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FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Monoclonal AntibodyOncologyFDA Approval
  • The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
  • In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
  • This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.

Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04005716CompletedPhase 3
BeiGene
Posted 7/22/2019

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03783442CompletedPhase 3
BeiGene
Posted 12/11/2018

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657CompletedPhase 3
BeiGene
Posted 12/13/2018

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843CompletedPhase 3
BeiGene
Posted 1/26/2018

Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

NCT03924986CompletedPhase 3
BeiGene
Posted 3/27/2019

Galderma's Phase III OLYMPIA 1 Trial Results Show Nemolizumab Significantly Improves Prurigo Nodularis Symptoms

Monoclonal AntibodyDrug Approval
• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo.
• The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo.
• Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

Düsseldorf UPC Ruling Clarifies "Imminent Infringement" Standards for Biosimilars

Monoclonal Antibody
  • The Düsseldorf Local Division of the Unified Patent Court has issued a significant ruling that establishes clearer standards for determining "imminent infringement" in pharmaceutical patent cases.
  • In the Novartis/Genentech v. Celltrion case, the court ruled that obtaining marketing authorization and promoting a biosimilar at conferences are insufficient to constitute imminent infringement without completed pricing negotiations.
  • The decision provides important guidance for pharmaceutical companies, indicating that patent holders must demonstrate that all pre-launch preparations have been completed before claiming imminent infringement.

LEO Pharma's Temtokibart Shows Comparable Efficacy to Dupilumab in Phase 2a Atopic Dermatitis Trial

Monoclonal Antibody
  • LEO Pharma's investigational IL-22 inhibitor temtokibart demonstrated comparable clinical improvements to dupilumab in a 16-week phase 2a trial for moderate-to-severe atopic dermatitis.
  • Temtokibart achieved faster and greater improvements in skin hydration and natural moisturizing factors compared to dupilumab, with significant benefits observed within one week.
  • The findings suggest IL-22 pathway inhibition represents a novel therapeutic approach beyond Type 2 inflammation targeting for atopic dermatitis treatment.
  • LEO Pharma has completed recruitment for a phase 2b dose-finding trial with results expected in Q1 2025.

Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

NCT05131477CompletedPhase 2
Kymab Limited
Posted 12/13/2021

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

NCT03100344CompletedPhase 2
Galderma R&D
Posted 6/14/2017

A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

NCT04444752CompletedPhase 2
Suzhou Connect Biopharmaceuticals, Ltd.
Posted 7/17/2020

A Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe AD

NCT05905133Active, Not RecruitingPhase 2
Suzhou Connect Biopharmaceuticals, Ltd.
Posted 7/15/2023

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

NCT06035354CompletedPhase 1
Akeso
Posted 11/3/2021

Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis

NCT06162507CompletedPhase 1
Keymed Biosciences Co.Ltd
Posted 12/22/2023

A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT06116565Not Yet RecruitingPhase 2
Keymed Biosciences Co.Ltd
Posted 3/30/2024

A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

NCT06015308Active, Not RecruitingPhase 2
Sanofi
Posted 10/6/2023

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

NCT05769777RecruitingPhase 2
Sanofi
Posted 4/3/2023

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

NCT05398445CompletedPhase 3
Amgen
Posted 5/31/2022

Study of CM310 in Adolescent Subjects With Atopic Dermatis

NCT06495229Not Yet RecruitingPhase 3
Keymed Biosciences Co.Ltd
Posted 8/30/2024

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05882877RecruitingPhase 3
Amgen
Posted 5/31/2023

A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

NCT03921411CompletedPhase 2
Galderma R&D
Posted 4/9/2019

A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

NCT05579925CompletedPhase 2
Keymed Biosciences Co.Ltd
Posted 10/7/2022

A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis

NCT05265923CompletedPhase 3
Keymed Biosciences Co.Ltd
Posted 4/22/2022

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05724199CompletedPhase 3
Amgen
Posted 2/21/2023

POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis

NCT05932654CompletedPhase 2
Aclaris Therapeutics, Inc.
Posted 7/31/2023

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

NCT05651711CompletedPhase 3
Amgen
Posted 12/14/2022

Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

NCT05694884RecruitingPhase 2
ASLAN Pharmaceuticals
Posted 12/21/2022

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03989349CompletedPhase 3
Galderma R&D
Posted 6/30/2019

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

NCT05492578RecruitingPhase 2
Sanofi
Posted 8/22/2022

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

NCT04921345RecruitingPhase 2
Galderma R&D
Posted 6/24/2021

Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT05715320CompletedPhase 2
Keymed Biosciences Co.Ltd
Posted 3/10/2023

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis

NCT04090229CompletedPhase 1
ASLAN Pharmaceuticals
Posted 9/9/2019

Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT05048056TerminatedPhase 2
Akesobio Australia Pty Ltd
Posted 9/30/2021

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

NCT06241118RecruitingPhase 3
Sanofi
Posted 2/29/2024

A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

NCT05899816CompletedPhase 3
Amgen
Posted 6/7/2023

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05633355Active, Not RecruitingPhase 3
Amgen
Posted 1/30/2023

Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis

NCT05158023CompletedPhase 2
ASLAN Pharmaceuticals
Posted 3/16/2022

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

NCT01986933CompletedPhase 2
Chugai Pharmaceutical
Posted 11/1/2013

The Study of CM310 in Patients With Atopic Dermatitis

NCT04893707CompletedPhase 2
Keymed Biosciences Co.Ltd
Posted 6/7/2021

A Study of KY1005 in Healthy Volunteers

NCT03161288CompletedPhase 1
Kymab Limited
Posted 5/29/2017

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03985943CompletedPhase 3
Galderma R&D
Posted 6/27/2019

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

NCT03989206Active, Not RecruitingPhase 3
Galderma R&D
Posted 12/30/2019

A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis

NCT06224192Active, Not RecruitingPhase 3
Amgen
Posted 4/2/2024

A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05704738Active, Not RecruitingPhase 3
Amgen
Posted 4/20/2023

Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

NCT06277765Not Yet RecruitingPhase 3
Keymed Biosciences Co.Ltd
Posted 5/30/2024

A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis

NCT03754309CompletedPhase 2
Kymab Limited
Posted 12/13/2018

A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

NCT06092762CompletedPhase 2
Akeso
Posted 11/6/2023

A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China

NCT05017480CompletedPhase 2
Suzhou Connect Biopharmaceuticals, Ltd.
Posted 8/31/2021

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

NCT05923099CompletedPhase 2
LEO Pharma
Posted 9/20/2023

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

NCT06130566Active, Not RecruitingPhase 3
Sanofi
Posted 11/8/2023

A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis

NCT06383468RecruitingPhase 3
Akeso
Posted 4/30/2024

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

NCT06181435Active, Not RecruitingPhase 3
Sanofi
Posted 12/21/2023

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

NCT06224348Active, Not RecruitingPhase 3
Sanofi
Posted 1/18/2024

Study of ASLAN004 in Healthy Subjects

NCT03721263CompletedPhase 1
ASLAN Pharmaceuticals
Posted 10/15/2018

A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

NCT06407934RecruitingPhase 3
Sanofi
Posted 5/8/2024

GV20 Therapeutics Reports First Clinical Data for AI-Designed Checkpoint Inhibitor GV20-0251 in Advanced Solid Tumors

Monoclonal AntibodyOncologyAI
  • GV20 Therapeutics presented Phase 1 data for GV20-0251, marking the first clinical results for an AI-designed antibody targeting an AI-predicted immune checkpoint IGSF8.
  • The study enrolled 38 heavily pre-treated patients and demonstrated favorable safety with no dose-limiting toxicities across all dose levels from 0.5 to 20 mg/kg.
  • Two confirmed partial responses were observed in 12 evaluable metastatic cutaneous melanoma patients, with 14 of 29 patients showing stable disease including tumor shrinkage.
  • The drug showed dose-proportional pharmacokinetics with a 25.6-day half-life and full target occupancy on circulating T cells at doses ≥3 mg/kg.

