reference products with significant annual sales, with Actemra® generating approximately $3 billion, Herceptin® $1.77 billion, and Lucentis® $1.475 billion in 2023.

Sandoz Receives FDA Approval for First Denosumab Biosimilars in US and Canada

Monoclonal AntibodyDrug ApprovalOncology
  • Sandoz received FDA approval for Jubbonti and Wyost, the first and only denosumab biosimilars approved in the United States and Canada, marking a significant milestone in biosimilar development.
  • The biosimilars are approved as interchangeable with Amgen's reference medicines Prolia and Xgeva for all indications, including osteoporosis treatment and prevention of cancer-related bone complications.
  • More than 10 million US adults aged 50 and over live with osteoporosis, with half of all women over 50 experiencing an osteoporotic fracture during their lifetime.
  • The approvals are based on robust phase I and phase III clinical studies demonstrating no clinically meaningful differences from the reference medicines.

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

NCT03974100CompletedPhase 3
Sandoz
Posted 7/2/2019

Chemomab Secures Global Patent Protection for CM-101 Antibody Targeting Primary Sclerosing Cholangitis

Monoclonal AntibodyOrphan Drug
  • Chemomab Therapeutics has secured new patents in Brazil, Israel, and Europe for CM-101, its first-in-class monoclonal antibody targeting CCL24 for fibro-inflammatory diseases.
  • The patents provide protection for CM-101's composition of matter and use in liver diseases including primary sclerosing cholangitis (PSC) until 2038, with potential five-year extensions.
  • CM-101 is currently in a Phase 2 SPRING trial for PSC treatment with completed patient enrollment and topline data expected midyear 2024.
  • PSC represents a significant unmet medical need as a potentially lethal condition with no FDA-approved therapies, often requiring liver transplantation.

FDA to Convene Advisory Committee for Eli Lilly's Alzheimer's Drug Donanemab

Monoclonal AntibodyNeurologyPrecision Medicine
• The FDA has announced plans to convene a Peripheral and Central Nervous System Drugs Advisory Committee to review donanemab's efficacy and safety profile before making a final approval decision.
• Donanemab's TRAILBLAZER-ALZ 2 trial employed innovative biomarker strategies, using both Amyvid® and Tauvid™ PET scans to identify early-stage patients with confirmed amyloid plaques most likely to benefit from treatment.
• Experts view anti-amyloid therapies like donanemab as just the first line of defense, with approximately 75% of Alzheimer's drugs in development now exploring novel targets related to aging pathways including inflammation and vascular dysfunction.

Bispecific Antibodies: Promising Advances Amid Adoption Challenges in Cancer Treatment

Drug ApprovalOncologyCAR-TMonoclonal Antibody
  • Bispecific antibodies represent a significant advancement in cancer immunotherapy, targeting both tumor antigens and immune cells to enhance cytotoxicity without requiring patient-derived cells like CAR-T therapy.
  • Despite clinical promise with nine FDA-approved bispecific antibodies, adoption faces challenges including transition between inpatient/outpatient settings, insurance coverage, adverse event management, and financial barriers in community settings.
  • Recent approvals of Mosunetuzumab, Glofitamab, and Epcoritamab have shown impressive response rates in relapsed/refractory indolent B-cell lymphomas, with manageable toxicity profiles when using step-up dosing strategies.

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

NCT05994235RecruitingPhase 2
Weill Medical College of Cornell University
Posted 11/1/2023

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

NCT05783596RecruitingPhase 2
Reid Merryman, MD
Posted 7/18/2023

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

NCT05169658CompletedPhase 2
University of Washington
Posted 3/23/2022

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

NCT05409066Active, Not RecruitingPhase 3
Genmab
Posted 9/20/2022

Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

NCT06006117RecruitingPhase 3
The Lymphoma Academic Research Organisation
Posted 9/5/2023

CAR-T Followed by Bispecific Antibodies

NCT04889716RecruitingPhase 2
Abramson Cancer Center at Penn Medicine
Posted 11/5/2021

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

NCT04712097Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/27/2021

Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

NCT05529524Completed
The Lymphoma Academic Research Organisation
Posted 11/7/2022

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

Upstream Bio Advances Verekitug into Phase 2 Trials for Severe Asthma and Chronic Rhinosinusitis with Nasal Polyps

Monoclonal Antibody
  • Upstream Bio has initiated Phase 2 clinical trials for verekitug (UPB-101), a novel TSLP receptor-blocking monoclonal antibody, in both severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
  • The VALIANT study in severe asthma will evaluate extended dosing regimens including every 24 weeks, enabled by Phase 1b data showing 54% reduction in disease biomarkers sustained through 32 weeks.
  • Verekitug demonstrated superior potency compared to published tezepelumab data and became the first TSLP signaling inhibitor to maintain maximal biomarker inhibition 24 weeks after the last dose.
  • The drug targets TSLP, a key upstream cytokine in inflammatory cascades, potentially addressing multiple pathological processes with a single treatment approach.

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