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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.

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

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

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

NCT05783596Active, Not RecruitingPhase 2
Reid Merryman, MD
Posted 7/18/2023

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

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

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

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

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

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

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

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.

Apogee's APG777 Shows 75-Day Half-Life in Phase 1 Trial for Atopic Dermatitis

Monoclonal Antibody
  • Apogee Therapeutics announced positive Phase 1 interim data for APG777, a novel IL-13-targeting monoclonal antibody with an extended 75-day half-life for atopic dermatitis treatment.
  • The first-in-human trial demonstrated favorable safety profile with single doses up to 1,200mg and multiple doses of 300mg being well-tolerated in 40 healthy volunteers.
  • APG777 showed deep and sustained inhibition of key atopic dermatitis biomarkers for up to 3 months, potentially enabling less frequent dosing intervals.
  • The company plans to initiate a Phase 2 trial in the first half of 2024, enrolling approximately 110 patients in part A and 360 patients in part B for dose optimization.

Isatuximab Combination Therapy Achieves Superior MRD Negativity Rates in Newly Diagnosed Multiple Myeloma

Monoclonal Antibody
  • The isatuximab-carfilzomib-lenalidomide-dexamethasone (Isa-KRd) combination significantly improved minimal residual disease (MRD) negativity rates compared to standard KRd therapy in newly diagnosed multiple myeloma patients.
  • In the phase 3 IsKia trial, Isa-KRd achieved 77% MRD negativity at 10-5 cutoff versus 67% with KRd alone, with even greater differences at the more stringent 10-6 cutoff (67% vs 48%).
  • High-risk multiple myeloma patients showed particularly strong responses, with the GMMG-CONCEPT trial demonstrating 67.7% MRD negativity in transplant-eligible patients and sustained negativity for at least one year in 62.6% of cases.
  • The treatment benefits were observed across all patient subgroups, including those with very high-risk cytogenetic features, while maintaining manageable safety profiles.

Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone

NCT03104842Active, Not RecruitingPhase 2
Universitätsklinikum Hamburg-Eppendorf
Posted 8/15/2017

Isa-KRd vs KRd in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL)

NCT04483739Active, Not RecruitingPhase 3
European Myeloma Network B.V.
Posted 9/25/2020

KRDI in Transplant-Eligible MM

NCT04430894Active, Not RecruitingPhase 2
Massachusetts General Hospital
Posted 7/10/2020

Eptinezumab Demonstrates Sustained Long-Term Efficacy in Treatment-Resistant Migraine Patients Over 18 Months

Monoclonal Antibody
  • The DELIVER trial extension study showed eptinezumab maintained significant migraine reduction benefits for up to 18 months in patients who had failed 2-4 prior preventive treatments.
  • Over 60% of patients achieved at least 50% reduction in monthly migraine days and more than 30% achieved at least 75% reduction by the end of the 18-month follow-up period.
  • Patients reduced acute migraine medication use by approximately 5 days per month, bringing usage below medication overuse thresholds and sustaining this improvement throughout treatment.
  • The study demonstrated excellent tolerability with a 90.4% completion rate and safety profile consistent with previous eptinezumab trials.

Eptinezumab in Adults With Migraine and Medication Overuse Headache

NCT04772742CompletedPhase 3
H. Lundbeck A/S
Posted 2/17/2021

A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments

NCT04418765CompletedPhase 3
H. Lundbeck A/S
Posted 6/1/2020

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