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

NCT05669430RecruitingPhase 1
GV20 Therapeutics
Posted 3/23/2023

Roche's PiaSky Approved in EU as First Monthly Self-Administered Treatment for Paroxysmal Nocturnal Haemoglobinuria

Monoclonal AntibodyRare DiseaseDrug Approval
  • The European Commission has approved PiaSky (crovalimab), the first monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria (PNH), offering patients the option to self-administer following training.
  • PiaSky utilizes innovative recycling antibody technology developed by Chugai Pharmaceutical, allowing it to bind to C5 protein multiple times and remain effective longer with a small volume of medicine.
  • Clinical trials demonstrated PiaSky's non-inferiority to eculizumab, the current standard of care, while potentially reducing treatment burden through less frequent administration and eliminating the need for regular clinic visits.

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

NCT04434092Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/8/2020

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

NCT04432584Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 9/30/2020

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04958265Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/17/2021

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04861259Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/22/2021

Enzene Biosciences Establishes $50 Million New Jersey Manufacturing Facility with Continuous Biologics Platform

Monoclonal Antibody
  • Enzene Biosciences, a subsidiary of Alkem Laboratories, has opened a $50 million biopharmaceutical manufacturing facility in Hopewell, New Jersey, marking the company's first location outside India.
  • The 54,000-square-foot facility features EnzeneX™, the company's fully-connected continuous manufacturing platform validated for commercial biologics supply, aimed at reducing production costs.
  • The company appointed Norm Stoffregen as SVP and site head to lead operations, with plans to employ 300 workers by end of 2025 and expand bioreactor capacity.
  • Enzene aims to reduce monoclonal antibody production costs to below $40 per gram by 2025 through its innovative continuous manufacturing technology.

Breakthrough Immunotherapy Combination Shows Promise Against Common Colorectal Cancer in Phase 1 Trial

Monoclonal Antibody
  • A phase 1 trial of 148 patients demonstrated that the combination of botensilimab and balstilimab immunotherapy drugs successfully treated microsatellite stable metastatic colorectal cancer, the most common form that has historically not responded to immunotherapy.
  • The study found that 61% of patients experienced tumor shrinkage or stabilization after six months of treatment, marking the first time consistent and durable responses to immunotherapy have been reported in this difficult-to-treat patient population.
  • The treatment was well-tolerated with common side effects including diarrhea and fatigue, and showed particular effectiveness in patients without liver metastases.
  • Agenus Inc. is planning to seek FDA approval and has initiated a phase 3 clinical trial, potentially offering new hope for colorectal cancer patients who face limited treatment options.

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

NCT03860272Active, Not RecruitingPhase 1
Agenus Inc.
Posted 3/20/2019

Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033

OncologyTargeted TherapyMonoclonal AntibodyAIPrecision MedicineDrug Approval
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.

Novartis' Ianalumab Advances in Phase 3 Trial for Lupus Nephritis as CDSCO Approves Protocol Amendment

Monoclonal Antibody
  • India's CDSCO expert committee has approved Novartis' protocol amendment for the Phase 3 SIRIUS-LN trial evaluating ianalumab in patients with active lupus nephritis.
  • Ianalumab is a novel BAFF-targeting monoclonal antibody that prevents BAFF signaling through its receptor and depletes BAFF-R-expressing B-cells through antibody-dependent cellular cytotoxicity.
  • The approval follows Novartis' presentation of protocol amendment version 03 dated December 14, 2023, potentially accelerating the development pathway for this investigational therapy for autoimmune conditions.
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